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Pharmacy practice-based research networks: Why, what, who, and how
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Pharmacy practice-based research networks: Why, what, who, and how Earlene E. Lipowski
Received February 5, 2008. Accepted for publication February 7, 2008.
Abstract
Objectives: To describe practice innovations that can lead to measurable advances in the safety and effectiveness of medication use and to recommend a course of action that is likely to lead to practicable improvements in the medication use system. Data sources: Proceedings of a national conference; review of the medical literature. Data synthesis: Only those interventions that can be reliably implemented by typical practitioners in a wide range of practice settings can produce lasting benefits for considerable numbers of patients. Teamwork between and among disciplines is needed for new insights and novel approaches to delivering pharmaceutical products and services. Building on the experience of other health disciplines, a cross section of pharmacy practitioners, researchers, educators, and leaders were able to identify the key questions, strategies, and actions needed to form collaborations for devising and testing new ideas and transferring the findings into everyday practice. Conclusion: Pharmacy practice research that leads to improvements in the medication use process is needed. Practice-based research networks provide a model for building a synergy among pharmacists and other stakeholders to devise improvements that provide sustainable and systemwide improvements in medication use. Keywords: Research, pharmacy practice, practice-based research networks. J Am Pharm Assoc. 2008;48:142–152. doi: 10.1331/JAPhA.2008.08018
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Earlene E. Lipowski, PhD, was Donald C. Brodie Academic Scholar in Residence, American Association of Colleges of Pharmacy, Alexandria, Va. at the time the conference discussed in this article was conducted; she is Associate Professor, College of Pharmacy, University of Florida, Gainesville. Correspondence: Earlene E. Lipowski, PhD, College of Pharmacy, University of Florida, PO Box 100496, Gainesville, FL 32610-0496. Fax: 352-273-6270. E-mail: [email protected] Disclosure: The author declares no conflicts of interests or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Funding: The conference (Embracing the PBRN Model to Improve Medication Use) was funded in part by 1 R13 HS016844 from the Agency for Healthcare Research and Quality. The views expressed in this publication do not necessarily reflect the official policies of the Department of Health and Human Services or imply endorsement by the U.S. Government. Acknowledgments: To Kenneth W. Miller and Lucinda Maine, American Association of Colleges of Pharmacy, for contributions and invaluable guidance; Patti Manolakis and Jann Skelton for expertise in planning and conducting the conference; Dana Hammer and Elizabeth Keim for facilitating group discussion; and student pharmacists Christy Weiland and Melanie Petilla, University of Washington, for clerical assistance. Proceedings of the conference, Embracing the PBRN Model to Improve the Medication Use Process, are available at http://aacp.org/site/page.asp?TRACKID=&VID =1&CID=1400&DID=8104.
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PBRNs: Why, what, who, and how
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racticing pharmacists and pharmacy researchers may hear about practice-based research initiatives under way in various pharmacy practice settings and may be skeptical that the same projects could be conducted in their practice or locale. Reports of innovative practice and research success in a few locations may not convince some community pharmacists that similar initiatives can be incorporated into their busy schedules. Is it any wonder, therefore, that payers and policy makers are skeptical about the general value of pharmacist immunization programs, medication therapy management services, or any other patient care initiative reported to work in a few select locations? Decision makers are bound to have serious doubts about whether the same results could be achieved among their patients, employees, beneficiaries, constituents, or fellow citizens. The efficiency and security of drug distribution systems, patient safety, and the appropriate prescribing and use of medications are widely viewed as problematic.1,2 Considerable evidence indicates that pharmacist services and programs have the potential to reduce these problems. Although many
At a Glance Synopsis: The proceedings of a national conference (Embracing the PBRN Model to Improve the Medication Use Process) and a review of the medical literature were used to determine innovations that can foster advances in the safety and efficacy of medication use and provide recommendations on the practices needed to generate practicable improvements in the medication use system. Practice-based research networks (PBRNs) provide a platform for collaboration between pharmacists and other stakeholders to facilitate sustainable, systemwide improvements in medication use. Interventions designed to improve the medication use process can be tested, refined, and evaluated in pharmacy PBRNs to achieve reliable results. Analysis: The time is right for comprehensive adoption of best practices inherent in the PBRN model. Professional associations such as the American Pharmacists Association, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, and American Society of Health-System Pharmacists have introduced research training and other support for practice-based research. Precedents in other arenas of health care provide valuable insight, and widespread adoption of modern information technology supports further expansion of practice networks. PBRNs work to blur the distinction between practice and research by effecting synergistic relationships among researchers, educators, practicing pharmacists, patients, and other key stakeholders.
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pharmacy-based programs hold promise and are efficacious for those who participate, they will remain limited in number and scope unless they can be reliably delivered at reasonable cost to large segments of the population in the majority of pharmacy settings.
Objectives The purpose of this article is to describe practice innovations that can lead to widely adopted advances in the safety and effectiveness of medication use and to recommend a course of action that is likely to lead to practicable improvements in the medication use system.
Background Variation in patients and their problems and among organizations and their resources requires that health care services be adapted to each locale. Quality improvement remains an important activity for improving practice delivery and maintaining quality in every health care setting. However, to achieve the greatest gains for the greatest number of locations, essential features of effective solutions need to be identified and disseminated to others seeking solutions to similar problems. Increasing the speed and breadth of advances in health care delivery would be possible if promising solutions to common problems could be transmitted to multiple locations simultaneously and successful adaptations and continuous improvements documented adequately.3,4 If innovations are tested in multiple locations simultaneously and the successful adaptations and improvements documented, then this constitutes research in practice. Multisite implementation can transform a quality improvement project from a narrowly defined activity in an individual delivery site to a systematic study of processes with a comparison of outcomes across sites. The rationale for conducting research in practice would be to find the commonalities across practices, both in the nature of the problems that are faced and in the interventions that address them. Genuine practice improvements that are conceived by colleagues and prove their worth in real work settings spread contagiously throughout the profession. The introduction of color-coded prescription bins, the adoption of unit dose systems, and the creation of drug interaction software are examples of ideas and tools that improved efficiency, effectiveness, and safety and led to widespread and permanent changes in pharmacy practice. A new drug with demonstrated efficacy in tightly controlled clinical trial settings may not prove safe and effective for use in general practice. Likewise, interventions that change the organization and delivery of health care in a single pharmacy, a health care organization, or a health maintenance organization may not be broadly applicable. Research results that can be transformed into improvements in general practice and practical clinical trials require evidence based on studies (1) about representative patients; (2) that use suitable research designs w w w. p h a r m a c i s t . c o m
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to compare alternative solutions, not placebos or usual care; (3) include a broad sample made up of typical providers; and (4) are carried out in multiple settings that are characteristic of the settings expected to adopt these practices.5,6 Practice-based research networks (PBRNs) have been adopted by most health care disciplines to produce evidence that is useful for widespread adoption. Some PBRNs are recognized by the National Institutes of Health (NIH), funded by the Agency for Healthcare Research and Quality (AHRQ), participants in the Prescription for Health initiative sponsored by the Robert Wood Johnson Foundation, or members of Breakthrough Series Collaboratives organized by the Institute for Healthcare Improvement.3 AHRQ sponsors a resource center for the support of PBRNs engaged in multidisciplinary studies (http://pbrn. ahrq.gov/portal/server.pt), and the American Academy of Family Physicians (AAFP) is home to the National Research Network and serves as the secretariat for the Federation of Practice Based Research Network (www.aafp.org/online/en/home/ clinical/research/natnet.html). Within the past 5 years, both AHRQ and Federation of Practice-Based Research Networks have held annual conferences for those associated with PBRNs. Anticipating an emerging interest and potential for practice-based research in pharmacy, the American Association of Colleges of Pharmacy (AACP) identified the need to bolster support for faculty and preceptors for conducting and supervising practice-based research, develop the relevant knowledge and skills in practice research among graduate students, and prepare future practitioners for participation. In 2006, AACP began preparations for a national conference at which PBRNs would be discussed among faculty, practitioners, representatives of professional associations in pharmacy, and interested parties from the Federation of Associations of Schools of the Health Professions.
PBRN conference The conference, Embracing the PBRN Model to Improve the Medication Use Process, was held February 22–24, 2007 in Charlotte, N.C., with financial support provided in part by a grant from AHRQ. The premise underpinning the conference was that PBRNs provide an attractive opportunity for supplying the evidence needed to improve the medication use process. A total of 80 individuals attended the conference, including participants, speakers, facilitators, and AACP staff. Among those present were academic–practitioner pairs who submitted applications in response to an announcement about the meeting along with representatives from community, health system, and managed care pharmacy sectors. (See Table 1 for a list of institutions and organizations represented at the conference.) The participants prepared for the conference with assigned readings from the literature on PBRNs and by taking part in an Internet survey that supplied input to the program implementation team. Speakers with experience in practice-based 144 • JAPhA • 4 8 : 2 • M a r /A p r 2 0 0 8
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Table 1. Institutions and organizations represented at the conference on Embracing the PBRN Model to Improve the Medication Use Process Academy of Managed Care Pharmacy/AMCP Foundation American College of Clinical Pharmacy/ACCP Research Institute Agency for Health Care Research and Quality PBRN Resource Center American Association of Colleges of Pharmacy American Society of Health-System Pharmacists/ASHP Research and Education Foundation American Pharmacists Association/APhA Foundation National Association of Chain Drug Stores National Institute of Dental and Craniofacial Research, National Institutes of Health North Carolina Association of Pharmacists Baylor University College of Medicine and SPUR-Net Midwestern University College of Pharmacy–Chicago Midwestern University College of Pharmacy–Glendale Oregon State University College of Pharmacy South University School of Pharmacy Texas Tech University School of Pharmacy University at Buffalo School of Pharmacy and Pharmaceutical Sciences University of Arizona College of Pharmacy University of Colorado at Denver School of Pharmacy University of Connecticut School of Pharmacy University of Florida College of Pharmacy University of Iowa College of Pharmacy University of Kansas School of Pharmacy University of Kentucky College of Pharmacy University of Michigan College of Pharmacy University of Minnesota College of Pharmacy University of Nebraska College of Pharmacy University of North Carolina at Chapel Hill School of Pharmacy University of Oklahoma College of Medicine and OKPRN University of Oklahoma College of Pharmacy University of Puerto Rico School of Pharmacy University of Rhode Island College of Pharmacy University of Tennessee College of Pharmacy University of Wisconsin–Madison School of Pharmacy Virginia Commonwealth University School of Pharmacy West Virginia University School of Pharmacy Western University of Health Sciences College of Pharmacy Abbreviations used: ACCP, American College of Clinical Pharmacy; AMCP, Academy of Managed Care Pharmacy; APhA, American Pharmacists Association; ASHP, American Society of Health-System Pharmacists; OKPRN, Oklahoma Physicians Resource/Research Network; PBRN, practice-based research network; SPUR-Net, Southern Primary-care Urban Research Network.
research and research networks addressed the assembly at the start of the conference and answered questions from the listeners. Attendees then divided into four work groups and engaged in a series of structured discussions led by trained facilitators. Journal of the American Pharmacists Association
PBRNs: Why, what, who, and how
The facilitators used group exercises and techniques designed to stimulate creative thinking, identify common themes, and build consensus.
Identifying questions, responses The end product of the conference was an action plan for developing PBRNs in pharmacy settings for the purpose of investigating the medication use process. Participants identified four key questions and prepared responses during an intense 2-day discussion. The resulting action plan enumerates the key strategies for initiating PBRNs and branches in successive steps to specify goals and offer increasingly detailed recommendations for action and tactics for launching a pharmacy PBRN initiative. Each key strategy was crafted in response to one of four key questions that emerged at the close of the first round of smallgroup discussions: How do you establish relationships with key stakeholders to further PBRN development? How do you develop a rigorous and robust PBRN program that studies and improves patient care? How do you empower and educate pharmacists to participate in practice-based research? How do you engage patients in practice-based research? Reactions to and thoughts about each key question are presented here along with the reasoning behind the recommendations for the action plans (Tables 2–5). Relationships with key stakeholders
The first set of recommendations aims to identify relevant organizations and involve them in specifying the basic structure and aims of an organization that will be capable of addressing problems that decision makers believe are important (Table 2). A central tenet of the PBRN model is that they address problems in practice that are identified by practitioners and those they serve. The network exists to supply answers to questions that affect the ability of practitioners to efficiently provide highquality care. PBRNs in other disciplines have established collaborations with academic health centers, hospitals, specialty societies, insurers, quality improvement organizations, community groups, nonprofit entities, and government agencies.3 Pharmacists might find support among individual colleagues from multiple health professional disciplines; through the students, faculty, alumni, and preceptors of an academic institution; and among fellow members of a professional association. Reports from several practice-based research projects demonstrate that many sectors are interested in working together to improve medication use, including physicians,7 academic institutions and residency programs,8,9 insurers,10,11 employers,12 and individual patients.13 Collegial and interdisciplinary relationships are germane to the PBRN model. The motivation for participating in the network is fed by ideas for research that arise from and resonate Journal of the American Pharmacists Association
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with those who are expected to conduct and be the subject of inquiry. Researchers accustomed to formulating the question before soliciting input of study participants need to cultivate their listening skills. Both researchers and pharmacists must consider the perceptions of all those who will be affected and solicit their involvement. The focus of a particular network might be a geographic region or a particular population (e.g., rural, urban). Some networks are built around a single practice specialty or disease such as diabetes, while others have a common type of practice setting such as a primary care clinic or long-term care. A common purpose enhances team building and facilitates communication. Reports in this issue of the Journal of the American Pharmacists Association illustrate the range of possibilities.7–13 After identifying a cadre of people with interest in a common theme, forming a network advisory board with representatives from the practice and research communities and the populations they serve is recommended. By coming together with the intent of conducting a series of studies rather than a single project, a PBRN seeks economies of scale and the opportunity to leverage resources to support multiple studies. A long-term commitment supports the goal of sustainable improvement and encourages cooperation in combating the tendency to hunker down and wait for disruptions in old routines to pass. Although PBRNs vary widely in their organizational structures, one common characteristic they have is the presence of a network director who is responsible for the administrative, financial, and planning aspects of the network. The PBRN should begin to plan for staff support of routine organizational duties and access to technical experts for consultation.14 The network will need a description of how individual practitioners and/or institutions become members and how membership is maintained. In most cases, the network will also need a formal affiliation agreement between members and the network. Rigorous, robust PBRN program
Questions regarding how to finance studies and the network structure will be asked early and often (Table 3). There are as many answers to these questions as there are networks. AHRQ- and NIH-funded network development at one time, but neither provides that support currently. AHRQ and NIH periodically solicit proposals from PBRNs, although grant funding from these organizations is extremely competitive. Some private foundations have supported network research; some are subsidized by professional associations or their affiliated charitable foundations, such as the American Academy of Pediatrics and AAFP. Some networks have a dues structure for members. In all cases, the member organizations contribute in-kind support by providing, for example, expertise, staff time, data, and information retrieval. Some funding sources are willing to support pilot studies, which may lead to additional support for full-scale projects from other sponsors. As with most research ventures, funding needs are constant and funding comes from multiple w w w. p h a r m a c i s t . c o m
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Table 2. Conference consensus about how to establish relationships with key stakeholders to further PBRN development Driver 1: Identify stakeholders Goal
Action
Identify consumer interests Identify resources
Conduct brown-bag sessions Meet with civic organizations Meet with advocacy groups Meet with public health groups Meet with government agencies Research funding agencies Discuss with deans, department chairs Meet with government officials Forge partnerships (interdisciplinary, individuals)
Conduct brown-bag sessions Partner with civic organizations
Tie in with existing brown-bag sessions Deliver well-created messages relevant to their needs Get an invitation to speak Deliver well-crafted message Retain high-profile speaker
Partner with advocacy groups Research public health/government sources
Get an invitation to speak Deliver well-crafted message Hire high-profile speaker Know their agenda Understand which agency to contact
Approach pharmacy organizations and foundations Engage preceptors
Conduct presentations at meetings Meet with leaders Communicate via e-mail, Web site, regular mail Communicate via e-mail Support peer recruitment
Engage alumni
Communicate via e-mail Support peer recruitment Publish in newsletter
Driver 2: Define the concept of the PBRN Goal
Action
Design an organizational structure Describe the purpose, goals, and scope
Appoint an advisory board Develop governance and procedures Determine staffing and management Access legal consultations Define endpoints Identify performance measures Determine frequency of measurement
Cast a wide net to identify interest among prospective researchers/practitioners
Develop a service description
Conduct a literature evaluation Gather opinions Solicit feedback
sources.14–16 The process of setting an agenda and building the requisite infrastructure is tailored in support of individual projects and defined programs of research. Existing PBRNs stress that 146 • JAPhA • 4 8 : 2 • M a r /A p r 2 0 0 8
Approach pharmacy organizations Approach pharmacy preceptors Approach school alumni
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successful networks have mission statements to give the organizations direction and a common sense of purpose. Seasoned network members warn newcomers that straying from the core focus is rarely a profitable use of time and money.14 Journal of the American Pharmacists Association
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Table 3. Conference consensus on how to develop a rigorous and robust research program that studies and improves patient care Driver 1: Identify funding sources Goal
Action
Identify seed funding for development Identify funding for ongoing infrastructure support Identify funding for pilot studies Identify funding for large-scale studies
Leverage institutional resources Rely on donors/membership fees Inquire about local foundation or organizations Apply to AHRQ, HRSA Leverage institutional resources Draw on donors/membership fees Approach local foundations/organizations Apply to AHRQ, HRSA Initiate large-scale studies (NIH) Leverage institutional resources Apply to NIH/AHRQ for R03 awards Seek support from PhRMA companies Ask foundations Seek state funds (tobacco) Approach professional organizations Seek program pilot funding (NIH) Affiliate with an NIH CTSA Apply to NIH/AHRQ for R01 awards Seek a Center grant Ask Foundations Research CDC, CMS, HRSA project grants
Perform needs assessment and gap analysis Assess feasibility Consider agency funding priorities
Perform literature review Identify and consult thought leaders Survey patients and providers Mine secondary data Assess unique population characteristics Consider duration of study/create timelines Gauge provider and researcher availability Plan and budget resources Conduct grant search (NIH, foundations, national, state, and local organizations) Make personal contact with key funders Seek collaborations/consulting with colleagues
Driver 2: Determine topic focus Goal
Driver 3: Develop PBRN structure Goal
Identify leaders Identify stakeholders and partners Create vision statement, mission, and bylaws Secure resources Establish communication procedures
Action
Action
Find existing experts Collaborate with national organizations Identify a home for PBRN activities Network with other health care professionals Collaborate with other networks Recruit pharmacy practitioners Collaborate with state/national organizations Develop relationship with relevant institutional review board Conduct a retreat for leaders and stakeholders Develop a catchy acronym Create a marketing plan Define scope of PBRN Locate space, technology, personnel Seek out funding groups Establish access to an information technology group Assess communication resources of network participants Determine data flow Communicate responsibilities/expectations Ensure secure communication and storage of data
Abbreviations used: AHRQ, Agency for Healthcare Research and Quality; CDC, Centers for Disease Control and Prevention; CMS, Centers for Medicare & Medicaid Services; CTSA, Clinical and Translational Science Award; HRSA, Health Resources and Services Administration; NIH, National Institutes of Health; PBRN, practice-based research network; PhRMA, Pharmaceutical Research and Manufacturers of America.
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Policies and procedures evolve as projects unfold and the enterprise grows. At the outset, the network needs policies for the protection of human participants, standards for data transfer and security, procedures to ensure the integrity of the research, and programs for member training and support. Other characteristics common to successful PBRNs include provision for regular communications with members using channels they prefer, compensation and incentives for project participation, and ongoing monitoring to ensure efficient project operations and prompt dissemination of results.14 Research in practice allows services and topics that are ignored in medical and health service journals to be addressed. Practice-based research requires both an appreciation and tolerance of the inherent complexity of mainstream health care practice. This type of research relies on both clinical and social sciences and is dedicated to transferring findings to practices and policies that lead to positives changes in real-world health care delivery.
Empowering and educating pharmacists
At least one group involved in the formation of a pharmacybased PBRN investigated and categorized the reasons that practitioners are reluctant to get involved (Table 4). The group identified four sources of skepticism: mindset, communication, infrastructure, and skills/knowledge.17 The first step must be to adjust the mindset of practitioners by addressing their questions (e.g., Why does it matter? Why should I care? How can I help?) Practitioners tend to be more motivated to work on questions that are important to them and that they generated. The mission and statement of goals will eliminate some ideas from consideration without the need to consult the membership. A project should not be pursued without the endorsement of the network members or their representatives in the form of an advisory board. Networks may anticipate that not every practice will participate in every study, but that participation must be sought. Further motivation is stimulated by incorporating pharmacists and practices into the design and implementation of the research plan.
Table 4. Conference consensus on how to empower and educate pharmacists to participate Driver 1: Develop a resource center for PBRN Goal
Action
Develop an Internet-based tool kit
Include protocols Solicit and post documentation tools Develop and distribute data collection tools Provide a source of drug information
Provide access to clinical guidelines Research potential funding avenues
Provide listings of potential funding sources Send funding leads via blast e-mails
Develop policies and procedures for PBRNs
Post job description templates Develop and post model agreements for authorship Develop and post model agreements for financial agreements Research responses to institutional review board issues
Driver 2: Develop tools to facilitate networking Goal
Action
Develop a listserv
Host an annual conference Develop a monitoring system
Implement a mini-sabbatical
Institute a visiting practitioner/scientist program
Driver 3: Identify and disseminate practitioners’ best practice models Goal Action Publish examples of best practices
Work with the American Journal of Pharmaceutical Education to include a section partner with JAPhA’s pharmacy media
Develop a list of experts as a resource
Driver 4: Develop education and training Goal
Action
Develop human participant training Develop training on disease management/clinical skills Develop training on research methods Develop training on grant writing Involve students in training programs Develop advocacy information to support funding requests 148 • JAPhA • 4 8 : 2 • M a r /A p r 2 0 0 8
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Communication in the form of consultation, guidance, and result sharing is critical. Informally, network directors report that practitioners are apt to feel exploited if they are subjected to inquiry. Networks frequently host annual conferences to share best practices and strengthen network bonds. Most networks find that visits to practices and provision of direct assistance with network projects are critical to success.14 One of the primary purposes of the network model is to supply the resources required to undertake a project. The network infrastructure must exist, and the particular needs of the investigation and the practices that participate must be met. In some cases, this process has meant supplying additional labor to the site during the study18 and providing on-site training rather than expecting practitioners to take time away from their workplaces. Distance education tools are helpful, and most PBRNs rely on the Internet for communication, linking members to useful resources and providing access to research materials and support.14 Pharmacists also are reluctant to get involved in practice research because of a lack of experience. The network is designed to address this concern. Projects build skills and knowledge over time. A few participants will be interested in acquiring the expertise of a researcher from the outset, but most networks should aspire to develop a cadre of proficient and reliable collaborators. The greatest and most important gains may not be in the research products themselves but in building knowledge and capacity for lifelong learning within the actual practice. Participation in network studies increases the likelihood of results being relevant, acceptable, and useful to practice. Networks operate with a balance of “top-down” and “bottomup” leadership to meet the needs of both research and practice. The top-down approach relies on researchers developing studies, securing funding, and directing projects, while the bottomup style places more responsibility on clinician members. The two approaches involve tradeoffs between sustaining the interest and transforming the practice culture against the desire for efficiency and speed demanded by research stakeholders.19 In most cases, the role of the researcher will be to help the group refine the question and verify that it is in the form of a research question. Network members will not fully appreciate the nature of systematic inquiry, which distinguishes a project as research rather than quality improvement or organizational change, until they experience the entire cycle. Like the proverbial flywheel, the first few turns require the most energy, but as momentum builds, the flywheel revolves faster and smoother with less effort expended to push the wheel. Engaging patients in practice-based research?
A properly functioning medication use system ultimately produces benefits for patients but relies on many inputs to produce that outcome (Table 5). The scope of practice-based research needed to improve the system is broad. It ranges Journal of the American Pharmacists Association
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from studying the work force and the organization of delivery systems to examining the relationships among practitioners, patients, their families, and the community. Important insights may be obtained without direct patient involvement, including monitoring trends in pharmacist consultations regarding selfcare, structuring the workplace and workflow to meet customer needs, and addressing the continuity and coordination of care services through referral systems and the interaction among practitioners. For some investigations, the outcome of interest may be financial rather than clinical or humanistic. Although some studies may not require direct patient involvement, at some point, a PBRN is likely to seek the input of patients to measure satisfaction or clinical endpoints. Pharmacists are routinely reminded of the importance of individual interactions as the way to achieve optimal patient outcomes. Practice-based research can both contribute to, and benefit from, existing patient relationships. The potential for direct benefits to patient care is augmented by appreciation of the value of improvement efforts while paying dividends in the form of the trust needed to involve patients in the process of investigation. PBRN members who posted their membership certificates find that patients are impressed by the involvement in studies to improve care. Participating practices contribute when they make it easy and fun for patients to participate and provide reassurance that risks are minimized through the responsible conduct of the inquiry. Dealing with the protection of human participants in research trials is probably the most important service a network can provide to its members. Meeting the ethical, moral, and legal requirements of research is an arduous process involving the oversight of institutional review boards (IRBs) and Health Insurance Portability and Accountability Act (HIPAA) compliance officers.20 Balancing human rights against the need for research is an ongoing struggle and best handled by persons with special expertise in this area. However, in an informationrich and fast-paced world, practice-based research or something closely related must come to be accepted by both pharmacists and their patients as a routine part of practice.
Discussion The development of an effective intervention for a single patient or for patients within a given practice is just the first step toward improving medication use.21 The quality of care for most patients will not change without a conscious effort. This means testing interventions, refining them, and disseminating the findings with adaptations to accommodate the variability in patients and in practices. The Institute of Medicine is on record as calling PBRNs “the most promising infrastructure development that [the committee] could find to support better science in primary care.”22 PBRNs serve as a means for removing lingering doubts about whether pharmacists are qualified to fulfill primary care provider roles, and the series of projects conducted by the American Pharmacists Association (APhA) Foundation w w w. p h a r m a c i s t . c o m
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Table 5. Conference consensus on how to engage patients in practice-based research Driver 1: Build relationships with patients Goal Action
Tactic
Develop and reinforce one-on-one patient–pharmacist relationships
Create stability
Nurture the relationship of patient with practice site
Build trust
Demonstrate consistent and high-quality care Have standardized training and expectations for pharmacists Demonstrate respect and reliability (e.g., know names) Be responsive
Foster communications
Communicate frequently and routinely Demonstrate empathy Provide a conducive environment
Create public awareness of the value of the profession
Develop a consistent message
Advertise
Engage in marketing to communicate the message
Influence one person at a time through personal selling Conduct public relations activities (e.g., health fairs) Use direct marketing (e.g., mail, bag stuffers) Have crisis management plan for negative media coverage
Driver 2: Remove barriers to participation in research Goal
Action
Tactic
Facilitate patient enrollment
Use technology to simplify the process
Facilitate scheduling
Train/educate staff
Develop and implement procedures
Facilitate patient eligibility/selection Explain purpose/benefits of research Develop inclusion criteria Explain global knowledge of research project structure
Involve stakeholders
Identify potential patients Advertise the study Enroll on site of employer
Integrate research into the pharmacy experience
Involve practice site in research design
Ensure practice drives research instead of research driving practice
Use technology
Educate patients/staff on use of technology Make technology part of normal practice
Reinforce and ensure safety and minimize risk
Inform patients of institutional review board oversight Inform patients of emergency plans/ monitoring Educate patients about possible risks
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come closest to demonstrating the potential impact of results that can be replicated, or scaled up, in multiple locations.12 Irrespective of pharmacist involvement, the medication use system is in dire need of practical clinical trials in which the hypothesis and study design are tailored to provide information that is relevant and valuable to both clinicians and decision makers.5 Each health care profession stands to advance its role in the medication use process by contributing new knowledge that is credible and of interest beyond its members. Even if pharmacy practice does not formally organize for the purpose of practice-based research, success in the health care enterprise will require that all participants share common characteristics, resources, and pursuits.3 That is, health care providers need a shared mission and values, an orientation to activities that produce consistent and high-quality care, and a commitment to collaboration for the purpose of collective inquiry.4 Beyond the benefits to society and the profession as a whole, PBRNs offer substantial benefits to individual practitioners. Practice-based research involves the systematic collection and interpretation of facts—a process that is core to individual professional development. Engaging in the activity enhances professional judgment, which leads to more effective intervention for patients in a self-renewing cycle. Other calls for practice-based research in pharmacy have occurred.23,24 Pharmacy practice research networks in Europe and Australia have achieved notable accomplishments.19,25 Many examples of worthy practice research projects exist in the United States, many of which exhibit characteristics associated with PBRNs.7–13 Perhaps this is the time for comprehensive adoption of best practices inherent in the PBRN model. The possibilities for important contributions are acknowledged by a cross section of practitioners and other stakeholders, and research training and other support for practice research is being introduced by several professional associations, including AACP, the American College of Clinical Pharmacy, American Society of HealthSystem Pharmacists, and APhA.26 Precedents in other health professions serve as exemplars, and widespread adoption of modern information technology supports further expansion of practice networks. The time is right to adopt the PBRN model and blur the distinction between practice and research by bringing practice into research and translating research into practice.
Limitations The action plan generated as an outcome of the conference was not circulated for endorsement and remains generally untested. However, the recommendations were formulated by a representative cross section of stakeholders under the expert guidance of trained facilitators and informed by experiences of existing PBRNs. Surveys conducted 1 and 6 months after the conference and anecdotal evidence revealed that several practice-based research initiatives are under way. The activities of conference participants included seeking administrative Journal of the American Pharmacists Association
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endorsement for an initiative, recruiting members and collaborators, framing an organizational structure, and assembling resources. Some have introduced practice-based research into their educational programs for students and practitioners or joined an existing PBRN. Complementary activities conducted by several professional associations in support of pharmacy practice-based research range from networking sessions, educational sessions, roundtable discussions, and poster sessions and teleconferences. As acknowledged at the outset, individuals and organizations that elect to join and participate in a PBRN may be fundamentally different from those who do not choose to engage in PBRN activities. However, networks increase the likelihood that variability in practice will be captured.
Conclusion Practice-based research has the potential to “(1) identify the problems that arise in daily practice that create the gap between recommended care and actual care; (2) demonstrate whether treatments with proven efficacy are truly effective and sustainable when provided in the real-world settings; and (3) provide a means for testing system improvements that can maximize the number of patients who benefit.”22 Interventions intended to improve the medication use process can be tested, refined, and evaluated in networks of pharmacists and pharmacies to achieve reliable results. Successful networks are likely to involve collaborations between practitioners and educators and between pharmacists and researchers representing a variety of organizations; collectively, these individuals have the appropriate combination of knowledge and skills to carry out the work. An action plan representing the input and efforts of the spectrum of stakeholders is proposed for the purpose of launching a PBRN initiative in pharmacy setting infrastructure. References
1. Shrank WH, Asch SM, Adams J, et al. The quality of pharmacologic care for adults in the United States. Med Care. 2006;44:936–45. 2. Institute of Medicine. Preventing medication errors: quality chasm series. Washington, D.C.: National Academies Press, 2007. 3. Phillip RL, Mold J, Peterson K. Practice-based research networks. In: The learning healthcare system: workshop summary. Washington, DC: National Academies Press; 2007:198–203. 4. Mold JW, Peterson KA. Primary care practice-based research networks: working at the interface between research and quality improvement. Ann Fam Med. 2005;May-Jun(3 suppl 1):S12–20. 5. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–32. 6. Glasgow RE, Davidson KW, Dobkin PL, et al. Practical behavioral trials to advance evidence-based behavioral medicine. Ann Behav Med. 2006;31:5–13. 7. Kuo GM, Steinbauer JR, Spann SJ. Conducting medication safety research projects in a primary care physician practicebased research network. J Am Pharm Assoc. 2008;48:163-70.
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8. Goode JR, Mott DA, Chater R. Collaborations to facilitate success of community pharmacy practice-based research networks. J Am Pharm Assoc. 2008;48:153–62. 9. Pruchnicki MC, Rodis JL, Beatty SJ, et al. Practice-based research network as a research training model for community/ambulatory pharmacy residents. J Am Pharm Assoc. 2008;48:191–202. 10. Lewis NJW, Bugdalski-Stutrud C, Abate MA, et al. The Medication Assessment Program: comprehensive medication assessments for persons taking multiple medications for chronic diseases. J Am Pharm Assoc. 2008;48:171–80. 11. Isetts BJ, Schondelmeyer SW, Artz MB, et al. Clinical and economic outcomes of medication therapy management services: the Minnesota experience. J Am Pharm Assoc. 2008;48:203–11. 12. Fera T, Bluml BM, Ellis WM, et al. The Diabetes Ten City Challenge: interim clinical and humanistic outcomes of a multisite community pharmacy diabetes care program. J Am Pharm Assoc. 2008;48:181–90. 13. Gardner JS, Miller L, Downing DF, et al. Pharmacist prescribing of hormonal contraceptives: results of the Direct Access study. J Am Pharm Assoc. 2008;48:212–21. 14. Green LA, White LL, Barry HC, et al. Infrastructure requirements for practice-based research networks. Ann Fam Med. 2005;3(suppl 1):S5–11. 15. Lindbloom EJ, Ewigman BG, Hickner JM. Practice-based research networks: the laboratories of primary care research. Med Care. 2004;42:III45–49. 16. Green LA, Hickner J. A short history of primary care practicebased research networks: from concept to essential research laboratories. J Am Board Fam Med. 2006;19:1–10.
17. Armour C, Brillan M, Krass I. Pharmacists’ views on involvement in pharmacy practice research: strategies for facilitating participation. Pharm Pract. 2007;5(2):59–66. 18. Nagykaldi Z, Mold JW, Aspy CB. Practice facilitators: a review of the literature. Fam Med. 2005;37:581–8. 19. Thomas P, Griffiths F, Kai J, O’Dwyer A. Networks for research in primary care. BMJ. 2001;322:588–90. 20. Ontario Institute for Studies in Education/University of Toronto Ethics Review Committee. Terms of reference. Appendix 1: principles to distinguish between research and field-based professional inquiry. Accessed at www.oise.utoronto.ca/ research/Termsofreference.pdf, January 16, 2008. 21. Westfall JM, Mold J, Fagan L. Practice-based research: “Blue Highways” on the NIH roadmap. JAMA. 2007;297:403–6. 22. Institute of Medicine. Primary care: America’s health in a new era. Washington, D.C.: National Academy Press; 1996. 23. Center for Pharmacy Practice Research. Improving health care through pharmacy practice research. Monograph 1: issues and strategies for pharmacy practice research. Pomona, Calif.: Western University of the Health Sciences; 1999. 24. Knapp KK. Adding a research component to clinical practice. Annual Meeting of American College of Clinical Pharmacy, San Francisco, October 23–26, 2005. Accessed at www.medscape. com/viewprogram/4751, December 12, 2005. 25. Seston E, Hassell K, Cantrill J, et al. Experiences of establishing and maintaining a community pharmacy research network. Prim Health Care Res Dev. 2003;4:245–55. 26. American Pharmacists Association. Conducting a practicebased project: a guide for community pharmacy residents & preceptors. Washington, DC: American Pharmacists Association, 2006.
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Journal of the American Pharmacists Association
Pharmacy practice-based research networks: Why, what, who, and how Earlene E. Lipowski
Received February 5, 2008. Accepted for publication February 7, 2008.
Abstract
Objectives: To describe practice innovations that can lead to measurable advances in the safety and effectiveness of medication use and to recommend a course of action that is likely to lead to practicable improvements in the medication use system. Data sources: Proceedings of a national conference; review of the medical literature. Data synthesis: Only those interventions that can be reliably implemented by typical practitioners in a wide range of practice settings can produce lasting benefits for considerable numbers of patients. Teamwork between and among disciplines is needed for new insights and novel approaches to delivering pharmaceutical products and services. Building on the experience of other health disciplines, a cross section of pharmacy practitioners, researchers, educators, and leaders were able to identify the key questions, strategies, and actions needed to form collaborations for devising and testing new ideas and transferring the findings into everyday practice. Conclusion: Pharmacy practice research that leads to improvements in the medication use process is needed. Practice-based research networks provide a model for building a synergy among pharmacists and other stakeholders to devise improvements that provide sustainable and systemwide improvements in medication use. Keywords: Research, pharmacy practice, practice-based research networks. J Am Pharm Assoc. 2008;48:142–152. doi: 10.1331/JAPhA.2008.08018
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Earlene E. Lipowski, PhD, was Donald C. Brodie Academic Scholar in Residence, American Association of Colleges of Pharmacy, Alexandria, Va. at the time the conference discussed in this article was conducted; she is Associate Professor, College of Pharmacy, University of Florida, Gainesville. Correspondence: Earlene E. Lipowski, PhD, College of Pharmacy, University of Florida, PO Box 100496, Gainesville, FL 32610-0496. Fax: 352-273-6270. E-mail: [email protected] Disclosure: The author declares no conflicts of interests or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Funding: The conference (Embracing the PBRN Model to Improve Medication Use) was funded in part by 1 R13 HS016844 from the Agency for Healthcare Research and Quality. The views expressed in this publication do not necessarily reflect the official policies of the Department of Health and Human Services or imply endorsement by the U.S. Government. Acknowledgments: To Kenneth W. Miller and Lucinda Maine, American Association of Colleges of Pharmacy, for contributions and invaluable guidance; Patti Manolakis and Jann Skelton for expertise in planning and conducting the conference; Dana Hammer and Elizabeth Keim for facilitating group discussion; and student pharmacists Christy Weiland and Melanie Petilla, University of Washington, for clerical assistance. Proceedings of the conference, Embracing the PBRN Model to Improve the Medication Use Process, are available at http://aacp.org/site/page.asp?TRACKID=&VID =1&CID=1400&DID=8104.
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P
racticing pharmacists and pharmacy researchers may hear about practice-based research initiatives under way in various pharmacy practice settings and may be skeptical that the same projects could be conducted in their practice or locale. Reports of innovative practice and research success in a few locations may not convince some community pharmacists that similar initiatives can be incorporated into their busy schedules. Is it any wonder, therefore, that payers and policy makers are skeptical about the general value of pharmacist immunization programs, medication therapy management services, or any other patient care initiative reported to work in a few select locations? Decision makers are bound to have serious doubts about whether the same results could be achieved among their patients, employees, beneficiaries, constituents, or fellow citizens. The efficiency and security of drug distribution systems, patient safety, and the appropriate prescribing and use of medications are widely viewed as problematic.1,2 Considerable evidence indicates that pharmacist services and programs have the potential to reduce these problems. Although many
At a Glance Synopsis: The proceedings of a national conference (Embracing the PBRN Model to Improve the Medication Use Process) and a review of the medical literature were used to determine innovations that can foster advances in the safety and efficacy of medication use and provide recommendations on the practices needed to generate practicable improvements in the medication use system. Practice-based research networks (PBRNs) provide a platform for collaboration between pharmacists and other stakeholders to facilitate sustainable, systemwide improvements in medication use. Interventions designed to improve the medication use process can be tested, refined, and evaluated in pharmacy PBRNs to achieve reliable results. Analysis: The time is right for comprehensive adoption of best practices inherent in the PBRN model. Professional associations such as the American Pharmacists Association, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, and American Society of Health-System Pharmacists have introduced research training and other support for practice-based research. Precedents in other arenas of health care provide valuable insight, and widespread adoption of modern information technology supports further expansion of practice networks. PBRNs work to blur the distinction between practice and research by effecting synergistic relationships among researchers, educators, practicing pharmacists, patients, and other key stakeholders.
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pharmacy-based programs hold promise and are efficacious for those who participate, they will remain limited in number and scope unless they can be reliably delivered at reasonable cost to large segments of the population in the majority of pharmacy settings.
Objectives The purpose of this article is to describe practice innovations that can lead to widely adopted advances in the safety and effectiveness of medication use and to recommend a course of action that is likely to lead to practicable improvements in the medication use system.
Background Variation in patients and their problems and among organizations and their resources requires that health care services be adapted to each locale. Quality improvement remains an important activity for improving practice delivery and maintaining quality in every health care setting. However, to achieve the greatest gains for the greatest number of locations, essential features of effective solutions need to be identified and disseminated to others seeking solutions to similar problems. Increasing the speed and breadth of advances in health care delivery would be possible if promising solutions to common problems could be transmitted to multiple locations simultaneously and successful adaptations and continuous improvements documented adequately.3,4 If innovations are tested in multiple locations simultaneously and the successful adaptations and improvements documented, then this constitutes research in practice. Multisite implementation can transform a quality improvement project from a narrowly defined activity in an individual delivery site to a systematic study of processes with a comparison of outcomes across sites. The rationale for conducting research in practice would be to find the commonalities across practices, both in the nature of the problems that are faced and in the interventions that address them. Genuine practice improvements that are conceived by colleagues and prove their worth in real work settings spread contagiously throughout the profession. The introduction of color-coded prescription bins, the adoption of unit dose systems, and the creation of drug interaction software are examples of ideas and tools that improved efficiency, effectiveness, and safety and led to widespread and permanent changes in pharmacy practice. A new drug with demonstrated efficacy in tightly controlled clinical trial settings may not prove safe and effective for use in general practice. Likewise, interventions that change the organization and delivery of health care in a single pharmacy, a health care organization, or a health maintenance organization may not be broadly applicable. Research results that can be transformed into improvements in general practice and practical clinical trials require evidence based on studies (1) about representative patients; (2) that use suitable research designs w w w. p h a r m a c i s t . c o m
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to compare alternative solutions, not placebos or usual care; (3) include a broad sample made up of typical providers; and (4) are carried out in multiple settings that are characteristic of the settings expected to adopt these practices.5,6 Practice-based research networks (PBRNs) have been adopted by most health care disciplines to produce evidence that is useful for widespread adoption. Some PBRNs are recognized by the National Institutes of Health (NIH), funded by the Agency for Healthcare Research and Quality (AHRQ), participants in the Prescription for Health initiative sponsored by the Robert Wood Johnson Foundation, or members of Breakthrough Series Collaboratives organized by the Institute for Healthcare Improvement.3 AHRQ sponsors a resource center for the support of PBRNs engaged in multidisciplinary studies (http://pbrn. ahrq.gov/portal/server.pt), and the American Academy of Family Physicians (AAFP) is home to the National Research Network and serves as the secretariat for the Federation of Practice Based Research Network (www.aafp.org/online/en/home/ clinical/research/natnet.html). Within the past 5 years, both AHRQ and Federation of Practice-Based Research Networks have held annual conferences for those associated with PBRNs. Anticipating an emerging interest and potential for practice-based research in pharmacy, the American Association of Colleges of Pharmacy (AACP) identified the need to bolster support for faculty and preceptors for conducting and supervising practice-based research, develop the relevant knowledge and skills in practice research among graduate students, and prepare future practitioners for participation. In 2006, AACP began preparations for a national conference at which PBRNs would be discussed among faculty, practitioners, representatives of professional associations in pharmacy, and interested parties from the Federation of Associations of Schools of the Health Professions.
PBRN conference The conference, Embracing the PBRN Model to Improve the Medication Use Process, was held February 22–24, 2007 in Charlotte, N.C., with financial support provided in part by a grant from AHRQ. The premise underpinning the conference was that PBRNs provide an attractive opportunity for supplying the evidence needed to improve the medication use process. A total of 80 individuals attended the conference, including participants, speakers, facilitators, and AACP staff. Among those present were academic–practitioner pairs who submitted applications in response to an announcement about the meeting along with representatives from community, health system, and managed care pharmacy sectors. (See Table 1 for a list of institutions and organizations represented at the conference.) The participants prepared for the conference with assigned readings from the literature on PBRNs and by taking part in an Internet survey that supplied input to the program implementation team. Speakers with experience in practice-based 144 • JAPhA • 4 8 : 2 • M a r /A p r 2 0 0 8
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Table 1. Institutions and organizations represented at the conference on Embracing the PBRN Model to Improve the Medication Use Process Academy of Managed Care Pharmacy/AMCP Foundation American College of Clinical Pharmacy/ACCP Research Institute Agency for Health Care Research and Quality PBRN Resource Center American Association of Colleges of Pharmacy American Society of Health-System Pharmacists/ASHP Research and Education Foundation American Pharmacists Association/APhA Foundation National Association of Chain Drug Stores National Institute of Dental and Craniofacial Research, National Institutes of Health North Carolina Association of Pharmacists Baylor University College of Medicine and SPUR-Net Midwestern University College of Pharmacy–Chicago Midwestern University College of Pharmacy–Glendale Oregon State University College of Pharmacy South University School of Pharmacy Texas Tech University School of Pharmacy University at Buffalo School of Pharmacy and Pharmaceutical Sciences University of Arizona College of Pharmacy University of Colorado at Denver School of Pharmacy University of Connecticut School of Pharmacy University of Florida College of Pharmacy University of Iowa College of Pharmacy University of Kansas School of Pharmacy University of Kentucky College of Pharmacy University of Michigan College of Pharmacy University of Minnesota College of Pharmacy University of Nebraska College of Pharmacy University of North Carolina at Chapel Hill School of Pharmacy University of Oklahoma College of Medicine and OKPRN University of Oklahoma College of Pharmacy University of Puerto Rico School of Pharmacy University of Rhode Island College of Pharmacy University of Tennessee College of Pharmacy University of Wisconsin–Madison School of Pharmacy Virginia Commonwealth University School of Pharmacy West Virginia University School of Pharmacy Western University of Health Sciences College of Pharmacy Abbreviations used: ACCP, American College of Clinical Pharmacy; AMCP, Academy of Managed Care Pharmacy; APhA, American Pharmacists Association; ASHP, American Society of Health-System Pharmacists; OKPRN, Oklahoma Physicians Resource/Research Network; PBRN, practice-based research network; SPUR-Net, Southern Primary-care Urban Research Network.
research and research networks addressed the assembly at the start of the conference and answered questions from the listeners. Attendees then divided into four work groups and engaged in a series of structured discussions led by trained facilitators. Journal of the American Pharmacists Association
PBRNs: Why, what, who, and how
The facilitators used group exercises and techniques designed to stimulate creative thinking, identify common themes, and build consensus.
Identifying questions, responses The end product of the conference was an action plan for developing PBRNs in pharmacy settings for the purpose of investigating the medication use process. Participants identified four key questions and prepared responses during an intense 2-day discussion. The resulting action plan enumerates the key strategies for initiating PBRNs and branches in successive steps to specify goals and offer increasingly detailed recommendations for action and tactics for launching a pharmacy PBRN initiative. Each key strategy was crafted in response to one of four key questions that emerged at the close of the first round of smallgroup discussions: How do you establish relationships with key stakeholders to further PBRN development? How do you develop a rigorous and robust PBRN program that studies and improves patient care? How do you empower and educate pharmacists to participate in practice-based research? How do you engage patients in practice-based research? Reactions to and thoughts about each key question are presented here along with the reasoning behind the recommendations for the action plans (Tables 2–5). Relationships with key stakeholders
The first set of recommendations aims to identify relevant organizations and involve them in specifying the basic structure and aims of an organization that will be capable of addressing problems that decision makers believe are important (Table 2). A central tenet of the PBRN model is that they address problems in practice that are identified by practitioners and those they serve. The network exists to supply answers to questions that affect the ability of practitioners to efficiently provide highquality care. PBRNs in other disciplines have established collaborations with academic health centers, hospitals, specialty societies, insurers, quality improvement organizations, community groups, nonprofit entities, and government agencies.3 Pharmacists might find support among individual colleagues from multiple health professional disciplines; through the students, faculty, alumni, and preceptors of an academic institution; and among fellow members of a professional association. Reports from several practice-based research projects demonstrate that many sectors are interested in working together to improve medication use, including physicians,7 academic institutions and residency programs,8,9 insurers,10,11 employers,12 and individual patients.13 Collegial and interdisciplinary relationships are germane to the PBRN model. The motivation for participating in the network is fed by ideas for research that arise from and resonate Journal of the American Pharmacists Association
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with those who are expected to conduct and be the subject of inquiry. Researchers accustomed to formulating the question before soliciting input of study participants need to cultivate their listening skills. Both researchers and pharmacists must consider the perceptions of all those who will be affected and solicit their involvement. The focus of a particular network might be a geographic region or a particular population (e.g., rural, urban). Some networks are built around a single practice specialty or disease such as diabetes, while others have a common type of practice setting such as a primary care clinic or long-term care. A common purpose enhances team building and facilitates communication. Reports in this issue of the Journal of the American Pharmacists Association illustrate the range of possibilities.7–13 After identifying a cadre of people with interest in a common theme, forming a network advisory board with representatives from the practice and research communities and the populations they serve is recommended. By coming together with the intent of conducting a series of studies rather than a single project, a PBRN seeks economies of scale and the opportunity to leverage resources to support multiple studies. A long-term commitment supports the goal of sustainable improvement and encourages cooperation in combating the tendency to hunker down and wait for disruptions in old routines to pass. Although PBRNs vary widely in their organizational structures, one common characteristic they have is the presence of a network director who is responsible for the administrative, financial, and planning aspects of the network. The PBRN should begin to plan for staff support of routine organizational duties and access to technical experts for consultation.14 The network will need a description of how individual practitioners and/or institutions become members and how membership is maintained. In most cases, the network will also need a formal affiliation agreement between members and the network. Rigorous, robust PBRN program
Questions regarding how to finance studies and the network structure will be asked early and often (Table 3). There are as many answers to these questions as there are networks. AHRQ- and NIH-funded network development at one time, but neither provides that support currently. AHRQ and NIH periodically solicit proposals from PBRNs, although grant funding from these organizations is extremely competitive. Some private foundations have supported network research; some are subsidized by professional associations or their affiliated charitable foundations, such as the American Academy of Pediatrics and AAFP. Some networks have a dues structure for members. In all cases, the member organizations contribute in-kind support by providing, for example, expertise, staff time, data, and information retrieval. Some funding sources are willing to support pilot studies, which may lead to additional support for full-scale projects from other sponsors. As with most research ventures, funding needs are constant and funding comes from multiple w w w. p h a r m a c i s t . c o m
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Table 2. Conference consensus about how to establish relationships with key stakeholders to further PBRN development Driver 1: Identify stakeholders Goal
Action
Identify consumer interests Identify resources
Conduct brown-bag sessions Meet with civic organizations Meet with advocacy groups Meet with public health groups Meet with government agencies Research funding agencies Discuss with deans, department chairs Meet with government officials Forge partnerships (interdisciplinary, individuals)
Conduct brown-bag sessions Partner with civic organizations
Tie in with existing brown-bag sessions Deliver well-created messages relevant to their needs Get an invitation to speak Deliver well-crafted message Retain high-profile speaker
Partner with advocacy groups Research public health/government sources
Get an invitation to speak Deliver well-crafted message Hire high-profile speaker Know their agenda Understand which agency to contact
Approach pharmacy organizations and foundations Engage preceptors
Conduct presentations at meetings Meet with leaders Communicate via e-mail, Web site, regular mail Communicate via e-mail Support peer recruitment
Engage alumni
Communicate via e-mail Support peer recruitment Publish in newsletter
Driver 2: Define the concept of the PBRN Goal
Action
Design an organizational structure Describe the purpose, goals, and scope
Appoint an advisory board Develop governance and procedures Determine staffing and management Access legal consultations Define endpoints Identify performance measures Determine frequency of measurement
Cast a wide net to identify interest among prospective researchers/practitioners
Develop a service description
Conduct a literature evaluation Gather opinions Solicit feedback
sources.14–16 The process of setting an agenda and building the requisite infrastructure is tailored in support of individual projects and defined programs of research. Existing PBRNs stress that 146 • JAPhA • 4 8 : 2 • M a r /A p r 2 0 0 8
Approach pharmacy organizations Approach pharmacy preceptors Approach school alumni
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Table 3. Conference consensus on how to develop a rigorous and robust research program that studies and improves patient care Driver 1: Identify funding sources Goal
Action
Identify seed funding for development Identify funding for ongoing infrastructure support Identify funding for pilot studies Identify funding for large-scale studies
Leverage institutional resources Rely on donors/membership fees Inquire about local foundation or organizations Apply to AHRQ, HRSA Leverage institutional resources Draw on donors/membership fees Approach local foundations/organizations Apply to AHRQ, HRSA Initiate large-scale studies (NIH) Leverage institutional resources Apply to NIH/AHRQ for R03 awards Seek support from PhRMA companies Ask foundations Seek state funds (tobacco) Approach professional organizations Seek program pilot funding (NIH) Affiliate with an NIH CTSA Apply to NIH/AHRQ for R01 awards Seek a Center grant Ask Foundations Research CDC, CMS, HRSA project grants
Perform needs assessment and gap analysis Assess feasibility Consider agency funding priorities
Perform literature review Identify and consult thought leaders Survey patients and providers Mine secondary data Assess unique population characteristics Consider duration of study/create timelines Gauge provider and researcher availability Plan and budget resources Conduct grant search (NIH, foundations, national, state, and local organizations) Make personal contact with key funders Seek collaborations/consulting with colleagues
Driver 2: Determine topic focus Goal
Driver 3: Develop PBRN structure Goal
Identify leaders Identify stakeholders and partners Create vision statement, mission, and bylaws Secure resources Establish communication procedures
Action
Action
Find existing experts Collaborate with national organizations Identify a home for PBRN activities Network with other health care professionals Collaborate with other networks Recruit pharmacy practitioners Collaborate with state/national organizations Develop relationship with relevant institutional review board Conduct a retreat for leaders and stakeholders Develop a catchy acronym Create a marketing plan Define scope of PBRN Locate space, technology, personnel Seek out funding groups Establish access to an information technology group Assess communication resources of network participants Determine data flow Communicate responsibilities/expectations Ensure secure communication and storage of data
Abbreviations used: AHRQ, Agency for Healthcare Research and Quality; CDC, Centers for Disease Control and Prevention; CMS, Centers for Medicare & Medicaid Services; CTSA, Clinical and Translational Science Award; HRSA, Health Resources and Services Administration; NIH, National Institutes of Health; PBRN, practice-based research network; PhRMA, Pharmaceutical Research and Manufacturers of America.
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Policies and procedures evolve as projects unfold and the enterprise grows. At the outset, the network needs policies for the protection of human participants, standards for data transfer and security, procedures to ensure the integrity of the research, and programs for member training and support. Other characteristics common to successful PBRNs include provision for regular communications with members using channels they prefer, compensation and incentives for project participation, and ongoing monitoring to ensure efficient project operations and prompt dissemination of results.14 Research in practice allows services and topics that are ignored in medical and health service journals to be addressed. Practice-based research requires both an appreciation and tolerance of the inherent complexity of mainstream health care practice. This type of research relies on both clinical and social sciences and is dedicated to transferring findings to practices and policies that lead to positives changes in real-world health care delivery.
Empowering and educating pharmacists
At least one group involved in the formation of a pharmacybased PBRN investigated and categorized the reasons that practitioners are reluctant to get involved (Table 4). The group identified four sources of skepticism: mindset, communication, infrastructure, and skills/knowledge.17 The first step must be to adjust the mindset of practitioners by addressing their questions (e.g., Why does it matter? Why should I care? How can I help?) Practitioners tend to be more motivated to work on questions that are important to them and that they generated. The mission and statement of goals will eliminate some ideas from consideration without the need to consult the membership. A project should not be pursued without the endorsement of the network members or their representatives in the form of an advisory board. Networks may anticipate that not every practice will participate in every study, but that participation must be sought. Further motivation is stimulated by incorporating pharmacists and practices into the design and implementation of the research plan.
Table 4. Conference consensus on how to empower and educate pharmacists to participate Driver 1: Develop a resource center for PBRN Goal
Action
Develop an Internet-based tool kit
Include protocols Solicit and post documentation tools Develop and distribute data collection tools Provide a source of drug information
Provide access to clinical guidelines Research potential funding avenues
Provide listings of potential funding sources Send funding leads via blast e-mails
Develop policies and procedures for PBRNs
Post job description templates Develop and post model agreements for authorship Develop and post model agreements for financial agreements Research responses to institutional review board issues
Driver 2: Develop tools to facilitate networking Goal
Action
Develop a listserv
Host an annual conference Develop a monitoring system
Implement a mini-sabbatical
Institute a visiting practitioner/scientist program
Driver 3: Identify and disseminate practitioners’ best practice models Goal Action Publish examples of best practices
Work with the American Journal of Pharmaceutical Education to include a section partner with JAPhA’s pharmacy media
Develop a list of experts as a resource
Driver 4: Develop education and training Goal
Action
Develop human participant training Develop training on disease management/clinical skills Develop training on research methods Develop training on grant writing Involve students in training programs Develop advocacy information to support funding requests 148 • JAPhA • 4 8 : 2 • M a r /A p r 2 0 0 8
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PBRNs: Why, what, who, and how
Communication in the form of consultation, guidance, and result sharing is critical. Informally, network directors report that practitioners are apt to feel exploited if they are subjected to inquiry. Networks frequently host annual conferences to share best practices and strengthen network bonds. Most networks find that visits to practices and provision of direct assistance with network projects are critical to success.14 One of the primary purposes of the network model is to supply the resources required to undertake a project. The network infrastructure must exist, and the particular needs of the investigation and the practices that participate must be met. In some cases, this process has meant supplying additional labor to the site during the study18 and providing on-site training rather than expecting practitioners to take time away from their workplaces. Distance education tools are helpful, and most PBRNs rely on the Internet for communication, linking members to useful resources and providing access to research materials and support.14 Pharmacists also are reluctant to get involved in practice research because of a lack of experience. The network is designed to address this concern. Projects build skills and knowledge over time. A few participants will be interested in acquiring the expertise of a researcher from the outset, but most networks should aspire to develop a cadre of proficient and reliable collaborators. The greatest and most important gains may not be in the research products themselves but in building knowledge and capacity for lifelong learning within the actual practice. Participation in network studies increases the likelihood of results being relevant, acceptable, and useful to practice. Networks operate with a balance of “top-down” and “bottomup” leadership to meet the needs of both research and practice. The top-down approach relies on researchers developing studies, securing funding, and directing projects, while the bottomup style places more responsibility on clinician members. The two approaches involve tradeoffs between sustaining the interest and transforming the practice culture against the desire for efficiency and speed demanded by research stakeholders.19 In most cases, the role of the researcher will be to help the group refine the question and verify that it is in the form of a research question. Network members will not fully appreciate the nature of systematic inquiry, which distinguishes a project as research rather than quality improvement or organizational change, until they experience the entire cycle. Like the proverbial flywheel, the first few turns require the most energy, but as momentum builds, the flywheel revolves faster and smoother with less effort expended to push the wheel. Engaging patients in practice-based research?
A properly functioning medication use system ultimately produces benefits for patients but relies on many inputs to produce that outcome (Table 5). The scope of practice-based research needed to improve the system is broad. It ranges Journal of the American Pharmacists Association
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from studying the work force and the organization of delivery systems to examining the relationships among practitioners, patients, their families, and the community. Important insights may be obtained without direct patient involvement, including monitoring trends in pharmacist consultations regarding selfcare, structuring the workplace and workflow to meet customer needs, and addressing the continuity and coordination of care services through referral systems and the interaction among practitioners. For some investigations, the outcome of interest may be financial rather than clinical or humanistic. Although some studies may not require direct patient involvement, at some point, a PBRN is likely to seek the input of patients to measure satisfaction or clinical endpoints. Pharmacists are routinely reminded of the importance of individual interactions as the way to achieve optimal patient outcomes. Practice-based research can both contribute to, and benefit from, existing patient relationships. The potential for direct benefits to patient care is augmented by appreciation of the value of improvement efforts while paying dividends in the form of the trust needed to involve patients in the process of investigation. PBRN members who posted their membership certificates find that patients are impressed by the involvement in studies to improve care. Participating practices contribute when they make it easy and fun for patients to participate and provide reassurance that risks are minimized through the responsible conduct of the inquiry. Dealing with the protection of human participants in research trials is probably the most important service a network can provide to its members. Meeting the ethical, moral, and legal requirements of research is an arduous process involving the oversight of institutional review boards (IRBs) and Health Insurance Portability and Accountability Act (HIPAA) compliance officers.20 Balancing human rights against the need for research is an ongoing struggle and best handled by persons with special expertise in this area. However, in an informationrich and fast-paced world, practice-based research or something closely related must come to be accepted by both pharmacists and their patients as a routine part of practice.
Discussion The development of an effective intervention for a single patient or for patients within a given practice is just the first step toward improving medication use.21 The quality of care for most patients will not change without a conscious effort. This means testing interventions, refining them, and disseminating the findings with adaptations to accommodate the variability in patients and in practices. The Institute of Medicine is on record as calling PBRNs “the most promising infrastructure development that [the committee] could find to support better science in primary care.”22 PBRNs serve as a means for removing lingering doubts about whether pharmacists are qualified to fulfill primary care provider roles, and the series of projects conducted by the American Pharmacists Association (APhA) Foundation w w w. p h a r m a c i s t . c o m
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Table 5. Conference consensus on how to engage patients in practice-based research Driver 1: Build relationships with patients Goal Action
Tactic
Develop and reinforce one-on-one patient–pharmacist relationships
Create stability
Nurture the relationship of patient with practice site
Build trust
Demonstrate consistent and high-quality care Have standardized training and expectations for pharmacists Demonstrate respect and reliability (e.g., know names) Be responsive
Foster communications
Communicate frequently and routinely Demonstrate empathy Provide a conducive environment
Create public awareness of the value of the profession
Develop a consistent message
Advertise
Engage in marketing to communicate the message
Influence one person at a time through personal selling Conduct public relations activities (e.g., health fairs) Use direct marketing (e.g., mail, bag stuffers) Have crisis management plan for negative media coverage
Driver 2: Remove barriers to participation in research Goal
Action
Tactic
Facilitate patient enrollment
Use technology to simplify the process
Facilitate scheduling
Train/educate staff
Develop and implement procedures
Facilitate patient eligibility/selection Explain purpose/benefits of research Develop inclusion criteria Explain global knowledge of research project structure
Involve stakeholders
Identify potential patients Advertise the study Enroll on site of employer
Integrate research into the pharmacy experience
Involve practice site in research design
Ensure practice drives research instead of research driving practice
Use technology
Educate patients/staff on use of technology Make technology part of normal practice
Reinforce and ensure safety and minimize risk
Inform patients of institutional review board oversight Inform patients of emergency plans/ monitoring Educate patients about possible risks
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Journal of the American Pharmacists Association
PBRNs: Why, what, who, and how
come closest to demonstrating the potential impact of results that can be replicated, or scaled up, in multiple locations.12 Irrespective of pharmacist involvement, the medication use system is in dire need of practical clinical trials in which the hypothesis and study design are tailored to provide information that is relevant and valuable to both clinicians and decision makers.5 Each health care profession stands to advance its role in the medication use process by contributing new knowledge that is credible and of interest beyond its members. Even if pharmacy practice does not formally organize for the purpose of practice-based research, success in the health care enterprise will require that all participants share common characteristics, resources, and pursuits.3 That is, health care providers need a shared mission and values, an orientation to activities that produce consistent and high-quality care, and a commitment to collaboration for the purpose of collective inquiry.4 Beyond the benefits to society and the profession as a whole, PBRNs offer substantial benefits to individual practitioners. Practice-based research involves the systematic collection and interpretation of facts—a process that is core to individual professional development. Engaging in the activity enhances professional judgment, which leads to more effective intervention for patients in a self-renewing cycle. Other calls for practice-based research in pharmacy have occurred.23,24 Pharmacy practice research networks in Europe and Australia have achieved notable accomplishments.19,25 Many examples of worthy practice research projects exist in the United States, many of which exhibit characteristics associated with PBRNs.7–13 Perhaps this is the time for comprehensive adoption of best practices inherent in the PBRN model. The possibilities for important contributions are acknowledged by a cross section of practitioners and other stakeholders, and research training and other support for practice research is being introduced by several professional associations, including AACP, the American College of Clinical Pharmacy, American Society of HealthSystem Pharmacists, and APhA.26 Precedents in other health professions serve as exemplars, and widespread adoption of modern information technology supports further expansion of practice networks. The time is right to adopt the PBRN model and blur the distinction between practice and research by bringing practice into research and translating research into practice.
Limitations The action plan generated as an outcome of the conference was not circulated for endorsement and remains generally untested. However, the recommendations were formulated by a representative cross section of stakeholders under the expert guidance of trained facilitators and informed by experiences of existing PBRNs. Surveys conducted 1 and 6 months after the conference and anecdotal evidence revealed that several practice-based research initiatives are under way. The activities of conference participants included seeking administrative Journal of the American Pharmacists Association
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endorsement for an initiative, recruiting members and collaborators, framing an organizational structure, and assembling resources. Some have introduced practice-based research into their educational programs for students and practitioners or joined an existing PBRN. Complementary activities conducted by several professional associations in support of pharmacy practice-based research range from networking sessions, educational sessions, roundtable discussions, and poster sessions and teleconferences. As acknowledged at the outset, individuals and organizations that elect to join and participate in a PBRN may be fundamentally different from those who do not choose to engage in PBRN activities. However, networks increase the likelihood that variability in practice will be captured.
Conclusion Practice-based research has the potential to “(1) identify the problems that arise in daily practice that create the gap between recommended care and actual care; (2) demonstrate whether treatments with proven efficacy are truly effective and sustainable when provided in the real-world settings; and (3) provide a means for testing system improvements that can maximize the number of patients who benefit.”22 Interventions intended to improve the medication use process can be tested, refined, and evaluated in networks of pharmacists and pharmacies to achieve reliable results. Successful networks are likely to involve collaborations between practitioners and educators and between pharmacists and researchers representing a variety of organizations; collectively, these individuals have the appropriate combination of knowledge and skills to carry out the work. An action plan representing the input and efforts of the spectrum of stakeholders is proposed for the purpose of launching a PBRN initiative in pharmacy setting infrastructure. References
1. Shrank WH, Asch SM, Adams J, et al. The quality of pharmacologic care for adults in the United States. Med Care. 2006;44:936–45. 2. Institute of Medicine. Preventing medication errors: quality chasm series. Washington, D.C.: National Academies Press, 2007. 3. Phillip RL, Mold J, Peterson K. Practice-based research networks. In: The learning healthcare system: workshop summary. Washington, DC: National Academies Press; 2007:198–203. 4. Mold JW, Peterson KA. Primary care practice-based research networks: working at the interface between research and quality improvement. Ann Fam Med. 2005;May-Jun(3 suppl 1):S12–20. 5. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–32. 6. Glasgow RE, Davidson KW, Dobkin PL, et al. Practical behavioral trials to advance evidence-based behavioral medicine. Ann Behav Med. 2006;31:5–13. 7. Kuo GM, Steinbauer JR, Spann SJ. Conducting medication safety research projects in a primary care physician practicebased research network. J Am Pharm Assoc. 2008;48:163-70.
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8. Goode JR, Mott DA, Chater R. Collaborations to facilitate success of community pharmacy practice-based research networks. J Am Pharm Assoc. 2008;48:153–62. 9. Pruchnicki MC, Rodis JL, Beatty SJ, et al. Practice-based research network as a research training model for community/ambulatory pharmacy residents. J Am Pharm Assoc. 2008;48:191–202. 10. Lewis NJW, Bugdalski-Stutrud C, Abate MA, et al. The Medication Assessment Program: comprehensive medication assessments for persons taking multiple medications for chronic diseases. J Am Pharm Assoc. 2008;48:171–80. 11. Isetts BJ, Schondelmeyer SW, Artz MB, et al. Clinical and economic outcomes of medication therapy management services: the Minnesota experience. J Am Pharm Assoc. 2008;48:203–11. 12. Fera T, Bluml BM, Ellis WM, et al. The Diabetes Ten City Challenge: interim clinical and humanistic outcomes of a multisite community pharmacy diabetes care program. J Am Pharm Assoc. 2008;48:181–90. 13. Gardner JS, Miller L, Downing DF, et al. Pharmacist prescribing of hormonal contraceptives: results of the Direct Access study. J Am Pharm Assoc. 2008;48:212–21. 14. Green LA, White LL, Barry HC, et al. Infrastructure requirements for practice-based research networks. Ann Fam Med. 2005;3(suppl 1):S5–11. 15. Lindbloom EJ, Ewigman BG, Hickner JM. Practice-based research networks: the laboratories of primary care research. Med Care. 2004;42:III45–49. 16. Green LA, Hickner J. A short history of primary care practicebased research networks: from concept to essential research laboratories. J Am Board Fam Med. 2006;19:1–10.
17. Armour C, Brillan M, Krass I. Pharmacists’ views on involvement in pharmacy practice research: strategies for facilitating participation. Pharm Pract. 2007;5(2):59–66. 18. Nagykaldi Z, Mold JW, Aspy CB. Practice facilitators: a review of the literature. Fam Med. 2005;37:581–8. 19. Thomas P, Griffiths F, Kai J, O’Dwyer A. Networks for research in primary care. BMJ. 2001;322:588–90. 20. Ontario Institute for Studies in Education/University of Toronto Ethics Review Committee. Terms of reference. Appendix 1: principles to distinguish between research and field-based professional inquiry. Accessed at www.oise.utoronto.ca/ research/Termsofreference.pdf, January 16, 2008. 21. Westfall JM, Mold J, Fagan L. Practice-based research: “Blue Highways” on the NIH roadmap. JAMA. 2007;297:403–6. 22. Institute of Medicine. Primary care: America’s health in a new era. Washington, D.C.: National Academy Press; 1996. 23. Center for Pharmacy Practice Research. Improving health care through pharmacy practice research. Monograph 1: issues and strategies for pharmacy practice research. Pomona, Calif.: Western University of the Health Sciences; 1999. 24. Knapp KK. Adding a research component to clinical practice. Annual Meeting of American College of Clinical Pharmacy, San Francisco, October 23–26, 2005. Accessed at www.medscape. com/viewprogram/4751, December 12, 2005. 25. Seston E, Hassell K, Cantrill J, et al. Experiences of establishing and maintaining a community pharmacy research network. Prim Health Care Res Dev. 2003;4:245–55. 26. American Pharmacists Association. Conducting a practicebased project: a guide for community pharmacy residents & preceptors. Washington, DC: American Pharmacists Association, 2006.
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