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Training rural practitioners to use buprenorphine
Journal of Substance Abuse Treatment 26 (2004) 203 – 208
Regular article
Training rural practitioners to use buprenorphine: Using The Change Book to facilitate technology transfer Dennis McCarty a,*, Traci Rieckmann a, Carla Green a, Steve Gallon a, Jeff Knudsen b a
Department of Public Health and Preventive Medicine, CB669, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland OR 97230-3079, USA b RMC Research, Portland, OR Received 13 July 2003; received in revised form 18 November 2003; accepted 4 December 2003
Abstract The Opiate Medication Initiative for Rural Oregon Residents trained physicians and counselors in Central and Southwestern Oregon to use buprenorphine and develop service models that supported patient participation in drug abuse counseling. The Change Book from Addiction Technology Transfer Centers was used to structure the change process. Fifty-one individuals (17 physicians, 4 pharmacists, 2 nurse practitioners, and 28 drug abuse counselors and administrators) from seven counties completed the training and contributed to the development of community treatment protocols. A pre-post measure of attitudes and beliefs toward the use of buprenorphine suggested significant improvements in attitude after training, especially among counselors. Eight months after training, 10 of 17 physicians trained had received waivers to use buprenorphine and 29 patients were in treatment with six of the physicians. The Change Book facilitated development of county change teams and structured the planning efforts. The initiative also demonstrated the potential to concurrently train physicians, pharmacists, and counselors on the use of buprenorphine. D 2004 Elsevier Inc. All rights reserved. Keywords: Buprenorphine; Training; Opioid treatment
1. Introduction The organization and delivery of treatment for opioid dependence may be changing as a result of scientific recommendations, changes in legislation, and the Food and Drug Administration’s approval of a medication to treat opioid dependence. In November 1997, a National Institutes on Health Consensus Panel identified opiate agonist therapies as exemplary but underutilized, and encouraged changes in federal legislation that would promote treatment through primary care practitioners (National Consensus Development Panel on Effective Treatment of Opiate Addiction, 1998). Legislative action followed. The Drug Addiction Treatment Act of 2000 (DATA 2000) permitted qualified physicians to use schedule III, IV, or V narcotics approved for the treatment of opioid dependence. Finally, on October 8, 2002, the Food and Drug Administration approved two
* Corresponding author. Tel.: +1-503-494-1177; fax: +1-503-494-4981. E-mail address: [email protected] (D. McCarty). 0740-5472/04/$ – see front matter D 2004 Elsevier Inc. All rights reserved. doi:10.1016/S0740-5472(03)00247-2
sublingual preparations of buprenorphine hydrochloride (buprenorphine) for treatment of opioid dependence: SubutexR (buprenorphine alone) and SuboxoneR (a combination of buprenorphine and naloxone). As a result of these events, physicians who meet the qualifications required in DATA 2000 and register with the Substance Abuse and Mental Health Services Administration are authorized to prescribe buprenorphine (when formulated as SubutexR or SuboxoneR) for the treatment of opioid dependence. Opiate dependent patients now may seek treatment for their dependence from primary care physicians. Changes in delivery of care systems, however, may be required. The development challenges are to engage health care practitioners more directly in the delivery of opioid agonist treatments and to craft linkages between physicians and drug abuse counseling services. Without strong referral mechanisms for drug abuse counseling, medicated patients may fail to initiate a program of behavior change and recovery. If the linkages are in place, buprenorphine may enhance access to care for opioid dependent women and men.
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Access to services for treatment of opioid dependence is even more limited in rural communities. Long travel times to access methadone, geographical isolation, and shortages of physicians inhibit access to agonist medication services. The Opioid Medication Initiative for Rural Oregon Residents (OMIROR) project was designed to increase access to and improve the quality of treatment for opioid dependence in seven rural counties of Central and Southwestern Oregon. The estimated need for opioid treatment services in four counties, previously without methadone services, was 1,100 individuals. The three counties with methadone services had 900 individuals enrolled, but had an estimated need for 3,200 methadone slots. A need for increased access to opioid treatment services was apparent. Thus, there were three primary objectives for the training:
Provide physicians and counselors with training in the use of buprenorphine for the treatment of opiate dependence. Link community-based drug abuse treatment programs with trained physicians so that patients who received agonist therapies would also have access to drug abuse counseling services. Develop a service model that encouraged patients to participate fully in drug abuse treatment and recovery. A 10-step blueprint for change described in The Change Book: A Blueprint for Technology Transfer (Addiction Technology Transfer Centers, 2000) was used to guide OMIROR system development and technology transfer activities. Successful initiatives build change plans that are relevant, timely, clear, credible, multifaceted, continuous, and bi-directional. Stakeholders are involved in all phases of program development and implementation. Ten steps guide project planning and provide a blueprint for initiating change: (1) identify the problem; (2) organize a team for addressing the problem; (3) identify the desired outcome; (4) assess the organization or agency; (5) assess the specific audience to be targeted; (6) identify the approach most likely to achieve the desired outcome; (7) design action and maintenance plans; (8) implement the action and maintenance plan; (9) evaluate the progress of the change initiative; and (10) revise the action and maintenance plans based on evaluation results. The sequencing of steps suggests a linear process. In practice, however, the process is iterative. Steps can occur simultaneously and may be revisited when project implementation encounters barriers or needs change. This report describes the formation of county teams, outlines the curriculum for a 12-hr (1.5-day) training for participants, summarizes the development of county treatment protocols, and provides evaluation results. The evaluation used: (a) the required CSAT Government Performance Results Act (GPRA) tools for assessing participant response to training events; (b) forms required for American Society of Addiction Medicine (ASAM) sponsored training; and (c)
a survey administered immediately before and after the training to assess attitudes and beliefs related to the use of medications for the treatment of opioid dependence.
2. Methods 2.1. Recruitment and formation of county teams Recruitment emphasized identification of physicians in each participating county and the construction of county teams that included counselors and administrators from drug abuse treatment programs as well as pharmacists and nurse practitioners. Three recruitment strategies were used. First, health officers in the targeted counties provided names of potential physician participants. Second, the local drug abuse treatment centers encouraged physicians they worked with to participate. Finally, the project director made repeated calls to medical directors, methadone programs, pharmacists, and local hospitals to identify and recruit potential participants. Potential participants received information on buprenorphine and its value in treating opiate dependence in rural communities. Consistent with The Change Book strategy, county teams were formed and met prior to the training. A facilitator provided an overview of buprenorphine, described the training, and outlined the drafting of a county protocol to connect pharmacy, counselors, and primary care physicians. The premeeting fostered the development of relationships, involvement of stakeholders, discussion of needs, and enhanced communication among team members. Participants received binders that included buprenorphine research findings, a copy and explanation of the Drug Abuse Treatment Act of 2000, pages from the www.suboxone.com website, and an overview of CSAT’s buprenorphine web pages (www. buprenorphine.samhsa.gov). The materials were reviewed with each team and issues of concern were identified prior to the training. County teams, as a result, entered the training with a sense of how buprenorphine could be used and understood that a county opioid treatment protocol would be drafted during the training and finalized after the training was complete. The facilitator revisited county teams after the training to promote completion of the treatment protocol and provide continued support for system development. 2.2. Training Fifty-one individuals (17 physicians, 4 pharmacists, 2 nurse practitioners, and 28 drug abuse counselors and administrators) from seven counties participated in the 1.5-day training, designed to clarify the nature of buprenorphine, its use and potential benefits when treating opioid dependent patients. County teams sat together to support continued team development. Teams drafted county protocols for patient assessment, referral and coordinated treatment during the training. The training included work sessions to promote
D. McCarty et al. / Journal of Substance Abuse Treatment 26 (2004) 203–208
synthesis and application of the training content to local realities. At the conclusion of the training, county teams submitted draft practice protocols for review and comment. Post-training meetings fostered continued refinement and supported implementation. Pretest evaluation forms and attitude surveys were distributed, completed, and collected prior to the start of training. The first day’s curriculum used the format developed for ASAM trainings and introduced case studies and tasks to foster development of county treatment protocols. Speakers reviewed the context, described the pharmacology, and discussed patient selection and use of buprenorphine in practice settings. Training continued with an overview of co-morbidity (medical and psychiatric) and presentation of case studies. The Drug Addiction Treatment Act of 2000 and the Food and Drug Administration’s approval for SuboxoneR and SubutexR were summarized. An overview of the pharmacology and neurobiology of opioid dependence helped trainees appreciate the pharmacology of buprenorphine and its use in the treatment of opioid dependent patients. A patient video guided the group through a discussion of the diagnostic criteria to assess and select patients appropriate for buprenorphine treatment. Training continued with a pragmatic discussion of inducting patients onto buprenorphine and a review of common clinical challenges. The trainers’ experiences treating patients with buprenorphine provided a framework for discussing buprenorphine maintenance and practical considerations in managing patients. A review of clinical case studies closed the day. Teams discussed how the cases might be handled within their communities; the cases helped structure team thinking on assessment, referral, and continuing care. Day Two began with breakfast work sessions to continue development of local clinical protocols. The training began with an update on the Oregon Health Plan (Medicaid) from the Medical Director of the Office of Mental Health and Addiction Services. Discussions of medical (HIV/AIDS, HCV, and TB) and psychiatric co-morbidity outlined treatment challenges. The advantages of coordinated care were emphasized. A final presentation reviewed special populations and included discussions of the use of buprenorphine with adolescents, pregnant women, elders, patients with chronic pain, and patients with renal failure. Training concluded with questions and answers. Teams continued to work on their protocols until they left the training room. American Society of Addiction Medicine evaluation forms, GPRA forms, and post-test attitude surveys were distributed and collected. County protocol development continued as teams returned to their communities. The project director conducted followup meetings with each group to facilitate protocol completion and promote next steps. Physicians completed waiver applications providing them the authority to write buprenorphine prescriptions. The training was approved for 11.5 Category I continuing medical education units through Oregon Health & Science
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University; pharmacists received credits from the Board of Pharmacy and counselors received continuing education credits from the Northwest Frontier Addiction Technology Transfer Center. ASAM approved the event and three ASAM trainers led the training.
3. Results Responses to the ASAM and GPRA evaluation forms suggested that participants were pleased with the training. Trainees indicated that the combination of counselors, pharmacists, and physicians worked well and fostered communication among the groups. The attitude survey found evidence of positive change in attitudes especially among counselors. 3.1. Evaluation of presentations The ASAM evaluation form rated each presentation on a 7-point scale (1 = very poor; 7 = superlative); 48 of the 51 participants (94%) returned the ASAM form with one or more sessions rated and 31 participants (61%) rated all of the presentations. Responses suggested strong overall satisfaction. More than half of the participants used the highest possible ratings (6 or 7) for each of the presentations. Four presentations recorded at least 70% high ratings (Medical Co-Morbidity, Pharmacology of Buprenorphine, Clinical Use of Buprenorphine, and the Update on the Oregon Health Plan). Conversely, negative and neutral ratings exceeded 20% on only two presentations—the discussions of Special Populations, and Office Management. For both discussions, time was limited and comments indicated that practitioners sought more detail on both topics. 3.2. Participant satisfaction Center for Substance Abuse Treatment grantees are required to ask trainees to complete evaluation forms and report data for compliance with GPRA. Participants completed a training satisfaction survey; 47 individuals returned surveys and 46 responded to all items (90% of the 51 participants). Responses suggested high rates of satisfaction. Nearly 100% recorded ‘‘Satisfied’’ or ‘‘Very Satisfied’’ on all of the items. Instructors were rated as knowledgeable, receptive, and prepared—more than 80% of the respondents ‘‘Strongly Agreed’’ with these statements. Seven of ten respondents ‘‘strongly agreed’’ that they would recommend the training and 65% ‘‘strongly agreed’’ that the training was relevant (nearly 100% either agreed or strongly agreed with these statements). The one item with little strong agreement (‘‘I am currently effective when working in this topic area’’; 9%) suggests that participants recognized a need for training and additional expertise in treating opioid dependent patients.
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D. McCarty et al. / Journal of Substance Abuse Treatment 26 (2004) 203–208 Table 2 Mean beliefs about the use of buprenorphine pre and post training
3.3. Attitude change Attitudes, beliefs, and social norms associated with the use of three medications (methadone, buprenorphine, and clonidine) to treat opiate dependence were assessed along with intentions to use the medications. Pre- and posttraining surveys were matched for 38 individuals (75% of participants) and 33 (65%) provided complete data on all items of interest. Before and after the training, attitudes, beliefs and social norms toward the use of these medications were generally supportive. Because the participants were self-selected and interested in learning more about the use of a medication (buprenorphine) to treat opiate dependence, the favorable ratings are not surprising. Table 1 provides the mean pre- and post-test ratings. Means are based on respondents with complete data for both the pre-test and the post-test. Attitude toward using buprenorphine (‘‘For me, working with clients who take buprenorphine to treat heroin dependence is . . .’’) was measured as the sum of responses (scaled 3 to +3) to three semantic differential items that assess affect (bad-good; useless-useful; and sad-happy) (potential range: 9 to +9). Attitudes were positive prior to the training (pre mean = 4.6) and were more positive following the training (post mean = 5.7). The small sample size limits the statistical power so the trend toward standard significance levels ( p < .06) suggests that the training had substantial impact on attitudes. A subanalysis comparing physicians and clinicians suggests that the counselors accounted for the majority of the improvement in attitudes. The sample size for this sub-analysis was too small for meaningful tests of significance. Measures of social norms (‘‘People important to me think I should work with clients taking buprenorphine’’), and intention (‘‘I intend to tell my heroin-dependent clients to take buprenorphine’’), did not show evidence of significant change following the training. A review of beliefs associated with the use of medications found evidence of significant change on four beliefs: (1) Buprenorphine is an effective heroin treatment; (2)
Before training Belief Items
N
Bup is effective Physicians Clinicians Bup saves patient lives Physicians Clinicians Pts taking bup have better health Physicians Clinicians Bup block heroin craving Physicians Clinicians Pts report few side effects Bup requires daily visits Bup is long-lasting Bup reduces heroin withdrawal symptoms Bup is easy to administer
38 12 11 38 12 11 38 12 11 37 12 11 37 37 38 37
1.74 2.14 1.33 1.87 2.00 2.00 1.82 2.23 1.58 1.84 2.23 1.50 0.86 0.95 1.89 2.14
37
1.30 1.29
Measure Attitude buprenorphine Physicians Clinicians Social Norm buprenorphine Physicians Clinicians Intention buprenorphine Physicians Clinicians
N
Before training
After training
Mean
Mean
SD
33 12 11
4.61 5.00 3.55
3.05 3.01 3.27
5.67 5.17 5.45
2.26 2.89 1.86
.062
35 12 11
0.69 0.08 1.45
1.71 2.15 1.21
0.80 0.08 1.72
1.66 2.15 1.10
ns
35 12 11
1.14 1.54 0.55
1.48 1.13 1.92
1.26 1.31 1.18
1.36 1.70 0.98
ns
2.32 2.54 2.17 2.21 2.31 2.17 2.24 2.53 2.00 2.16 2.38 2.00 1.22 0.86 2.05 2.21
SD
p<
0.62 0.52 0.72 0.91 0.85 0.94 0.82 0.88 0.85 0.87 0.65 1.21 1.25 1.72 1.31 0.82
.001
.017
.006
.07
ns ns ns ns
1.24 1.04 ns
Six of the seven counties drafted local assessment, referral and treatment protocols. The protocols addressed nine elements:
p<
Mean
3.4. Protocols
SD
SD 1.11 0.99 1.55 1.04 1.00 0.74 1.11 0.83 1.08 1.26 0.73 1.68 1.25 1.47 1.20 0.82
Buprenorphine saves patient lives; (3) Patients taking buprenorphine have better health; and (4) Buprenorphine blocks craving for heroin. The significant changes in these beliefs contributed to the positive change in attitudes. Table 2 presents pre- and post-training means on the belief items. Physician and counselor data are presented for items with significant pre-post change.
Table 1 Mean attitudes, social norms, and intentions to use buprenorphine
Mean
After training
Screening (who, where, how) Assessment (withdrawal potential, primary and cooccurring diagnoses, treatment planning) Treatment supports (motivation for treatment, family) Willingness to comply with treatment requirements Treatment goals (maintenance vs. detoxification) Immediate objectives (withdrawal management) Maintenance procedures (induction, treatment schedule, stabilization, long-term medication management) Patient management (linkages with counseling, urine screens) Confidentiality requirements
Participation in OMIROR facilitated new relationships. Assessment and referral procedures were developed that emphasized collaboration between local drug abuse treatment centers, community health centers, and participating physicians. Douglas County, for example, built around the county’s primary drug abuse treatment center, while Klamath County structured services through their health
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center. ASAM patient placement criteria and DSM-IV diagnostic interviews provided a core of the assessment and planning processes. Mechanisms were devised to link primary care physicians, pharmacists, and drug abuse treatment counselors. The Josephine County protocol, for example, directs the pharmacist to call the physician if a patient fails to refill a prescription. Confidentiality issues included HIPAA regulations as well as 42 CFR Part II (Code of Federal Regulations: the federal confidentiality regulation for alcohol and drug abuse treatment). Lane County planned physician training on the federal confidentiality standards for alcohol and drug abuse treatment. 3.5. GPRA 30-day followup Individuals (n = 42) who agreed to participate in the posttraining GPRA survey received the followup survey approximately 30 days after completing the training and 34 (81%) responded. Satisfaction levels remained high although there was evidence of a decrement in enthusiasm. Virtually all (94%) reported sharing information from the training with colleagues, two of three (62%) shared training materials, and more than half (56%) noted that the information was being used in their work setting. 3.6. Access to care Followup interviews approximately 9 months after completion of training (October 2003) found that 10 of the 17 rural physicians had CSAT waivers authorizing them to write prescriptions and six of the physicians were treating a total of 29 patients. Physicians who did not apply for waivers reported concerns that they would be overwhelmed with needy patients, that systems of care were not in place, and that most patients could not afford the cost of the medication. Two counties were using the teams to facilitate recommendations for system modifications.
4. Discussion The Opiate Medication Initiative for Rural Oregon Residents built relationships between primary care physicians in rural health clinics and private practices with drug abuse treatment services and community pharmacies. These care teams gained from participation with the other county teams and from a diversity of perspectives within each team. The training was associated with significant improvements in team member attitudes and care coordination behaviors. Physicians became more confident of their capacity to work with local drug abuse treatment centers and to care for their patients more effectively. Nurse practitioners advocated for access to the trainings because they would ultimately be expected to provide much of the service for opioid dependent patients being cared for in primary care. Pharmacists understood their role in effective
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care for opioid dependent patients and how to work collaboratively with physicians and drug treatment services. Drug abuse treatment clinics and their counselors developed and reaffirmed relationships with primary care practitioners in their communities. These relationships will be useful for all alcohol and drug dependent patients, not just those being treated with buprenorphine. The county teams contributed a sense of purpose and enthusiasm to the conference. Teams not only developed systems but created networks of relationships with the potential to continue to benefit patients in the years ahead. The Change Book emphasizes the importance of establishing a planning team to develop and facilitate system change. Teams included a variety of stakeholders so the local protocols incorporated multiple points of view and the product was accepted as inclusive. County teams viewed the system development activity as a change exercise and relied on principles and strategies described in The Change Book for guidance. The development of the local protocol occurred over a period of time and the structure of The Change Book helped teams progress through tasks and become more confident in their plan and committed to implementation. One key to successful implementation was the presence of a project coordinator who facilitated initial meetings of the county teams. Her persistent contact encouraged teams to complete the process and assured that the training and followup were effective. Continued use of The Change Book is encouraged, though additional formal testing will be useful. The OMIROR training suggests that it is reasonable to format trainings for 1.5 days and to include pharmacists, allied health practitioners, and drug abuse counselors in addition to physicians. The effectiveness of the training was seen in pre-post changes in attitudes and in the number of physicians who obtained SAMHSA waivers and authorization to write buprenorphine prescriptions for treatment of opioid dependence. Although interpretation of these data must be cautious because of the small sample sizes and the selected nature of the training participants, it seems feasible to build information campaigns that promote use of buprenorphine, even in rural settings. A more sophisticated analysis of cognitive variables that influence attitudes toward the use of buprenorphine may facilitate the development of marketing campaigns. In support of this conclusion, followup with county teams and physician participants (in October 2003) found that teams continued to use the training to facilitate linkages between physicians and drug abuse treatment programs. At that point, 10 physicians had completed the waiver application and six were providing buprenorphine treatment in their communities. Two aspects of the training generated complaints: (1) the relatively lengthy set of evaluation forms; and (2) scheduling the second day of training on a Sunday. The content of the training was rated highly although participants wanted more attention to office management issues and special populations. The overall positive results led ASAM to replicate the
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1.5-day format (without the evaluation emphasis) with an audience of counselors and physicians in Portland, Oregon in November 2003. Physicians who did not apply for waivers expressed concerns that they would be the only source of buprenoprhine and that the 30-patient restriction would be a problem within their group practice. Shortly after the training was completed, moreover, the Oregon Health Plan (Oregon’s Medicaid plan) eliminated outpatient benefits for mental health and substance abuse treatment for many recipients. Thus, financing for care has been inhibited. 4.1. Limitations The OMIROR forum documented feasibility but generalization may be limited. It was structured to address services in rural communities; it may be more difficult to build community teams in more urbanized settings. The number of physicians and counselors was relatively small and selected and may not reflect the diversity of attitudes, beliefs, and behaviors found across the country. Nonetheless, the positive responses of the participants and the continued development of the county capacity to treat opioid dependence suggest this approach can be effective. In this regard, an advocacy organization, Join Together, also noted barriers to the use of buprenorphine. Their survey of physicians approved to prescribe buprenophine found persistent problems in adoption and use. One in three physicians with the waiver had not prescribed the medication and many who were prescribing reported difficulty finding pharmacies that carried SuboxoneR (Join Together, 2003). The persistent concerns and resistance to the use of buprenorphine in Oregon and across the nation suggest that a broader initiative to counter stigma associated with opioid dependence may be needed to enhance adoption. 4.2. Conclusion Buprenorphine offers a unique opportunity to expand the armamentarium of drug abuse treatment and to reorganize and to improve treatment for the adolescents, women, and men using heroin and other opioids. Organized system
change initiatives that foster linkages between primary care physicians and drug abuse treatment services may be needed to facilitate the adoption of a new science-based practice. Improved access to the medication, however, will require more than training if communities are to achieve the potential for enhanced access to more comprehensive care for opioid dependent women and men living in rural communities. The Change Book can help structure those system change initiatives.
Acknowledgments An award from the Center for Substance Abuse Treatment provided primary support for OMIROR (KD1 TI 13568). Additional support was provided through a grant from the National Institute on Drug Abuse (R01 DA14688) and the Center for Substance Abuse Treatment for the Northwest Frontier Addiction Technology Transfer Center (UD1 TI 13424). Linda Clary provided project management and county support for OMIROR; Josh Boverman and Alan Melnick assisted with physician recruitment. The American Society of Addiction Medicine approved the training and three ASAM trainers led the 1.5-day event: Judy Martin (14th Street Clinic in Oakland, CA), Laura McNicholas (Philadelphia VA Medical Center), and Andy Saxon (University of Washington and the VA Puget Sound Health Care System). Finally, we acknowledge and thank the OMIROR participants—counselors, physicians, pharmacists, and nurse practitioners.
References Join Together. National Poll of Physicians on Barriers to Widespread Buprenorphine Use, October. (2003). http://www.jointogether.org/sa/files/ pdf/bupereport. pdf . Accessed November 16, 2003. Addiction Technology Transfer Centers. (2000). The Change Book: A blueprint for technology transfer. Kansas City, MO: Addiction Technology Transfer Center National Office. National Consensus Development Panel on Effective Treatment of Opiate Addiction. (1998). Effective Medical Treatment of Opiate Addiction. Journal of the American Medical Association, 280, 1936 – 1943.
Regular article
Training rural practitioners to use buprenorphine: Using The Change Book to facilitate technology transfer Dennis McCarty a,*, Traci Rieckmann a, Carla Green a, Steve Gallon a, Jeff Knudsen b a
Department of Public Health and Preventive Medicine, CB669, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland OR 97230-3079, USA b RMC Research, Portland, OR Received 13 July 2003; received in revised form 18 November 2003; accepted 4 December 2003
Abstract The Opiate Medication Initiative for Rural Oregon Residents trained physicians and counselors in Central and Southwestern Oregon to use buprenorphine and develop service models that supported patient participation in drug abuse counseling. The Change Book from Addiction Technology Transfer Centers was used to structure the change process. Fifty-one individuals (17 physicians, 4 pharmacists, 2 nurse practitioners, and 28 drug abuse counselors and administrators) from seven counties completed the training and contributed to the development of community treatment protocols. A pre-post measure of attitudes and beliefs toward the use of buprenorphine suggested significant improvements in attitude after training, especially among counselors. Eight months after training, 10 of 17 physicians trained had received waivers to use buprenorphine and 29 patients were in treatment with six of the physicians. The Change Book facilitated development of county change teams and structured the planning efforts. The initiative also demonstrated the potential to concurrently train physicians, pharmacists, and counselors on the use of buprenorphine. D 2004 Elsevier Inc. All rights reserved. Keywords: Buprenorphine; Training; Opioid treatment
1. Introduction The organization and delivery of treatment for opioid dependence may be changing as a result of scientific recommendations, changes in legislation, and the Food and Drug Administration’s approval of a medication to treat opioid dependence. In November 1997, a National Institutes on Health Consensus Panel identified opiate agonist therapies as exemplary but underutilized, and encouraged changes in federal legislation that would promote treatment through primary care practitioners (National Consensus Development Panel on Effective Treatment of Opiate Addiction, 1998). Legislative action followed. The Drug Addiction Treatment Act of 2000 (DATA 2000) permitted qualified physicians to use schedule III, IV, or V narcotics approved for the treatment of opioid dependence. Finally, on October 8, 2002, the Food and Drug Administration approved two
* Corresponding author. Tel.: +1-503-494-1177; fax: +1-503-494-4981. E-mail address: [email protected] (D. McCarty). 0740-5472/04/$ – see front matter D 2004 Elsevier Inc. All rights reserved. doi:10.1016/S0740-5472(03)00247-2
sublingual preparations of buprenorphine hydrochloride (buprenorphine) for treatment of opioid dependence: SubutexR (buprenorphine alone) and SuboxoneR (a combination of buprenorphine and naloxone). As a result of these events, physicians who meet the qualifications required in DATA 2000 and register with the Substance Abuse and Mental Health Services Administration are authorized to prescribe buprenorphine (when formulated as SubutexR or SuboxoneR) for the treatment of opioid dependence. Opiate dependent patients now may seek treatment for their dependence from primary care physicians. Changes in delivery of care systems, however, may be required. The development challenges are to engage health care practitioners more directly in the delivery of opioid agonist treatments and to craft linkages between physicians and drug abuse counseling services. Without strong referral mechanisms for drug abuse counseling, medicated patients may fail to initiate a program of behavior change and recovery. If the linkages are in place, buprenorphine may enhance access to care for opioid dependent women and men.
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Access to services for treatment of opioid dependence is even more limited in rural communities. Long travel times to access methadone, geographical isolation, and shortages of physicians inhibit access to agonist medication services. The Opioid Medication Initiative for Rural Oregon Residents (OMIROR) project was designed to increase access to and improve the quality of treatment for opioid dependence in seven rural counties of Central and Southwestern Oregon. The estimated need for opioid treatment services in four counties, previously without methadone services, was 1,100 individuals. The three counties with methadone services had 900 individuals enrolled, but had an estimated need for 3,200 methadone slots. A need for increased access to opioid treatment services was apparent. Thus, there were three primary objectives for the training:
Provide physicians and counselors with training in the use of buprenorphine for the treatment of opiate dependence. Link community-based drug abuse treatment programs with trained physicians so that patients who received agonist therapies would also have access to drug abuse counseling services. Develop a service model that encouraged patients to participate fully in drug abuse treatment and recovery. A 10-step blueprint for change described in The Change Book: A Blueprint for Technology Transfer (Addiction Technology Transfer Centers, 2000) was used to guide OMIROR system development and technology transfer activities. Successful initiatives build change plans that are relevant, timely, clear, credible, multifaceted, continuous, and bi-directional. Stakeholders are involved in all phases of program development and implementation. Ten steps guide project planning and provide a blueprint for initiating change: (1) identify the problem; (2) organize a team for addressing the problem; (3) identify the desired outcome; (4) assess the organization or agency; (5) assess the specific audience to be targeted; (6) identify the approach most likely to achieve the desired outcome; (7) design action and maintenance plans; (8) implement the action and maintenance plan; (9) evaluate the progress of the change initiative; and (10) revise the action and maintenance plans based on evaluation results. The sequencing of steps suggests a linear process. In practice, however, the process is iterative. Steps can occur simultaneously and may be revisited when project implementation encounters barriers or needs change. This report describes the formation of county teams, outlines the curriculum for a 12-hr (1.5-day) training for participants, summarizes the development of county treatment protocols, and provides evaluation results. The evaluation used: (a) the required CSAT Government Performance Results Act (GPRA) tools for assessing participant response to training events; (b) forms required for American Society of Addiction Medicine (ASAM) sponsored training; and (c)
a survey administered immediately before and after the training to assess attitudes and beliefs related to the use of medications for the treatment of opioid dependence.
2. Methods 2.1. Recruitment and formation of county teams Recruitment emphasized identification of physicians in each participating county and the construction of county teams that included counselors and administrators from drug abuse treatment programs as well as pharmacists and nurse practitioners. Three recruitment strategies were used. First, health officers in the targeted counties provided names of potential physician participants. Second, the local drug abuse treatment centers encouraged physicians they worked with to participate. Finally, the project director made repeated calls to medical directors, methadone programs, pharmacists, and local hospitals to identify and recruit potential participants. Potential participants received information on buprenorphine and its value in treating opiate dependence in rural communities. Consistent with The Change Book strategy, county teams were formed and met prior to the training. A facilitator provided an overview of buprenorphine, described the training, and outlined the drafting of a county protocol to connect pharmacy, counselors, and primary care physicians. The premeeting fostered the development of relationships, involvement of stakeholders, discussion of needs, and enhanced communication among team members. Participants received binders that included buprenorphine research findings, a copy and explanation of the Drug Abuse Treatment Act of 2000, pages from the www.suboxone.com website, and an overview of CSAT’s buprenorphine web pages (www. buprenorphine.samhsa.gov). The materials were reviewed with each team and issues of concern were identified prior to the training. County teams, as a result, entered the training with a sense of how buprenorphine could be used and understood that a county opioid treatment protocol would be drafted during the training and finalized after the training was complete. The facilitator revisited county teams after the training to promote completion of the treatment protocol and provide continued support for system development. 2.2. Training Fifty-one individuals (17 physicians, 4 pharmacists, 2 nurse practitioners, and 28 drug abuse counselors and administrators) from seven counties participated in the 1.5-day training, designed to clarify the nature of buprenorphine, its use and potential benefits when treating opioid dependent patients. County teams sat together to support continued team development. Teams drafted county protocols for patient assessment, referral and coordinated treatment during the training. The training included work sessions to promote
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synthesis and application of the training content to local realities. At the conclusion of the training, county teams submitted draft practice protocols for review and comment. Post-training meetings fostered continued refinement and supported implementation. Pretest evaluation forms and attitude surveys were distributed, completed, and collected prior to the start of training. The first day’s curriculum used the format developed for ASAM trainings and introduced case studies and tasks to foster development of county treatment protocols. Speakers reviewed the context, described the pharmacology, and discussed patient selection and use of buprenorphine in practice settings. Training continued with an overview of co-morbidity (medical and psychiatric) and presentation of case studies. The Drug Addiction Treatment Act of 2000 and the Food and Drug Administration’s approval for SuboxoneR and SubutexR were summarized. An overview of the pharmacology and neurobiology of opioid dependence helped trainees appreciate the pharmacology of buprenorphine and its use in the treatment of opioid dependent patients. A patient video guided the group through a discussion of the diagnostic criteria to assess and select patients appropriate for buprenorphine treatment. Training continued with a pragmatic discussion of inducting patients onto buprenorphine and a review of common clinical challenges. The trainers’ experiences treating patients with buprenorphine provided a framework for discussing buprenorphine maintenance and practical considerations in managing patients. A review of clinical case studies closed the day. Teams discussed how the cases might be handled within their communities; the cases helped structure team thinking on assessment, referral, and continuing care. Day Two began with breakfast work sessions to continue development of local clinical protocols. The training began with an update on the Oregon Health Plan (Medicaid) from the Medical Director of the Office of Mental Health and Addiction Services. Discussions of medical (HIV/AIDS, HCV, and TB) and psychiatric co-morbidity outlined treatment challenges. The advantages of coordinated care were emphasized. A final presentation reviewed special populations and included discussions of the use of buprenorphine with adolescents, pregnant women, elders, patients with chronic pain, and patients with renal failure. Training concluded with questions and answers. Teams continued to work on their protocols until they left the training room. American Society of Addiction Medicine evaluation forms, GPRA forms, and post-test attitude surveys were distributed and collected. County protocol development continued as teams returned to their communities. The project director conducted followup meetings with each group to facilitate protocol completion and promote next steps. Physicians completed waiver applications providing them the authority to write buprenorphine prescriptions. The training was approved for 11.5 Category I continuing medical education units through Oregon Health & Science
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University; pharmacists received credits from the Board of Pharmacy and counselors received continuing education credits from the Northwest Frontier Addiction Technology Transfer Center. ASAM approved the event and three ASAM trainers led the training.
3. Results Responses to the ASAM and GPRA evaluation forms suggested that participants were pleased with the training. Trainees indicated that the combination of counselors, pharmacists, and physicians worked well and fostered communication among the groups. The attitude survey found evidence of positive change in attitudes especially among counselors. 3.1. Evaluation of presentations The ASAM evaluation form rated each presentation on a 7-point scale (1 = very poor; 7 = superlative); 48 of the 51 participants (94%) returned the ASAM form with one or more sessions rated and 31 participants (61%) rated all of the presentations. Responses suggested strong overall satisfaction. More than half of the participants used the highest possible ratings (6 or 7) for each of the presentations. Four presentations recorded at least 70% high ratings (Medical Co-Morbidity, Pharmacology of Buprenorphine, Clinical Use of Buprenorphine, and the Update on the Oregon Health Plan). Conversely, negative and neutral ratings exceeded 20% on only two presentations—the discussions of Special Populations, and Office Management. For both discussions, time was limited and comments indicated that practitioners sought more detail on both topics. 3.2. Participant satisfaction Center for Substance Abuse Treatment grantees are required to ask trainees to complete evaluation forms and report data for compliance with GPRA. Participants completed a training satisfaction survey; 47 individuals returned surveys and 46 responded to all items (90% of the 51 participants). Responses suggested high rates of satisfaction. Nearly 100% recorded ‘‘Satisfied’’ or ‘‘Very Satisfied’’ on all of the items. Instructors were rated as knowledgeable, receptive, and prepared—more than 80% of the respondents ‘‘Strongly Agreed’’ with these statements. Seven of ten respondents ‘‘strongly agreed’’ that they would recommend the training and 65% ‘‘strongly agreed’’ that the training was relevant (nearly 100% either agreed or strongly agreed with these statements). The one item with little strong agreement (‘‘I am currently effective when working in this topic area’’; 9%) suggests that participants recognized a need for training and additional expertise in treating opioid dependent patients.
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D. McCarty et al. / Journal of Substance Abuse Treatment 26 (2004) 203–208 Table 2 Mean beliefs about the use of buprenorphine pre and post training
3.3. Attitude change Attitudes, beliefs, and social norms associated with the use of three medications (methadone, buprenorphine, and clonidine) to treat opiate dependence were assessed along with intentions to use the medications. Pre- and posttraining surveys were matched for 38 individuals (75% of participants) and 33 (65%) provided complete data on all items of interest. Before and after the training, attitudes, beliefs and social norms toward the use of these medications were generally supportive. Because the participants were self-selected and interested in learning more about the use of a medication (buprenorphine) to treat opiate dependence, the favorable ratings are not surprising. Table 1 provides the mean pre- and post-test ratings. Means are based on respondents with complete data for both the pre-test and the post-test. Attitude toward using buprenorphine (‘‘For me, working with clients who take buprenorphine to treat heroin dependence is . . .’’) was measured as the sum of responses (scaled 3 to +3) to three semantic differential items that assess affect (bad-good; useless-useful; and sad-happy) (potential range: 9 to +9). Attitudes were positive prior to the training (pre mean = 4.6) and were more positive following the training (post mean = 5.7). The small sample size limits the statistical power so the trend toward standard significance levels ( p < .06) suggests that the training had substantial impact on attitudes. A subanalysis comparing physicians and clinicians suggests that the counselors accounted for the majority of the improvement in attitudes. The sample size for this sub-analysis was too small for meaningful tests of significance. Measures of social norms (‘‘People important to me think I should work with clients taking buprenorphine’’), and intention (‘‘I intend to tell my heroin-dependent clients to take buprenorphine’’), did not show evidence of significant change following the training. A review of beliefs associated with the use of medications found evidence of significant change on four beliefs: (1) Buprenorphine is an effective heroin treatment; (2)
Before training Belief Items
N
Bup is effective Physicians Clinicians Bup saves patient lives Physicians Clinicians Pts taking bup have better health Physicians Clinicians Bup block heroin craving Physicians Clinicians Pts report few side effects Bup requires daily visits Bup is long-lasting Bup reduces heroin withdrawal symptoms Bup is easy to administer
38 12 11 38 12 11 38 12 11 37 12 11 37 37 38 37
1.74 2.14 1.33 1.87 2.00 2.00 1.82 2.23 1.58 1.84 2.23 1.50 0.86 0.95 1.89 2.14
37
1.30 1.29
Measure Attitude buprenorphine Physicians Clinicians Social Norm buprenorphine Physicians Clinicians Intention buprenorphine Physicians Clinicians
N
Before training
After training
Mean
Mean
SD
33 12 11
4.61 5.00 3.55
3.05 3.01 3.27
5.67 5.17 5.45
2.26 2.89 1.86
.062
35 12 11
0.69 0.08 1.45
1.71 2.15 1.21
0.80 0.08 1.72
1.66 2.15 1.10
ns
35 12 11
1.14 1.54 0.55
1.48 1.13 1.92
1.26 1.31 1.18
1.36 1.70 0.98
ns
2.32 2.54 2.17 2.21 2.31 2.17 2.24 2.53 2.00 2.16 2.38 2.00 1.22 0.86 2.05 2.21
SD
p<
0.62 0.52 0.72 0.91 0.85 0.94 0.82 0.88 0.85 0.87 0.65 1.21 1.25 1.72 1.31 0.82
.001
.017
.006
.07
ns ns ns ns
1.24 1.04 ns
Six of the seven counties drafted local assessment, referral and treatment protocols. The protocols addressed nine elements:
p<
Mean
3.4. Protocols
SD
SD 1.11 0.99 1.55 1.04 1.00 0.74 1.11 0.83 1.08 1.26 0.73 1.68 1.25 1.47 1.20 0.82
Buprenorphine saves patient lives; (3) Patients taking buprenorphine have better health; and (4) Buprenorphine blocks craving for heroin. The significant changes in these beliefs contributed to the positive change in attitudes. Table 2 presents pre- and post-training means on the belief items. Physician and counselor data are presented for items with significant pre-post change.
Table 1 Mean attitudes, social norms, and intentions to use buprenorphine
Mean
After training
Screening (who, where, how) Assessment (withdrawal potential, primary and cooccurring diagnoses, treatment planning) Treatment supports (motivation for treatment, family) Willingness to comply with treatment requirements Treatment goals (maintenance vs. detoxification) Immediate objectives (withdrawal management) Maintenance procedures (induction, treatment schedule, stabilization, long-term medication management) Patient management (linkages with counseling, urine screens) Confidentiality requirements
Participation in OMIROR facilitated new relationships. Assessment and referral procedures were developed that emphasized collaboration between local drug abuse treatment centers, community health centers, and participating physicians. Douglas County, for example, built around the county’s primary drug abuse treatment center, while Klamath County structured services through their health
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center. ASAM patient placement criteria and DSM-IV diagnostic interviews provided a core of the assessment and planning processes. Mechanisms were devised to link primary care physicians, pharmacists, and drug abuse treatment counselors. The Josephine County protocol, for example, directs the pharmacist to call the physician if a patient fails to refill a prescription. Confidentiality issues included HIPAA regulations as well as 42 CFR Part II (Code of Federal Regulations: the federal confidentiality regulation for alcohol and drug abuse treatment). Lane County planned physician training on the federal confidentiality standards for alcohol and drug abuse treatment. 3.5. GPRA 30-day followup Individuals (n = 42) who agreed to participate in the posttraining GPRA survey received the followup survey approximately 30 days after completing the training and 34 (81%) responded. Satisfaction levels remained high although there was evidence of a decrement in enthusiasm. Virtually all (94%) reported sharing information from the training with colleagues, two of three (62%) shared training materials, and more than half (56%) noted that the information was being used in their work setting. 3.6. Access to care Followup interviews approximately 9 months after completion of training (October 2003) found that 10 of the 17 rural physicians had CSAT waivers authorizing them to write prescriptions and six of the physicians were treating a total of 29 patients. Physicians who did not apply for waivers reported concerns that they would be overwhelmed with needy patients, that systems of care were not in place, and that most patients could not afford the cost of the medication. Two counties were using the teams to facilitate recommendations for system modifications.
4. Discussion The Opiate Medication Initiative for Rural Oregon Residents built relationships between primary care physicians in rural health clinics and private practices with drug abuse treatment services and community pharmacies. These care teams gained from participation with the other county teams and from a diversity of perspectives within each team. The training was associated with significant improvements in team member attitudes and care coordination behaviors. Physicians became more confident of their capacity to work with local drug abuse treatment centers and to care for their patients more effectively. Nurse practitioners advocated for access to the trainings because they would ultimately be expected to provide much of the service for opioid dependent patients being cared for in primary care. Pharmacists understood their role in effective
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care for opioid dependent patients and how to work collaboratively with physicians and drug treatment services. Drug abuse treatment clinics and their counselors developed and reaffirmed relationships with primary care practitioners in their communities. These relationships will be useful for all alcohol and drug dependent patients, not just those being treated with buprenorphine. The county teams contributed a sense of purpose and enthusiasm to the conference. Teams not only developed systems but created networks of relationships with the potential to continue to benefit patients in the years ahead. The Change Book emphasizes the importance of establishing a planning team to develop and facilitate system change. Teams included a variety of stakeholders so the local protocols incorporated multiple points of view and the product was accepted as inclusive. County teams viewed the system development activity as a change exercise and relied on principles and strategies described in The Change Book for guidance. The development of the local protocol occurred over a period of time and the structure of The Change Book helped teams progress through tasks and become more confident in their plan and committed to implementation. One key to successful implementation was the presence of a project coordinator who facilitated initial meetings of the county teams. Her persistent contact encouraged teams to complete the process and assured that the training and followup were effective. Continued use of The Change Book is encouraged, though additional formal testing will be useful. The OMIROR training suggests that it is reasonable to format trainings for 1.5 days and to include pharmacists, allied health practitioners, and drug abuse counselors in addition to physicians. The effectiveness of the training was seen in pre-post changes in attitudes and in the number of physicians who obtained SAMHSA waivers and authorization to write buprenorphine prescriptions for treatment of opioid dependence. Although interpretation of these data must be cautious because of the small sample sizes and the selected nature of the training participants, it seems feasible to build information campaigns that promote use of buprenorphine, even in rural settings. A more sophisticated analysis of cognitive variables that influence attitudes toward the use of buprenorphine may facilitate the development of marketing campaigns. In support of this conclusion, followup with county teams and physician participants (in October 2003) found that teams continued to use the training to facilitate linkages between physicians and drug abuse treatment programs. At that point, 10 physicians had completed the waiver application and six were providing buprenorphine treatment in their communities. Two aspects of the training generated complaints: (1) the relatively lengthy set of evaluation forms; and (2) scheduling the second day of training on a Sunday. The content of the training was rated highly although participants wanted more attention to office management issues and special populations. The overall positive results led ASAM to replicate the
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1.5-day format (without the evaluation emphasis) with an audience of counselors and physicians in Portland, Oregon in November 2003. Physicians who did not apply for waivers expressed concerns that they would be the only source of buprenoprhine and that the 30-patient restriction would be a problem within their group practice. Shortly after the training was completed, moreover, the Oregon Health Plan (Oregon’s Medicaid plan) eliminated outpatient benefits for mental health and substance abuse treatment for many recipients. Thus, financing for care has been inhibited. 4.1. Limitations The OMIROR forum documented feasibility but generalization may be limited. It was structured to address services in rural communities; it may be more difficult to build community teams in more urbanized settings. The number of physicians and counselors was relatively small and selected and may not reflect the diversity of attitudes, beliefs, and behaviors found across the country. Nonetheless, the positive responses of the participants and the continued development of the county capacity to treat opioid dependence suggest this approach can be effective. In this regard, an advocacy organization, Join Together, also noted barriers to the use of buprenorphine. Their survey of physicians approved to prescribe buprenophine found persistent problems in adoption and use. One in three physicians with the waiver had not prescribed the medication and many who were prescribing reported difficulty finding pharmacies that carried SuboxoneR (Join Together, 2003). The persistent concerns and resistance to the use of buprenorphine in Oregon and across the nation suggest that a broader initiative to counter stigma associated with opioid dependence may be needed to enhance adoption. 4.2. Conclusion Buprenorphine offers a unique opportunity to expand the armamentarium of drug abuse treatment and to reorganize and to improve treatment for the adolescents, women, and men using heroin and other opioids. Organized system
change initiatives that foster linkages between primary care physicians and drug abuse treatment services may be needed to facilitate the adoption of a new science-based practice. Improved access to the medication, however, will require more than training if communities are to achieve the potential for enhanced access to more comprehensive care for opioid dependent women and men living in rural communities. The Change Book can help structure those system change initiatives.
Acknowledgments An award from the Center for Substance Abuse Treatment provided primary support for OMIROR (KD1 TI 13568). Additional support was provided through a grant from the National Institute on Drug Abuse (R01 DA14688) and the Center for Substance Abuse Treatment for the Northwest Frontier Addiction Technology Transfer Center (UD1 TI 13424). Linda Clary provided project management and county support for OMIROR; Josh Boverman and Alan Melnick assisted with physician recruitment. The American Society of Addiction Medicine approved the training and three ASAM trainers led the 1.5-day event: Judy Martin (14th Street Clinic in Oakland, CA), Laura McNicholas (Philadelphia VA Medical Center), and Andy Saxon (University of Washington and the VA Puget Sound Health Care System). Finally, we acknowledge and thank the OMIROR participants—counselors, physicians, pharmacists, and nurse practitioners.
References Join Together. National Poll of Physicians on Barriers to Widespread Buprenorphine Use, October. (2003). http://www.jointogether.org/sa/files/ pdf/bupereport. pdf . Accessed November 16, 2003. Addiction Technology Transfer Centers. (2000). The Change Book: A blueprint for technology transfer. Kansas City, MO: Addiction Technology Transfer Center National Office. National Consensus Development Panel on Effective Treatment of Opiate Addiction. (1998). Effective Medical Treatment of Opiate Addiction. Journal of the American Medical Association, 280, 1936 – 1943.