- Email: [email protected]
The Tennessee medication therapy management program: A hybrid type 2 effectiveness-implementation trial study protocol
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Contents lists available at ScienceDirect
Research in Social and Administrative Pharmacy journal homepage: www.elsevier.com/locate/rsap
The Tennessee medication therapy management program: A hybrid type 2 effectiveness-implementation trial study protocol Jacqueline Woeppela, Renee Clarka, Lora Underwooda, Justin Gatwoodb, Kea Turnerc,∗, Chelsea Renfrob, Kenneth C. Hohmeierb a
TennCare Pharmacy Division, Nashville, TN, USA University of Tennessee College of Pharmacy, Memphis, TN, USA c University of Florida College of Public Health & Health Professions, Gainesville, FL, USA b
A R T I C LE I N FO
A B S T R A C T
Keywords: Medication therapy management Medicaid Pharmacy reimbursement Chronic disease management Pharmacy quality Adherence Hybrid type 2 trial Mixed methods CFIR
Background: Pharmacist-led medication therapy management (MTM) programs are considered evidence-based and have clearly defined core components. Despite this, MTM programs are often implemented without fidelity due to notable implementation barriers, such as physician-pharmacist relationships and pharmacist access to patient medical records. To improve MTM implementation, the Tennessee Medicaid program developed a MTM intervention that incorporates implementation strategies to address some of the known barriers to implementation (e.g., formalizing pharmacist-physician relationships through collaborative practice agreements, ensuring pharmacists’ access to medical records). Objectives: The purpose of this hybrid type 2 effectiveness-implementation study is to (1) assess the effectiveness of the MTM pilot program in Tennessee (e.g., medication adherence, healthcare utilization, quality and cost of care) and (2) assess the implementation of the MTM pilot program (e.g., feasibility, appropriateness, acceptability, penetration). Methods: The Tennessee MTM pilot program is being assessed as a hybrid type 2 effectiveness-implementation study with a quasi-experimental design. A mixed methods approach (QUAN + QUAL) for the purpose of complementarity (e.g., answering related research questions). Data will include surveys, interviews, MTM platform encounter information, and medical and pharmacy claims. Initial analyses will include data between January 2018 and December 2019. Conclusion: The study will further add to the evidence base of MTM interventions by testing an intervention that addresses known barriers to implementation and simultaneously collecting data on effectiveness and implementation to speed up MTM translation. The Tennessee MTM program is expected to serve as a guide to other states seeking to expand pharmacist-delivered clinical services to their Medicaid members, particularly those intending to incorporate MTM into programs seeking to improve primary care delivery. Further, by improving the implementation of MTM, the pilot program is expected to improve the reliability of MTM program benefits including healthcare quality and cost and patient outcomes.
Background Since the 1970s, pharmacists have undertaken increasingly greater responsibility in ensuring quality patient care by optimizing medication therapy. This process of pharmacist-provided patient care above-andbeyond medication distribution was first defined as “pharmaceutical care” and included core components meant to ensure fidelity of care quality. In the 2000s, the major pharmacy organizations of the
profession further refined and then jointly adopted a Medication Therapy Management (MTM) consensus definition and core components creating a national standard.1,2 In 2005, with its Final Rule on the Medicare Prescription Drug Benefit, the Centers for Medicare and Medicaid Services (CMS) created the first reimbursable MTM program for beneficiaries of the newly created Medicare Part D program. This program became the largest in the country and served elderly patients with multiple comorbid conditions and prescription drug therapies.3,4
∗
Corresponding author. Department of Health Services Research, Management & Policy, College of Public Health & Health Professions, University of Florida, PO Box 100195, Gainesville, FL, 32610, USA. E-mail addresses: [email protected] (J. Woeppel), [email protected] (R. Clark), [email protected] (L. Underwood), [email protected] (J. Gatwood), [email protected]fl.edu (K. Turner), [email protected] (C. Renfro), [email protected] (K.C. Hohmeier). https://doi.org/10.1016/j.sapharm.2019.05.018 Received 23 May 2019; Accepted 23 May 2019 1551-7411/ © 2019 Elsevier Inc. All rights reserved.
Please cite this article as: Jacqueline Woeppel, et al., Research in Social and Administrative Pharmacy, https://doi.org/10.1016/j.sapharm.2019.05.018
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used to assess implementation and effectiveness in addressing the needs of Tennessee Medicaid (TennCare) beneficiaries. The study period will be from January 2018 to December 2019. This study protocol was reviewed by CMS and the TennCare Medicaid Program. All study procedures were approved by the Institutional Review Board of [Name of University]. We adhered to the Template for Intervention Description and Replication (TIDieR) and Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklists to describe implementation and fidelity assessment of the MTM pilot program in this study protocol. This intervention trial is currently being registered with the ISRCTN registry. This is the version one of the study protocol, 5.15.19.
Since that time, the Centers for Disease Control and Prevention has further endorsed pharmacist-provided MTM services as having “wellsupported” evidence of effectiveness in improving patient outcomes.3 The Medicare Part D MTM program demonstrated two things: (1) that pharmacist-provided medication management services were effective in a real-world care setting; and (2) that the community pharmacy setting may be leveraged successfully to provide large scale clinical care. The success of the Medicare MTM program provided pragmatic evidence of the pharmacist's important role in ensuring positive patient outcomes for the elderly patient population. Concurrent with the roll out of this program was a growing evidence base for other novel applications of MTM in varying patient populations, expanding scope of practice, and technology which would enhance care delivery.5–10 Given these and other reasons, CMS announced in 2016 a plan to expand the Medicare MTM program through the launch of several pilots throughout the U.S. to test MTM delivery across high-risk patient populations beyond the elderly.11 Simultaneously, state Medicaid programs have also benefited from pharmacist-delivered, state-specific MTM programs.12–14 Despite varying approaches to MTM program delivery, results have consistently been positive and range from annual savings of $1595 per beneficiary to a 4.4:1 return on investment.12,13,15 Furthermore, several innovative approaches to MTM delivery have emerged from these Medicaid programs, including providing access to electronic medical records, incorporating the pharmacist into patient-centered medical homes (PCMHs), credentialing the pharmacist as a provider through the state, and using collaborative practice agreements (CPAs) to expand the pharmacist's ability to manage drug therapy regiments.13,15–17 As is the case for any evidence-based intervention, the translation of MTM into practice has been inconsistent due to a variety of barriers including reimbursement, staff support, access to patient health information, physician-pharmacist relationships, and time issues.18–22 For example, a recent CMS report found that overall MTM completion rates were low: 15.5% for Prescription Drug Plans and 30.9% for Medicare Advantage Plans.23 Although implementation strategies designed to address notable barriers in MTM delivery have emerged organically across several MTM programs both federally and on the state level, no one program has incorporated them proactively within an MTM program. To overcome these barriers, the Tennessee MTM Program will use CPAs and integrate pharmacists into a PCMH to facilitate physicianpharmacist collaboration around medication management. Further, the Tennessee MTM Program will provide pharmacists with access to patient medical records, enhancing access to patient health information. If this approach proves to be effective, it will be important to quickly spread this approach to other state and federal MTM programs to improve the consistency of MTM implementation so that more patients can benefit from this evidence-based intervention. For quick translation, this study will use a hybrid type 2 effectiveness-implementation design so that insights regarding effectiveness and implementation can be gathered simultaneously.24
Intervention overview The overall objective of the TennCare MTM Pilot Program is to support and improve primary care through the inclusion of MTM as a component of primary care transformation. The methods employed were constructed based on observed limitations of other states' efforts to implement an MTM program for their Medicaid members.12,13,17 During development of the MTM Pilot Program in 2017, TennCare investigated various MTM programs from the nationwide Medicare MTM program to state-specific MTM programs including Texas, Wisconsin, and Florida. Ultimately, North Carolina's MTM program model best aligned with TennCare's goals. Specifically, North Carolina's MTM program had three main strategies that met TennCare's needs: (1) focus on patient-centered care, (2) collaborative, interdisciplinary care, and (3) alignment with a value-based delivery model. First, TennCare's MTM pilot program implemented this patient-centered approach by integrating the MTM pilot program into the larger, overarching TennCare Primary Care Transformation (PCT) initiative (that includes PCMH and Tennessee Health Link providers …), which aims to assist providers in promoting higher quality care, improving population health, and reducing the overall cost of care. Second, the MTM pilot promotes a collaborative approach between pharmacists and the existing primary care team to optimize patient interactions with community pharmacists under a CPA. Third, TennCare's MTM pilot program adopts a valuebased payment model approach utilizing a case-rate payment method (e.g., a form of bundled payment that covers the cost of a ‘case’). The MTM pilot model was based on technical advisory input and focused on four key areas: patient attribution, reporting and documentation, payment, and quality metrics. First, eligible members are risk stratified. Second, pharmacists are provided access to eligible TennCare members via a Care Coordination Tool, which is configured to enable the pharmacists to document encounters in a standard method. Third, the payment model is focused on value-based reimbursement with a case rate per month. Finally, specific MTM performance measures will be evaluated. A single platform (the Care Coordination Tool) is being utilized for identifying and documenting MTM interventions. As part of the risk design, the MTM pilot program uses the Chronic Illness and Disability Payment System plus Pharmacy (CDPS + Rx). CDPS is a diagnostic classification system developed by Richard Kronick and Tod Gilmer at the University of California San Diego to help Medicaid programs measure illness burden and to adjust calculated capitation rates to health plans that enroll Medicaid beneficiaries.25,26 The risk scores are an additive summary of age- and sex-based rates and the risk weights for each separate diagnosis code. The system includes costs associated for the population through claims, and the risk model is reflective of actual diagnoses and treatment patterns. Different scores are comprised of and represent distinct scores to the population (i.e., adults vs children). The MTM pilot program developed hierarchical logic building upon the CDPS + RX stratifications. There are three risk stratifications and two-targeted disease states. The general risk stratifications are critical, high, and medium high. The two targeted disease states focus on
Methods/design Study overview The purpose of this hybrid type 2 effectiveness-implementation study is to (1) assess the effectiveness of the MTM pilot program in Tennessee (e.g., medication adherence, healthcare utilization, quality and cost of care) and (2) assess the implementation of the MTM pilot program (e.g., feasibility, appropriateness, acceptability, penetration) using a quasi-experimental study design. The hybrid type 2 design incorporates elements of determining a program's clinical effectiveness in parallel with its feasibility and overall utility.20 We felt that a hybrid type 2 design was appropriate given that there is momentum for MTM implementation (e.g., increasingly being adopted by other state programs) and MTM has a strong evidence base.24 Mixed methods will be 2
Research in Social and Administrative Pharmacy xxx (xxxx) xxx–xxx N/A N/A U2 U3 U3
U3
TDS 2
U1 U1
Reimbursement Maximum Services (per pilot year) CPT Modifier
TDS 2
U2
Pharmacists Members of the MTM pilot program include the patient, MTM pharmacist, and TennCare PCMH or Tennessee Health Link (THL). The MTM model design integrates pharmacists into the PCMH or THL care teams to maximize patient-pharmacist and physician-pharmacist interactions, and collaboration is further established between participants via the requirement of a CPA. Pharmacists are required to complete the following steps to participate in the MTM pilot program: (1) obtain a valid Tennessee pharmacist license; (2) acquire a Medicaid/TennCare identification number; (3) develop a collaborative practice agreement with a participating TennCare PCMH or Tennessee Health Link (THL) program; (4) complete Care Coordination Tool training and agree to document in the selected MTM platform; and (5) complete the network contracting and credentialing process with the TennCare managed care organizations (MCOs). The MTM program consists of a diverse community of pharmacists ranging from consultants, those employed with a PCMH or THL, to community pharmacists associated with a retail pharmacy (chain or independent). The CPA between the pharmacist(s) and PCT organization is the foundation for integrating the pharmacists into the primary care team, offering structures such as scope of practice, communication, documentation, quality assessment.
CPT: current procedural terminology. DM: diabetes mellitus. TDS: targeted disease state.
N/A N/A N/A N/A Medium-High 3 Critical 6 High 6
High 6
Critical DM (Yes) Low or Moderate Risk (pediatric)
Medium High 3
pediatric members from ages 2–17 with either asthma and/or diabetes. The MTM program assigned to the targeted disease state is dependent on the risk categories. For example, if a pediatric member has a diagnosis of asthma with a risk stratification of low or moderate, the member would be classified as an MTM pediatric asthma patient. However, if the member had asthma with a medium high risk, the member would be classified as CPDS- Medium High. Therefore, the member with a higher risk would be eligible for the associated higher level of MTM intervention. The MTM services provided by the pilot program include, but are not limited to, evaluation and monitoring of medication therapy, patient and prescriber education, medication care plans, and comprehensive medication reviews. The number of MTM services are based on the TennCare member's risk stratification or pediatric targeted disease states (asthma and diabetes mellitus). Table 1 illustrates the five MTM programs associated with the number of authorized reimbursable services an eligible member may receive. The payment model associated with the MTM pilot program is consistent with the move away from fee-for-service and focuses on value-based reimbursement. The TennCare reimbursement model was established on a per month case rate based on targeted disease state (TDS) or risk category. For example, if a member has a critical risk they would be identified in the Care Coordination Tool as MTM High CDPSHigh Critical. The member would then be eligible to receive up to 6 months of services and the pharmacist would be reimbursed based on a case rate associated with critical (by signifying U3 modifier on the claim). The current procedural terminology (CPT) code is appended with a MTM modifier to specify how many services for which the patient is eligible per time period. Additional information about the intervention can be found in the Provider Operations Manual available at the Bureau of TennCare website. Participants
Asthma (Yes) Low or Moderate Risk (pediatric) Care Coordination Tool
Targeted Disease States and Risk Stratifications Category
Table 1 Crosswalk between MTM logic and reimbursement.
Asthma and DM (pediatric) Low, moderate, and medium high
Asthma and DM (pediatric) High or Critical Risk
High
Medium-High
Moderate
Low
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Patients The MTM pilot model identifies eligible TennCare members through MTM risk model logic and an association with a PCMH or THL. For the first criteria, TennCare members are identified based on specific risk stratification and targeted disease states (e.g., pediatric diabetes and asthma). For the second criterion, the MTM logic is applied to only TennCare members with a PCP that is connected to TennCare's PCT programs (PCMH and THL). The MTM pilot program is voluntary and does not require PCT organizations to participate in the MTM program. 3
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Table 2 Effectiveness and implementation measures. Outcome Effectiveness Adherence
Healthcare utilization
Healthcare cost
Quality of care Implementation Perceptions
(Penetration
Individual measures
How measured
• Asntidepressants • Asthma • Diabetes • Antipsychotic therapy • Concomitant • Hospitalizations Visits • ED visits • Outpatient cost of care • Total • Return on investment
of days covered • Proportion • Persistence • User rate
• Number of paid claims
• Primary care transformation • Feasibility • Acceptability • Appropriateness about other determinants of implementation (inner setting, • Perceptions process, individual characteristics) delivery • Care • Patient outreach
on investment • Return per event avoided • Cost per adherent patient • Cost return on investment • Overall measures • HEDIS • Star measures survey instrument • FIM survey instrument • IAM survey instrument • AIM covering CFIR • Interview domains of claims submitted • Number of patients seen/ • Number eligible
When measured 6, 12 months • Baseline, and 90-day gaps over one • Baseline year period and 30-day periods over one • Baseline year period • Baseline and 12 months
• Baseline and 12 months • Baseline and 12 months • Early (first 3 months) • Middle, late
FIM: Feasibility of Intervention Measure. IAM: Intervention Appropriateness Measure. AIM: Acceptability of Implementation Measure. HEDIS: Healthcare Effectiveness Data and Information Set.
Alliance (PQA).27 This measure accounts for the percent of days in a defined observation period during which prescribed medications were on-hand. For the purposes of this program, both 180 and 365 days will be used as the denominators, and a proportion of days covered ≥80% will deem a patient adherent in a given period.27 To assess persistence, the number of 30-day, 60-day, and 90-day gaps in therapy will be described, and both logistic and binomial regression will be used. To account for variable dosing of injectable therapies, a user rate will describe the extent to which patients with diabetes were persistent with their insulin or other injectable regimens.28 Healthcare utilization will be assessed using both counts of distinct encounters and economic assessment of service use. Individual assessments will include hospitalization, outpatient, inpatient, and emergency department visits. Healthcare costs will be measured in two ways: (1) per-member per month costs of care, both overall and by service type; and (2) program return-on-investment according to dollars saved to prevent events, utilization, and non-adherence. Healthcare quality will be measured using a series of quality measures derived from both HEDIS and pharmacy quality measures, which are endorsed by the National Committee for Quality Assurance and the Pharmacy Quality Alliance, respectively (Table 2). Implementation outcomes will include acceptability, appropriateness, feasibility, and penetration. We will use three psychometrically assessed measures including the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), and the Feasibility Intervention Measure (FIM).30,31 These measures will be collected earlier during implementation (first three months) since implementation outcomes such as feasibility are typically collected prior to or early on in implementation. Program penetration will be measured by the number of claims submitted and the proportion of patient visits completed by credentialed pharmacists based on the total number of eligible patients. In addition to these measures, we will explore other determinants of implementation based on the Consolidated Framework for Implementation Research (CFIR).31 We will focus on the domains most relevant for the MTM program: (1) inner setting; (2)
The PCMH program includes an estimated 86 organizations committed to patient-centered access, team-based care, population-health management, care-management support, coordination, and performance measurement and improvement. The THL is a program offered by at least 20 mental and physical health providers that coordinate health care services for TennCare members with the highest behavioral health needs. Current MTM program participation As of winter 2019, TennCare has 12 PCT organizations with projections of at least eight additional PCT organizations. The estimated eligible population is approximately 60,000 members. Pharmacist training and credentialing started in 2018 and to date, there are at least 40 pharmacists in the onboarding process with 28 pharmacists actively credentialed with MCOs. The onboarding process is rolling and pharmacists are continuously exploring opportunities to join the program. Study outcomes Table 2 outlines the primary study outcomes focused on effectiveness (aim 1) and implementation (aim 2) and the timeline for data collection. These outcomes include five focus areas: (1) medication adherence; (2) healthcare utilization; (3) healthcare costs; (4) healthcare quality; and (5) implementation outcomes (e.g., acceptability, feasibility, appropriateness, and penetration). Effectiveness measures will be collected at least twice (e.g., baseline and 12 months). However, some effectiveness measures will be collected at additional time points (e.g., 6 months). Implementation measures will be collected either early during implementation (within first three months) or later in implementation (last 6–9 months) depending on the outcome. A more detailed description is below. Medication adherence will be analyzed using multiple metrics: 1) proportion of days covered; 2) persistence; and 3) user rates. Proportion of days covered is a commonly used measure of adherence to chronic disease medications and is the preferred metric of the Pharmacy Quality 4
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measures in a pharmacy context, which involves s different provider type and a different setting. By testing these measures in diverse settings and a greater variety of provider types, our study can contribute more information about the generalizability of these measures.29 Despite the long history of MTM implementation, this is the first study that conducts a hybrid effectiveness-implementation trial of a MTM program. By simultaneously collecting data on effectiveness and implementation, we will be able to provide much needed guidance to other states and federal programs seeking to increase the extent to which pharmacists can contribute to improving the quality of patient care among high-risk populations. Too often, effectiveness data is collected without generating insights about the implementation process, limiting the generalizability of interventions. MTM programs, in particular, are resource-intensive, have notable barriers to implementation, and are implemented inconsistently (without fidelity), heightening the need for a strong evidence-base of not only what works but also how it works in practice.34
characteristics of individuals; and (3) process. Program penetration and perceptions about other determinants of implementation will be collected later on during implementation (last 6–9 months) so that participants have some experience with implementation and will have an informed opinion about implementation. Data collection Data to assess the program will be derived from multiple sources, including TennCare pharmacy and medical claims, the Care Coordination Tool (Altruista Health GuidingCare® MTM application), and interviews with and surveys completed by key stakeholders of the program (e.g., credentialed pharmacists, physician groups, health system administrators). The study team will monitor data collection; the project does not include a formal data monitoring committee. The data will be reviewed quarterly by the study team to review progress and to identify any potential unintended consequences. The study team will also be responsible for communicating any changes to the study protocol to study stakeholders including participants and funders. Select members of the study team who have established a data use agreement will have access to the final trial dataset. Data will be served on a secure drive at the University of Tennessee Health Sciences Center.
Potential limitations The pilot has funding support for two years, and this timeframe may be an insufficient length to implement and evaluate outcomes associated with MTM services. Although the MTM program officially launched on time, there was a service delay due to credentialing and health plan contracting limitations. There are also limitations associated with technology implementation for pharmacists to acclimate to the new platform and process. The intent of the MTM program design was to have pharmacists integrated into the PCMH and THL care teams to maximize the interactions between both patients and pharmacists and physicians and pharmacists. However, the design allowed for voluntary participation by the PCT organizations, and this aspect of the model was often challenging to outside community pharmacists seeking to establish collaborative practice and business agreements. Additionally, one of the key design components of the program was to require the pharmacists to utilize a single platform for identifying and documenting MTM services, but this requirement often led pharmacists documenting in multiple health record systems. The risk model is also dependent upon claims submission (i.e. diagnosis coding), and without appropriate submissions of claims, eligible members would not be accurately captured. Furthermore, the ability to close gaps such as HEDIS measures is also dependent upon timely submission of encounter claims.
Data analysis For aim 1, we plan to produce descriptive statistics and conduct multivariable linear and logistic regressions. We plan to conduct pre/ post comparisons (i.e., TennCare members being serviced by MTM providers serving as their own control) and matched cohort analyses (i.e., comparisons between eligible TennCare with and without MTM encounters) will be reported. For aim 2, we plan to produce descriptive statistics to summarize program penetration and participants' perceptions about acceptability, feasibility, and appropriateness. We will use thematic analysis to explore themes from the interviews regarding other determinants of implementation. All interviews will be recorded, transcribed, and thematically sequenced by members of the study team. Aim 2 will employ a mixed-methods approach (QUAN + QUAL) where qualitative and quantitative data is collected simultaneously for the purpose of exploring participants’ perceptions about implementation (e.g., feasibility, appropriateness, acceptability) and other factors that may affect implementation (e.g., CFIR domains). The quantitative and qualitative data will be used to answer related questions (e.g., complementarity function). After the analysis is completed, the study team will disseminate the results of the study through a report issued to the funder and through peer reviewed manuscripts.
Expected results Discussion A pharmacist-led MTM program is an evidence-based intervention with clearly defined core components.1,2 The goal of the MTM program is to address misuse, overuse, and underuse of medications. Federal and state programs are currently expanding the use of MTM programs beyond the elderly to new, high-risk patients, such as Medicaid beneficiaries. To maximize the benefit of MTM programs, it is critical to promote consistent, high-quality implementation. This study will contribute to this end in two ways: (1) by testing the effectiveness of an intervention that proactively addresses known implementation barriers, and (2) by simultaneously studying effectiveness and implementation so that guidance regarding implementation can be disseminated quickly.
The purpose of this study is to demonstrate the effectiveness of the Tennessee MTM Program while gathering information about implementation outcomes (e.g., feasibility, acceptability, appropriateness, penetration). The present study contains several important innovations in pharmacy care. First, the Tennessee MTM Program is an innovative approach to MTM delivery that includes implementation strategies to overcome known barriers to MTM implementation (e.g., establishment of CPAs and PCMH integration to facilitate patient-physician collaboration, access to patient medical records to enhance pharmacist access to health information). To our knowledge, this is the first MTM program that formally incorporates all of these implementation strategies into a MTM program. This study also tests newly developed measures of implementation outcomes (e.g., the FIM, AIM, and IAM) in a pharmacy context.29 These newly developed measures have been proposed as measures in several study protocols in other contexts (e.g., substance use, child welfare).32,33 It is beneficial to test these implementation outcome
Acknowledgements N/A. All authors read and approved the final manuscript. 5
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List of abbreviations
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CMS to test enhanced medication therapy management model: aims for greater use of pharmacists, cost savings, and better outcomes. Pharm Therapeut. 2016;41(7):423. 12. Urick B, Brown P, Easter JC. Achieving better quality and lower costs in Medicaid through enhanced pharmacy services. N C Med J. 2017;78(3):188–189. 13. Neyarapally GA, Smith MA. Variability in state Medicaid medication management initiatives. Res Soc Adm Pharm. 2017;13(1):214–223. 14. Chrischilles EA, Carter BL, Lund BC, et al. Evaluation of the Iowa Medicaid pharmaceutical case management program. J Am Pharm Assoc. 2004;44(3):337–349. 15. Smith M, Giuliano MR, Starkowski MP. In Connecticut: improving patient medication management in primary care. Health Aff. 2011;30(4):646–654. 16. 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(2):203–214. 17. Michaels NM, Jenkins GF, Pruss DL, Heidrick JE, Ferreri SP. Retrospective analysis of community pharmacists' recommendations in the North Carolina Medicaid medication therapy management program. J Am Pharm Assoc. 2010;50(3):347–353. 18. Lounsbery JL, Green CG, Bennett MS, et al. Evaluation of pharmacists' barriers to the implementation of medication therapy management services. J Am Pharm Assoc. 2009;49(1):51–58. 19. Blake KB, Madhavan SS. Perceived barriers to provision of medication therapy management services (MTMS) and the likelihood of a pharmacist to work in a pharmacy that provides MTMS. Ann Pharmacother. 2010;44(3):424–431. 20. Vora J. Access to a Health System's Electronic Medical Record. Pharmacy Times September 2015. [Internet]. Accessed April 5, 2019. Available at:. https://www. pharmacytimes.com/publications/health-system-edition/2015/september2015/ access-to-a-health-systems-electronic-medical-record. 21. Lounsbery JL, Green CG, Bennett MS, et al. Evaluation of pharmacists' barriers to the implementation of medication therapy management services. J Am Pharm Assoc. 2009;49(1):51–58. 22. Chui MA, Stone JA, Odukoya AK, Maxwell L. Facilitating collaboration between pharmacists and physicians using an iterative interview process. J Am Pharm Assoc. 2014;54(1):35–41. 23. PQA Measures Used by CMS in the Star Ratings & as Display Ratings Program. By CMS in the Star Ratings & as Display Ratings Program. Accessed November 1, 2017 http://pqaalliance.org/measures/cms.asp. 24. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–226. 25. Kronick R, Gilmer T, Dreyfus T, Lee L. Improving health-based payment for Medicaid beneficiaries: CDPS. Health Care Financ Rev. 2000;21(3):29–64. 26. Chronic Illness and Disability Payment System. University of California, San Diego [Internet]. Accessed February 26, 2019. Available at: http://cdps.ucsd.edu/. 27. Nau DP. Proportion of Days Covered (PDC) as a Preferred Method of Measuring Medication Adherence. Springfield, VA: Pharmacy Quality Alliance; 2012 Jun 25. 28. Gibson TB, Mahoney JJ, Lucas K, Heithoff K, Gatwood J. Value-based design and prescription drug utilization patterns among diabetes patients. Am J Pharm Benefits. 2013;5(3):113–120. 29. Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):108. 30. Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76. 31. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. 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AIM CFIR CMS CPA CDPS +
Acceptability of Implementation Measure Consolidated Framework for Implementation Research Centers for Medicare and Medicaid Services Collaborative Practice Agreement Rx Chronic Illness and Disability Payment System plus Pharmacy CPT Current Procedural Terminology DM Diabetes Mellitus FIM Feasibility of Intervention Measure HEDIS Healthcare Effectiveness Data and Information Set IAM Intervention Appropriateness Measure MCO Managed Care Organization MTM Medication Therapy Management PCMH Patient-centered Medical Home PCT Primary Care Transformation TennCare Tennessee Medicaid Program TDS Targeted Disease State THL Tennessee Health Link Declarations Ethics approval and consent to participate All study procedures were approved by the Institutional Review Board of [Name of University]. Participants provided oral consent to the study team to participate, which was approved of by the IRB. Consent for publication Not applicable. Availability of data and materials Data sharing is not applicable to this study protocol as no datasets were generated or analyzed for this study protocol. Competing interests The authors declare that they have no competing interests. Funding This research was funded by TennCare, Tennessee's Medicaid Program. The funding body reviewed the study design, data collection, and analysis procedures. The funder does not play a role in interpreting the data or writing up the findings. There are no publication restrictions. The contact information for this organization is TennCare, 310 Great Circle Road, Nashville, TN, 37243, 1-800-342-3145. References 1. American Pharmacists Association and the National Association of Chain Drug Stores Foundation. Medication therapy management in pharmacy practice: core elements of an MTM service model (version 2.0). J Am Pharm Assoc. 2003;48:3 2008. 2. American Pharmacists Association. Medication Therapy Management Services Definition and Program Criteria. 2004; 2004. 3. Division for Heart Disease and Stroke Prevention. Community Pharmacists and Medication Therapy Management [Internet]. Centers for Disease Control and Prevention. Accessed February 11, 2019. Available at: https://www.cdc.gov/dhdsp/ pubs/guides/best-practices/pharmacist-mtm.htm. 4. Centers for Medicare and Medicaid Services. Prescription Drug Benefit Manual [Internet]. US Department of Health and Human Services. Accessed February 11, 2019. Available at: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/
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Research in Social and Administrative Pharmacy journal homepage: www.elsevier.com/locate/rsap
The Tennessee medication therapy management program: A hybrid type 2 effectiveness-implementation trial study protocol Jacqueline Woeppela, Renee Clarka, Lora Underwooda, Justin Gatwoodb, Kea Turnerc,∗, Chelsea Renfrob, Kenneth C. Hohmeierb a
TennCare Pharmacy Division, Nashville, TN, USA University of Tennessee College of Pharmacy, Memphis, TN, USA c University of Florida College of Public Health & Health Professions, Gainesville, FL, USA b
A R T I C LE I N FO
A B S T R A C T
Keywords: Medication therapy management Medicaid Pharmacy reimbursement Chronic disease management Pharmacy quality Adherence Hybrid type 2 trial Mixed methods CFIR
Background: Pharmacist-led medication therapy management (MTM) programs are considered evidence-based and have clearly defined core components. Despite this, MTM programs are often implemented without fidelity due to notable implementation barriers, such as physician-pharmacist relationships and pharmacist access to patient medical records. To improve MTM implementation, the Tennessee Medicaid program developed a MTM intervention that incorporates implementation strategies to address some of the known barriers to implementation (e.g., formalizing pharmacist-physician relationships through collaborative practice agreements, ensuring pharmacists’ access to medical records). Objectives: The purpose of this hybrid type 2 effectiveness-implementation study is to (1) assess the effectiveness of the MTM pilot program in Tennessee (e.g., medication adherence, healthcare utilization, quality and cost of care) and (2) assess the implementation of the MTM pilot program (e.g., feasibility, appropriateness, acceptability, penetration). Methods: The Tennessee MTM pilot program is being assessed as a hybrid type 2 effectiveness-implementation study with a quasi-experimental design. A mixed methods approach (QUAN + QUAL) for the purpose of complementarity (e.g., answering related research questions). Data will include surveys, interviews, MTM platform encounter information, and medical and pharmacy claims. Initial analyses will include data between January 2018 and December 2019. Conclusion: The study will further add to the evidence base of MTM interventions by testing an intervention that addresses known barriers to implementation and simultaneously collecting data on effectiveness and implementation to speed up MTM translation. The Tennessee MTM program is expected to serve as a guide to other states seeking to expand pharmacist-delivered clinical services to their Medicaid members, particularly those intending to incorporate MTM into programs seeking to improve primary care delivery. Further, by improving the implementation of MTM, the pilot program is expected to improve the reliability of MTM program benefits including healthcare quality and cost and patient outcomes.
Background Since the 1970s, pharmacists have undertaken increasingly greater responsibility in ensuring quality patient care by optimizing medication therapy. This process of pharmacist-provided patient care above-andbeyond medication distribution was first defined as “pharmaceutical care” and included core components meant to ensure fidelity of care quality. In the 2000s, the major pharmacy organizations of the
profession further refined and then jointly adopted a Medication Therapy Management (MTM) consensus definition and core components creating a national standard.1,2 In 2005, with its Final Rule on the Medicare Prescription Drug Benefit, the Centers for Medicare and Medicaid Services (CMS) created the first reimbursable MTM program for beneficiaries of the newly created Medicare Part D program. This program became the largest in the country and served elderly patients with multiple comorbid conditions and prescription drug therapies.3,4
∗
Corresponding author. Department of Health Services Research, Management & Policy, College of Public Health & Health Professions, University of Florida, PO Box 100195, Gainesville, FL, 32610, USA. E-mail addresses: [email protected] (J. Woeppel), [email protected] (R. Clark), [email protected] (L. Underwood), [email protected] (J. Gatwood), [email protected]fl.edu (K. Turner), [email protected] (C. Renfro), [email protected] (K.C. Hohmeier). https://doi.org/10.1016/j.sapharm.2019.05.018 Received 23 May 2019; Accepted 23 May 2019 1551-7411/ © 2019 Elsevier Inc. All rights reserved.
Please cite this article as: Jacqueline Woeppel, et al., Research in Social and Administrative Pharmacy, https://doi.org/10.1016/j.sapharm.2019.05.018
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used to assess implementation and effectiveness in addressing the needs of Tennessee Medicaid (TennCare) beneficiaries. The study period will be from January 2018 to December 2019. This study protocol was reviewed by CMS and the TennCare Medicaid Program. All study procedures were approved by the Institutional Review Board of [Name of University]. We adhered to the Template for Intervention Description and Replication (TIDieR) and Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklists to describe implementation and fidelity assessment of the MTM pilot program in this study protocol. This intervention trial is currently being registered with the ISRCTN registry. This is the version one of the study protocol, 5.15.19.
Since that time, the Centers for Disease Control and Prevention has further endorsed pharmacist-provided MTM services as having “wellsupported” evidence of effectiveness in improving patient outcomes.3 The Medicare Part D MTM program demonstrated two things: (1) that pharmacist-provided medication management services were effective in a real-world care setting; and (2) that the community pharmacy setting may be leveraged successfully to provide large scale clinical care. The success of the Medicare MTM program provided pragmatic evidence of the pharmacist's important role in ensuring positive patient outcomes for the elderly patient population. Concurrent with the roll out of this program was a growing evidence base for other novel applications of MTM in varying patient populations, expanding scope of practice, and technology which would enhance care delivery.5–10 Given these and other reasons, CMS announced in 2016 a plan to expand the Medicare MTM program through the launch of several pilots throughout the U.S. to test MTM delivery across high-risk patient populations beyond the elderly.11 Simultaneously, state Medicaid programs have also benefited from pharmacist-delivered, state-specific MTM programs.12–14 Despite varying approaches to MTM program delivery, results have consistently been positive and range from annual savings of $1595 per beneficiary to a 4.4:1 return on investment.12,13,15 Furthermore, several innovative approaches to MTM delivery have emerged from these Medicaid programs, including providing access to electronic medical records, incorporating the pharmacist into patient-centered medical homes (PCMHs), credentialing the pharmacist as a provider through the state, and using collaborative practice agreements (CPAs) to expand the pharmacist's ability to manage drug therapy regiments.13,15–17 As is the case for any evidence-based intervention, the translation of MTM into practice has been inconsistent due to a variety of barriers including reimbursement, staff support, access to patient health information, physician-pharmacist relationships, and time issues.18–22 For example, a recent CMS report found that overall MTM completion rates were low: 15.5% for Prescription Drug Plans and 30.9% for Medicare Advantage Plans.23 Although implementation strategies designed to address notable barriers in MTM delivery have emerged organically across several MTM programs both federally and on the state level, no one program has incorporated them proactively within an MTM program. To overcome these barriers, the Tennessee MTM Program will use CPAs and integrate pharmacists into a PCMH to facilitate physicianpharmacist collaboration around medication management. Further, the Tennessee MTM Program will provide pharmacists with access to patient medical records, enhancing access to patient health information. If this approach proves to be effective, it will be important to quickly spread this approach to other state and federal MTM programs to improve the consistency of MTM implementation so that more patients can benefit from this evidence-based intervention. For quick translation, this study will use a hybrid type 2 effectiveness-implementation design so that insights regarding effectiveness and implementation can be gathered simultaneously.24
Intervention overview The overall objective of the TennCare MTM Pilot Program is to support and improve primary care through the inclusion of MTM as a component of primary care transformation. The methods employed were constructed based on observed limitations of other states' efforts to implement an MTM program for their Medicaid members.12,13,17 During development of the MTM Pilot Program in 2017, TennCare investigated various MTM programs from the nationwide Medicare MTM program to state-specific MTM programs including Texas, Wisconsin, and Florida. Ultimately, North Carolina's MTM program model best aligned with TennCare's goals. Specifically, North Carolina's MTM program had three main strategies that met TennCare's needs: (1) focus on patient-centered care, (2) collaborative, interdisciplinary care, and (3) alignment with a value-based delivery model. First, TennCare's MTM pilot program implemented this patient-centered approach by integrating the MTM pilot program into the larger, overarching TennCare Primary Care Transformation (PCT) initiative (that includes PCMH and Tennessee Health Link providers …), which aims to assist providers in promoting higher quality care, improving population health, and reducing the overall cost of care. Second, the MTM pilot promotes a collaborative approach between pharmacists and the existing primary care team to optimize patient interactions with community pharmacists under a CPA. Third, TennCare's MTM pilot program adopts a valuebased payment model approach utilizing a case-rate payment method (e.g., a form of bundled payment that covers the cost of a ‘case’). The MTM pilot model was based on technical advisory input and focused on four key areas: patient attribution, reporting and documentation, payment, and quality metrics. First, eligible members are risk stratified. Second, pharmacists are provided access to eligible TennCare members via a Care Coordination Tool, which is configured to enable the pharmacists to document encounters in a standard method. Third, the payment model is focused on value-based reimbursement with a case rate per month. Finally, specific MTM performance measures will be evaluated. A single platform (the Care Coordination Tool) is being utilized for identifying and documenting MTM interventions. As part of the risk design, the MTM pilot program uses the Chronic Illness and Disability Payment System plus Pharmacy (CDPS + Rx). CDPS is a diagnostic classification system developed by Richard Kronick and Tod Gilmer at the University of California San Diego to help Medicaid programs measure illness burden and to adjust calculated capitation rates to health plans that enroll Medicaid beneficiaries.25,26 The risk scores are an additive summary of age- and sex-based rates and the risk weights for each separate diagnosis code. The system includes costs associated for the population through claims, and the risk model is reflective of actual diagnoses and treatment patterns. Different scores are comprised of and represent distinct scores to the population (i.e., adults vs children). The MTM pilot program developed hierarchical logic building upon the CDPS + RX stratifications. There are three risk stratifications and two-targeted disease states. The general risk stratifications are critical, high, and medium high. The two targeted disease states focus on
Methods/design Study overview The purpose of this hybrid type 2 effectiveness-implementation study is to (1) assess the effectiveness of the MTM pilot program in Tennessee (e.g., medication adherence, healthcare utilization, quality and cost of care) and (2) assess the implementation of the MTM pilot program (e.g., feasibility, appropriateness, acceptability, penetration) using a quasi-experimental study design. The hybrid type 2 design incorporates elements of determining a program's clinical effectiveness in parallel with its feasibility and overall utility.20 We felt that a hybrid type 2 design was appropriate given that there is momentum for MTM implementation (e.g., increasingly being adopted by other state programs) and MTM has a strong evidence base.24 Mixed methods will be 2
Research in Social and Administrative Pharmacy xxx (xxxx) xxx–xxx N/A N/A U2 U3 U3
U3
TDS 2
U1 U1
Reimbursement Maximum Services (per pilot year) CPT Modifier
TDS 2
U2
Pharmacists Members of the MTM pilot program include the patient, MTM pharmacist, and TennCare PCMH or Tennessee Health Link (THL). The MTM model design integrates pharmacists into the PCMH or THL care teams to maximize patient-pharmacist and physician-pharmacist interactions, and collaboration is further established between participants via the requirement of a CPA. Pharmacists are required to complete the following steps to participate in the MTM pilot program: (1) obtain a valid Tennessee pharmacist license; (2) acquire a Medicaid/TennCare identification number; (3) develop a collaborative practice agreement with a participating TennCare PCMH or Tennessee Health Link (THL) program; (4) complete Care Coordination Tool training and agree to document in the selected MTM platform; and (5) complete the network contracting and credentialing process with the TennCare managed care organizations (MCOs). The MTM program consists of a diverse community of pharmacists ranging from consultants, those employed with a PCMH or THL, to community pharmacists associated with a retail pharmacy (chain or independent). The CPA between the pharmacist(s) and PCT organization is the foundation for integrating the pharmacists into the primary care team, offering structures such as scope of practice, communication, documentation, quality assessment.
CPT: current procedural terminology. DM: diabetes mellitus. TDS: targeted disease state.
N/A N/A N/A N/A Medium-High 3 Critical 6 High 6
High 6
Critical DM (Yes) Low or Moderate Risk (pediatric)
Medium High 3
pediatric members from ages 2–17 with either asthma and/or diabetes. The MTM program assigned to the targeted disease state is dependent on the risk categories. For example, if a pediatric member has a diagnosis of asthma with a risk stratification of low or moderate, the member would be classified as an MTM pediatric asthma patient. However, if the member had asthma with a medium high risk, the member would be classified as CPDS- Medium High. Therefore, the member with a higher risk would be eligible for the associated higher level of MTM intervention. The MTM services provided by the pilot program include, but are not limited to, evaluation and monitoring of medication therapy, patient and prescriber education, medication care plans, and comprehensive medication reviews. The number of MTM services are based on the TennCare member's risk stratification or pediatric targeted disease states (asthma and diabetes mellitus). Table 1 illustrates the five MTM programs associated with the number of authorized reimbursable services an eligible member may receive. The payment model associated with the MTM pilot program is consistent with the move away from fee-for-service and focuses on value-based reimbursement. The TennCare reimbursement model was established on a per month case rate based on targeted disease state (TDS) or risk category. For example, if a member has a critical risk they would be identified in the Care Coordination Tool as MTM High CDPSHigh Critical. The member would then be eligible to receive up to 6 months of services and the pharmacist would be reimbursed based on a case rate associated with critical (by signifying U3 modifier on the claim). The current procedural terminology (CPT) code is appended with a MTM modifier to specify how many services for which the patient is eligible per time period. Additional information about the intervention can be found in the Provider Operations Manual available at the Bureau of TennCare website. Participants
Asthma (Yes) Low or Moderate Risk (pediatric) Care Coordination Tool
Targeted Disease States and Risk Stratifications Category
Table 1 Crosswalk between MTM logic and reimbursement.
Asthma and DM (pediatric) Low, moderate, and medium high
Asthma and DM (pediatric) High or Critical Risk
High
Medium-High
Moderate
Low
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Patients The MTM pilot model identifies eligible TennCare members through MTM risk model logic and an association with a PCMH or THL. For the first criteria, TennCare members are identified based on specific risk stratification and targeted disease states (e.g., pediatric diabetes and asthma). For the second criterion, the MTM logic is applied to only TennCare members with a PCP that is connected to TennCare's PCT programs (PCMH and THL). The MTM pilot program is voluntary and does not require PCT organizations to participate in the MTM program. 3
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Table 2 Effectiveness and implementation measures. Outcome Effectiveness Adherence
Healthcare utilization
Healthcare cost
Quality of care Implementation Perceptions
(Penetration
Individual measures
How measured
• Asntidepressants • Asthma • Diabetes • Antipsychotic therapy • Concomitant • Hospitalizations Visits • ED visits • Outpatient cost of care • Total • Return on investment
of days covered • Proportion • Persistence • User rate
• Number of paid claims
• Primary care transformation • Feasibility • Acceptability • Appropriateness about other determinants of implementation (inner setting, • Perceptions process, individual characteristics) delivery • Care • Patient outreach
on investment • Return per event avoided • Cost per adherent patient • Cost return on investment • Overall measures • HEDIS • Star measures survey instrument • FIM survey instrument • IAM survey instrument • AIM covering CFIR • Interview domains of claims submitted • Number of patients seen/ • Number eligible
When measured 6, 12 months • Baseline, and 90-day gaps over one • Baseline year period and 30-day periods over one • Baseline year period • Baseline and 12 months
• Baseline and 12 months • Baseline and 12 months • Early (first 3 months) • Middle, late
FIM: Feasibility of Intervention Measure. IAM: Intervention Appropriateness Measure. AIM: Acceptability of Implementation Measure. HEDIS: Healthcare Effectiveness Data and Information Set.
Alliance (PQA).27 This measure accounts for the percent of days in a defined observation period during which prescribed medications were on-hand. For the purposes of this program, both 180 and 365 days will be used as the denominators, and a proportion of days covered ≥80% will deem a patient adherent in a given period.27 To assess persistence, the number of 30-day, 60-day, and 90-day gaps in therapy will be described, and both logistic and binomial regression will be used. To account for variable dosing of injectable therapies, a user rate will describe the extent to which patients with diabetes were persistent with their insulin or other injectable regimens.28 Healthcare utilization will be assessed using both counts of distinct encounters and economic assessment of service use. Individual assessments will include hospitalization, outpatient, inpatient, and emergency department visits. Healthcare costs will be measured in two ways: (1) per-member per month costs of care, both overall and by service type; and (2) program return-on-investment according to dollars saved to prevent events, utilization, and non-adherence. Healthcare quality will be measured using a series of quality measures derived from both HEDIS and pharmacy quality measures, which are endorsed by the National Committee for Quality Assurance and the Pharmacy Quality Alliance, respectively (Table 2). Implementation outcomes will include acceptability, appropriateness, feasibility, and penetration. We will use three psychometrically assessed measures including the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), and the Feasibility Intervention Measure (FIM).30,31 These measures will be collected earlier during implementation (first three months) since implementation outcomes such as feasibility are typically collected prior to or early on in implementation. Program penetration will be measured by the number of claims submitted and the proportion of patient visits completed by credentialed pharmacists based on the total number of eligible patients. In addition to these measures, we will explore other determinants of implementation based on the Consolidated Framework for Implementation Research (CFIR).31 We will focus on the domains most relevant for the MTM program: (1) inner setting; (2)
The PCMH program includes an estimated 86 organizations committed to patient-centered access, team-based care, population-health management, care-management support, coordination, and performance measurement and improvement. The THL is a program offered by at least 20 mental and physical health providers that coordinate health care services for TennCare members with the highest behavioral health needs. Current MTM program participation As of winter 2019, TennCare has 12 PCT organizations with projections of at least eight additional PCT organizations. The estimated eligible population is approximately 60,000 members. Pharmacist training and credentialing started in 2018 and to date, there are at least 40 pharmacists in the onboarding process with 28 pharmacists actively credentialed with MCOs. The onboarding process is rolling and pharmacists are continuously exploring opportunities to join the program. Study outcomes Table 2 outlines the primary study outcomes focused on effectiveness (aim 1) and implementation (aim 2) and the timeline for data collection. These outcomes include five focus areas: (1) medication adherence; (2) healthcare utilization; (3) healthcare costs; (4) healthcare quality; and (5) implementation outcomes (e.g., acceptability, feasibility, appropriateness, and penetration). Effectiveness measures will be collected at least twice (e.g., baseline and 12 months). However, some effectiveness measures will be collected at additional time points (e.g., 6 months). Implementation measures will be collected either early during implementation (within first three months) or later in implementation (last 6–9 months) depending on the outcome. A more detailed description is below. Medication adherence will be analyzed using multiple metrics: 1) proportion of days covered; 2) persistence; and 3) user rates. Proportion of days covered is a commonly used measure of adherence to chronic disease medications and is the preferred metric of the Pharmacy Quality 4
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measures in a pharmacy context, which involves s different provider type and a different setting. By testing these measures in diverse settings and a greater variety of provider types, our study can contribute more information about the generalizability of these measures.29 Despite the long history of MTM implementation, this is the first study that conducts a hybrid effectiveness-implementation trial of a MTM program. By simultaneously collecting data on effectiveness and implementation, we will be able to provide much needed guidance to other states and federal programs seeking to increase the extent to which pharmacists can contribute to improving the quality of patient care among high-risk populations. Too often, effectiveness data is collected without generating insights about the implementation process, limiting the generalizability of interventions. MTM programs, in particular, are resource-intensive, have notable barriers to implementation, and are implemented inconsistently (without fidelity), heightening the need for a strong evidence-base of not only what works but also how it works in practice.34
characteristics of individuals; and (3) process. Program penetration and perceptions about other determinants of implementation will be collected later on during implementation (last 6–9 months) so that participants have some experience with implementation and will have an informed opinion about implementation. Data collection Data to assess the program will be derived from multiple sources, including TennCare pharmacy and medical claims, the Care Coordination Tool (Altruista Health GuidingCare® MTM application), and interviews with and surveys completed by key stakeholders of the program (e.g., credentialed pharmacists, physician groups, health system administrators). The study team will monitor data collection; the project does not include a formal data monitoring committee. The data will be reviewed quarterly by the study team to review progress and to identify any potential unintended consequences. The study team will also be responsible for communicating any changes to the study protocol to study stakeholders including participants and funders. Select members of the study team who have established a data use agreement will have access to the final trial dataset. Data will be served on a secure drive at the University of Tennessee Health Sciences Center.
Potential limitations The pilot has funding support for two years, and this timeframe may be an insufficient length to implement and evaluate outcomes associated with MTM services. Although the MTM program officially launched on time, there was a service delay due to credentialing and health plan contracting limitations. There are also limitations associated with technology implementation for pharmacists to acclimate to the new platform and process. The intent of the MTM program design was to have pharmacists integrated into the PCMH and THL care teams to maximize the interactions between both patients and pharmacists and physicians and pharmacists. However, the design allowed for voluntary participation by the PCT organizations, and this aspect of the model was often challenging to outside community pharmacists seeking to establish collaborative practice and business agreements. Additionally, one of the key design components of the program was to require the pharmacists to utilize a single platform for identifying and documenting MTM services, but this requirement often led pharmacists documenting in multiple health record systems. The risk model is also dependent upon claims submission (i.e. diagnosis coding), and without appropriate submissions of claims, eligible members would not be accurately captured. Furthermore, the ability to close gaps such as HEDIS measures is also dependent upon timely submission of encounter claims.
Data analysis For aim 1, we plan to produce descriptive statistics and conduct multivariable linear and logistic regressions. We plan to conduct pre/ post comparisons (i.e., TennCare members being serviced by MTM providers serving as their own control) and matched cohort analyses (i.e., comparisons between eligible TennCare with and without MTM encounters) will be reported. For aim 2, we plan to produce descriptive statistics to summarize program penetration and participants' perceptions about acceptability, feasibility, and appropriateness. We will use thematic analysis to explore themes from the interviews regarding other determinants of implementation. All interviews will be recorded, transcribed, and thematically sequenced by members of the study team. Aim 2 will employ a mixed-methods approach (QUAN + QUAL) where qualitative and quantitative data is collected simultaneously for the purpose of exploring participants’ perceptions about implementation (e.g., feasibility, appropriateness, acceptability) and other factors that may affect implementation (e.g., CFIR domains). The quantitative and qualitative data will be used to answer related questions (e.g., complementarity function). After the analysis is completed, the study team will disseminate the results of the study through a report issued to the funder and through peer reviewed manuscripts.
Expected results Discussion A pharmacist-led MTM program is an evidence-based intervention with clearly defined core components.1,2 The goal of the MTM program is to address misuse, overuse, and underuse of medications. Federal and state programs are currently expanding the use of MTM programs beyond the elderly to new, high-risk patients, such as Medicaid beneficiaries. To maximize the benefit of MTM programs, it is critical to promote consistent, high-quality implementation. This study will contribute to this end in two ways: (1) by testing the effectiveness of an intervention that proactively addresses known implementation barriers, and (2) by simultaneously studying effectiveness and implementation so that guidance regarding implementation can be disseminated quickly.
The purpose of this study is to demonstrate the effectiveness of the Tennessee MTM Program while gathering information about implementation outcomes (e.g., feasibility, acceptability, appropriateness, penetration). The present study contains several important innovations in pharmacy care. First, the Tennessee MTM Program is an innovative approach to MTM delivery that includes implementation strategies to overcome known barriers to MTM implementation (e.g., establishment of CPAs and PCMH integration to facilitate patient-physician collaboration, access to patient medical records to enhance pharmacist access to health information). To our knowledge, this is the first MTM program that formally incorporates all of these implementation strategies into a MTM program. This study also tests newly developed measures of implementation outcomes (e.g., the FIM, AIM, and IAM) in a pharmacy context.29 These newly developed measures have been proposed as measures in several study protocols in other contexts (e.g., substance use, child welfare).32,33 It is beneficial to test these implementation outcome
Acknowledgements N/A. All authors read and approved the final manuscript. 5
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List of abbreviations
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Michaels NM, Jenkins GF, Pruss DL, Heidrick JE, Ferreri SP. Retrospective analysis of community pharmacists' recommendations in the North Carolina Medicaid medication therapy management program. J Am Pharm Assoc. 2010;50(3):347–353. 18. Lounsbery JL, Green CG, Bennett MS, et al. Evaluation of pharmacists' barriers to the implementation of medication therapy management services. J Am Pharm Assoc. 2009;49(1):51–58. 19. Blake KB, Madhavan SS. Perceived barriers to provision of medication therapy management services (MTMS) and the likelihood of a pharmacist to work in a pharmacy that provides MTMS. Ann Pharmacother. 2010;44(3):424–431. 20. Vora J. Access to a Health System's Electronic Medical Record. Pharmacy Times September 2015. [Internet]. Accessed April 5, 2019. Available at:. https://www. pharmacytimes.com/publications/health-system-edition/2015/september2015/ access-to-a-health-systems-electronic-medical-record. 21. Lounsbery JL, Green CG, Bennett MS, et al. Evaluation of pharmacists' barriers to the implementation of medication therapy management services. J Am Pharm Assoc. 2009;49(1):51–58. 22. Chui MA, Stone JA, Odukoya AK, Maxwell L. Facilitating collaboration between pharmacists and physicians using an iterative interview process. J Am Pharm Assoc. 2014;54(1):35–41. 23. PQA Measures Used by CMS in the Star Ratings & as Display Ratings Program. By CMS in the Star Ratings & as Display Ratings Program. Accessed November 1, 2017 http://pqaalliance.org/measures/cms.asp. 24. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–226. 25. Kronick R, Gilmer T, Dreyfus T, Lee L. Improving health-based payment for Medicaid beneficiaries: CDPS. Health Care Financ Rev. 2000;21(3):29–64. 26. Chronic Illness and Disability Payment System. 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AIM CFIR CMS CPA CDPS +
Acceptability of Implementation Measure Consolidated Framework for Implementation Research Centers for Medicare and Medicaid Services Collaborative Practice Agreement Rx Chronic Illness and Disability Payment System plus Pharmacy CPT Current Procedural Terminology DM Diabetes Mellitus FIM Feasibility of Intervention Measure HEDIS Healthcare Effectiveness Data and Information Set IAM Intervention Appropriateness Measure MCO Managed Care Organization MTM Medication Therapy Management PCMH Patient-centered Medical Home PCT Primary Care Transformation TennCare Tennessee Medicaid Program TDS Targeted Disease State THL Tennessee Health Link Declarations Ethics approval and consent to participate All study procedures were approved by the Institutional Review Board of [Name of University]. Participants provided oral consent to the study team to participate, which was approved of by the IRB. Consent for publication Not applicable. Availability of data and materials Data sharing is not applicable to this study protocol as no datasets were generated or analyzed for this study protocol. Competing interests The authors declare that they have no competing interests. Funding This research was funded by TennCare, Tennessee's Medicaid Program. The funding body reviewed the study design, data collection, and analysis procedures. The funder does not play a role in interpreting the data or writing up the findings. There are no publication restrictions. The contact information for this organization is TennCare, 310 Great Circle Road, Nashville, TN, 37243, 1-800-342-3145. References 1. American Pharmacists Association and the National Association of Chain Drug Stores Foundation. Medication therapy management in pharmacy practice: core elements of an MTM service model (version 2.0). J Am Pharm Assoc. 2003;48:3 2008. 2. American Pharmacists Association. Medication Therapy Management Services Definition and Program Criteria. 2004; 2004. 3. Division for Heart Disease and Stroke Prevention. Community Pharmacists and Medication Therapy Management [Internet]. Centers for Disease Control and Prevention. Accessed February 11, 2019. Available at: https://www.cdc.gov/dhdsp/ pubs/guides/best-practices/pharmacist-mtm.htm. 4. Centers for Medicare and Medicaid Services. Prescription Drug Benefit Manual [Internet]. US Department of Health and Human Services. Accessed February 11, 2019. Available at: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/
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