Establishing a Common Language for Comprehensive Medication Management JCPP 4th Quarter Meeting November 29, 2018

Questions Framing Today’s Discussion What does implementation science tell us about defining and measuring innovations/interventions? How does the Pharmacist’s Patient Care Process relate to specific services delivered by pharmacists? How can we accelerate the dissemination and adoption of pharmacist-delivered services with fidelity?

Do the clinical services of pharmacists produce value in the health care system in ambulatory care? AHRQ Effective Health Care Program Provide valid evidence about the comparative effectiveness of different medical interventions Systematic analysis of 44 studies What are components and implementation features of medication management services? Are medication management services effective in improving intermediate outcomes, patient-centered outcomes and/or resource utilization? Does effectiveness of medication management services differ by implementation features or patient characteristics? Are there harms from medication management services? AHRQ Publication No. 14(15)-EHC037-EF. Rockville, MD: Agency for Healthcare2014. AHRQ Publication No. 14(15)-EHC037-EF. Rockville, MD: Agency for Healthcare Research and Quality; November 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

AHRQ Effective Health Care Program MTM Interventions in Outpatient Settings Systematic review of 44 studies Conclusion: The evidence base offers low evidence of benefit for a limited number of intermediate and health utilization outcomes. We graded the evidence as insufficient for most outcomes because of inconsistency in direction, magnitude and precision, rather than lack of evidence. Wide variations in populations and interventions, both within and across studies, likely explain these inconsistencies…. AHRQ Publication No. 14(15)-EHC037-EF. Rockville, MD: Agency for Healthcare2014. New research, regardless of specific focus, will likely continue to find inconsistent results until underlying sources of heterogeneity are accounted for.

A Payer’s Perspective on Evidence Integrated health care provider and health insurance company Analyses: To determine if the medication therapy management (MTM) program has a positive effect on the total costs of care for fully insured members who have been identified as eligible for the program and have enrolled to participate Methods: matched case/control analysis approach Matched members from the fully insured MTM enrolled case study group to members of a self insured control group based on demographics as well as pre-invitation utilization information Adjusted clinical groups, reimbursement amount, gender, age, CDC grouping sum 374 matched members

A Payer’s Perspective on Evidence Results: Return on investment of 11:1 when annualized savings were compared to fully loaded expenses (including indirect expenses at 60%). Repeated analysis in 2016, same results Key Environmental Factors Common patient care process (CMM) – fidelity of service Face-to-face assessments Competency of practitioners Service integrated with medical providers Integration with EMR Population management – targeting highest utilizing patients

Are these questions the same? Do the clinical services of pharmacists produce value to patients and payers? Versus Does a team-based medication management service defined and delivered consistently produce value to patients and payers?

Reasons for Mixed Results Implementation Variability Ill-defined intervention and delivery context Lack of pharmacy-centric implementation measures Lack of a systematic implementation strategy The lack of conclusive results is attributed, in part, to implementation variability. Delivery of medication optimization interventions, like CMM, appears to be highly variable across pharmacists, patients, and settings. The reason inconsistent implementation is important is because it is has been associated with inconclusive clinical outcomes. There are several reasons that can lead to implementation variability including: insufficiently defined interventions and lack of guidance on how to operationalize these interventions in practice minimal efforts to monitor implementation to ensure that interventions are delivered as intended limited use of proactive implementation strategies designed to facilitate successful uptake Inconclusive Health Research Outcomes

Implementing an Intervention that Consistently Produces Value Define the care process Replication Sustainability Scaling Implementation strategy, learnings, and tools Successful Implementation This study represented a huge opportunity to address these problems by exploring and creating the conditions and tools necessary for successful implementation of CMM…not only to enhance the likelihood of clinical outcomes but also to prepare for successful replication, sustainability, and scaling of CMM CMM Fidelity Assessment Context Wraparound Infrastructure Practice Management Self-Assessment Content CMM Patient Care Process CMM Self-Assessment Competence Quality of Clinical Decision Making Patient Responsiveness Survey Fidelity and other implementation outcomes measures

A Common Language for the Patient Care Process for Comprehensive Medication Management

JCPP Pharmacists’ Patient Care Process Nursing Patient Care Process

What is unique about the pharmacists’ patient care process?

Defining a Usable Innovation Clear description of the program Clear Philosophy, Values, and Principles Clear inclusion and exclusion criteria that define the population for which the program is intended Clear description of the essential functions that define the program Clear description of the features that must be present to say that a program exists in a given location Operational definitions of the essential functions Profiles describe the core activities that allow a program to be teachable, learnable, and doable in practice; promote consistency across practitioners at the level of service delivery A practical assessment of the performance of practitioners (and patients) who are using the program Michie and colleagues, 2005; 2009 Fixsen, Blase, Metz, & Van Dyke, 2013

Research Methods for Producing a “Common Language” for CMM

Establishing a Common Language for the Patient Care Process for Delivering CMM Literature Review Vetting & Consensus Focus Groups First Draft Second Draft Expert Panel Review Third Draft Stabilized Draft Key Informant Interviews Document Review TAP Interviews Phase 1 Phase 2 Phase 3 Phase 4

JCPP Pharmacists Patient Care Process Alignment of JCPP and the CMM Patient Care Process JCPP Pharmacists Patient Care Process CMM Patient Care Process Collect and Analyze Information Assess Information and Formulate a Medication Therapy Problem List Develop the Care Plan Implement the Care Plan Follow-up and Monitor Note: Same 5 Essential Functions or Steps

Operational Definition Essential Function Assess the Information and Formulate a Medication Therapy Problem List The clinical pharmacist assesses the information collected and formulates a problem list consisting of the patient’s active medical problems and medication therapy problems in order to prioritize recommendations to optimize medication use and achieve clinical goals. Operational Definition Assess and prioritize the patient’s active medical conditions taking into account clinical and patient goals of therapy. Assess the indication of each medication the patient is taking. Assess the effectiveness of each medication the patient is taking. Assess the safety of each medication the patient is taking. Assess adherence of each medication the patient is taking. Formulate a medication therapy problem list via the medication therapy problem categories established by the Pharmacy Quality Alliance Prioritize the patient’s medication therapy problems. The pharmacist assesses the information collected and analyzes the clinical effects of the patient’s therapy in the context of the patient’s overall health goals in order to identify and prioritize problems and achieve optimal care. This process includes assessing: • Each medication for appropriateness, effectiveness, safety, and patient adherence • Health and functional status, risk factors, health data, cultural factors, health literacy, and access to medications or other aspects of care • Immunization status and the need for preventive care and other health care services, where appropriate

Operational Definition Assess and prioritize the patient’s active medical conditions taking into account clinical and patient goals of therapy. Assess the indication of each medication the patient is taking by considering the following: Does the patient have an indication for the medication? Is the medication appropriate for the medical condition being treated? Does the patient have an untreated medical condition that requires therapy, but is not being treated or prevented? Assess the effectiveness of each medication the patient is taking by considering the following: Is the patient meeting clinical goals of therapy? Is the patient meeting overall personal goals of therapy? Is the most appropriate drug product being used for the medical condition? Is the dose, frequency, and duration appropriate for the patient? Do additional labs need to be obtained to monitor the effectiveness of the medication therapy? Assess the safety of each medication the patient is taking by considering the following: Is the patient experiencing an allergy or adverse effect from a medication? Is the dose too high for the patient? Is the frequency and duration appropriate for the patient? Do safer alternatives exist? Are there any pertinent drug-disease, drug-drug, or drug-food interactions? Do additional labs need to be obtained to monitor the safety of the medication therapy? Assess adherence of each medication the patient is taking by considering the following: Is the patient receiving the most affordable option to optimize adherence? Is the patient able to obtain his/her medications, and, if not, why? Are the medications taken at times during the day that are convenient for the patient? Is the patient taking the medications as prescribed/instructed or missing doses? If the patient is not taking as instructed or missing doses, why? Is the frequency and formulation appropriate for the patient to optimize adherence? Formulate a medication problem list via the medication therapy problem categories established by the Pharmacy Quality Alliance Prioritize the patient’s medication therapy problems.

Pharmacists Patient Care Process vs Pharmacists Patient Care Process vs. Patient Care Process for a Defined Service Patient Care Process for Comprehensive Medication Management Patient Care Process for Targeted Disease Management

The Diffusion-Dissemination-Implementation Continuum The passive, untargeted and unplanned spread of new practices. Active spread of new practices to the target audience using planned strategies. The process of adoption, integration and use of new practices within a setting Implementation Dissemination Diffusion

How can we accelerate the dissemination and adoption of a consistent approach to the delivery of CMM in the context of the PPCP? Current Dissemination Strategies Additional Venues for Dissemination ACCP communications channels ACCP Team-Based Practice Forum “Pharmacy Forward” podcast Web-based CMM Implementation Platform hosted by UNC “Intro to CMM” online course hosted by UMN Foundational component of the A3 Collaborative JCPP organizations Social media Practitioner programs Professional education Students Preceptors Residency education Other workforce development strategies

A special thank you to ACCP and the ACCP Foundation