Community Pharmacy Medication Therapy Management for Heart Failure
- Conditions
- Heart Failure
- Interventions
- Behavioral: Patient Heart failure MTM interventionBehavioral: Pharmacist Heart failure MTM training
- Registration Number
- NCT03608085
- Lead Sponsor
- Providence VA Medical Center
- Brief Summary
Pharmacist-provided medication therapy management (MTM) services have been suggested as a way to improve heart failure (HF) outcomes and counter fragmented care. Nevertheless, broad implementation of MTM services, especially for HF, has not occurred. Therefore, the investigators propose a community engagement pilot study to evaluate the feasibility of 1) training of community pharmacists to perform MTM for HF patients by the University of Rhode Island (URI) Faculty and Brown University Physicians, 2) community pharmacists performing MTM post-training for patients discharged with HF in their own community, 3) establishment of a community based research network (CBRN) and registry to assess the efficacy of the training and the MTM intervention through collaboration among patients with HF, community pharmacists and URI pharmacists and Brown University physicians.
- Detailed Description
The pharmacists (n=53) of the 20 community pharmacies located in Newport and Bristol Counties will serve as the CBRN intervention sites. The investigators will also enroll 30 independently living community dwelling subjects who are prescribed at least 1 cardiovascular medication for HF and 3 additional chronic medications after discharge from Newport Hospital for an MTM consultation at a CBRN pharmacy. The investigators will assess the implementation of our community intervention based on the REAIM framework. The specific aims are:
Specific Aim 1 (Efficacy): To investigate whether pharmacists who receive the CBRN MTM empowerment training will experience improvement in (aim 1a) self-efficacy and (aim 1b) empowerment from baseline to 180-days.
Specific Aim 2: To assess over the 180-day period, 2a) the reach, 2b) adoption, 2c) implementation (consistency, time spent in lieu of cost and adaptation) including barriers and facilitators.
Specific Aim 3 Exploratory: To determine whether HF patients who receive an MTM intervention from a CBRN community pharmacist experience improvement in HF Self-care behaviors and medication adherence from baseline to 180 days.
Specific Aim 4: To establish a CBRN registry of HF patients to track community pharmacy practices in MTM, hard events such as rehospitalization and death and to evaluate the feasibility of collecting HF outcomes from EPIC electronic health record compared to patient self-report and physician adjudication.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 83
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient Heart failure MTM intervention Patient Heart failure MTM intervention Independently living community dwelling subjects who are prescribed at least 1 cardiovascular medication for HF and 3 additional chronic medications after discharge from the Hospital for an MTM consultation by a pharmacist trained in heart failure medication therapy management. Pharmacist Heart failure MTM training Pharmacist Heart failure MTM training Community pharmacist who will receive heart failure medication therapy management training
- Primary Outcome Measures
Name Time Method Change in the 31-item MTM self-efficacy scale baseline to 180 days Improvement from baseline in the 31-item MTM Self-efficacy Scale to 180 days. The pharmacists' self-efficacy in performing medication therapy management services scale is a 31-item scale and is divided into the following 5 domains: identify and enroll patients (4 items), provide services (14 items), document and bill services (5 items), collaborating with others (2 items), and specific service tools (8 items). An 11-point Likert scale asks pharmacists to rate "how certain you are that you can do these activities," with response options ranging from 0=cannot do at all to 5=moderately certain can do, and 10= highly certain can do. A total score of ≤124 is determined to represent low self-efficacy, a score of 125-217 is considered moderate, and a score of 218-310 is considered to represent high self-efficacy.
- Secondary Outcome Measures
Name Time Method Change in the Conditions of Work Effectiveness Questionnaire II (CWEQ-II Scale) baseline to 180 days Improvement from baseline in (aim 1b) empowerment (Conditions of Work Effectiveness Questionnaire II (CWEQ-II Scale) to 180 days. The Conditions of Work Effectiveness Questionnaire II (CWEQ-II) consists of 19 items that measures the six subscales of structural empowerment (opportunity, information, support, resources, formal power and informal power). These subscales help define the relationship the pharmacist has with the healthcare team and in the practice setting. Based on results of a confirmatory factor analysis that validated the factor structure of this instrument, a total empowerment score is created by summing the six subscales with a score range between 6-30. Responses to all items are made on a 5-point Likert scale (1 = None and 5 = A lot). Total mean scores ranging from 6 to 13 are low levels of empowerment and 14 to 22 are moderate levels of empower and 23 to 30 as high levels of empowerment.
Trial Locations
- Locations (2)
Providence VAMC
🇺🇸Providence, Rhode Island, United States
Ocean State Research Institute
🇺🇸Providence, Rhode Island, United States