Trials / Unknown
UnknownNCT03608085
Community Pharmacy Medication Therapy Management for Heart Failure
Community Medication Therapy Management by Pharmacists for Patients Recently Discharged From Heart Failure Hospitalization
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- Sponsor
- Providence VA Medical Center · Federal
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Pharmacist Heart failure MTM training | The MTM training for pharmacists will consist of: 1. Online material for home self-study (10 contact hours); 2. Didactic coursework to obtain a national American Pharmaceutical Association (APhA) MTM certification (8 contact hours); and HF pharmacotherapy (4 contact hours); 3. 1 60-minute sessions of point of care training in the community pharmacy practice lab setting by URI faculty; 4. Monthly coaching conference calls/webinars with URI and Brown Faculty; |
| BEHAVIORAL | Patient Heart failure MTM intervention | The baseline visit will take place \>= 7 but \<= 30 days post discharge from the HF hospitalization. Follow-up visits will occur either in person at the patients local pharmacy or via telephone at 30, 60, 90 and 120 days post baseline and will consist of the following: Preparation: Develop personal medication record (PMR). Assessment: Medication therapy reconciliation; Education: Review heart failure basics and behavioral goals Planning: Documentation of a medication related action plan and identify medication related problems Implementation: Communication of medication related action plan and changes in heart failure symptoms to the patients providers. Follow up: Monitor and evaluate the care plan in collaboration with the patient's providers. |
Timeline
- Start date
- 2018-05-23
- Primary completion
- 2023-01-01
- Completion
- 2023-01-01
- First posted
- 2018-07-31
- Last updated
- 2021-10-11
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03608085. Inclusion in this directory is not an endorsement.