Clinical trial NCT03608085: Community Pharmacy Medication Therapy Management for Heart Failure
Official title: Community Medication Therapy Management by Pharmacists for Patients Recently Discharged From Heart Failure Hospitalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Providence VA Medical Center
Sponsor class: FED
Collaborators: name: Lifespan
name: University of Rhode Island
First posted: 2018-07-31
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Pharmacist Participants:

All pharmacists employed in community pharmacies (n=20) located in either Newport or Bristol county, Rhode Island pharmacies will be offered study enrollment. Pharmacist who meet the inclusion criteria below but chose to not to participate in the training intervention will still be asked to enroll to participate in surveys and interviews to determine their reasons for non-participation.

Inclusion Criteria

* All licensed pharmacists aged ≥18 years that are employed at least part time (minimum of 4 hours per week) in a community pharmacy located in either Newport or Bristol Counties.
* All licensed pharmacists who anticipate working in a community pharmacy located in either Newport or Bristol Counties for the next 6 months
* Able to sign informed consent

The State of Rhode Island pharmacy licensure requirements are as follows:

* Completion of a first professional degree program in pharmacy located within the United States and accredited by the American Council on Pharmaceutical Education.
* Completion of 1,500 internship hours.
* Passage of the North American Pharmacist Licensure Examination (NAPLEX), administered through the National Association of Boards of Pharmacy.
* Passage of the Multistate Pharmacy Jurisprudence Examination (MPJE) for Rhode Island, administered through the National Association of Boards of Pharmacy.

Exclusion Criteria

* Pharmacists with an expired, inactive, suspended license.
* Pharmacist who, in the investigator's opinion, will not comply with study procedures or are unable to provide informed consent.
* Of note, we will not exclude pharmacists who have already completed the general National APhA certification program as this training intervention will focus on MTM in patients with HF

Patient Participants

Thirty patients aged \>18 years discharged from Newport Hospital for a HF hospitalization who are prescribed at least 1 cardiovascular medication for HF and at least 3 other medications for chronic disease

Inclusion Criteria

* All subjects \>18 years old,
* ≤30 days post-HF hospitalization discharged to a community dwelling,
* Prescribed at least 1 cardiovascular medication for HF (ACE-Inbitors, Angiotensin Receptor Blockers, sacubitril, aldosterone antagonist, diuretics, digoxin, ivabradine and hydralazine, beta blockers and nitrates), and 3 other medications for chronic disease
* Able to sign consent and participate in a MTM consultation

Exclusion Criteria

* Psychiatric instability (acutely suicidal, psychotic) or organic brain injury that precludes self-reporting on health status,
* Discharged to hospice or nursing home or assisted living facilities, or patients with a code status of comfort-measures-only
* Recipients of heart transplant, ventricular assist devices, intravenous inotropic infusions or woman who are pregnant since these conditions would preclude them from standard HF care.

Primary outcomes:
measure: Change in the 31-item MTM self-efficacy scale
timeFrame: baseline to 180 days
Secondary outcomes:
measure: Change in the Conditions of Work Effectiveness Questionnaire II (CWEQ-II Scale)
timeFrame: baseline to 180 days
Other outcomes:
measure: Reach, adoption and implementation
timeFrame: baseline to 180 days
measure: Change in heart failure self care behaviors scale (Self Care HF Index v6)
timeFrame: baseline to 180 days
measure: Change in medication adherence
timeFrame: baseline to 180 days
measure: Death and re-hospitalizations
timeFrame: baseline to 180 days
Locations:
city: Providence
country: United States
facility: Ocean State Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Providence VAMC
state: Rhode Island
Study officials:
References: