Community Pharmacy Medication Therapy Management for Heart Failure

NCT ID: NCT03608085

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2023-01-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pharmacist Heart failure MTM training

Community pharmacist who will receive heart failure medication therapy management training

Group Type: EXPERIMENTAL

Pharmacist Heart failure MTM training

Intervention Type: BEHAVIORAL

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;

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.

Group Type: EXPERIMENTAL

Patient Heart failure MTM intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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;

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Training intervention for pharmacists; MTM intervention for patients

Eligibility Criteria

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.

• 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

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifespan

OTHER

Sponsor Role: collaborator

University of Rhode Island

OTHER

Sponsor Role: collaborator

Providence VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Tracey H. Taveira

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ocean State Research Institute

Providence, Rhode Island, United States

Site Status: RECRUITING

Providence VAMC

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Ford

Role: CONTACT

Mary.Ford@va.gov

4012737100 ext. 3674

Facility Contacts

Mary Ford

Role: primary

Mary.Ford@va.gov

401-273-7100 ext. 3674

Melanie R Parent, Ba

Role: primary

Melanie.Parent@va.gov

401-273-7100 ext. 6293

Other Identifiers

1087691-2

Identifier Type: -

Identifier Source: org_study_id