Community Pharmacy Medication Therapy Management for Heart Failure

NCT03608085 | Unknown DMC

• 1 other identifier: 1087691-2
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in the 31-item MTM self-efficacy scale

  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.

  baseline to 180 days

Secondary Outcomes (1)

• Change in the Conditions of Work Effectiveness Questionnaire II (CWEQ-II Scale)

  baseline to 180 days

Other Outcomes (4)

• Reach, adoption and implementation

  baseline to 180 days

• Change in heart failure self care behaviors scale (Self Care HF Index v6)

  baseline to 180 days

• Change in medication adherence

  baseline to 180 days

Study Arms (2)

Pharmacist Heart failure MTM training

EXPERIMENTAL

Community pharmacist who will receive heart failure medication therapy management training

Behavioral: Pharmacist Heart failure MTM training

Patient Heart failure MTM intervention

EXPERIMENTAL

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.

Behavioral: Patient Heart failure MTM intervention

Interventions

Pharmacist Heart failure MTM training 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;

Also known as: Training intervention for pharmacists

Pharmacist Heart failure MTM training

Patient Heart failure MTM intervention 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.

Also known as: MTM intervention for patients

Patient Heart failure MTM intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Providence VA Medical Center: lead
• Lifespan: collaborator
• University of Rhode Island: collaborator

Study Sites (2)

Ocean State Research Institute

Providence, Rhode Island, 02908, United States

RECRUITING

Providence VAMC

Providence, Rhode Island, 02908, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Pharmacists

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Central Study Contacts

Mary Ford

CONTACT

4012737100; Mary.Ford@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: July 31, 2018
• Study Start: May 23, 2018
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

US (2)