Recruiting

Medication Therapy Management

Sponsor:

Providence VA Medical Center

Code:

NCT03608085

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pharmacist Heart failure MTM training

Patient Heart failure MTM intervention

Study Details

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

Study ID

NCT03608085

Start date

May 23, 2018

Status verified date

Oct, 2021

Completion date

Jan 1, 2023

Anticipated

Primary completion date

Jan 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

83 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Pharmacist Heart failure MTM training

Community pharmacist who will receive heart failure medication therapy management training

experimental: 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.

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;

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.

Primary outcome measure

  • Change in the 31-item MTM self-efficacy scale [ Time Frame: baseline to 180 days ]

Central Contacts and Locations

Central contacts

Mary Ford

4012737100Mary.Ford@va.gov

Locations

Ocean State Research Institute

Recruiting

Providence, Rhode Island, United States, 02908

Contacts

Mary Ford

401-273-7100Mary.Ford@va.gov

Principal Investigator:

Tracey H Taveira, Pharm.D.

Providence VAMC

Recruiting

Providence, Rhode Island, United States, 02908

Contacts

Melanie R Parent, Ba

401-273-7100Melanie.Parent@va.gov

Principal Investigator:

Tracey H Taveira, Pharm.D.

More Information

Sponsor

Providence VA Medical Center

Last update posted

Oct 11, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Providence VA Medical Center on 2021-10-11.