Community Pharmacy Medication Therapy Management for Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/2/2018 |
| Start Date: | May 23, 2018 |
| End Date: | May 31, 2019 |
| Contact: | Mary Ford |
| Email: | Mary.Ford@va.gov |
| Phone: | 4012737100 |
Community Medication Therapy Management by Pharmacists for Patients Recently Discharged From Heart Failure Hospitalization
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.
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.
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.
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.
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.
We found this trial at
2
sites
Providence, Rhode Island 02908
Principal Investigator: Tracey H Taveira, Pharm.D.
Phone: 401-273-7100
Click here to add this to my saved trials
Providence, Rhode Island 02908
Principal Investigator: Tracey H Taveira, Pharm.D.
Phone: 401-273-7100
Click here to add this to my saved trials