Heart FailureNCT03608085
Community Pharmacy Medication Therapy Management for Heart Failure
A study testing Pharmacist Heart failure MTM training and Patient Heart failure MTM intervention in people with Heart Failure, run by Providence VA Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pharmacist Heart failure MTM training and Patient Heart failure MTM intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 May 2018to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Ocean State Research Institute
Providence, Rhode Island, 02908
Mary Ford, 401-273-7100 ext. 3674, Mary.Ford@va.gov
Tracey H Taveira, Pharm.D.
- Recruiting
Providence VAMC
Providence, Rhode Island, 02908
Melanie R Parent, Ba, 401-273-7100 ext. 6293, Melanie.Parent@va.gov
Tracey H Taveira, Pharm.D.
About this study
Official title: 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.
Read the 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
- Being tested
- Pharmacist Heart failure MTM training, Patient Heart failure MTM intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist Heart failure MTM trainingBehavioural
Also called Training intervention for pharmacists
The MTM training for pharmacists will consist of:
- Online material for home self-study (10 contact hours);
- Didactic coursework to obtain a national American Pharmaceutical Association (APhA) MTM certification (8 contact hours); and HF pharmacotherapy (4 contact hours);
- 1 60-minute sessions of point of care training in the community pharmacy practice lab setting by URI faculty;
- Monthly coaching conference calls/webinars with URI and Brown Faculty;
Patient Heart failure MTM interventionBehavioural
Also called MTM intervention for patients
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Heart failure MTM training | Experimental | Community pharmacist who will receive heart failure medication therapy management training Receives: 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. Receives: Behavioral: Patient Heart failure MTM intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 180 days
Secondary outcomes (1)
Change in the Conditions of Work Effectiveness Questionnaire II (CWEQ-II Scale)
Improvement from baseline in (aim 1b) empowerment (Conditions of Work Effectiveness Questionnaire II (CWEQ-II Scale) to 180 days. The Conditions of Work Effectiveness Questionnaire II (CWEQ-II) consists of 19 items that measures the six subscales of structural empowerment (opportunity, information, support, resources, formal power and informal power). These subscales help define the relationship the pharmacist has with the healthcare team and in the practice setting. Based on results of a confirmatory factor analysis that validated the factor structure of this instrument, a total empowerment score is created by summing the six subscales with a score range between 6-30. Responses to all items are made on a 5-point Likert scale (1 = None and 5 = A lot). Total mean scores ranging from 6 to 13 are low levels of empowerment and 14 to 22 are moderate levels of empower and 23 to 30 as high levels of empowerment.
Measured: baseline to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start23 May 2018
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Lifespan, University of Rhode Island
- Responsible party
- Principal investigator, Tracey H. Taveira, Providence VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608085
- Sponsor's protocol ID
- 1087691-2
- Status last verified
- Oct 2021
- First submitted
- 31 May 2018
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Medication Therapy Management by Pharmacists for Patients Recently Discharged From Heart Failure Hospitalization
- ClinicalTrials.gov ID
- NCT03608085
- Acronym / sponsor ID
- 1087691-2
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Collaborators
- Lifespan, University of Rhode Island
- Study start
- 23 May 2018 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Heart failure MTM training | Experimental | Behavioral: Pharmacist Heart failure MTM trainingCommunity pharmacist who will receive heart failure medication therapy management training |
| Patient Heart failure MTM intervention | Experimental | Behavioral: Patient Heart failure MTM interventionIndependently 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist Heart failure MTM trainingAlso: Training intervention for pharmacistsThe 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; | Behavioural | Pharmacist Heart failure MTM training |
| Patient Heart failure MTM interventionAlso: MTM intervention for patientsThe 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. | Behavioural | Patient Heart failure MTM intervention |
Primary outcome
Change in the 31-item MTM self-efficacy scale
Time frame: baseline to 180 days
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.
1 secondary outcome
Change in the Conditions of Work Effectiveness Questionnaire II (CWEQ-II Scale)
Time frame: baseline to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Heart failure MTM training and Patient Heart failure MTM intervention in people with Heart Failure, run by Providence VA Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Ford (4012737100 ext. 3674, Mary.Ford@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 31-item MTM self-efficacy scale (time frame: baseline to 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.