Heart FailureNCT06099808
Veterans Affairs Pharmacist Heart Failure Medication Titration Project 1
A study testing Audit and Feedback Emails, Patient Specific Targets and Educational Resources in people with Heart Failure, run by Stanford University at 1 site in United States.
Trial summary
This is a randomized quality improvement project to evaluate the impact of an audit and feedback intervention to motivate pharmacists to provide heart failure (HF) medication management to patients in the Veterans Health Administration (VHA) Sierra Pacific region (VISN 21). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Audit and Feedback Emails, Patient Specific Targets and Educational Resources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 30 Sep 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical pharmacists in the Veterans Health Administration that provide Patient Aligned Care Team (PACT) care in VA Sierra Pacific Network (VISN 21)
Who cannot join
- Excluded per pharmacist supervisor decision
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Veteran's Affairs Hospital
Palo Alto, California, 94304
About this study
Official title: Randomized Evaluation of Audit and Feedback Intervention to Promote Pharmacist Heart Failure Medication Titration in Veterans Affairs Sierra Pacific Network
This is a randomized quality improvement project to evaluate the impact of an audit and feedback intervention to motivate pharmacists to provide heart failure (HF) medication management to patients in the Veterans Health Administration (VHA) Sierra Pacific region (VISN 21). The results of this project could provide guidance for how to successfully scale a pharmacist-based HF remote management program in the VHA more broadly.
Pharmacists providing clinical care as part of Patient Aligned Care Team (PACT) within VHA VISN 21 will be included. Pharmacists will be randomized to one of 3 arms in a 1:1:2 ratio: (1) monthly audit and feedback of HF medication titration activities (AF) vs. (2) educational resources and monthly notification of HF medication titration actions in addition to a list of potential patients for HF optimization (AF+) vs. (3) usual care without audit and feedback (UC). Pharmacists across all three arms will be given access to shared educational resources on HF pharmacist care and educational webinars. Six months after the intervention, rates of pharmacist HF medication titration encounters will be compared among the 3 groups.
- Conditions
- Heart Failure
- Being tested
- Audit and Feedback Emails, Patient Specific Targets, Educational Resources
- Keywords
- Pharmacist, Medication therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and Feedback EmailsOther
Monthly email containing information including their total medication titration encounters over a 3 month period, as well as the site and VISN level for comparison. This will include rates of GDMT utilization and percentage of patients on >50% of the target dose of GDMT stratified by site, VISN and national. This data will be obtained from VHA national HF dashboard.
Patient Specific TargetsOther
Monthly emails include a list of 5-7 HF patients who are potentially eligible for pharmacist HF medication titration. This data will be obtained from VHA national HF dashboard.
Educational ResourcesOther
Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.
| Study group | Role | What they receive |
|---|---|---|
| Audit and Feedback (AF) | Experimental | Pharmacists randomized to audit and feedback will receive a monthly email containing information including their total medication titration encounters over a 3 month period, as well as the site and VISN level for comparison. The audit and feedback email will also contain rates of medical therapy and percentage of patients on >50% of the target dose of medical therapy stratified by site, VISN and national. This data will be obtained from VHA national HF dashboard. Pharmacists in AF will also receive invitations to monthly educational sessions and access to shared resources on HF medication management. Receives: Other: Audit and Feedback Emails; Other: Educational Resources |
| Audit and Feedback with Patient Specific Targets (AF+) | Experimental | Pharmacists randomized to the AF+ group will receive the audit and feedback intervention described above with the addition of a list of 5-7 HF patients who are potentially eligible for pharmacist HF medication titration. These patients will be identified using the VHA national HF dashboard. Receives: Other: Audit and Feedback Emails; Other: Patient Specific Targets; Other: Educational Resources |
| Usual Care | Active comparator | Pharmacists randomized to the usual care arm will have access to monthly educational sessions and to shared resources on HF medication management. They will receive no additional feedback. Receives: Other: Educational Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of monthly heart failure medication adjustment encounters
Encounters in which pharmacist adjusted heart failure medications
Measured: 2 months post-randomization to 6 months post-randomization
Secondary outcomes (8)
Percentage of heart failure patients with medication management by pharmacist
For each pharmacist, will calculate the percentage of patients with heart failure in their panel that receive medication adjustments from pharmacist
Measured: Within 6 months post-randomization
Number of new patients with pharmacist HF management
For each pharmacist, will calculate the number of patients with heart failure in their panel that receive care from pharmacist that were not receiving care prior to randomization
Measured: Within 6 months post-randomization
Guideline medical therapy score
Composite score of heart failure medical therapy among patients with heart failure for patients within each pharmacists panel
Measured: At 6 months post randomization
Beta-blocker therapy
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with beta-blocker therapy
Measured: At 6 months post randomization
Renin-angiotensin system inhibitor (RASI) therapy
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with RASI therapy
Measured: At 6 months post randomization
Angiotensin receptor neprilysin inhibitor (ARNI) therapy
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with ARNI therapy
Measured: At 6 months post randomization
Mineralocorticoid receptor antagonist (MRA) therapy
Percentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy
Measured: At 6 months post randomization
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy
Percentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy
Measured: At 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start20 Nov 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Paul A. Heidenreich, Stanford University
- Investigators
- Paul A Heidenreich, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099808
- Sponsor's protocol ID
- 72662
- Status last verified
- Apr 2024
- First submitted
- 18 Oct 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Audit and Feedback Intervention to Promote Pharmacist Heart Failure Medication Titration in Veterans Affairs Sierra Pacific Network
- ClinicalTrials.gov ID
- NCT06099808
- Acronym / sponsor ID
- 72662
- Conditions
- Heart Failure
- Keywords
- Pharmacist, Medication therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
This is a randomized quality improvement project to evaluate the impact of an audit and feedback intervention to motivate pharmacists to provide heart failure (HF) medication management to patients in the Veterans Health Administration (VHA) Sierra Pacific region (VISN 21). The results of this project could provide guidance for how to successfully scale a pharmacist-based HF remote management program in the VHA more broadly.
Pharmacists providing clinical care as part of Patient Aligned Care Team (PACT) within VHA VISN 21 will be included. Pharmacists will be randomized to one of 3 arms in a 1:1:2 ratio: (1) monthly audit and feedback of HF medication titration activities (AF) vs. (2) educational resources and monthly notification of HF medication titration actions in addition to a list of potential patients for HF optimization (AF+) vs. (3) usual care without audit and feedback (UC). Pharmacists across all three arms will be given access to shared educational resources on HF pharmacist care and educational webinars. Six months after the intervention, rates of pharmacist HF medication titration encounters will be compared among the 3 groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Audit and Feedback (AF) | Experimental | Other: Audit and Feedback Emails, Other: Educational ResourcesPharmacists randomized to audit and feedback will receive a monthly email containing information including their total medication titration encounters over a 3 month period, as well as the site and VISN level for comparison. The audit and feedback email will also contain rates of medical therapy and percentage of patients on >50% of the target dose of medical therapy stratified by site, VISN and national. This data will be obtained from VHA national HF dashboard. Pharmacists in AF will also receive invitations to monthly educational sessions and access to shared resources on HF medication management. |
| Audit and Feedback with Patient Specific Targets (AF+) | Experimental | Other: Audit and Feedback Emails, Other: Patient Specific Targets, Other: Educational ResourcesPharmacists randomized to the AF+ group will receive the audit and feedback intervention described above with the addition of a list of 5-7 HF patients who are potentially eligible for pharmacist HF medication titration. These patients will be identified using the VHA national HF dashboard. |
| Usual Care | Active comparator | Other: Educational ResourcesPharmacists randomized to the usual care arm will have access to monthly educational sessions and to shared resources on HF medication management. They will receive no additional feedback. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical pharmacists in the Veterans Health Administration that provide Patient Aligned Care Team (PACT) care in VA Sierra Pacific Network (VISN 21)
Key exclusion criteria (1 listed)
- Excluded per pharmacist supervisor decision
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 |
|---|---|---|
| Audit and Feedback EmailsMonthly email containing information including their total medication titration encounters over a 3 month period, as well as the site and VISN level for comparison. This will include rates of GDMT utilization and percentage of patients on >50% of the target dose of GDMT stratified by site, VISN and national. This data will be obtained from VHA national HF dashboard. | Other | Audit and Feedback (AF), Audit and Feedback with Patient Specific Targets (AF+) |
| Patient Specific TargetsMonthly emails include a list of 5-7 HF patients who are potentially eligible for pharmacist HF medication titration. This data will be obtained from VHA national HF dashboard. | Other | Audit and Feedback with Patient Specific Targets (AF+) |
| Educational ResourcesMonthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management. | Other | Audit and Feedback (AF), Audit and Feedback with Patient Specific Targets (AF+), Usual Care |
Primary outcome
Number of monthly heart failure medication adjustment encounters
Time frame: 2 months post-randomization to 6 months post-randomization
Encounters in which pharmacist adjusted heart failure medications
8 secondary outcomes
Percentage of heart failure patients with medication management by pharmacist
Time frame: Within 6 months post-randomization
Number of new patients with pharmacist HF management
Time frame: Within 6 months post-randomization
Guideline medical therapy score
Time frame: At 6 months post randomization
Beta-blocker therapy
Time frame: At 6 months post randomization
Renin-angiotensin system inhibitor (RASI) therapy
Time frame: At 6 months post randomization
Angiotensin receptor neprilysin inhibitor (ARNI) therapy
Time frame: At 6 months post randomization
Mineralocorticoid receptor antagonist (MRA) therapy
Time frame: At 6 months post randomization
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy
Time frame: At 6 months post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Paul A Heidenreich, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Feedback Emails, Patient Specific Targets and Educational Resources in people with Heart Failure, run by Stanford University at 1 site 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 1 inclusion and 1 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of monthly heart failure medication adjustment encounters (time frame: 2 months post-randomization to 6 months post-randomization). 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 17 Apr 2024.