Veterans Affairs Pharmacist Heart Failure Medication Titration Project 1

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06099808

Collaborator

VA Palo Alto Health Care System (U.S. Fed)

110

Enrollment

Location

Arms

11.2

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Audit and Feedback Emails Other: Patient Specific Targets Other: Educational Resources	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Randomized Evaluation of Audit and Feedback Intervention to Promote Pharmacist Heart Failure Medication Titration in Veterans Affairs Sierra Pacific Network

Anticipated Study Start Date :

Oct 24, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Audit and Feedback (AF) 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.	Other: Audit and Feedback Emails 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. Other: Educational Resources Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.
Experimental: Audit and Feedback with Patient Specific Targets (AF+) 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.	Other: Audit and Feedback Emails 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. Other: Patient Specific Targets 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. Other: Educational Resources Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.
Active Comparator: Usual Care 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.	Other: Educational Resources Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.

Arm

Intervention/Treatment

Experimental: Audit and Feedback (AF)

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.

Other: Audit and Feedback Emails

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.

Other: Educational Resources

Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.

Experimental: Audit and Feedback with Patient Specific Targets (AF+)

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.

Other: Audit and Feedback Emails

Other: Patient Specific Targets

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.

Other: Educational Resources

Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.

Active Comparator: Usual Care

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.

Other: Educational Resources

Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.

Outcome Measures

Primary Outcome Measures

Number of monthly heart failure medication adjustment encounters [2 months post-randomization to 6 months post-randomization]
Encounters in which pharmacist adjusted heart failure medications

Secondary Outcome Measures

Percentage of heart failure patients with medication management by pharmacist [Within 6 months post-randomization]
For each pharmacist, will calculate the percentage of patients with heart failure in their panel that receive medication adjustments from pharmacist
Number of new patients with pharmacist HF management [Within 6 months post-randomization]
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
Guideline medical therapy score [At 6 months post randomization]
Composite score of heart failure medical therapy among patients with heart failure for patients within each pharmacists panel
Beta-blocker therapy [At 6 months post randomization]
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with beta-blocker therapy
Renin-angiotensin system inhibitor (RASI) therapy [At 6 months post randomization]
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with RASI therapy
Angiotensin receptor neprilysin inhibitor (ARNI) therapy [At 6 months post randomization]
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with ARNI therapy
Mineralocorticoid receptor antagonist (MRA) therapy [At 6 months post randomization]
Percentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy [At 6 months post randomization]
Percentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical pharmacists in the Veterans Health Administration that provide Patient Aligned Care Team (PACT) care in VA Sierra Pacific Network (VISN 21)

Exclusion Criteria:

Excluded per pharmacist supervisor decision

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto Veteran's Affairs Hospital	Palo Alto	California	United States	94304

Sponsors and Collaborators

Stanford University
VA Palo Alto Health Care System

Investigators

Principal Investigator: Paul A Heidenreich, MD, MS, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul A. Heidenreich, Professor of Medicine, Stanford University

ClinicalTrials.gov Identifier:

NCT06099808

Other Study ID Numbers:

72662

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 25, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Paul A. Heidenreich, Professor of Medicine, Stanford University

Pharmacist

Medication therapy

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Oct 25, 2023