Veterans Affairs Pharmacist Heart Failure Medication Titration Project 1

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure
• Intervention / Treatment: Other: Audit and Feedback Emails; Other: Educational Resources; Other: Patient Specific Targets

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander T Sandhu, MD, MS; Phone Number: 650-723-4000; Email: ats114@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Palo Alto Veteran's Affairs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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: Educational Resources; Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of monthly heart failure medication adjustment encounters	Encounters in which pharmacist adjusted heart failure medications	2 months post-randomization to 6 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	At 6 months post randomization

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: VA Palo Alto Health Care System
• Investigators: Principal Investigator: Paul A Heidenreich, MD, MS, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacist; Medication therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 72662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No