NCT06099808

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

October 18, 2023

Last Update Submit

April 15, 2024

Conditions

Keywords

PharmacistMedication therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Percentage of heart failure patients with medication management by pharmacist

    Within 6 months post-randomization

  • Number of new patients with pharmacist HF management

    Within 6 months post-randomization

  • Guideline medical therapy score

    At 6 months post randomization

  • Beta-blocker therapy

    At 6 months post randomization

  • Renin-angiotensin system inhibitor (RASI) therapy

    At 6 months post randomization

  • +3 more secondary outcomes

Study Arms (3)

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.

Other: Audit and Feedback EmailsOther: 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.

Other: Audit and Feedback EmailsOther: Patient Specific TargetsOther: 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.

Other: Educational Resources

Interventions

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.

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

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.

Audit and Feedback with Patient Specific Targets (AF+)

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

Audit and Feedback (AF)Audit and Feedback with Patient Specific Targets (AF+)Usual Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Excluded per pharmacist supervisor decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto Veteran's Affairs Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Paul A Heidenreich, MD, MS

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 25, 2023

Study Start

November 20, 2023

Primary Completion

June 30, 2024

Study Completion

September 30, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations