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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06099808
Other study ID # 72662
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 20, 2023
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 110
Est. completion date September 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Palo Alto Veteran's Affairs Hospital Palo Alto California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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