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Veterans Affairs Pharmacist Heart Failure Medication Titration Project 1

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit and Feedback Emails
Patient Specific Targets
Educational Resources
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Pharmacist, Medication therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Palo Alto Veteran's Affairs Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Audit and Feedback (AF)

Audit and Feedback with Patient Specific Targets (AF+)

Usual Care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of monthly heart failure medication adjustment encounters
Encounters in which pharmacist adjusted heart failure medications

Secondary Outcome Measures

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
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
Guideline medical therapy score
Composite score of heart failure medical therapy among patients with heart failure for patients within each pharmacists panel
Beta-blocker therapy
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
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
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
Percentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy
Percentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy

Full Information

First Posted
October 18, 2023
Last Updated
October 24, 2023
Sponsor
Stanford University
Collaborators
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT06099808
Brief Title
Veterans Affairs Pharmacist Heart Failure Medication Titration Project 1
Official Title
Randomized Evaluation of Audit and Feedback Intervention to Promote Pharmacist Heart Failure Medication Titration in Veterans Affairs Sierra Pacific Network
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 24, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
VA Palo Alto Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Pharmacist, Medication therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Audit and Feedback (AF)
Arm Type
Experimental
Arm Description
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.
Arm Title
Audit and Feedback with Patient Specific Targets (AF+)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Audit and Feedback Emails
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patient Specific Targets
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Resources
Intervention Description
Monthly educational webinars on pharmacist HF management and access to material and protocols on HF medication management.
Primary Outcome Measure Information:
Title
Number of monthly heart failure medication adjustment encounters
Description
Encounters in which pharmacist adjusted heart failure medications
Time Frame
2 months post-randomization to 6 months post-randomization
Secondary Outcome Measure Information:
Title
Percentage of heart failure patients with medication management by pharmacist
Description
For each pharmacist, will calculate the percentage of patients with heart failure in their panel that receive medication adjustments from pharmacist
Time Frame
Within 6 months post-randomization
Title
Number of new patients with pharmacist HF management
Description
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
Time Frame
Within 6 months post-randomization
Title
Guideline medical therapy score
Description
Composite score of heart failure medical therapy among patients with heart failure for patients within each pharmacists panel
Time Frame
At 6 months post randomization
Title
Beta-blocker therapy
Description
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with beta-blocker therapy
Time Frame
At 6 months post randomization
Title
Renin-angiotensin system inhibitor (RASI) therapy
Description
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with RASI therapy
Time Frame
At 6 months post randomization
Title
Angiotensin receptor neprilysin inhibitor (ARNI) therapy
Description
Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with ARNI therapy
Time Frame
At 6 months post randomization
Title
Mineralocorticoid receptor antagonist (MRA) therapy
Description
Percentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy
Time Frame
At 6 months post randomization
Title
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy
Description
Percentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy
Time Frame
At 6 months post randomization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander T Sandhu, MD, MS
Phone
650-723-4000
Email
ats114@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Heidenreich, MD, MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Veteran's Affairs Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Veterans Affairs Pharmacist Heart Failure Medication Titration Project 1

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