Informational Nudge to Improve Heart Failure Prescribing

NCT05986695 | Completed Results

• 1 other identifier: PPO 22-091
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This study addresses a critical gap of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving recommended SGLT2 and MRA therapies that save lives and prevents HF hospitalizations. The investigators will compare the effect of clinician directed nudges as strategies to improve the health of Veterans with HF.

Conditions

Heart Failure

Keywords

Sodium-Glucose Transporter 2 Inhibitors; Mineralocorticoid Receptor Antagonists; Economics, Behavioral; feedback; medical audit

Outcome Measures

Primary Outcomes (2)

• Effectiveness (MRA Prescriptions)

  The primary effectiveness outcome is the amount of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician). Data represent a cumulative number of prescriptions filled.

  30 days

• Effectiveness (SGLT2 Prescriptions)

  The primary effectiveness outcome is the amount of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician). Data represent a cumulative number of prescriptions filled.

  30 days

Secondary Outcomes (7)

• Reach-Clinician

  6 months

• Incidence of Treatment Emergent Adverse Events

  30 days

• Implementation-Acceptability

  6 months

• Reach-Patient

  6 months

• Reach-Comparison of Strategies

  6 months

Study Arms (4)

Peer Comparison Report

ACTIVE COMPARATOR

Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance.

Behavioral: Peer comparison report

Alert

ACTIVE COMPARATOR

Clinicians in the alert arm will receive an alert two business days prior to a patient's upcoming appointment. Clinicians will receive approximately two alerts per week.

Behavioral: Alert

Alert and Peer Comparison

ACTIVE COMPARATOR

The combined alert and peer comparison arm will receive both interventions.

Behavioral: Alert; Behavioral: Peer comparison report

Control

NO INTERVENTION

No alert or peer comparison

Interventions

Alert BEHAVIORAL

Interruptive alert. The prototype alert is in the form of a chart note with evidence-based practice guidelines that will actively display in the clinician's list of daily alerts (like an inbox) that must be cleared daily. It is interruptive because can only be dismissed from the clinician's inbox list after signing the note

Alert; Alert and Peer Comparison

Peer comparison report BEHAVIORAL

Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers.

Alert and Peer Comparison; Peer Comparison Report

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care and cardiology clinicians at Southern AZ VA Health Care System working in outpatient clinic setting

You may not qualify if:

• Clinicians who are in training status (resident, fellow) will be excluded.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Arizona State University: collaborator

Study Sites (1)

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723-0001, United States

Location

MeSH Terms

Conditions

Heart Failure; Behavior

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

At this point the study does not have any limitations nor caveats.

Results Point of Contact

• Title: Sandesh Dev
• Organization: Tucson VA Medical Center

sandesh.dev@va.gov

(602) 888-1257

Study Officials

• Sandesh Dev, MD

  Southern Arizona VA Health Care System, Tucson, AZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Statistician will be blinded to treatment assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a type 3 hybrid (implementation focused), four group, pragmatic trial of cardiology and primary care clinicians at a single VA medical center. The trial will include a 3-month preintervention period and 3-month intervention period. Clinicians will be randomized to one of four arms: usual care, informational alert, peer comparison feedback, and combination of alert and peer comparison.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: August 14, 2023
• Study Start: June 9, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (1)