Informational Nudge to Improve Heart Failure Prescribing

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT05986695
Collaborator
Arizona State University (Other)
100
1
4
16.8
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Alert
  • Behavioral: Peer comparison report
N/A

Detailed Description

This study addresses a critical gap in quality of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving SGLT2 inhibitors and mineralocorticoid receptor antagonists, both medications that save lives and prevents HF hospitalizations. The investigators will combine insights from behavioral science and quality improvement science to create two types of 'nudges' - informational alerts and peer comparison feedback - to increase prescribing of these medications. The investigators will create two types of 'nudges' - informational alerts and peer comparison feedback - to increase prescribing of these medications. The investigators will compare the effect of these two nudge strategies alone and in combination compared to usual care. This project will develop simple, scalable, and low-cost strategies to improve the health of Veterans with HF.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
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.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.
Masking:
Single (Investigator)
Masking Description:
Statistician will be blinded to treatment assignment.
Primary Purpose:
Health Services Research
Official Title:
Preliminary Implementation of an Informational Nudge to Improve Heart Failure Prescribing
Actual Study Start Date :
Jun 9, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Peer Comparison Report

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

Active Comparator: Alert

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
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

Active Comparator: Alert and Peer Comparison

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

Behavioral: Alert
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

Behavioral: Peer comparison report
Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers.

No Intervention: Control

No alert or peer comparison

Outcome Measures

Primary Outcome Measures

  1. Effectiveness [30 days]

    The primary effectiveness outcome is the proportion 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).

Secondary Outcome Measures

  1. Reach-Clinician [6 months]

    Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison.

  2. Incidence of Treatment Emergent Adverse Events [30 days]

    The investigators will measure safety as the number of discontinued prescribed medicine due to suspected adverse effects within 30 days of the nudge interventions.

  3. Implementation-Acceptability [6 months]

    Implementation will be assessed by clinician-directed survey of Acceptability of intervention Measure. Likert Scale: minimum 1 and maximum 5. 5 being the highest.

  4. Reach-Patient [6 months]

    At the patient level, Reach will be measured as the number of informational alerts delivered for unique patient visits and unique patients.

  5. Reach-Comparison of Strategies [6 months]

    the investigators will measure the proportion of alerts relative to the total number of eligible patients with HF; this denominator will allow for comparisons of representativeness of the alert strategy.

  6. Implementation-Appropriateness [6 months]

    Implementation will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest.

  7. Implementation-Feasibility [6 months]

    Implementation will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Primary care and cardiology clinicians at Southern AZ VA Health Care System working in outpatient clinic setting
Exclusion Criteria:
  • Clinicians who are in training status (resident, fellow) will be excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southern Arizona VA Health Care System, Tucson, AZ Tucson Arizona United States 85723-0001

Sponsors and Collaborators

  • VA Office of Research and Development
  • Arizona State University

Investigators

  • Principal Investigator: Sandesh Dev, MD, Southern Arizona VA Health Care System, Tucson, AZ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT05986695
Other Study ID Numbers:
  • PPO 22-091
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023