Informational Nudge to Improve Heart Failure Prescribing (Nudge)

Preliminary Implementation of an Informational Nudge to Improve Heart Failure Prescribing

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Peer comparison report; Behavioral: Alert

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85723-0001
      • Southern Arizona VA Health Care System, Tucson, AZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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: Peer comparison report; Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers.; 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
No Intervention: Control; No alert or peer comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach-Clinician	Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison report. The control group did not receive any alert.	6 months
Incidence of Treatment Emergent Adverse Events	The investigators will measure safety as the number of patients who were deemed by the participant (clinician) to discontinued prescribed medicine due to suspected adverse effects within 30 days of the nudge interventions.	30 days
Implementation-Acceptability	Implementation will be assessed by clinician-directed survey of Acceptability of intervention Measure. The REDCap survey was on the Likert Scale: minimum 1 and maximum 5. With 5 being the highest. Acceptability was determine by the number of participants who were neutral or positive with their responses according the the Likert Scale. The anonymous surveys were sent to all in the three groups and did not collect any identifying information.	6 months
Reach-Patient	At the patient level, Reach will be measured as the number of unique patients for whom the participants received informational alerts	6 months
Reach-Comparison of Strategies	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 months
Implementation-Appropriateness	Appropriateness will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. With 5 being the highest. The number of respondents who were neutral and positive were counted. The anonymous surveys were sent to all in the three groups and did not collect any identifying information.	6 months
Implementation-Feasibility	Feasibility will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. With 5 being the highest. The survey participants responded used the Likert scale to determine if the intervention would be feasible. All responses neutral or positive were counted. The anonymous surveys were sent to all in the three groups and did not collect any identifying information.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Arizona State University
• Investigators: Principal Investigator: Sandesh Dev, MD, Southern Arizona VA Health Care System, Tucson, AZ

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: feedback; Sodium-Glucose Transporter 2 Inhibitors; Economics, Behavioral; Mineralocorticoid Receptor Antagonists; medical audit
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Behavior; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Purinones; Purines; Xanthines; Caffeine
• Other Study ID Numbers: PPO 22-091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

There is a plan to make IPD and related data dictionaries available.

A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• 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