CClinicalTrials.gg
CompletedNCT05986695NudgeUpdated May 1, 2026Results posted

Informational Nudge to Improve Heart Failure Prescribing

An interventional study of Alert and Peer comparison report in Heart Failure, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

Keywords

  • Sodium-Glucose Transporter 2 Inhibitors
  • Mineralocorticoid Receptor Antagonists
  • Economics, Behavioral
  • feedback
  • medical audit
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 81 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Clinicians who are in training status (resident, fellow) will be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
81 participants (actual)

Study arms

  • 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

  • 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

  • Active comparator
    Alert and Peer Comparison

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

    Behavioral: Alert · Behavioral: Peer comparison report

  • No intervention
    Control

    No alert or peer comparison

Interventions

  • BehavioralAlert

    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

  • BehavioralPeer comparison report

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 30 days

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 30 days

  3. 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.

    Time frame: 6 months

  4. Reach-Patient

    At the patient level, Reach will be measured as the number of unique patients for whom the participants received informational alerts

    Time frame: 6 months

  5. 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.

    Time frame: 6 months

  6. 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.

    Time frame: 6 months

  7. 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.

    Time frame: 6 months

07

Results

Posted May 1, 2026
Limitations and caveats
At this point the study does not have any limitations nor caveats.

Participant flow

All employed providers within Cardiology and Primary Care units were enrolled into this study per agreement with management.

Participant flow — Overall Study
MilestoneControlAlertPeer Comparison ReportAlert & Peer Comparison Report
Started19192122
Completed19192122
Not completed0000

Outcome measures

PrimaryEffectiveness (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.

Time frame:
30 days
Reported as:
Number · Count of MRA prescriptions Filled
Effectiveness (MRA Prescriptions)
Count of MRA prescriptions FilledControlAlertPeer Comparison ReportBoth Alert and Peer Comparison Report
Effectiveness (MRA Prescriptions)0222
SecondaryReach-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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Reach-Clinician
ParticipantsControlAlertPeer Comparison ReportBoth Alert and Peer Comparison Report
Reach-Clinician0192122
SecondaryIncidence 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.

Time frame:
30 days
Reported as:
Number · Deprescribed patients
Incidence of Treatment Emergent Adverse Events
Deprescribed patientsAlert (Group 2) SGLT2 DeprescribedPeer Comparison Report (Group 3) SGLT2 DeprescribedAlert & Peer Comparison Report (Group 4) SGLT2 DeprescribedAlert (Group 2) MRA DeprescribedPeer Comparison Report (Group 3) MRA DeprescribedAlert & Peer Comparison Report (Group 4) MRA Deprescribed
Incidence of Treatment Emergent Adverse Events302100
SecondaryImplementation-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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Implementation-Acceptability
ParticipantsAll Participants (Clinicians) Completed Survey
Acceptability of the Intervention Measure for the Alert4
Acceptability of the Intervention Measure for the Peer Comparison Report2
SecondaryReach-Patient

At the patient level, Reach will be measured as the number of unique patients for whom the participants received informational alerts

Time frame:
6 months
Reported as:
Number · Total unique patients
Reach-Patient
Total unique patientsNumber of Patients
Reach-Patient604
SecondaryReach-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.

Time frame:
6 months
Reported as:
Number · alerts sent
Reach-Comparison of Strategies
alerts sentControlAlertPeer Comparison ReportAlert & Peer Comparison Report
Reach-Comparison of Strategies0211202191
SecondaryImplementation-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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Implementation-Appropriateness
ParticipantsAll Participants (Clinicians) Completed Survey
Intervention Appropriateness Measure for the Alert5
Intervention Appropriateness Measure for the Peer Comparison Report0
SecondaryImplementation-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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Implementation-Feasibility
ParticipantsAll Participants (Clinicians) Completed Survey
Feasibility of the Intervention Measure for the Alert4
Feasibility of the Intervention Measure for the Peer Comparison Report1
PrimaryEffectiveness (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.

Time frame:
30 days
Reported as:
Number · Count of SGLT2 Prescriptions Filled
Effectiveness (SGLT2 Prescriptions)
Count of SGLT2 Prescriptions FilledControlAlertPeer Comparison ReportBoth Alert and Peer Comparison Report
Effectiveness (SGLT2 Prescriptions)224116

Adverse events

Collected over From enrollment through intervention completion, an average of 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control0/19 (0%)0/19 (0%)0/19 (0%)
Alert0/19 (0%)0/19 (0%)0/19 (0%)
Peer Comparison Report0/21 (0%)0/21 (0%)0/21 (0%)
Alert & Peer Comparison Report0/22 (0%)0/22 (0%)0/22 (0%)

Baseline characteristics

Baseline characteristic data was not collected for participants of this study

Age, Customized
Age, CustomizedControlAlertPeer Comparison ReportAlert & Peer Comparison ReportTotal
Sex/Gender, Customized
Sex/Gender, CustomizedControlAlertPeer Comparison ReportAlert & Peer Comparison ReportTotal
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)ControlAlertPeer Comparison ReportAlert & Peer Comparison ReportTotal
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Study locations

1 site
  • Southern Arizona VA Health Care System, Tucson, AZ
    Tucson, Arizona 85723-0001, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 11, 2023
  • Informed consent form · Mar 1, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Icf, Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05986695
Lead sponsor
VA Office of Research and Development
Collaborators
Arizona State University
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Jun 9, 2023
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Results posted
May 1, 2026
Last update
May 1, 2026

Study contacts

Sandesh Dev, MD
principal investigator · Southern Arizona VA Health Care System, Tucson, AZ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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