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Clinical Trial NCT05986695 (Nudge) for Heart Failure is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Informational Nudge to Improve Heart Failure Prescribing
Clinical Trial NCT05986695 (Nudge) is an interventional study for Heart Failure that is active, not recruiting. It started on 9 June 2023 with plans to enroll 89 participants. Led by VA Office of Research and Development, it is expected to complete by 30 September 2025. The latest data from ClinicalTrials.gov was last updated on 20 July 2025.
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.
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.
Official Title
Preliminary Implementation of an Informational Nudge to Improve Heart Failure Prescribing
Conditions
Heart FailureOther Study IDs
- Nudge
- PPO 22-091
NCT ID Number
Start Date (Actual)
2023-06-09
Last Update Posted
2025-07-20
Completion Date (Estimated)
2025-09-30
Enrollment (Estimated)
89
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Sodium-Glucose Transporter 2 Inhibitors
Mineralocorticoid Receptor Antagonists
Economics, Behavioral
feedback
medical audit
Mineralocorticoid Receptor Antagonists
Economics, Behavioral
feedback
medical audit
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Factorial
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorPeer Comparison Report Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance. | Peer Comparison Report Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers. |
Active ComparatorAlert 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. | 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 ComparatorAlert and Peer Comparison The combined alert and peer comparison arm will receive both interventions. | 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 Peer Comparison Report Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers. |
No InterventionControl No alert or peer comparison | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Effectiveness | 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). | 30 days |
| 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. | 6 months |
Incidence of Treatment Emergent Adverse Events | The investigators will measure safety as the number of 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. Likert Scale: minimum 1 and maximum 5. 5 being the highest. | 6 months |
Reach-Patient | At the patient level, Reach will be measured as the number of informational alerts delivered for unique patient visits and unique patients. | 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 | Implementation will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest. | 6 months |
Implementation-Feasibility | Implementation will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest. | 6 months |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Primary care and cardiology clinicians at Southern AZ VA Health Care System working in outpatient clinic setting
- Clinicians who are in training status (resident, fellow) will be excluded.
VA Office of Research and DevelopmentArizona State UniversityNo contact data.
1 Study Locations in 1 Countries
Arizona
Southern Arizona VA Health Care System, Tucson, AZ, Tucson, Arizona, 85723-0001, United States