Heart FailureNudgeNCT05986695
Informational Nudge to Improve Heart Failure Prescribing
A study testing Alert and Peer comparison report in people with Heart Failure, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Alert and Peer comparison report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care and cardiology clinicians at Southern AZ VA Health Care System working in outpatient clinic setting
Who cannot join
- Clinicians who are in training status (resident, fellow) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723-0001
About this study
Official title: 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.
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.
- Conditions
- Heart Failure
- Being tested
- Alert, Peer comparison report
- Keywords
- Sodium-Glucose Transporter 2 Inhibitors, Mineralocorticoid Receptor Antagonists, Economics, Behavioral, feedback, medical audit
- Medical subject headings
- Heart Failure, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlertBehavioural
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 reportBehavioural
Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Alert |
| Alert and Peer Comparison | Active comparator | The combined alert and peer comparison arm will receive both interventions. Receives: Behavioral: Alert; Behavioral: Peer comparison report |
| Control | No intervention | No alert or peer comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start9 Jun 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
- Investigators
- Sandesh Dev, MD, Principal investigator, Southern Arizona VA Health Care System, Tucson, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986695
- Sponsor's protocol ID
- PPO 22-091
- Acronym
- Nudge
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2023
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Implementation of an Informational Nudge to Improve Heart Failure Prescribing
- ClinicalTrials.gov ID
- NCT05986695
- Acronym / sponsor ID
- Nudge / PPO 22-091
- Conditions
- Heart Failure
- Keywords
- Sodium-Glucose Transporter 2 Inhibitors, Mineralocorticoid Receptor Antagonists, Economics, Behavioral, feedback, medical audit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Arizona State University
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Peer Comparison Report | Active comparator | Behavioral: Peer comparison reportClinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance. |
| Alert | Active comparator | Behavioral: AlertClinicians 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 and Peer Comparison | Active comparator | Behavioral: Alert, Behavioral: Peer comparison reportThe combined alert and peer comparison arm will receive both interventions. |
| Control | No intervention | –No alert or peer comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care and cardiology clinicians at Southern AZ VA Health Care System working in outpatient clinic setting
Key exclusion criteria (1 listed)
- Clinicians who are in training status (resident, fellow) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlertInterruptive 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 | Behavioural | Alert, Alert and Peer Comparison |
| Peer comparison reportClinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers. | Behavioural | Alert and Peer Comparison, Peer Comparison Report |
Primary outcome
Effectiveness (MRA Prescriptions)
Time frame: 30 days
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.
Effectiveness (SGLT2 Prescriptions)
Time frame: 30 days
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.
7 secondary outcomes
Reach-Clinician
Time frame: 6 months
Incidence of Treatment Emergent Adverse Events
Time frame: 30 days
Implementation-Acceptability
Time frame: 6 months
Reach-Patient
Time frame: 6 months
Reach-Comparison of Strategies
Time frame: 6 months
Implementation-Appropriateness
Time frame: 6 months
Implementation-Feasibility
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandesh Dev, MD principal investigator
Southern Arizona VA Health Care System, Tucson, AZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert and Peer comparison report in people with Heart Failure, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (MRA Prescriptions) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.