Heart Failure
Conditions
Keywords
Sodium-Glucose Transporter 2 Inhibitors, Mineralocorticoid Receptor Antagonists, Economics, Behavioral, feedback, medical audit
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.
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.
Sponsors
VA Office of Research and Development
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
Statistician will be blinded to treatment 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness (MRA Prescriptions) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 report. The control group did not receive any alert. |
| Incidence of Treatment Emergent Adverse Events | 30 days | 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. |
| Implementation-Acceptability | 6 months | 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. |
| Reach-Patient | 6 months | At the patient level, Reach will be measured as the number of unique patients for whom the participants received informational alerts |
| 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. |
| Implementation-Appropriateness | 6 months | 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. |
| Implementation-Feasibility | 6 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSandesh Dev, MD
Southern Arizona VA Health Care System, Tucson, AZ
Participant flow
Recruitment details
All employed providers within Cardiology and Primary Care units were enrolled into this study per agreement with management.
Pre-assignment details
The leadership of both units agreed that all providers would participate. The 81 participants (providers) were randomly assigned to one of four study arms (control, Alert \[EHR note\], Pier Comparison Report \[Email notification\], or Both \[EHR and Email\]. The providers were numbered and blindly randomize by department, education, and employment site.
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 0 / 19 | 0 / 19 | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 21 | 0 / 22 |
Outcome results
None listed