Informational Nudge to Improve Heart Failure Prescribing

Heart Failure Clinical Trial

— Nudge  

Official title:

Preliminary Implementation of an Informational Nudge to Improve Heart Failure Prescribing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986695
• Other study ID #: PPO 22-091
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Jenice Ria S Guzman, PhD MSN
• Phone: (520) 792-1450
• Email: JeniceRia.Guzman[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators will compare the effect of clinician directed nudges as strategies to improve the health of Veterans with HF.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Southern Arizona VA Health Care System, Tucson, AZ	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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