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Informational Nudge to Improve Heart Failure Prescribing (Nudge)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alert
Peer comparison report
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Sodium-Glucose Transporter 2 Inhibitors, Mineralocorticoid Receptor Antagonists, Economics, Behavioral, feedback, medical audit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Southern Arizona VA Health Care System, Tucson, AZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Peer Comparison Report

Alert

Alert and Peer Comparison

Control

Arm Description

Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance.

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.

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

No alert or peer comparison

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Reach-Clinician
Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison.
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.
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.
Reach-Patient
At the patient level, Reach will be measured as the number of informational alerts delivered for unique patient visits and unique patients.
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.
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.
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.

Full Information

First Posted
June 12, 2023
Last Updated
August 2, 2023
Sponsor
VA Office of Research and Development
Collaborators
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05986695
Brief Title
Informational Nudge to Improve Heart Failure Prescribing
Acronym
Nudge
Official Title
Preliminary Implementation of an Informational Nudge to Improve Heart Failure Prescribing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Sodium-Glucose Transporter 2 Inhibitors, Mineralocorticoid Receptor Antagonists, Economics, Behavioral, feedback, medical audit

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Investigator
Masking Description
Statistician will be blinded to treatment assignment.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer Comparison Report
Arm Type
Active Comparator
Arm Description
Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance.
Arm Title
Alert
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Alert and Peer Comparison
Arm Type
Active Comparator
Arm Description
The combined alert and peer comparison arm will receive both interventions.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No alert or peer comparison
Intervention Type
Behavioral
Intervention Name(s)
Alert
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Peer comparison report
Intervention Description
Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers.
Primary Outcome Measure Information:
Title
Effectiveness
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Reach-Clinician
Description
Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison.
Time Frame
6 months
Title
Incidence of Treatment Emergent Adverse Events
Description
The investigators will measure safety as the number of discontinued prescribed medicine due to suspected adverse effects within 30 days of the nudge interventions.
Time Frame
30 days
Title
Implementation-Acceptability
Description
Implementation will be assessed by clinician-directed survey of Acceptability of intervention Measure. Likert Scale: minimum 1 and maximum 5. 5 being the highest.
Time Frame
6 months
Title
Reach-Patient
Description
At the patient level, Reach will be measured as the number of informational alerts delivered for unique patient visits and unique patients.
Time Frame
6 months
Title
Reach-Comparison of Strategies
Description
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
Title
Implementation-Appropriateness
Description
Implementation will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest.
Time Frame
6 months
Title
Implementation-Feasibility
Description
Implementation will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenice Ria S Guzman, PhD MSN
Phone
(520) 792-1450
Email
JeniceRia.Guzman@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Eric E Glenn
Phone
(520) 792-1450
Ext
15446
Email
Eric.Glenn@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandesh Dev, MD
Organizational Affiliation
Southern Arizona VA Health Care System, Tucson, AZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona VA Health Care System, Tucson, AZ
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rene C Hearns, MPA BBA
Phone
216-791-2300
Ext
5835
Email
Rene.Hearns@va.gov
First Name & Middle Initial & Last Name & Degree
Sandesh Dev, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

Informational Nudge to Improve Heart Failure Prescribing

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