MINDSPACE Strategy for Risk Optimization

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT02721446
• Lead Sponsor: Indiana Institute for Medical Research

Brief Summary

The purpose of this study is to find out which types of written stroke messages may help high risk stroke patients take action to improve their health.

Detailed Description

In this project, the investigators will draw on the science that has provided a foundation for behavioral economics as a guide to activation interventions. Specifically, the investigators will use the MINDSPACE framework that was created by some of the founders of behavioral economics. That framework details nine approaches to behavioral activation that have particularly solid evidence bases. Two of these, salience and incentives, the investigative team identified as most promising and practical for stroke activation.

Aims:

1. Use electronic health record data to construct Framingham stroke risk scores in both Richard L. Roudebush Veterans Affairs Medical Center and Eskenazi Health System.

2. Conduct iterative testing with high risk stroke patients from both health systems to refine two different stroke risk messages based on the behavioral strategies of salience and incentives.

3. Conduct a randomized trial of four mailed stroke risk messages, comparing the impact on patient activation of: 1) a standard stroke risk message, 2) a salience-focused stroke risk message, 3) an incentive-focused stroke risk message, and 4) a salience plus incentive message.

4. Compare the proportion in each messaging group that completes a stroke risk factor relevant healthcare system visit within two months of receiving the stroke risk message.

Study Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Study Start: 2016-06
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 641

Inclusion Criteria

• • High risk stroke patients 18 years of age or older, as determined by calculation of a Framingham Stroke Risk Score

  • At least one primary care visit 12 months prior to study initiation with the Richard L. Roudebush VA Medical Center (VHA) or Sidney & Lois Eskenazi (EHS) Health System primary care clinics

Exclusion Criteria

• • Patients with at least one primary care provider visit in the prior 12 months in both the VA and EHS systems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients responding to mailings in each of four intervention groups	Eight months with 132 mailings per intervention group per month	The primary outcome is the proportion responding to the mailings in each of the four intervention groups. Investigators will calculate the denominator as the number of patients that were sent a mailing (mailing was not returned as undeliverable and patient did not opt out) and the numerator as the number of these mailings that generate a telephone call response. Investigators will track whether the response occurs after the first, second, or third mailing to estimate the utility of subsequent mailings.

Trial Locations

Locations (1)

Richard L. Roudebush VA Medical Center; 🇺🇸 Indianapolis, Indiana, United States