MINDSPACE Strategy for Risk Optimization

Indiana Institute for Medical Research

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Salience; Behavioral: Standard; Behavioral: Incentive + Salience; Behavioral: Incentive

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT02721446

1510315819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 641 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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641 participants in 2 patient groups

VHA Cohort

Other group

Description:

Investigators will use Veteran Health Administration (VHA) electronic health record (EHR) data to construct patient-level Framingham stroke risk scores using previously validated methodology. Investigators will establish a cohort of live patients with at least one primary care visit 12 months prior to study initiation (Oct 1, 2015). Investigators will obtain EHR data for Framingham measurements of age, sex, systolic blood pressure (SBP), blood pressure treatment (yes/no), total cholesterol, high-density lipoprotein cholesterol, and smoking status in the prior 12 month period. SBP will be obtained from outpatient primary care visits only; if \> 1 SBP is available the investigators will use the average of the last 2 outpatient SBPs prior to study initiation.

Treatment:

Behavioral: Incentive + Salience

Behavioral: Incentive

Behavioral: Salience

Behavioral: Standard

Eskenazi Health System Cohort

Other group

Description:

Investigators will use EHR data from Indiana Network for Patient Care (INPC) to identify a cohort of live patients with at least one primary care visit in the prior 12 months. Investigators will use identical methods to construct Framingham risk score variables from the EHR data.

Treatment:

Behavioral: Incentive + Salience

Behavioral: Incentive

Behavioral: Salience

Behavioral: Standard