MINDSPACE Strategy for Risk Optimization

Stroke Clinical Trial

Official title:

MINDSPACE Strategy for Risk Optimization, Knowledge, and Empowerment (MINDSPACE Stroke)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721446
• Other study ID #: 1510315819
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Indiana Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 641
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Standard
Investigators will develop a "standard" informational stroke risk message that will not undergo iterative review. This will inform the patient that based on information in the healthcare system, the patient is at higher risk of stroke than many others receiving care in the patient's healthcare system; it will describe options for working with their health care team to reduce the risk of stroke; and encourage the patient to call the health navigator to discuss these options and make a decision about next steps to take to reduce the patient's risk of stroke.
• Incentive
Investigators anticipate that the baseline incentive stroke risk message will inform the patient that they are at higher risk of stroke than many others receiving care in the patient's healthcare system, and will provide information about obtaining an incentive if the patient calls to make contact with a health navigator who will help them plan a next step to reduce their stroke risk. The investigators also anticipate including information that all patients who call will also be entered in a random drawing to receive an additional incentive, with up to six patients receiving this incentive.
• Salience
Investigators anticipate that the baseline salience stroke risk message will inform the patient that they are at higher risk of stroke than many other patients receiving care in the patient's healthcare system, and will specifically focus on the patient's own risk factors (rather than all stroke risk factors). The salience message will also include visual depictions of stroke patients that are gender and ethnically matched to each subject. This is intended to prompt action by emphasizing that stroke is a real possibility for "patients like me."
• Incentive + Salience
Combined message of incentive plus salience.

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center	Indianapolis	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana Institute for Medical Research	Genentech, Inc., Regenstrief Institute, Inc., Richard L. Roudebush VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients responding to mailings in each of four intervention groups	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.	Eight months with 132 mailings per intervention group per month