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CompletedNCT02721446

MINDSPACE Strategy for Risk Optimization

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
641 (actual)
Sponsor
Indiana Institute for Medical Research · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStandardInvestigators 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.
BEHAVIORALIncentiveInvestigators 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.
BEHAVIORALSalienceInvestigators 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."
BEHAVIORALIncentive + SalienceCombined message of incentive plus salience.

Timeline

Start date
2016-06-01
Primary completion
2018-08-01
Completion
2018-08-01
First posted
2016-03-29
Last updated
2018-08-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02721446. Inclusion in this directory is not an endorsement.