MINDSPACE Strategy for Risk Optimization
- Conditions
- Stroke
- Interventions
- Behavioral: StandardBehavioral: IncentiveBehavioral: SalienceBehavioral: Incentive + Salience
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 641
-
• 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
- • 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
- Arm && Interventions
Group Intervention Description Eskenazi Health System Cohort Salience 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. VHA Cohort Standard 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. Eskenazi Health System Cohort Incentive 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. VHA Cohort Incentive 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. VHA Cohort Incentive + Salience 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. VHA Cohort Salience 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. Eskenazi Health System Cohort Standard 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. Eskenazi Health System Cohort Incentive + Salience 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.
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Richard L. Roudebush VA Medical Center
🇺🇸Indianapolis, Indiana, United States