MINDSPACE Strategy for Risk Optimization
1 other identifier
interventional
641
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jun 2016
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 29, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedAugust 17, 2018
August 1, 2018
2.2 years
March 9, 2016
August 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
VHA Cohort
OTHERInvestigators 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
OTHERInvestigators 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.
Interventions
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.
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.
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."
Combined message of incentive plus salience.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with at least one primary care provider visit in the prior 12 months in both the VA and EHS systems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Institute for Medical Researchlead
- Genentech, Inc.collaborator
- Regenstrief Institute, Inc.collaborator
- Richard L. Roudebush VA Medical Centercollaborator
Study Sites (1)
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, 46202, United States
Related Publications (1)
Groves CC, Damush TM, Myers LJ, Baye F, Daggy JK, Perkins AJ, Martin H, Mounsey L, Clark DO, Williams LS. Enhancing Stroke Awareness and Activation Among High-Risk Populations: A Randomized Direct Mail Intervention in Diverse Healthcare Settings. Circ Cardiovasc Qual Outcomes. 2025 May;18(5):e011425. doi: 10.1161/CIRCOUTCOMES.124.011425. Epub 2025 Mar 24.
PMID: 40123486DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda S Williams, MD
Richard L. Roudebush VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 29, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
August 17, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share