Adapting Enhanced Recovery Programs for Low Health Literacy Patients
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT06356558
- Status
- Recruiting
Conditions
- Colorectal Disorders
- Health Knowledge, Attitudes, Practice
- Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Educational intervention (VISACT) — OTHERThe intervention is an implementation strategy called VISACT: VISuAl aids, Coach providers in communication, and Train organizations in health literacy. This strategy will be delivered to patients, providers, and organizations through a novel interactive response platform.
Study Details
Low health literacy patients are a vulnerable population at high-risk for surgical disparities including longer hospital stays, more complications, and more readmissions. This study will adapt enhanced recovery programs (ERPs) to low health literacy patients with a multilevel, health literacy-based implementation strategy (called VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) to improve ERP fidelity and thereby outcomes. In the final aim of this project (Specific Aim 3), the VISACT intervention will be tested in a pilot trial. Findings from this study will lay the foundation for a multi-institutional stepped-wedge trial and establish key principles for adapting interventions to eliminate disparities.
Key Dates
- Start date
- Jun 15, 2026
- Status verified
- Jun 2026
- Primary completion
- Aug 1, 2027
- Completion
- May 1, 2028
Study Design
- Enrollment
- 1,050 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Pre-Post ArmThe overall pilot trial will last for 2.5 years at 2 sites. For each of the 2 sites: * Baseline data will be acquired over 6-12 months (pre-intervention) * The intervention (VISACT) will be delivered over a 1-month period and then maintained * Experimental data will be acquired over 18-24 months (post-intervention)
Primary Outcome Measure
Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers. [ Time Frame: 16-24 months ]
Central Contacts
- Daniel I Chu, MD205-975-1932
- Kaycee Hair205-975-1932
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 |
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