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) — OTHER
    The 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 Arm
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Daniel I Chu, MD
205-975-1932
Kaycee Hair
205-975-1932

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