Recruiting

VISACT

Sponsor:

University of Alabama at Birmingham

Code:

NCT06356558

Conditions

Surgery

Health Knowledge, Attitudes, Practice

Colorectal Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational intervention (VISACT)

Study Details

Brief summary:

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.

Conditions

Surgery

Health Knowledge, Attitudes, Practice

Colorectal Disorders

Study ID

NCT06356558

Start date

Jun 15, 2026

Status verified date

Jun, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult patients >= 18 years of age undergoing surgery under an enhanced recovery program (ERPs)
  • Adult caregivers/providers, organizational leaders, >= 18 years of age with direct or indirect involvement with ERP implementation
  • All genders
  • All race/ethnicities
  • Able to consent
  • English-speaking

Exclusion Criteria:

  • Child (<18 years of age)
  • Patients undergoing operations not included under ERPs
  • Participants unable to consent for the study
  • Participants whose mental state excludes them from being able to understand contents of the informed consent form and/or patients whose family members or patient representative do not wish for them to participate in the study

Study Design

Enrollment

1050 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

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)

Interventions

Educational intervention (VISACT)

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.

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 and Locations

Central contacts

Daniel I Chu, MD

205-975-1932dchu@uab.edu

Kaycee Hair

205-975-1932khair@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Daniel I Chu, MD

205-975-1932dchu@uab.edu

Kaycee Hair

205-975-1932khair@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Surgery
  • Health Literacy
  • Enhanced Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-29.