Adapting Enhanced Recovery Programs for Low Health Literacy Patients

NCT06356558 | Not Yet Recruiting DMC

• 2 other identifiers: IRB-300010279R01CA271303
• Study Type: interventional
• Target: 1,050
• Locations: 0 countries
• Sites: N/A

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

Keywords

Surgery; Health Literacy; Enhanced Recovery

Outcome Measures

Primary Outcomes (1)

• Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers.

  Percentage of patient and provider participants who are exposed to the intervention (VISACT) per month.

  16-24 months

Secondary Outcomes (6)

• Efficacy - Length-of-stay of index surgical hospitalization

  16-24 months

• Adoption - Completion rate of the intervention (VISACT) by participants per month

  16-24 months

• Implementation - Fidelity rate of patients with components of the Enhanced Recovery Program

  16-24 months

• Maintenance - Long-term adoption rate of the intervention (VISACT) per year

  16-24 months

• Efficacy - Readmission rate

  16-24 months

Study Arms (1)

Pre-Post Arm

EXPERIMENTAL

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)

Other: Educational intervention (VISACT)

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.

Pre-Post Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Behavior

Study Officials

• Daniel I Chu, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel I Chu, MD

CONTACT

205-975-1932; dchu@uab.edu

Kaycee Hair

CONTACT

205-975-1932; khair@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This pilot study will be a pre-post trial of the intervention (VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) at 2 sites. This design was selected because the intervention is an implementation strategy and it will not be possible to randomize patients to a non-intervention arm once the VISACT is delivered to a facility. All patients, providers, and organizational units will be subject to downstream effects of VISACT once implemented.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 10, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share