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RecruitingNCT06356558Updated Jun 29, 2026

Adapting Enhanced Recovery Programs for Low Health Literacy Patients

An interventional study of Educational intervention (VISACT) in Surgery, Health Knowledge, Attitudes, Practice and Colorectal Disorders, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,050
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Rationale: Low health literacy affects over a third of surgical populations and is associated with significantly worse outcomes in surgery. Interventions that reduce disparities in this large population are urgently needed. Previous work has shown that enhanced recovery programs (ERPs) mitigate racial disparities in surgical outcomes and offer a pragmatic way to address surgical disparities. Existing ERPs, however, work poorly for patients with low health literacy who still experience worse outcomes. This gap arises from the lack of fit between current ERPs and the needs of low health literacy patients. Prior work through a K23 grant assessed these needs and developed a novel multilevel strategy to improve fit: engage patients with VISuAl aids, Coach providers in communication, and Train organizations in health literacy (VISACT). An opportunity now exists to deliver and test the VISACT using a theory-based adaptation framework. Successful adaptations would transform existing ERPs and broaden its disparity-reducing impact to low health literacy populations. Objectives: The long-term objective is to eliminate disparities and improve outcomes for low health literacy populations in surgery through context-driven adaptations of existing ERPs. The hypothesis is that VISACT will improve fidelity to ERP's components for low health literacy patients and thereby surgical outcomes. To achieve this objective, the aims are: (SA1) identify the health literacy-sensitive components of ERPs to augment with VISACT, (SA2) assess the health literacy needs of providers and organizational units on ERP teams, and (SA3) deliver and pilot test the VISACT implementation strategy on existing ERPs. Methods: First, guided by the Dynamics Adaptation Process framework, machine learning on a large ERP database (n>7,000) will be used to identify the health literacy-sensitive components of ERPs to augment with VISACT (SA1). Second, a convergent mixed-methods integrative approach will be used to identify gaps in health literacy knowledge, best practices, and preparedness to adapt on ERP implementation teams through three interrelated methods: in vivo observations of ERPs in-action at 4 Alabama facilities, extended semi-structured interviews of 120 stakeholders, and surveys measuring health literacy knowledge and organizational preparedness to adapt. Third, the VISACT intervention will be tested at two sites in Alabama (urban and rural) through a novel interactive response platform in a pilot study and assessed for feasibility/acceptability through a RE-AIM framework of reach, efficacy, adoption, implementation, and maintenance measures. Acquired data will inform design of a multi-institutional stepped-wedge trial of the VISACT in the Deep South. Significance: This study will advance the NIH/NIMHD mission to eliminate surgical disparities and responds directly to the NIMHD Science Visioning Research Strategies by removing health literacy barriers (#24) and building the science of adapting interventions to different contexts (#30). The project will furthermore (i) deliver the first health literate intervention in surgery, (ii) establish a novel implementation strategy (VISACT) to address surgical disparities and (iii) advance the science of interventions through adaptations.

02

Conditions studied

  • Surgery
  • Health Knowledge, Attitudes, Practice
  • Colorectal Disorders

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Keywords

  • Surgery
  • Health Literacy
  • Enhanced Recovery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,050 participants (estimated)

Study 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)

    Other: Educational intervention (VISACT)

Interventions

  • OtherEducational 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.

05

What researchers measure

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.

    Time frame: 16-24 months

Secondary outcomes

  1. Efficacy - Length-of-stay of index surgical hospitalization

    Total days (d) in the hospital for index surgical hospitalization.

    Time frame: 16-24 months

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

    Percentage (%) of patient and provider participants who complete the intervention (VISACT) per month.

    Time frame: 16-24 months

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

    Percentage (%) of components of the Enhanced Recovery Program completed by participants. This will be reported, for example, as 5 out of 15 components (33% adherence) or 15 out of 15 components (100% adherence). Higher fidelity will indicate high-quality implementation of the program.

    Time frame: 16-24 months

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

    Percentage (%) of patient and provider participants who complete the intervention (VISACT) per year.

    Time frame: 16-24 months

  5. Efficacy - Readmission rate

    Percentage (%) of readmissions 30-days after discharge from hospital (# of readmissions/# of discharge patients per month)

    Time frame: 16-24 months

  6. Efficacy - Complications rate

    Percentage (%) of patients with one or more post-operative complications

    Time frame: 16-24 months

06

Study locations

1 of 1 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — No immediate plan to share except as de-identified data to NIH.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06356558
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
Responsible party
Daniel Chu (Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Apr 10, 2024
Start date
Jun 15, 2026
Primary completion
Aug 1, 2027 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Jun 29, 2026

Study contacts

Daniel I Chu, MD
Contact
dchu@uab.edu
205-975-1932
Kaycee Hair
Contact
khair@uabmc.edu
205-975-1932
Daniel I Chu, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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