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SurgeryNCT06356558

Adapting Enhanced Recovery Programs for Low Health Literacy Patients

A study testing Educational intervention (VISACT) in people with Surgery and Health Knowledge, Attitudes, Practice, run by University of Alabama at Birmingham at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Educational intervention (VISACT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
1 siteUnited States
Study dates
15 Jun 2026to 1 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel I Chu, MD contact

205-975-1932

dchu@uab.edu

Kaycee Hair contact

205-975-1932

khair@uabmc.edu

United States1 site, 1 recruiting
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Daniel I Chu, MD, 205-975-1932, dchu@uab.edu

    Kaycee Hair, 205-975-1932, khair@uabmc.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Educational intervention (VISACT)
Keywords
Surgery, Health Literacy, Enhanced Recovery
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 groups in NCT06356558
Study groupRoleWhat they receive
Pre-Post ArmExperimentalThe 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)
Receives: Other: Educational intervention (VISACT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16-24 months

Secondary outcomes (6)
  1. Efficacy - Length-of-stay of index surgical hospitalization

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 16-24 months

  5. Efficacy - Readmission rate

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

    Measured: 16-24 months

  6. Efficacy - Complications rate

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

    Measured: 16-24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start15 Jun 2026
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
1,050 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356558
Sponsor's protocol ID
IRB-300010279
Other IDs
R01CA271303
Status last verified
Jun 2026
First submitted
25 Mar 2024
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No immediate plan to share except as de-identified data to NIH.

Questions about this trial

What is this clinical trial studying?

A study testing Educational intervention (VISACT) in people with Surgery and Health Knowledge, Attitudes, Practice, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel I Chu, MD (205-975-1932, dchu@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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