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NCT Number: NCT06356558

Adapting Enhanced Recovery Programs for Low Health Literacy Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 16-24 months

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

Secondary outcomes

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

    Time frame: 16-24 months

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

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

    Time frame: 16-24 months

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

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

    Time frame: 16-24 months

    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.

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

    Time frame: 16-24 months

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

  5. Efficacy - Readmission rate

    Time frame: 16-24 months

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

  6. Efficacy - Complications rate

    Time frame: 16-24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel I Chu, MD

CONTACT

[email protected]

205-975-1932

Kaycee Hair

CONTACT

[email protected]

205-975-1932

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 10, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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