Skip to content

Adapting Enhanced Recovery Programs for Low Health Literacy Patients

Adapting Enhanced Recovery Programs for Low Health Literacy Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06356558
Enrollment
1050
Registered
2024-04-10
Start date
2026-06-15
Completion date
2028-05-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disorders, Health Knowledge, Attitudes, Practice, Surgery

Keywords

Surgery, Health Literacy, Enhanced Recovery

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.

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.

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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers.16-24 monthsPercentage of patient and provider participants who are exposed to the intervention (VISACT) per month.

Secondary

MeasureTime frameDescription
Efficacy - Length-of-stay of index surgical hospitalization16-24 monthsTotal days (d) in the hospital for index surgical hospitalization.
Adoption - Completion rate of the intervention (VISACT) by participants per month16-24 monthsPercentage (%) of patient and provider participants who complete the intervention (VISACT) per month.
Implementation - Fidelity rate of patients with components of the Enhanced Recovery Program16-24 monthsPercentage (%) 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.
Maintenance - Long-term adoption rate of the intervention (VISACT) per year16-24 monthsPercentage (%) of patient and provider participants who complete the intervention (VISACT) per year.
Efficacy - Readmission rate16-24 monthsPercentage (%) of readmissions 30-days after discharge from hospital (# of readmissions/# of discharge patients per month)
Efficacy - Complications rate16-24 monthsPercentage (%) of patients with one or more post-operative complications

Countries

United States

Contacts

CONTACTDaniel I Chu, MD
dchu@uab.edu205-975-1932
CONTACTKaycee Hair
khair@uabmc.edu205-975-1932
PRINCIPAL_INVESTIGATORDaniel I Chu, MD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026