protocolSection identificationModule nctId: NCT06356558, orgStudyIdInfo id: IRB-300010279, secondaryIdInfos id: R01CA271303, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA271303, briefTitle: Adapting Enhanced Recovery Programs for Low Health Literacy Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-05, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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., conditionsModule conditions: Surgery, conditions: Health Knowledge, Attitudes, Practice, conditions: Colorectal Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Educational intervention (VISACT), outcomesModule primaryOutcomes measure: Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers., secondaryOutcomes measure: Efficacy - Length-of-stay of index surgical hospitalization, secondaryOutcomes measure: Adoption - Completion rate of the intervention (VISACT) by participants per month, secondaryOutcomes measure: Implementation - Fidelity rate of patients with components of the Enhanced Recovery Program, secondaryOutcomes measure: Maintenance - Long-term adoption rate of the intervention (VISACT) per year, secondaryOutcomes measure: Efficacy - Readmission rate, secondaryOutcomes measure: Efficacy - Complications rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False