Adapting Enhanced Recovery Programs for Low Health Literacy Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Educational intervention (VISACT)
Other interventionThe 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.
Treatment groups
1,050 Participants
are divided into 1 treatment groupGroup A: Pre-Post ArmExperimental treatment 1 intervention
Trial outcomes
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 monthsSecondary outcomes
1
Efficacy - Length-of-stay of index surgical hospitalization
Total days (d) in the hospital for index surgical hospitalization.
Time frame
16-24 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov