Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06356558 |
| Other study ID # |
IRB-300010279 |
| Secondary ID |
R01CA271303 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2026 |
| Est. completion date |
May 2028 |
Study information
| Verified date |
March 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
Daniel I Chu, MD |
| Phone |
205-975-1932 |
| Email |
dchu[@]uab.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
