Decision Support Tool for Spinal Cord Injury
(CAPP-FIT Trial)
Trial Summary
What is the purpose of this trial?
Spinal cord injury (SCI) is a permanent condition affecting every aspect of life including health, daily activities, and participation and quality of life. Persons with SCI are at high risk of pressure injury (PrI) throughout their lives due to loss of sensation, nerve damage and immobility. PrIs are local areas of damage to the skin and underlying soft tissue caused by pressure and shear commonly located over bony prominences. While most PrIs are hospital- or nursing home-acquired, in people with SCI, PrIs typically develop in the community. Community-acquired pressure injuries (CAPrIs) are common, devastating, and costly. This grant proposal will assess how well a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT), is used in the clinic and how well it prevents CAPrIs. The CAPP-FIT will be implemented at seven sites across the country in a staggered fashion. The CAPP-FIT includes: 1) an automated Veteran survey to identify risks, actions, and resources needed to prevent CAPrIs and 2) a companion Provider Report immediately available in the electronic health record listing Veteran responses to survey items with recommended evidence-based provider actions. The Veteran survey can be completed via a secured email on the computer or phone. There are three aims in the proposal: Aim 1 is implementing the CAPP-FIT at the seven geographically diverse VA SCI clinics. After CAPP-FIT implementation, each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability. Aim 2 assesses how well the CAPP-FIT prevents CAPrIs and CAPrI-associated hospitalizations and assesses provider and Veteran satisfaction. Aim 3 assesses how well the CAPP-FIT is implemented in the SCI clinic.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment CAPP-FIT for preventing pressure injuries in patients with spinal cord injury?
What makes the CAPP-FIT treatment unique for preventing pressure injuries in spinal cord injury patients?
CAPP-FIT is unique because it focuses on preventing pressure injuries in spinal cord injury patients by using a decision support tool that is specifically designed for community settings, addressing the lack of formal guidelines and integrating self-management technologies to improve adherence and independence.24678
Research Team
Elizabeth E Burkhart, PhD
Principal Investigator
Edward Hines Jr. VA Hospital, Hines, IL
Eligibility Criteria
This trial is for individuals with spinal cord injury (SCI) who are at risk of developing pressure injuries, commonly known as bedsores. The study aims to prevent these injuries which often occur in the community setting after hospital discharge.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Complete clinic workflow designs and redesigns to integrate CAPP-FIT into clinic workflow per site. Recruit and train providers in use of the CAPP-FIT through TMS training, demonstration, and simulation with a standardized patient.
Implementation
Implement the CAPP-FIT at the seven geographically diverse VA SCI clinics, including workflow redesign, provider training, and evaluation of provider readiness.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessing new CAPrI incidence and provider and Veteran satisfaction.
Maintenance
Each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability.
Treatment Details
Interventions
- CAPP-FIT
CAPP-FIT is already approved in United States for the following indications:
- Prevention of Community-Acquired Pressure Injuries in Spinal Cord Injury
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
VA Palo Alto Health Care System
Collaborator
Saint Louis VA Medical Center
Collaborator
Iowa City Veterans Affairs Medical Center
Collaborator
Edward Hines Jr. VA Hospital
Collaborator
Michael E. DeBakey VA Medical Center
Collaborator
James A. Haley Veterans' Hospital
Collaborator
VA Long Beach Healthcare System
Collaborator
San Diego Veterans Healthcare System
Collaborator
Louis Stokes VA Medical Center
Collaborator