Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic

Part of paid clinical trials in Long Beach, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06529094
Status
Recruiting

Conditions

  • Pressure Injury
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Provider training — BEHAVIORAL
    Provider participants will complete TMS training, CAPP-FIT demonstration and simulation in use of the CAPP-FIT with a standardized patient.
  • CAPP-FIT intervention with RA facilitation — BEHAVIORAL
    After consent and survey completion, RA to email/text CAPP-FIT link to Veteran the day before established clinic visit. RA to remain available to answer questions to help Veteran participant complete Veteran Survey and submit the responses through eScreening. The Provider Report will appear in CPRS with a Provider notification. RA to meet Veteran participant in the clinic after the clinic visit to complete the Veteran satisfaction survey.
  • CAPP-FIT implementation during maintenance phase — BEHAVIORAL
    Providers will attend focus group after Arm 2 to determine sustainability of CAPP-FIT use in clinic workflow. Clinic provider will act on that determination for 10 months during maintenance phase.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Nov 2025
Primary completion
May 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
808 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Other: Preparation to implement the CAPP-FIT per site
    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.
  • Active Comparator: Implement CAPP-FIT with RA facilitation
    Veteran completes Veteran Survey and Provider uses Provider report around an established clinic visit per site
  • Other: Implement CAPP-FIT without RA facilitation
    Each site will determine how they will integrate use of the CAPP-FIT in clinic workflow.

Primary Outcome Measure

Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation [ Time Frame: 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Walter Chua, MD
Ariel Baria, PhD
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Doug T Ota, MD
650-493-5000
Sujuan Cai, PhD
(650) 493-5000
Doug T Ota, MD (SUB_INVESTIGATOR)
Katherine C Stenson (SUB_INVESTIGATOR)
Kevin T White, MD (SUB_INVESTIGATOR)
Mary K Henzel (SUB_INVESTIGATOR)
Walter C Chua (SUB_INVESTIGATOR)
James A. Haley Veterans' Hospital, Tampa, FLTampaFlorida33612
Kevin White, MD
Susan VanBreman, BSN
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
Rebecca Hasley
708-864-1628
Chad M Osteen, MAS BA
(708) 202-8387
Elizabeth E Burkhart, PhD (PRINCIPAL_INVESTIGATOR)
St. Louis VA Medical Center John Cochran Division, St. Louis, MOSt LouisMissouri63106-1621
Katherine Stenson, MD
Rachael Beard, PhD
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Mary K Henzel, MD
Elizabeth Edmiston, PhD
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Felicia Skelton, MD MS
713-794-7128
Sameer Siddiqui, MD
(713) 791-1414
Felicia Skelton, MD MS (SUB_INVESTIGATOR)
James Pittman, PhD MSW (SUB_INVESTIGATOR)

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