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 — BEHAVIORALProvider 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 — BEHAVIORALAfter 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 — BEHAVIORALProviders 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 siteComplete 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 facilitationVeteran completes Veteran Survey and Provider uses Provider report around an established clinic visit per site
- Other: Implement CAPP-FIT without RA facilitationEach 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
- Elizabeth E Burkhart, PhD(708) 202-5884
- Frances M Weaver, PhD MA BA(708) 202-2414
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California | 90822 | Walter Chua, MD Ariel Baria, PhD |
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | 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, FL | Tampa | Florida | 33612 | Kevin White, MD Susan VanBreman, BSN |
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-3030 | Elizabeth E Burkhart, PhD (PRINCIPAL_INVESTIGATOR) |
| St. Louis VA Medical Center John Cochran Division, St. Louis, MO | St Louis | Missouri | 63106-1621 | Katherine Stenson, MD Rachael Beard, PhD |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | Mary K Henzel, MD Elizabeth Edmiston, PhD |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | Felicia Skelton, MD MS (SUB_INVESTIGATOR) James Pittman, PhD MSW (SUB_INVESTIGATOR) |
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