Recruiting

Decision Support Tool

Sponsor:

VA Office of Research and Development

Code:

NCT06529094

Conditions

Spinal Cord Injury

Pressure Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Provider training

CAPP-FIT intervention with RA facilitation

CAPP-FIT implementation during maintenance phase

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injury

Pressure Injury

Study ID

NCT06529094

Start date

Nov 1, 2024

Status verified date

Nov, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Veteran participant eligibility criteria include:

  • assigned provider in SCI clinic who is willing to participate in the study
  • has a scheduled appointment in the SCI clinic
  • ability to complete survey

Exclusion Criteria:

  • active diagnosis of dementia

Study Design

Enrollment

808 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Provider training

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

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Frances M Weaver, PhD MA BA

(708) 202-2414frances.weaver@va.gov

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Edward Hines Jr. VA Hospital, Hines, IL

Recruiting

Hines, Illinois, United States, 60141-3030

Contacts

Principal Investigator:

Elizabeth E Burkhart, PhD

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Mary K Henzel, MD

Mary.henzel@va.gov

Elizabeth Edmiston, PhD

elizabeth.edmistron@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • prevention
  • spinal cord injury
  • pressure injury
  • Veteran
  • community

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-14.