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Behavioral Intervention

Implement CAPP-FIT without RA facilitation for Spinal Cord Injury (CAPP-FIT Trial)

N/A
Waitlist Available
Led By Elizabeth E Burkhart, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* assigned provider in SCI clinic who is willing to participate in the study
* has a scheduled appointment in the SCI clinic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly to 6-weeks (month 5-35), at end of implementation (month 35-36) and maintenance phases (month 45-46)
Awards & highlights

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.

Who is the study for?
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.
What is being tested?
The trial tests a decision support tool called CAPP-FIT designed to help prevent community-acquired pressure injuries in SCI patients. It involves an automated survey and provider report within the health record, implemented across seven VA clinics.
What are the potential side effects?
Since this intervention is non-medical and more about information gathering and decision support, traditional side effects associated with medications are not applicable here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly to 6-weeks (month 5-35), at end of implementation (month 35-36) and maintenance phases (month 45-46)
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly to 6-weeks (month 5-35), at end of implementation (month 35-36) and maintenance phases (month 45-46) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation
Secondary study objectives
Change in proportion of NP/MD/RN providers implementing the CAPP-FIT between implementation and maintenance
Completed Veteran survey and accessed Provider Reports during implementation
Describe and compare the patient population of participating VA SCI Centers: ASIA Impairment Scale score
+18 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Preparation to implement the CAPP-FIT per siteExperimental Treatment1 Intervention
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.
Group II: Implement CAPP-FIT without RA facilitationExperimental Treatment1 Intervention
Each site will determine how they will integrate use of the CAPP-FIT in clinic workflow.
Group III: Implement CAPP-FIT with RA facilitationActive Control1 Intervention
Veteran completes Veteran Survey and Provider uses Provider report around an established clinic visit per site

Find a Location

Who is running the clinical trial?

VA Palo Alto Health Care SystemFED
92 Previous Clinical Trials
57,353 Total Patients Enrolled
Saint Louis VA Medical CenterFED
3 Previous Clinical Trials
419 Total Patients Enrolled
Iowa City Veterans Affairs Medical CenterFED
7 Previous Clinical Trials
1,184 Total Patients Enrolled
~539 spots leftby May 2027