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Behavioral Intervention

Decision Support Tool 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
Be older than 18 years old
Must not have
Active diagnosis of dementia
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

This trial aims to evaluate a tool called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT) in preventing pressure injuries in individuals with spinal cord injuries. The tool includes a survey

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with dementia.

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
57,351 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
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