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Behavioral Intervention
Decision Support Tool for Spinal Cord Injury (CAPP-FIT Trial)
N/A
Recruiting
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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ monthly to 6-weeks (month 5-35), at end of implementation (month 35-36) and maintenance phases (month 45-46)
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)
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
93 Previous Clinical Trials
57,194 Total Patients Enrolled
Saint Louis VA Medical CenterFED
3 Previous Clinical Trials
419 Total Patients Enrolled
Iowa City Veterans Affairs Medical CenterFED
8 Previous Clinical Trials
2,193 Total Patients Enrolled
Edward Hines Jr. VA HospitalFED
15 Previous Clinical Trials
1,782 Total Patients Enrolled
Michael E. DeBakey VA Medical CenterFED
67 Previous Clinical Trials
16,421 Total Patients Enrolled
James A. Haley Veterans' HospitalUNKNOWN
1 Previous Clinical Trials
600 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,058 Total Patients Enrolled
VA Long Beach Healthcare SystemFED
15 Previous Clinical Trials
3,687 Total Patients Enrolled
San Diego Veterans Healthcare SystemFED
37 Previous Clinical Trials
4,657 Total Patients Enrolled
Louis Stokes VA Medical CenterFED
20 Previous Clinical Trials
3,335 Total Patients Enrolled