808 Participants Needed

Decision Support Tool for Spinal Cord Injury

(CAPP-FIT Trial)

Recruiting at 6 trial locations
FM
EE
Overseen ByElizabeth E Burkhart, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment CAPP-FIT for preventing pressure injuries in patients with spinal cord injury?

Research suggests that using decision support tools and educational interventions can help improve treatment adherence and prevent pressure injuries in patients with spinal cord injury by enhancing coordination and collaboration among healthcare providers.12345

What makes the CAPP-FIT treatment unique for preventing pressure injuries in spinal cord injury patients?

CAPP-FIT is unique because it focuses on preventing pressure injuries in spinal cord injury patients by using a decision support tool that is specifically designed for community settings, addressing the lack of formal guidelines and integrating self-management technologies to improve adherence and independence.24678

Research Team

EE

Elizabeth E Burkhart, PhD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Eligibility Criteria

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.

Inclusion Criteria

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

I have been diagnosed with dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

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.

5 months

Implementation

Implement the CAPP-FIT at the seven geographically diverse VA SCI clinics, including workflow redesign, provider training, and evaluation of provider readiness.

30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessing new CAPrI incidence and provider and Veteran satisfaction.

6 months

Maintenance

Each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability.

10 months

Treatment Details

Interventions

  • CAPP-FIT
Trial OverviewThe 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.
Participant Groups
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

CAPP-FIT is already approved in United States for the following indications:

🇺🇸
Approved in United States as CAPP-FIT for:
  • Prevention of Community-Acquired Pressure Injuries in Spinal Cord Injury

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

VA Palo Alto Health Care System

Collaborator

Trials
97
Recruited
58,500+

Saint Louis VA Medical Center

Collaborator

Trials
4
Recruited
1,200+

Iowa City Veterans Affairs Medical Center

Collaborator

Trials
10
Recruited
3,100+

Edward Hines Jr. VA Hospital

Collaborator

Trials
18
Recruited
2,800+

Michael E. DeBakey VA Medical Center

Collaborator

Trials
68
Recruited
17,200+

James A. Haley Veterans' Hospital

Collaborator

Trials
2
Recruited
1,400+

VA Long Beach Healthcare System

Collaborator

Trials
16
Recruited
4,500+

San Diego Veterans Healthcare System

Collaborator

Trials
38
Recruited
5,500+

Louis Stokes VA Medical Center

Collaborator

Trials
21
Recruited
4,100+

Findings from Research

A computerized decision support system (CDSS) was implemented in a study involving 30 patients with spinal cord injury and stage III/IV pressure injuries, but it did not significantly improve treatment adherence or clinical outcomes compared to standard care.
Healthcare professionals found the CDSS helpful for visualizing treatment processes, but technical issues like slow performance and poor accessibility hindered its effective implementation, indicating a need for better integration into clinical systems.
Effect of a computerized decision support system on the treatment approach of stage III or IV pressure injury in patients with spinal cord injury: a feasibility study.Scheel-Sailer, A., Koligi, K., Lampart, P., et al.[2023]
The implementation of best practices for pressure ulcer prevention in spinal cord injury rehabilitation led to a significant increase in risk assessment completion rates from 29% to 82% and a PUPP completion rate of 89%.
Patient education documentation improved from 21% to 45% after implementing these practices, demonstrating the effectiveness of using implementation science frameworks to enhance care quality.
The application of implementation science for pressure ulcer prevention best practices in an inpatient spinal cord injury rehabilitation program.Scovil, CY., Flett, HM., McMillan, LT., et al.[2021]
Both spinal cord injury (SCI) providers and veterans agree on the importance of basic care and support systems in preventing community-acquired pressure injuries (CAPrI), highlighting the need for family and caregiver involvement.
However, there are differing views on motivation and the adequacy of support systems, indicating that tailored approaches may be necessary to effectively promote CAPrI prevention among veterans.
Triangulation of veteran and provider models of preventing community-acquired pressure injuries in spinal cord injury to reveal convergence and divergence of perspectives.Burkhart, L., Skemp, L., Siddiqui, S.[2023]

References

Effect of a computerized decision support system on the treatment approach of stage III or IV pressure injury in patients with spinal cord injury: a feasibility study. [2023]
The application of implementation science for pressure ulcer prevention best practices in an inpatient spinal cord injury rehabilitation program. [2021]
Triangulation of veteran and provider models of preventing community-acquired pressure injuries in spinal cord injury to reveal convergence and divergence of perspectives. [2023]
Developing a decision support tool to prevent community-acquired pressure injuries in spinal cord injury in ambulatory care: A nurse-led protocol for mix methods research. [2021]
Systematic review of behavioral and educational interventions to prevent pressure ulcers in adults with spinal cord injury. [2018]
A qualitative analysis of pressure injury development among medically underserved adults with spinal cord injury. [2023]
Assistive technologies for self-managed pressure ulcer prevention in spinal cord injury: a scoping review. [2015]
Pressure ulcer prevalence in people with spinal cord injury: age-period-duration effects. [2022]