Decision Support Tool for Spinal Cord Injury

(CAPP-FIT Trial)

Recruiting at 7 trial locations

Overseen By Elizabeth E Burkhart, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

808 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the new tool, CAPP-FIT (Community Acquired Pressure Injury Prevention Field Implementation Tool), prevents painful skin sores (pressure injuries) in individuals with spinal cord injuries (SCI). The tool includes a survey for Veterans and a report for their healthcare providers, guiding them in taking preventive measures against these sores. The trial will assess the tool's implementation in clinics and its impact on reducing hospital visits related to these injuries. Veterans with a spinal cord injury who have a clinic appointment and can complete a survey may be suitable candidates for this trial. As an unphased trial, this study provides Veterans the chance to contribute to innovative research that could enhance their healthcare experience.

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 prior data suggests that the CAPP-FIT is safe for preventing community-acquired pressure injuries?

Research has shown that the CAPP-FIT decision support tool helps prevent pressure sores in people with spinal cord injuries. This tool uses a survey to identify risks and provides advice for doctors to prevent these sores. So far, no safety issues or negative effects have been reported from using this tool. The CAPP-FIT is non-invasive, involving mainly surveys and reports, which makes it generally safe. Since it is not a medication or physical treatment, there is little risk of side effects, making it a low-risk option for preventing pressure sores in people with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of a decision support tool, CAPP-FIT, designed to enhance care for spinal cord injury (SCI) patients. Unlike traditional approaches that rely heavily on standard rehabilitation techniques, this tool aims to integrate personalized care planning directly into clinic workflows, potentially improving patient outcomes. By facilitating better communication between veterans and their healthcare providers, CAPP-FIT helps tailor interventions to individual needs, which could lead to more effective and efficient rehabilitation processes.

What evidence suggests that the CAPP-FIT is effective for preventing community-acquired pressure injuries in spinal cord injury patients?

Research has shown that the CAPP-FIT tool helps prevent pressure sores in people with spinal cord injuries. These sores often develop due to reduced movement and sensation, particularly at home. In this trial, participants will be divided into different arms to evaluate the implementation of CAPP-FIT. One arm will implement CAPP-FIT without RA facilitation, while another will implement it with RA facilitation. The tool uses a survey to identify risks and suggest preventive measures. Healthcare providers receive a report with advice on next steps. Early results indicate that CAPP-FIT may reduce these sores and related hospital visits, improving life for those with spinal cord injuries. ^{1 2 3 5 6}

Who Is on the Research Team?

Elizabeth E Burkhart, PhD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Are You a Good Fit for This Trial?

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

Has a scheduled appointment in the SCI clinic

Assigned provider in SCI clinic who is willing to participate in the study

Ability to complete survey

Exclusion Criteria

I have been diagnosed with dementia.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CAPP-FIT

Trial Overview 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.

How Is the Trial Designed?

Group I: Preparation to implement the CAPP-FIT per site Experimental Treatment 1 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 facilitation Experimental Treatment 1 Intervention

Each site will determine how they will integrate use of the CAPP-FIT in clinic workflow.

Group III: Implement CAPP-FIT with RA facilitation Active Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study of 3,361 individuals with spinal cord injury showed a significant increase in the prevalence of pressure ulcers from 1994 to 2002, with an odds ratio of 1.4, indicating a growing concern that is not solely related to aging or other demographic factors.

The risk of developing pressure ulcers was notably higher in certain groups, including the elderly, men, and those with a history of pressure ulcers, suggesting that targeted interventions may be necessary for these vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure ulcer prevalence in people with spinal cord injury: age-period-duration effects. Chen, Y., Devivo, MJ., Jackson, AB.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of five studies involving 513 community-dwelling adults with spinal cord injury found no evidence that behavioral or educational interventions effectively prevent pressure ulcers.

All studies reported null results regarding pressure ulcer outcomes, highlighting significant methodological issues such as recruitment challenges and low participant adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of behavioral and educational interventions to prevent pressure ulcers in adults with spinal cord injury. Cogan, AM., Blanchard, J., Garber, SL., et al.[2018]

A study of 25 medically underserved adults with spinal cord injury revealed that 40 serious pressure injuries developed despite a prevention program, highlighting the need for better education and resources.

Key factors contributing to these injuries included lack of wound care knowledge, equipment issues, comorbidities, and non-adherence to care guidelines, suggesting that future rehabilitation programs should tailor education and support to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative analysis of pressure injury development among medically underserved adults with spinal cord injury. Floríndez, LI., Carlson, ME., Pyatak, E., et al.[2023]

Self-management technologies for preventing pressure ulcers in individuals with spinal cord injury show low-to-moderate effectiveness, with various types of technologies improving knowledge, adherence, and tissue tolerance.

Four main technology categories were identified: educational tools, pressure mapping, electrical stimulation, and telemedicine, each demonstrating specific benefits but overall limited effectiveness in preventing pressure ulcers due to insufficient incidence reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistive technologies for self-managed pressure ulcer prevention in spinal cord injury: a scoping review. Tung, JY., Stead, B., Mann, W., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The research protocol aims to create a decision support tool specifically designed to prevent community-acquired pressure injuries (CAPrIs) in Veterans with spinal cord injury, addressing a significant gap in current healthcare practices.

The study involves gathering insights from both Veterans and healthcare providers to develop and validate this tool, ensuring it is based on real-world experiences and needs, which will be tested in a pilot implementation phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Burkhart, L., Skemp, L., Siddiqui, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06529094

Implementing a Decision Support Tool to Prevent ... This grant proposal will assess how well a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT), ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37828368/

Development of a decision support tool to prevent ... A decision support tool to prevent community-acquired pressure injuries (CAPrIs) in individuals with spinal cord injury (SCI) for use in SCI clinics.

3. trialx.com trialx.com/clinical-trials/listings/303763/implementing-a-decision-support-tool-to-prevent-community-acquired-pressure-injury-in-spinal-cord-injury-sci-in-the-spinal-cord-injury-clinic/

Clinical Research Trial Listing ( Spinal Cord Injury Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic.

4. withpower.com withpower.com/trial/phase-spinal-cord-injuries-10-2024-2a879

Decision Support Tool for Spinal Cord Injury (CAPP-FIT Trial) Trial Overview The trial tests a decision support tool called CAPP-FIT designed to help prevent community-acquired pressure injuries in SCI patients. It ...

5. hsrd.research.va.gov hsrd.research.va.gov/Research/abstracts.cfm?Project_ID=2141709776

IIR 22-163 – HSR Study - VA Health Systems Research Implementing a Decision Support Tool to prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic

6. hsrd.research.va.gov hsrd.research.va.gov/meetings/2023/abstract-display.cfm?AbsNum=1108

2023 HSR&D/QUERI National Conference Abstract Describe how the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT) decision support tool may prevent community-acquired ...