Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic (CAPP-FIT)

November 12, 2025 updated by: VA Office of Research and Development
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 is a type 1 hybrid stepped wedge randomized design at six additional SCI Clinics to assess the efficacy and implementation of a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT) previously developed and piloted at one site. The CAPP-FIT includes: 1) a Veteran survey to identify risks, actions, and resources needed to prevent CAPrIs and 2) a companion Provider Report immediately available in print or downloaded into the electronic health record listing Veteran responses to survey items with recommended evidence-based provider actions. The Veteran survey can be completed at home via a secured email or by using an iPad in the clinic. There are three aims in the proposal, guided by the RE-AIM framework. Aim 1 is implementing the CAPP-FIT at the seven geographically diverse VA SCI clinics, including workflow redesign, provider training, and evaluation of provider readiness. The CAPP-FIT will be implemented in a staggered fashion consistent with the stepped wedge design. After CAPP-FIT implementation, each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability (maintenance phase). Aim 2 assesses efficacy, assessing provider and Veteran satisfaction in CAPrI use, new CAPrI incidence for 6 months post-initial CAPP-FIT implementation, and overall and CAPrI-associated hospitalizations. Aim 3 assesses implementation using RE-AIM. Reach is the proportion of providers and Veterans participating in the intervention. Adoption is assessed by the proportion of Veteran-identified modifiable risk factors acted upon by SCI providers, as well as a comparison of non-modifiable risk factors of participating and non-participating VA SCI clinics. Implementation is assessed by describing completed CAPP-FITs during implementation, describing Veteran CAPrI risk factors, and describing provider identified facilitators and barriers to implementation. Maintenance is assessed by describing how each clinic will continue to integrate CAPP-FIT into workflow and by describing the number of providers using the CAPP-FIT during maintenance phase.

Study Type

Interventional

Enrollment (Estimated)

808

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822
      • Palo Alto, California, United States, 94304-1207
        • Recruiting
        • VA Palo Alto Health Care System, Palo Alto, CA
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Doug T Ota, MD
        • Sub-Investigator:
          • Katherine C Stenson
        • Sub-Investigator:
          • Kevin T White, MD
        • Sub-Investigator:
          • Mary K Henzel
        • Sub-Investigator:
          • Walter C Chua
    • Florida
      • Tampa, Florida, United States, 33612
    • Illinois
      • Hines, Illinois, United States, 60141-3030
        • Recruiting
        • Edward Hines Jr. VA Hospital, Hines, IL
        • Principal Investigator:
          • Elizabeth E Burkhart, PhD
        • Contact:
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63106-1621
    • Ohio
      • Cleveland, Ohio, United States, 44106-1702
    • Texas
      • Houston, Texas, United States, 77030-4211
        • Recruiting
        • Michael E. DeBakey VA Medical Center, Houston, TX
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Felicia Skelton, MD MS
        • Sub-Investigator:
          • James Pittman, PhD MSW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Veteran participant eligibility criteria include:

  • 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:

  • active diagnosis of dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Preparation to implement the CAPP-FIT per site
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.
Behavioral: Provider training
Provider participants will complete TMS training, CAPP-FIT demonstration and simulation in use of the CAPP-FIT with a standardized patient.
Active Comparator: Implement CAPP-FIT with RA facilitation
Veteran completes Veteran Survey and Provider uses Provider report around an established clinic visit per site
Behavioral: CAPP-FIT intervention with RA facilitation
After consent and survey completion, RA to email/text CAPP-FIT link to Veteran the day before established clinic visit. RA to remain available to answer questions to help Veteran participant complete Veteran Survey and submit the responses through eScreening. The Provider Report will appear in CPRS with a Provider notification. RA to meet Veteran participant in the clinic after the clinic visit to complete the Veteran satisfaction survey.
Other: Implement CAPP-FIT without RA facilitation
Each site will determine how they will integrate use of the CAPP-FIT in clinic workflow.
Behavioral: CAPP-FIT implementation during maintenance phase
Providers will attend focus group after Arm 2 to determine sustainability of CAPP-FIT use in clinic workflow. Clinic provider will act on that determination for 10 months during maintenance phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation
Time Frame: 6 months
New CAPrI incidence within 6 months of first CAPP-FIT survey measured for each unique patient
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root causes of new CAPrIs that occur 6 months post CAPP-FIT implementation
Time Frame: 6 months
Use of root cause analysis (RCA) to determine the cause of a new CAPrIs within 6 months post CAPP-FIT implementation in Veteran participants
6 months
Veteran satisfaction with the CAPP-FIT Information
Time Frame: after first CAPP-FIT completion-month 5 through 35
Veteran satisfaction with the initial use of the CAPP-FIT will be assessed using the Information subscale of the Mobile Application Rating Scale (MARS), which rates the six items of a 5-point scale from 1 (inadequate) to 5 (excellent). Minimum score is 6, maximum score is 30.
after first CAPP-FIT completion-month 5 through 35
Provider satisfaction with CAPP-FIT
Time Frame: Month 35-36 and month 45-46 (after implementation and after maintenance phases)
The investigators will hold focus groups with providers per site after implementation to evaluate provider satisfaction with the CAPP-FIT. The investigators anticipate focus groups to include approximately 6-12 participating interprofessional providers/site. Each focus group will be audiotaped and transcribed verbatim. Data will be analyzed using content analysis to identify themes that emerge from the data per site. Qualitative coders will independently code the focus group data, meet to discuss codes, and discrepancies and come to consensus to develop the codebook and finalize themes.
Month 35-36 and month 45-46 (after implementation and after maintenance phases)
Inpatient admissions and PrI-associated inpatient admissions
Time Frame: 6 months post initial CAPP-FIT implementation
The incidence of inpatient admission within 6 months of first CAPP-FIT survey measured for each unique patient over time. Covariates of interest include non-modifiable CAPrI risk factors.
6 months post initial CAPP-FIT implementation
Proportion of SCI providers that attend training and simulation
Time Frame: prior to CAPP-FIT implementation
The investigators will obtain a roster of all providers who see patients in the SCI clinic (denominator). Those who agree to participate in the study will be the numerator to determine reach, such that the proportion of the target population participating in the intervention is calculated as the numerator divided by the denominator.
prior to CAPP-FIT implementation
Proportion of Veteran participants completing CAPP-FIT during study periods
Time Frame: after Veteran CAPP-FIT completion (Months 5 through 35)
The number of unique patients that meet inclusion criteria and have completed clinic appointments with participating providers during data collection periods is the denominator. Those who agree to participate in the study and complete the CAPP-FIT eScreening will be the numerator. Veteran reach is calculated as the numerator divided by the denominator.
after Veteran CAPP-FIT completion (Months 5 through 35)
Veteran risk factors identified per site during CAPP-FIT implementation
Time Frame: after Veteran CAPP-FIT completion (Months 5 through 35)
Veteran identified risk factors will be collected from the Provider Report in RedCap. Risk factor categories are issues associated with pressure reduction, nutrition, access to care, skincare, incontinence, acute illness, coping/motivation, mobility/activity, repositioning, caregiver, life integration, and substance use.
after Veteran CAPP-FIT completion (Months 5 through 35)
Provider actions on Veteran risks identified on the Veteran survey during implementation
Time Frame: One week after Veteran CAPP-FIT completion/Provider Report generation (month 5 through 36)
Chart review will reveal whether recommended provider actions listed on the Provider Report for Veteran-identified risk factors were addressed at or within one week of CAPP-FIT completion during a clinic visit.
One week after Veteran CAPP-FIT completion/Provider Report generation (month 5 through 36)
Completed Veteran survey and accessed Provider Reports during implementation
Time Frame: Day of CAPP-FIT completion (month 5-35)
Proportion of completed Veteran surveys that Providers accessed during implementation.
Day of CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: Healthcare access (travel time)
Time Frame: 6 months after CAPP-FIT completion (month 5-35)
Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: healthcare access (travel time). Travel time from home to nearest VA Hospital.
6 months after CAPP-FIT completion (month 5-35)
Facilitators/barriers in implementing the CAPP-FIT per site
Time Frame: monthly to 6-weeks (month 5-35), at end of implementation (month 35-36) and maintenance phases (Month 45-46)
Contextual inquiry will be conducted four times a month per site during implementation to identify identify implementation barriers including fidelity in CAPP-FIT use. Contextual summaries will be shared and discussed with providers during each site provider group monthly to 6 week meetings and discuss facilitators, barriers, and possible recommended changes to workflow, patient flow in implementation. Meeting minutes will be maintained. A focus group of provider participants per site will be conducted at the end of implementation and maintenance to evaluate provider satisfaction, facilitators, and barriers to implement the CAPP-FIT. Focus groups will be audiotaped, transcribed, and verified and analyzed by two qualitative researchers.
monthly to 6-weeks (month 5-35), at end of implementation (month 35-36) and maintenance phases (Month 45-46)
Description of how sites will maintain the CAPP-FIT in clinic workflow post implementation
Time Frame: end of implementation (month 35-36) and maintenance phases (months 45-46)
The end-of-implementation provider focus group will reveal how the CAPP-FIT will be maintained in clinic workflow. This includes any change in adapting the CAPP-FIT to clinic practice, changed workflow, and implementation protocols. This assessment will be repeated during the end-of-maintenance focus group.
end of implementation (month 35-36) and maintenance phases (months 45-46)
Describe and compare the patient population of participating VA SCI Centers: Medium and Dark Skin Tone
Time Frame: At initial CAPP-FIT completion (month 5-35)
Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: African-American/non-African-American
At initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: Level of Injury
Time Frame: at initial CAPP-FIT completion (month 5-35)
Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: tetraplegia or paraplegia
at initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: history of pressure injury
Time Frame: At initial CAPP-FIT completion (month 5-35)
Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: a documented pressure injury within 5 years prior to the initial CAPP-FIT completion.
At initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: Age
Time Frame: at initial CAPP-FIT completion (month 5-35)
Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: age in years
at initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: Care Assessment Needs (CAN score)
Time Frame: At initial CAPP-FIT completion (month 5-35)
Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: CAN score. CAN score is risk of hospitalization in 90 days. The score also compares the Veteran with other individuals and ranks them in a percentile from zero (lowest risk) to 99 (highest risk).
At initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: ASIA Impairment Scale score
Time Frame: At initial CAPP-FIT completion
Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: ASIA Impairment Scale (AIS) measures functional impairment due to the spinal cord injury. Grade A=The impairment is complete. There is no motor or sensory function left below the level of injury. Grade B=The impairment is incomplete. Sensory function, but not motor function, is preserved below the neurologic level and some sensation is preserved in the sacral segments S4 and S5. Grade C=Motor function is preserved below the neurologic level and not strong enough to move against gravity. Grade D: The impairment is incomplete. Joints can move against gravity. Grade E: functions are normal.
At initial CAPP-FIT completion
Veteran satisfaction with the CAPP-FIT Functionality
Time Frame: after first CAPP-FIT completion-month 5 through 35
Veteran satisfaction with the initial use of the CAPP-FIT will be assessed using the Functionality subscale of the Mobile Application Rating Scale (MARS), which rates the five items of a 5-point scale from 1 (inadequate) to 5 (excellent). Minimum score is 5, maximum score is 25.
after first CAPP-FIT completion-month 5 through 35
Veteran Satisfaction with healthcare
Time Frame: immediately prior to first CAPP-FIT completion (month 5 through 35) and six months after first CAPP-FIT completion (month 11 - 41)Implemen and again at the end of
Veteran satisfaction with healthcare will be measured pre and 6 months post CAPP-FIT intervention using the Scale of Patient Satisfaction with Primary Care Provider, which is a 10-item scale measured on 7-point Likert scale (1=strongly disagree, 7=strongly agree). Minimum value is 7; maximum value is 70.
immediately prior to first CAPP-FIT completion (month 5 through 35) and six months after first CAPP-FIT completion (month 11 - 41)Implemen and again at the end of
Change in proportion of NP/MD/RN providers implementing the CAPP-FIT between implementation and maintenance
Time Frame: end of implementation months (month 5-35) and maintenance phases (month 36-45)
The number of providers per site who access the CAPP-FIT during implementation and maintenance phases (numerator). Total number of providers at each site (denominator). The comparison is the change in proportion of providers who use the CAPP-FIT at each site.
end of implementation months (month 5-35) and maintenance phases (month 36-45)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

VA Palo Alto Health Care System
Louis Stokes VA Medical Center
Edward Hines Jr. VA Hospital
Michael E. DeBakey VA Medical Center
Saint Louis VA Medical Center
San Diego Veterans Healthcare System
Iowa City Veterans Affairs Medical Center
VA Long Beach Healthcare System
James A. Haley Veterans' Hospital

Investigators

  • Principal Investigator: Elizabeth E Burkhart, PhD, Edward Hines Jr. VA Hospital, Hines, IL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 22-163
  • HX003704 (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Final data sets underlying all publications resulting from the proposed research will be shared outside VA.

A de-identified, anonymized dataset will be created and shared. The VA privacy officer will certify whether the data sets meet conditions for disclosure to the public within one year of publication. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Data Use Agreement (DUA) in compliance with VA and non-VA privacy regulations.

Documentation will accompany each dataset. The analytical datasets and statistical code used in the publication will be retained for 6 years, in accordance with VA record retention policy.

IPD Sharing Time Frame

The analytical datasets and statistical code used in the publication will be retained for 6 years, in accordance with VA record retention policy.

IPD Sharing Access Criteria

Data will become available at the end of the study. The analytical datasets and statistical code used in the publication will be retained for 6 years, in accordance with VA record retention policy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injury

Clinical Trials on Provider training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe