Spinal Cord InjuryCAPP-FITNCT06529094
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
A study testing Provider training, CAPP-FIT intervention with RA facilitation and CAPP-FIT implementation during maintenance phase in people with Spinal Cord Injury and Pressure Injury, run by VA Office of Research and Development at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Pressure Injury
- What is being tested?
- Provider training, CAPP-FIT intervention with RA facilitation and CAPP-FIT implementation during maintenance phase
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 808 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Nov 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran participant eligibility criteria include:
- assigned provider in Spinal Cord Injury (SCI) clinic who is willing to participate in the study
- has a scheduled appointment in the Spinal Cord Injury (SCI) clinic
- ability to complete survey
Who cannot join
- active diagnosis of dementia
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 7 recruiting
- Not yet recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Sunil Sabharwal, MD, 857-203-6574, sunil.sabharwal2@va.gov
- Withdrawn
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
- Recruiting
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
Rebecca Hasley, (708) 864-1628, rebecca1.hasley@va.gov
Chad M Osteen, MAS BA, (708) 202-8387 ext. 24553, chad.osteen@va.gov
- Recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Felicia Skelton, MD MS, (713) 794-7128, Felicia.Skelton2@va.gov
Hilary Touchett, PhD MSN BSN, (713) 791-1414, hilary.touchett@va.gov
- Recruiting
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Walter Chua, MD, walter.chua@va.gov
Ariel Baria, PhD, Ariel.baria@va.gov
- Recruiting
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Doug T Ota, MD, (650) 493-5000 ext. 64007, Doug.Ota@va.gov
Sujuan Cai, PhD, (650) 493-5000 ext. 65474, Sujuan.cai@va.gov
- Recruiting
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106-1621
Katherine Stenson, MD, Katherine.stenson@va.gov
Rachael Beard, PhD, rachael.beard@va.gov
- Recruiting
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
Kevin White, MD, Keith.white@va.gov
Susan VanBreman, BSN, susan.vanbreman@va.gov
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Pressure Injury
- Being tested
- Provider training, CAPP-FIT intervention with RA facilitation, CAPP-FIT implementation during maintenance phase
- Keywords
- prevention, spinal cord injury, pressure injury, Veteran, community
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider trainingBehavioural
Provider participants will complete TMS training, CAPP-FIT demonstration and simulation in use of the CAPP-FIT with a standardized patient.
CAPP-FIT intervention with RA facilitationBehavioural
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.
CAPP-FIT implementation during maintenance phaseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Preparation to implement the CAPP-FIT per site | Other | 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. Receives: Behavioral: Provider training |
| Implement CAPP-FIT with RA facilitation | Active comparator | Veteran completes Veteran Survey and Provider uses Provider report around an established clinic visit per site Receives: Behavioral: CAPP-FIT intervention with RA facilitation |
| Implement CAPP-FIT without RA facilitation | Other | Each site will determine how they will integrate use of the CAPP-FIT in clinic workflow. Receives: Behavioral: CAPP-FIT implementation during maintenance phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation
New CAPrI incidence within 6 months of first CAPP-FIT survey measured for each unique patient
Measured: 6 months
Secondary outcomes (21)
Root causes of new CAPrIs that occur 6 months post CAPP-FIT implementation
Use of root cause analysis (RCA) to determine the cause of a new CAPrIs within 6 months post CAPP-FIT implementation in Veteran participants
Measured: 6 months
Veteran satisfaction with the CAPP-FIT Information
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.
Measured: after first CAPP-FIT completion-month 5 through 35
Provider satisfaction with CAPP-FIT
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.
Measured: Month 35-36 and month 45-46 (after implementation and after maintenance phases)
Inpatient admissions and PrI-associated inpatient admissions
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.
Measured: 6 months post initial CAPP-FIT implementation
Proportion of SCI providers that attend training and simulation
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.
Measured: prior to CAPP-FIT implementation
Proportion of Veteran participants completing CAPP-FIT during study periods
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.
Measured: after Veteran CAPP-FIT completion (Months 5 through 35)
Veteran risk factors identified per site during CAPP-FIT implementation
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.
Measured: after Veteran CAPP-FIT completion (Months 5 through 35)
Provider actions on Veteran risks identified on the Veteran survey during implementation
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.
Measured: One week after Veteran CAPP-FIT completion/Provider Report generation (month 5 through 36)
Completed Veteran survey and accessed Provider Reports during implementation
Proportion of completed Veteran surveys that Providers accessed during implementation.
Measured: Day of CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: Healthcare access (travel time)
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.
Measured: 6 months after CAPP-FIT completion (month 5-35)
Facilitators/barriers in implementing the CAPP-FIT per site
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.
Measured: 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
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.
Measured: 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
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
Measured: At initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: Level of Injury
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
Measured: at initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: history of pressure injury
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.
Measured: At initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: Age
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
Measured: at initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: Care Assessment Needs (CAN score)
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).
Measured: At initial CAPP-FIT completion (month 5-35)
Describe and compare the patient population of participating VA SCI Centers: ASIA Impairment Scale score
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.
Measured: At initial CAPP-FIT completion
Veteran satisfaction with the CAPP-FIT Functionality
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.
Measured: after first CAPP-FIT completion-month 5 through 35
Veteran Satisfaction with healthcare
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.
Measured: 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
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.
Measured: end of implementation months (month 5-35) and maintenance phases (month 36-45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Nov 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework will guide this study to assess implementation. For this study, Reach is the proportion of the outpatient SCI population that complete the CAPP-FIT. Efficacy is success rate, measured as reduction in incidence of CAPrIs, CAPrI-associated hospitalizations, and patient and provider satisfaction. Adoption is the degree that sites use the CAPP-FIT. Implementation is the extent to which the CAPP-FIT is implemented as intended. Maintenance is the extent to which CAPP-FIT is maintained over time.
- Masking
- None (open label)
- Enrolment
- 808 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Palo Alto Health Care System, VA Long Beach Healthcare System, Saint Louis VA Medical Center, Louis Stokes VA Medical Center, Michael E. DeBakey VA Medical Center, Iowa City Veterans Affairs Medical Center, San Diego Veterans Healthcare System, Edward Hines Jr. VA Hospital, West Roxbury VA Medical Center, James A. Haley Veterans Administration Hospital
- Responsible party
- Sponsor
- Investigators
- Elizabeth E Burkhart, PhD, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529094
- Sponsor's protocol ID
- IIR 22-163
- Other IDs
- HX003704, 1I01HX003704-01A2
- Acronym
- CAPP-FIT
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
- ClinicalTrials.gov ID
- NCT06529094
- Acronym / sponsor ID
- CAPP-FIT / IIR 22-163
- Conditions
- Spinal Cord Injury, Pressure Injury
- Keywords
- prevention, spinal cord injury, pressure injury, Veteran, community
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 808 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Palo Alto Health Care System, VA Long Beach Healthcare System, Saint Louis VA Medical Center, Louis Stokes VA Medical Center, Michael E. DeBakey VA Medical Center, Iowa City Veterans Affairs Medical Center, San Diego Veterans Healthcare System, Edward Hines Jr. VA Hospital, West Roxbury VA Medical Center, James A. Haley Veterans Administration Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework will guide this study to assess implementation. For this study, Reach is the proportion of the outpatient SCI population that complete the CAPP-FIT. Efficacy is success rate, measured as reduction in incidence of CAPrIs, CAPrI-associated hospitalizations, and patient and provider satisfaction. Adoption is the degree that sites use the CAPP-FIT. Implementation is the extent to which the CAPP-FIT is implemented as intended. Maintenance is the extent to which CAPP-FIT is maintained over time.
| Arm | Type | Receives |
|---|---|---|
| Preparation to implement the CAPP-FIT per site | Other | Behavioral: Provider trainingComplete 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. |
| Implement CAPP-FIT with RA facilitation | Active comparator | Behavioral: CAPP-FIT intervention with RA facilitationVeteran completes Veteran Survey and Provider uses Provider report around an established clinic visit per site |
| Implement CAPP-FIT without RA facilitation | Other | Behavioral: CAPP-FIT implementation during maintenance phaseEach site will determine how they will integrate use of the CAPP-FIT in clinic workflow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- assigned provider in Spinal Cord Injury (SCI) clinic who is willing to participate in the study
- has a scheduled appointment in the Spinal Cord Injury (SCI) clinic
- ability to complete survey
Key exclusion criteria (1 listed)
- active diagnosis of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provider trainingProvider participants will complete TMS training, CAPP-FIT demonstration and simulation in use of the CAPP-FIT with a standardized patient. | Behavioural | Preparation to implement the CAPP-FIT per site |
| CAPP-FIT intervention with RA facilitationAfter 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. | Behavioural | Implement CAPP-FIT with RA facilitation |
| CAPP-FIT implementation during maintenance phaseProviders 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. | Behavioural | Implement CAPP-FIT without RA facilitation |
Primary outcome
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
21 secondary outcomes
Root causes of new CAPrIs that occur 6 months post CAPP-FIT implementation
Time frame: 6 months
Veteran satisfaction with the CAPP-FIT Information
Time frame: 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)
Inpatient admissions and PrI-associated inpatient admissions
Time frame: 6 months post initial CAPP-FIT implementation
Proportion of SCI providers that attend training and simulation
Time frame: 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)
Veteran risk factors identified per site during CAPP-FIT implementation
Time frame: 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)
Completed Veteran survey and accessed Provider Reports during implementation
Time frame: 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)
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)
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)
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)
Describe and compare the patient population of participating VA SCI Centers: Level of Injury
Time frame: 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)
Describe and compare the patient population of participating VA SCI Centers: Age
Time frame: 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)
Describe and compare the patient population of participating VA SCI Centers: ASIA Impairment Scale score
Time frame: 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 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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth E Burkhart, PhD principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider training, CAPP-FIT intervention with RA facilitation and CAPP-FIT implementation during maintenance phase in people with Spinal Cord Injury and Pressure Injury, run by VA Office of Research and Development at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth E Burkhart, PhD ((708) 202-5884, elizabeth.burkhart@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.