MedDataX Logo

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

NCT ID: NCT06529094

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2028-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury Pressure Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

prevention spinal cord injury pressure injury Veteran community

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Provider training

Intervention Type BEHAVIORAL

Provider participants will complete TMS training, CAPP-FIT demonstration and simulation in use of the CAPP-FIT with a standardized patient.

Implement CAPP-FIT with RA facilitation

Veteran completes Veteran Survey and Provider uses Provider report around an established clinic visit per site

Group Type ACTIVE_COMPARATOR

CAPP-FIT intervention with RA facilitation

Intervention Type BEHAVIORAL

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.

Implement CAPP-FIT without RA facilitation

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

Group Type OTHER

CAPP-FIT implementation during maintenance phase

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Provider training

Provider participants will complete TMS training, CAPP-FIT demonstration and simulation in use of the CAPP-FIT with a standardized patient.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Palo Alto Health Care System

FED

Sponsor Role collaborator

VA Long Beach Healthcare System

FED

Sponsor Role collaborator

Saint Louis VA Medical Center

FED

Sponsor Role collaborator

James A. Haley Veterans' Hospital

UNKNOWN

Sponsor Role collaborator

Louis Stokes VA Medical Center

FED

Sponsor Role collaborator

Michael E. DeBakey VA Medical Center

FED

Sponsor Role collaborator

Iowa City Veterans Affairs Medical Center

FED

Sponsor Role collaborator

San Diego Veterans Healthcare System

FED

Sponsor Role collaborator

Edward Hines Jr. VA Hospital

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth E Burkhart, PhD

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

Site Status NOT_YET_RECRUITING

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status RECRUITING

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Site Status NOT_YET_RECRUITING

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Site Status RECRUITING

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, United States

Site Status NOT_YET_RECRUITING

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Site Status RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Elizabeth E Burkhart, PhD

Role: CONTACT

Phone: (708) 202-5884

Email: [email protected]

Frances M Weaver, PhD MA BA

Role: CONTACT

Phone: (708) 202-2414

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Walter Chua, MD

Role: primary

Ariel Baria, PhD

Role: backup

Doug T Ota, MD

Role: primary

Sujuan Cai, PhD

Role: backup

Kevin White, MD

Role: primary

Susan VanBreman, BSN

Role: backup

Rebecca Hasley

Role: primary

Chad M Osteen, MAS BA

Role: backup

Katherine Stenson, MD

Role: primary

Rachael Beard, PhD

Role: backup

Mary K Henzel, MD

Role: primary

Elizabeth Edmiston, PhD

Role: backup

Felicia Skelton, MD MS

Role: primary

Sameer Siddiqui, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HX003704

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIR 22-163

Identifier Type: -

Identifier Source: org_study_id