NCT06529094

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
808

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Nov 2024Jul 2028

First Submitted

Initial submission to the registry

July 16, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

2.6 years

First QC Date

July 16, 2024

Last Update Submit

November 12, 2025

Conditions

Spinal Cord InjuryPressure Injury

Keywords

preventionspinal cord injurypressure injuryVeterancommunity

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (21)

  • Root causes of new CAPrIs that occur 6 months post CAPP-FIT implementation

    6 months

  • Veteran satisfaction with the CAPP-FIT Information

    after first CAPP-FIT completion-month 5 through 35

  • Provider satisfaction with CAPP-FIT

    Month 35-36 and month 45-46 (after implementation and after maintenance phases)

  • Inpatient admissions and PrI-associated inpatient admissions

    6 months post initial CAPP-FIT implementation

  • Proportion of SCI providers that attend training and simulation

    prior to CAPP-FIT implementation

  • +16 more secondary outcomes

Study Arms (3)

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.

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

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.

Behavioral: CAPP-FIT implementation during maintenance phase

Interventions

Provider trainingBEHAVIORAL

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

Preparation to implement the CAPP-FIT per site
CAPP-FIT intervention with RA facilitationBEHAVIORAL

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 with RA facilitation
CAPP-FIT implementation during maintenance phaseBEHAVIORAL

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.

Implement CAPP-FIT without RA facilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • active diagnosis of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

NOT YET RECRUITING

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

RECRUITING

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

RECRUITING

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

St Louis, Missouri, 63106-1621, United States

NOT YET RECRUITING

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesPressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elizabeth E Burkhart, PhD

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth E Burkhart, PhD

CONTACT

(708) 202-5884elizabeth.burkhart@va.gov

Frances M Weaver, PhD MA BA

CONTACT

(708) 202-2414frances.weaver@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 31, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.
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.

Locations

US(7)