Menu
Recruiting NCT06529094

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

No phase Interventional Spinal Cord Injury Pressure Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Provider training, CAPP-FIT intervention with RA facilitation, CAPP-FIT implementation during maintenance phase.
Who it may be relevant to
Registry conditions: Spinal Cord Injury, Pressure Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation [Time frame: 6 months]
Secondary outcome measures (12)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 7 centers
  • VA Long Beach Healthcare System, Long Beach, CA — Long Beach
  • VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
  • James A. Haley Veterans' Hospital, Tampa, FL — Tampa
  • Edward Hines Jr. VA Hospital, Hines, IL — Hines
  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis
  • Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
  • Michael E. DeBakey VA Medical Center, Houston, TX — Houston

Identifiers

NCT: NCT06529094 · IIR 22-163 · HX003704

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗