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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

active diagnosis of dementia

Trial design

Design model

Sequential

Treatments tested in this trial

  • Provider training

    Behavioral

    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 facilitation

    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.

  • CAPP-FIT implementation during maintenance phase

    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.

Treatment groups

808 Participants
are divided into 3 treatment groups
Group A: Preparation to implement the CAPP-FIT per siteOther 1 intervention
Group B: Implement CAPP-FIT with RA facilitationActive comparator 1 intervention
Group C: Implement CAPP-FIT without RA facilitationOther 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months
2

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.

Time frame
after first CAPP-FIT completion-month 5 through 35
3

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.

Time frame
Month 35-36 and month 45-46 (after implementation and after maintenance phases)
4

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.

Time frame
6 months post initial CAPP-FIT implementation

Other outcomes

Sponsors and contacts

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VA Office of Research and Development

Lead sponsor

VA Palo Alto Health Care System

Collaborator

VA Long Beach Healthcare System

Collaborator

Saint Louis VA Medical Center

Collaborator

James A. Haley Veterans' Hospital

Collaborator

Louis Stokes VA Medical Center

Collaborator

Michael E. DeBakey VA Medical Center

Collaborator

Iowa City Veterans Affairs Medical Center

Collaborator

San Diego Veterans Healthcare System

Collaborator

Edward Hines Jr. VA Hospital

Collaborator