Clinical trial NCT06529094: Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Official title: Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Pressure Injury
Keywords: prevention
spinal cord injury
pressure injury
Veteran
community
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Palo Alto Health Care System
name: VA Long Beach Healthcare System
name: Saint Louis VA Medical Center
name: Louis Stokes VA Medical Center
name: Michael E. DeBakey VA Medical Center
name: Iowa City Veterans Affairs Medical Center
name: San Diego Veterans Healthcare System
name: Edward Hines Jr. VA Hospital
name: James A. Haley Veterans' Hospital
First posted: 2024-07-31
Enrollment: 808
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation
timeFrame: 6 months
Secondary outcomes:
measure: Root causes of new CAPrIs that occur 6 months post CAPP-FIT implementation
timeFrame: 6 months
measure: Veteran satisfaction with the CAPP-FIT Information
timeFrame: after first CAPP-FIT completion-month 5 through 35
measure: Provider satisfaction with CAPP-FIT
timeFrame: Month 35-36 and month 45-46 (after implementation and after maintenance phases)
measure: Inpatient admissions and PrI-associated inpatient admissions
timeFrame: 6 months post initial CAPP-FIT implementation
measure: Proportion of SCI providers that attend training and simulation
timeFrame: prior to CAPP-FIT implementation
measure: Proportion of Veteran participants completing CAPP-FIT during study periods
timeFrame: after Veteran CAPP-FIT completion (Months 5 through 35)
measure: Veteran risk factors identified per site during CAPP-FIT implementation
timeFrame: after Veteran CAPP-FIT completion (Months 5 through 35)
measure: Provider actions on Veteran risks identified on the Veteran survey during implementation
timeFrame: One week after Veteran CAPP-FIT completion/Provider Report generation (month 5 through 36)
measure: Completed Veteran survey and accessed Provider Reports during implementation
timeFrame: Day of CAPP-FIT completion (month 5-35)
measure: Describe and compare the patient population of participating VA SCI Centers: Healthcare access (travel time)
timeFrame: 6 months after CAPP-FIT completion (month 5-35)
measure: Facilitators/barriers in implementing the CAPP-FIT per site
timeFrame: monthly to 6-weeks (month 5-35), at end of implementation (month 35-36) and maintenance phases (Month 45-46)
measure: Description of how sites will maintain the CAPP-FIT in clinic workflow post implementation
timeFrame: end of implementation (month 35-36) and maintenance phases (months 45-46)
measure: Describe and compare the patient population of participating VA SCI Centers: Medium and Dark Skin Tone
timeFrame: At initial CAPP-FIT completion (month 5-35)
measure: Describe and compare the patient population of participating VA SCI Centers: Level of Injury
timeFrame: at initial CAPP-FIT completion (month 5-35)
measure: Describe and compare the patient population of participating VA SCI Centers: history of pressure injury
timeFrame: At initial CAPP-FIT completion (month 5-35)
measure: Describe and compare the patient population of participating VA SCI Centers: Age
timeFrame: at initial CAPP-FIT completion (month 5-35)
measure: Describe and compare the patient population of participating VA SCI Centers: Care Assessment Needs (CAN score)
timeFrame: At initial CAPP-FIT completion (month 5-35)
measure: Describe and compare the patient population of participating VA SCI Centers: ASIA Impairment Scale score
timeFrame: At initial CAPP-FIT completion
measure: Veteran satisfaction with the CAPP-FIT Functionality
timeFrame: after first CAPP-FIT completion-month 5 through 35
measure: Veteran Satisfaction with healthcare
timeFrame: 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
measure: Change in proportion of NP/MD/RN providers implementing the CAPP-FIT between implementation and maintenance
timeFrame: end of implementation months (month 5-35) and maintenance phases (month 36-45)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System, Long Beach, CA
state: California
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Saint Louis
country: United States
facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
state: Missouri
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Elizabeth E Burkhart, PhD
role: PRINCIPAL_INVESTIGATOR
References: