Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529094
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury SCI in the Spinal Cord Injury Clinic
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury SCI in the Spinal Cord Injury Clinic
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPP-FIT
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None