跳至主要内容
临床试验/NCT06529094
NCT06529094招募中不适用

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

VA Office of Research and Development14 个研究点 分布在 1 个国家目标入组 808 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
808
试验地点
14
主要终点
Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • active diagnosis of dementia

结局指标

主要结局

Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation

时间窗: 6 months

New CAPrI incidence within 6 months of first CAPP-FIT survey measured for each unique patient

次要结局

  • 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)
  • Proportion of Veteran participants completing CAPP-FIT during study periods(after Veteran CAPP-FIT completion (Months 5 through 35))
  • Veteran risk factors identified per site during CAPP-FIT implementation(after Veteran CAPP-FIT completion (Months 5 through 35))
  • Description of how sites will maintain the CAPP-FIT in clinic workflow post implementation(end of implementation (month 35-36) and maintenance phases (months 45-46))
  • Provider actions on Veteran risks identified on the Veteran survey during implementation(One week after Veteran CAPP-FIT completion/Provider Report generation (month 5 through 36))
  • Completed Veteran survey and accessed Provider Reports during implementation(Day of CAPP-FIT completion (month 5-35))
  • Describe and compare the patient population of participating VA SCI Centers: Healthcare access (travel time)(6 months after CAPP-FIT completion (month 5-35))
  • Facilitators/barriers in implementing the CAPP-FIT per site(monthly to 6-weeks (month 5-35), at end of implementation (month 35-36) and maintenance phases (Month 45-46))
  • Describe and compare the patient population of participating VA SCI Centers: Medium and Dark Skin Tone(At initial CAPP-FIT completion (month 5-35))
  • Describe and compare the patient population of participating VA SCI Centers: Level of Injury(at initial CAPP-FIT completion (month 5-35))
  • Describe and compare the patient population of participating VA SCI Centers: history of pressure injury(At initial CAPP-FIT completion (month 5-35))
  • Describe and compare the patient population of participating VA SCI Centers: Age(at initial CAPP-FIT completion (month 5-35))
  • Describe and compare the patient population of participating VA SCI Centers: Care Assessment Needs (CAN score)(At initial CAPP-FIT completion (month 5-35))
  • Describe and compare the patient population of participating VA SCI Centers: ASIA Impairment Scale score(At initial CAPP-FIT completion)
  • Change in proportion of NP/MD/RN providers implementing the CAPP-FIT between implementation and maintenance(end of implementation months (month 5-35) and maintenance phases (month 36-45))
  • Veteran satisfaction with the CAPP-FIT Functionality(after first CAPP-FIT completion-month 5 through 35)
  • Veteran Satisfaction with healthcare(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)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (14)

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