Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
- Conditions
- Spinal Cord InjuryPressure Injury
- Interventions
- Behavioral: Provider trainingBehavioral: CAPP-FIT implementation during maintenance phaseBehavioral: CAPP-FIT intervention with RA facilitation
- Registration Number
- NCT06529094
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 808
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
- active diagnosis of dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Preparation to implement the CAPP-FIT per site Provider training Complete clinic workflow designs and redesigns to integrate CAPP-FIT into clinic workflow per site. Recruit and train providers in use of the CAPP-FIT through TMS training, demonstration, and simulation with a standardized patient. Implement CAPP-FIT without RA facilitation CAPP-FIT implementation during maintenance phase Each site will determine how they will integrate use of the CAPP-FIT in clinic workflow. Implement CAPP-FIT with RA facilitation CAPP-FIT intervention with RA facilitation Veteran completes Veteran Survey and Provider uses Provider report around an established clinic visit per site
- Primary Outcome Measures
Name Time Method Incidence of new community acquired pressure injury 6 months post CAPP-FIT implementation 6 months New CAPrI incidence within 6 months of first CAPP-FIT survey measured for each unique patient
- Secondary Outcome Measures
Name Time Method Root causes of new CAPrIs that occur 6 months post CAPP-FIT implementation 6 months Use of root cause analysis (RCA) to determine the cause of a new CAPrIs within 6 months post CAPP-FIT implementation in Veteran participants
Veteran satisfaction with the CAPP-FIT Information after first CAPP-FIT completion-month 5 through 35 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.
Provider satisfaction with CAPP-FIT Month 35-36 and month 45-46 (after implementation and after maintenance phases) 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.
Inpatient admissions and PrI-associated inpatient admissions 6 months post initial CAPP-FIT implementation 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.
Proportion of SCI providers that attend training and simulation prior to CAPP-FIT implementation The investigators will obtain a roster of all providers who see patients in the SCI clinic (denominator). Those who agree to participate in the study will be the numerator to determine reach, such that the proportion of the target population participating in the intervention is calculated as the numerator divided by the denominator.
Proportion of Veteran participants completing CAPP-FIT during study periods after Veteran CAPP-FIT completion (Months 5 through 35) The number of unique patients that meet inclusion criteria and have completed clinic appointments with participating providers during data collection periods is the denominator. Those who agree to participate in the study and complete the CAPP-FIT eScreening will be the numerator. Veteran reach is calculated as the numerator divided by the denominator.
Veteran risk factors identified per site during CAPP-FIT implementation after Veteran CAPP-FIT completion (Months 5 through 35) Veteran identified risk factors will be collected from the Provider Report in RedCap. Risk factor categories are issues associated with pressure reduction, nutrition, access to care, skincare, incontinence, acute illness, coping/motivation, mobility/activity, repositioning, caregiver, life integration, and substance use.
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) The end-of-implementation provider focus group will reveal how the CAPP-FIT will be maintained in clinic workflow. This includes any change in adapting the CAPP-FIT to clinic practice, changed workflow, and implementation protocols. This assessment will be repeated during the end-of-maintenance focus group.
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) Chart review will reveal whether recommended provider actions listed on the Provider Report for Veteran-identified risk factors were addressed at or within one week of CAPP-FIT completion during a clinic visit.
Completed Veteran survey and accessed Provider Reports during implementation Day of CAPP-FIT completion (month 5-35) Proportion of completed Veteran surveys that Providers accessed during implementation.
Describe and compare the patient population of participating VA SCI Centers: Healthcare access (travel time) 6 months after CAPP-FIT completion (month 5-35) Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: healthcare access (travel time). Travel time from home to nearest VA Hospital.
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) Contextual inquiry will be conducted four times a month per site during implementation to identify identify implementation barriers including fidelity in CAPP-FIT use. Contextual summaries will be shared and discussed with providers during each site provider group monthly to 6 week meetings and discuss facilitators, barriers, and possible recommended changes to workflow, patient flow in implementation. Meeting minutes will be maintained. A focus group of provider participants per site will be conducted at the end of implementation and maintenance to evaluate provider satisfaction, facilitators, and barriers to implement the CAPP-FIT. Focus groups will be audiotaped, transcribed, and verified and analyzed by two qualitative researchers.
Describe and compare the patient population of participating VA SCI Centers: Medium and Dark Skin Tone At initial CAPP-FIT completion (month 5-35) Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: African-American/non-African-American
Describe and compare the patient population of participating VA SCI Centers: Level of Injury at initial CAPP-FIT completion (month 5-35) Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: tetraplegia or paraplegia
Describe and compare the patient population of participating VA SCI Centers: history of pressure injury At initial CAPP-FIT completion (month 5-35) Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: a documented pressure injury within 5 years prior to the initial CAPP-FIT completion.
Describe and compare the patient population of participating VA SCI Centers: Age at initial CAPP-FIT completion (month 5-35) Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: age in years
Describe and compare the patient population of participating VA SCI Centers: Care Assessment Needs (CAN score) At initial CAPP-FIT completion (month 5-35) Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: CAN score. CAN score is risk of hospitalization in 90 days. The score also compares the Veteran with other individuals and ranks them in a percentile from zero (lowest risk) to 99 (highest risk).
Describe and compare the patient population of participating VA SCI Centers: ASIA Impairment Scale score At initial CAPP-FIT completion Description and comparison of Veterans who have an assigned primary care provider in the SCI Clinic on non-modifiable characteristics that affect CAPrI incidence: ASIA Impairment Scale (AIS) measures functional impairment due to the spinal cord injury. Grade A=The impairment is complete. There is no motor or sensory function left below the level of injury. Grade B=The impairment is incomplete. Sensory function, but not motor function, is preserved below the neurologic level and some sensation is preserved in the sacral segments S4 and S5. Grade C=Motor function is preserved below the neurologic level and not strong enough to move against gravity. Grade D: The impairment is incomplete. Joints can move against gravity. Grade E: functions are normal.
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) The number of providers per site who access the CAPP-FIT during implementation and maintenance phases (numerator). Total number of providers at each site (denominator). The comparison is the change in proportion of providers who use the CAPP-FIT at each site.
Veteran satisfaction with the CAPP-FIT Functionality after first CAPP-FIT completion-month 5 through 35 Veteran satisfaction with the initial use of the CAPP-FIT will be assessed using the Functionality subscale of the Mobile Application Rating Scale (MARS), which rates the five items of a 5-point scale from 1 (inadequate) to 5 (excellent). Minimum score is 5, maximum score is 25.
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 Veteran satisfaction with healthcare will be measured pre and 6 months post CAPP-FIT intervention using the Scale of Patient Satisfaction with Primary Care Provider, which is a 10-item scale measured on 7-point Likert scale (1=strongly disagree, 7=strongly agree). Minimum value is 7; maximum value is 70.
Trial Locations
- Locations (5)
VA Long Beach Healthcare System, Long Beach, CA
đŸ‡ºđŸ‡¸Long Beach, California, United States
James A. Haley Veterans' Hospital, Tampa, FL
đŸ‡ºđŸ‡¸Tampa, Florida, United States
Edward Hines Jr. VA Hospital, Hines, IL
đŸ‡ºđŸ‡¸Hines, Illinois, United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
đŸ‡ºđŸ‡¸Saint Louis, Missouri, United States
Louis Stokes VA Medical Center, Cleveland, OH
đŸ‡ºđŸ‡¸Cleveland, Ohio, United States