Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
NCT Number: NCT06529094
Acronym: CAPP-FIT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injury|Pressure Injury
Interventions: BEHAVIORAL: Provider training|BEHAVIORAL: CAPP-FIT intervention with RA facilitation|BEHAVIORAL: CAPP-FIT implementation during maintenance phase
Sponsor: VA Office of Research and Development
Collaborators: VA Palo Alto Health Care System|VA Long Beach Healthcare System|Saint Louis VA Medical Center|James A. Haley Veterans' Hospital|Louis Stokes VA Medical Center|Michael E. DeBakey VA Medical Center|Iowa City Veterans Affairs Medical Center|San Diego Veterans Healthcare System|Edward Hines Jr. VA Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 808
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-11-01
Completion Date: 2028-07-31
Locations: VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, 90822, United States|VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, 94304-1207, United States|James A. Haley Veterans' Hospital, Tampa, FL, Tampa, Florida, 33612, United States|Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, 60141-3030, United States|St. Louis VA Medical Center John Cochran Division, St. Louis, MO, Saint Louis, Missouri, 63106-1621, United States|Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, 44106-1702, United States|Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas, 77030-4211, United States

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.

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