Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)

The major objective of this randomized control trial is to determine whether a multi-component self-management intervention can increase the use of skin-protective behaviors in veterans with SCI. We will also determine whether improvements in skin care behaviors prevent or delay PrU recurrence.

Expected Contribution to the VA and Others: Lack of sensation and immobility increase risk of pressure ulcers (PrUs) in SCI, making them a serious, costly, and life-long complication for veterans with SCI. Prevention and/or early detection and reporting of PrUs in the community-dwelling SCI population is important because: SCI is the most costly medical condition in VA; PrUs cause morbidity and mortality in the SCI population; everyone with SCI is at risk of developing ulcers; and little empirical evidence exists to guide prevention/treatment of PrUs in this population. Reducing the prevalence of PrUs in SCI will have a significant impact on the VA's financial and resources. The study's long-term objective is to implement effective, consistent, and cost-effective PrU prevention protocols into routine clinical practice within VHA, enhancing veterans' general health and quality of life by reducing the need for costly hospitalizations and PrU surgery.

Objectives: The primary objective of this study is to determine whether a multi-component self-management (SM) intervention increases the use of skin-protective behaviors and reduce skin worsening in veterans with SCI. The SM intervention consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill-building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology. An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care. This project focuses on improving patient behavior and making health system changes.

Methods:

Research Design: A randomized prospective multi-site, pre-test/post-test design.

Population: Veterans hospitalized for Stage III/IV pelvic PrUs from 6 VA SCI Centers. Participants must be >18 years, >6 months post-SCI, cognitively intact, reside in the community and oversee their own skin care.

Sources of Data: Patient demographic information measures of pressure ulcer knowledge, skin management needs assessment, readiness-to-change SM behaviors (symptom management, communication with providers, cognitive symptom management, etc.), and self-efficacy will be collect at 0, 3 and 6 months, Medical diagnosis, treatment and utilization information will be obtained from VA administrative data. Digital photos will be used to verify patient self-reported skin status.

Analysis: The primary outcomes of this study are: 1) increased use of skin-protective behaviors and 2) skin worsening outcomes (e.g., recurrence/new skin breakdown, median time to skin worsening,). Secondary objectives include: days in bed due to skin problems, severity of the recurrence/new skin breakdown, and hospital days due to skin problems; PrU knowledge, skin care self-efficacy, community integration/ participation and perceived quality of life. Multivariate and Cox proportional hazards regression models will be used to examine study outcomes.

• Pressure Ulcers
• Spinal Cord Injuries

• Behavioral: Self Management (SM)
  Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
• Behavioral: Education (ED)
  An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.

• Experimental: Arm 1
  Self Management (SM)
  Intervention: Behavioral: Self Management (SM)
• Active Comparator: Arm 2
  Education (ED)
  Intervention: Behavioral: Education (ED)

Inclusion Criteria:

• over 18 years of age,
• SCI of at least six month's duration,
• hospitalized for a Stage III or IV PrU,
• cognitively intact,
• available for telephone follow-up, and
• discharged to a community setting or able to direct own care.

Exclusion Criteria:

• significant psychiatric co-morbidities (e.g., schizophrenia and other active psychoses), or
• terminal diagnosis.