Lifestyle intervention for adults with spinal cord injury: Results of the USC–RLANRC Pressure Ulcer Prevention Study
Journal of Spinal Cord Medicine
Occupational therapy; Pressure injury; Pressure ulcer; Randomized controlled trial; Risk reduction behavior; Spinal cord injuries
© 2019, © The Academy of Spinal Cord Injury Professionals, Inc. 2019. Context/Objective: Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI. Design: A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. Setting: Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. Participants: Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group. Interventions: The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. Outcome Measures: Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures. Results: Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were.56 for intervention recipients,.48 for randomized controls, and.65 for nonrandomized controls. At follow-up, rates were.44 and.39 respectively for randomized intervention and control participants. Conclusions: Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect. Trial Registration: ClinicalTrials.gov NCT01999816.
Carlson, M., Vigen, C., Rubayi, S., Blanche, E., Blanchard, J., Atkins, M., Bates-Jensen, B., Garber, S., Pyatak, E., Diaz, J., Florindez, L., Hay, J., Mallinson, T., Unger, J., Azen, S., Scott, M., Cogan, A., & Clark, F. (2019). Lifestyle intervention for adults with spinal cord injury: Results of the USC–RLANRC Pressure Ulcer Prevention Study. Journal of Spinal Cord Medicine, 42 (1). http://dx.doi.org/10.1080/10790268.2017.1313931