Pressure Ulcer Prevention Study in SCI (PUPS)

The purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the intervention's cost-effectiveness and potential cost savings and its effects on participants' quality of life.

Medically serious pressure ulcers are a common complication of spinal cord injury (SCI), and are associated with high treatment costs and reduced quality of life. This study will examine the efficacy and cost-effectiveness of a promising lifestyle-based intervention designed to reduce the incidence of pressure ulcers among culturally diverse, community dwelling adults with SCI who have had serious pressure ulcers. The intervention being tested, termed lifestyle redesign (LR), is based on prior SCI literature as well as on the results of a qualitative pilot study undertaken by our study group. This intervention targets several psychosocial mediating variables that have been shown to be important in prevention of pressure ulcers in daily living contexts. Participants assigned to the LR condition receive individualized in-home sessions, personal phone calls, and incident-based contacts for a 12-month period, followed by 12 months of no intervention. Participants in the control condition do not receive any study-based intervention, but (along with the LR group) have continuing access to the standard options for prevention and treatment that are available through Rancho Los Amigos National Rehabilitation Center. In addition to identifying a pressure ulcer prevention strategy, the planned research will lead to the development of testable theoretical models of the intervening process mechanisms that link the intervention to pressure ulcer reduction.

Individualized program for lifestyle redesign aimed at decreasing the risk of medically serious pressure ulcers led by licensed occupational therapists trained in the implementation of the lifestyle redesign program

Estimated cost of healthcare services including inpatient, outpatient, ER, home healthcare, lab, imaging, etc.

Inclusion Criteria: Spinal cord injury (paraplegia or tetraplegia) Non-ambulatory Able to undergo intervention and testing in English or Spanish At least 6 months post-injury History of at least one serious (Stage 3 or 4) pressure ulcer in the past 5 years Cognitively intact Personally expressed willingness to undertake recommended lifestyle changes for ulcer prevention. Can be reached by telephone. Reside in or within 100 miles of Rancho Los Amigos National Rehabilitation Center (Downey, CA) with no plans to relocate beyond this area. Agreement to participate and completion of consent form. Exclusion Criteria: Present serious stage 4 pressure ulcer Participation in our preliminary research studies Participating in the neuromuscular stimulation study

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Clark F, Pyatak EA, Carlson M, Blanche EI, Vigen C, Hay J, Mallinson T, Blanchard J, Unger JB, Garber SL, Diaz J, Florindez LI, Atkins M, Rubayi S, Azen SP; PUPS Study Group. Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS). Clin Trials. 2014 Apr;11(2):218-29. doi: 10.1177/1740774514521904. Epub 2014 Feb 26.

Carlson M, Vigen CLP, Rubayi S, Blanche EI, Blanchard J, Atkins M, Bates-Jensen B, Garber SL, Pyatak EA, Diaz J, Florindez LI, Hay JW, Mallinson T, Unger JB, Azen SP, Scott M, Cogan A, Clark F. Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study. J Spinal Cord Med. 2019 Jan;42(1):2-19. doi: 10.1080/10790268.2017.1313931. Epub 2017 Apr 17.