Advanced pressure ulcers are a common and medically serious complication of spinal cord injury (SCI) and are associated with extremely high treatment costs and reduced quality of life. However, preventive interventions that address this problem have received very little research attention. To address this gap, we will investigate the efficacy of a promising lifestyle intervention designed to prevent pressure ulcers among at-risk members of the SCI population. The resulting five-year study will involve collaboration between researchers from the University of Southern California (USC) and Rancho Los Amigos National Rehabilitation Center (RLANRC), who have developed the intervention based on the results of a qualitative investigation of lifestyle and ulcer risk among adults with SCI. The long-term objective of this project is to identify an intervention option that can enhance the health and life quality of the population of adults with SCI while simultaneously diminishing the heavy healthcare burden that results from the problem of SCI-related pressure ulcers.
The specific aims of the proposed research are to: (a) conduct a randomized clinical trial of the intervention's ability to reduce the incidence of high grade (Stage 3 or 4) pressure ulcers in adults with SCI;(b) assess the cost-effectiveness and potential cost savings of the intervention;(c) examine the intervention's effects on participants'quality of life;and (d) model the process mechanisms that mediate the effects of the intervention. To accomplish these aims, 160 ethnically diverse men and women (including English and Spanish speakers) who are at least 6 months post-SCI and who have a history of at least one previous severe pressure ulcer will be recruited at a major rehabilitation facility and randomly assigned to either a 12- month lifestyle-based intervention condition or a standard care control condition. The intervention will consist of in-home visits and phone calls, with the intent to develop for each client a personalized plan for pressure ulcer prevention. Study participants will be followed for one year following the completion of the intervention phase of the trial. Outcome analyses will test whether the intervention reduces the incidence of new serious ulcers, reduces surgeries and other ulcer-linked medical treatment costs, and/or enhances quality of life. The project will benefit public health by increasing the physical and emotional wellness of a large sector of individuals who are at high risk for sickness and hospitalization due to the pressure ulcer problem. If successful, the intervention has the capacity to generate large financial savings and thereby help counteract society's rising healthcare costs.

Public Health Relevance

Medically serious pressure ulcers are a common complication of spinal cord injury and are associated with extremely high treatment costs and reduced quality of life. In this study we will test a lifestyle intervention that promises to significantly reduce pressure ulcers in the population of adults with spinal cord injury.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD056267-04
Application #
8106104
Study Section
Nursing Science: Adults and Older Adults Study Section (NSAA)
Program Officer
Quatrano, Louis A
Project Start
2008-09-01
Project End
2013-07-31
Budget Start
2011-08-01
Budget End
2012-07-31
Support Year
4
Fiscal Year
2011
Total Cost
$507,883
Indirect Cost
Name
University of Southern California
Department
Other Health Professions
Type
Schools of Dentistry
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
Ghaisas, Samruddhi; Pyatak, Elizabeth A; Blanche, Erna et al. (2015) Lifestyle changes and pressure ulcer prevention in adults with spinal cord injury in the pressure ulcer prevention study lifestyle intervention. Am J Occup Ther 69:6901290020p1-10
Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike et al. (2014) Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS). Clin Trials 11:218-29
Pyatak, Elizabeth A; Blanche, Erna I; Garber, Susan L et al. (2013) Conducting intervention research among underserved populations: lessons learned and recommendations for researchers. Arch Phys Med Rehabil 94:1190-8
Blanche, Erna Imperatore; Fogelberg, Donald; Diaz, Jesus et al. (2011) Manualization of occupational therapy interventions: illustrations from the pressure ulcer prevention research program. Am J Occup Ther 65:711-9
Vaishampayan, Ashwini; Clark, Florence; Carlson, Mike et al. (2011) Preventing pressure ulcers in people with spinal cord injury: targeting risky life circumstances through community-based interventions. Adv Skin Wound Care 24:275-84; quiz 285-6
Fogelberg, Donald; Atkins, Michal; Blanche, Erna Imperatore et al. (2009) Decisions and Dilemmas in Everyday Life: Daily Use of Wheelchairs by Individuals with Spinal Cord Injury and the Impact on Pressure Ulcer Risk. Top Spinal Cord Inj Rehabil 15:16-32