New Pressure Ulcer Prevention Study Grant
November 24, 2008
USC OS/OT is awarded a grant to study Lifestyle Redesign® intervention for people with spinal cord injury.
As discovered by a team of researchers led by USC OS/OT in a 3-year, NIDRR-funded qualitative study, “Daily Living Context and Pressure Sores in Consumers with SCI,” the ordinary daily experiences of people with spinal cord injury (SCI) can present challenges that make maintaining good health precarious. Of particular concern is the susceptibility people with SCI have to developing pressure ulcers. A constellation of factors, including injury, unrelieved pressure, limited sensation, shearing, friction, skin that is compromised, nutrition, moisture and substance use, can alllead to the formation of pernicious pressure ulcers. Difficult to treat, pressure ulcers can penetrate otherwise healthy tissue, creating gaping craters that can go bone-deep, give rise to systemic infections and even result in death. Treatment can consist of surgery and/or months of bedrest, causing serious disruptions in the life of the person with SCI and limiting participation in desired activities. However, preventive interventions that address the issue have received very little attention.
To address this gap, investigators from USC OS/OT and Rancho Los Amigos National Rehabilitation Center will once again collaborate under the leadership of Principal Investigator Florence Clark, Ph.D., OTR/L, FAOTA to study pressure ulcer risk for people with SCI. In the new 5-year study, to be funded by an NIH R01 grant totalling $2,882,372, a randomized controlled trial (RCT) will be conducted of a Lifestyle Redesign® (LR) intervention designed to help study participants learn to take a variety of healthpromoting measures to prevent pressure ulcer formation. The team used this approach in a small pilot study last year and found it to be feasible for further testing. This pilot study, along with the original qualitative investigation (which was nicknamed “PUPS”; an acronym for “Pressure Ulcer Prevention Study”) and principles identified in the Division’s two Well Elderly Studies, led researchers to develop the larger RCT now being launched.
“The new PUPS grant is a terrific achievement,” declared Dr. Clark. “It indicates that our years of investment in studying the life circumstances in people with SCI that contribute to recurrent pressure ulcers has had a huge payoff. This trial has the potential to show that the Lifestyle Redesign® intervention we have tailored based on this earlier work can cost-effectively protect countless consumers from lifethreatening ulcers. And it may lead to more OTs being funded out in the community to help them.”
Joining Dr. Clark as co-investigators in the study, which officially started on September 1st, will be Stanley Azen, Ph.D., Erna Blanche, Ph.D., OTR/L, FAOTA, Michael Carlson, Ph.D. and Joel Hay, Ph.D. from USC; Salah Rubayi, M.D. and Michael Scott, M.D. from Rancho Los Amigos; Barbara Bates-Jensen, Ph.D., RN from UCLA; and Jennifer Unger, Ph.D. of Claremont Graduate University. Drs. Carlson, Rubayi and Scott were also investigators in the first PUPS research.
Goals of the RCT will be to measure the intervention’s ability to reduce incidence of Stage 3 and 4 pressure ulcers; assess cost-effectiveness and potential cost savings of the intervention; examine the effects of the intervention on participants’ quality of life, and model the process mechanisms that mediate effects. A total of 160 ethnically diverse men and women, including both English and Spanish speakers, will be recruited and randomly assigned to either a 12-month LR intervention or a standard care control group. The intervention will consist of in-home visits and phone calls to help each client create a personalized plan for pressure ulcer prevention. Tools used with consumers will include PressureUlcerPrevention.com, the interactive consumer self-education website created as a product of the first PUPS.
“The acquisition of this grant bolsters the presence of our Division in the rehabilitation science community,” Dr. Clark added. “It also contributes to our reputation of excellence in conducting randomized clinical trials and cost-effectiveness studies.”