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, et al.
The journal of spinal cord medicine. Date of publication 2019 Jan 1;volume 42(1):2-19.
1. J Spinal Cord Med. 2019 Jan;42(1):2-19. doi: 10.1080/10790268.2017.1313931. Epub
2017 Apr 17.
Lifestyle intervention for adults with spinal cord injury: Results of the
USC-RLANRC Pressure Ulcer Prevention Study.
Carlson M(1), Vigen CLP(1), Rubayi S(2), Blanche EI(1), Blanchard J(1), Atkins
M(2), Bates-Jensen B(3), Garber SL(4), Pyatak EA(1), Diaz J(1), Florindez LI(1),
Hay JW(5), Mallinson T(1), Unger JB(6), Azen SP(7), Scott M(2), Cogan A(1), Clark
F(1).
Author information:
(1)a Division of Occupational Science and Occupational Therapy , University of
Southern California , Los Angeles, California , USA.
(2)b Rancho Los Amigos National Rehabilitation Center , Downey, California , USA.
(3)c School of Nursing , University of California Los Angeles , Los Angeles,
California , USA.
(4)d Department of Physical Medicine and Rehabilitation, Baylor College of
Medicine , Houston, Texas , USA.
(5)e Leonard Schaeffer Center for Health Policy and Economics , University of
Southern California , Los Angeles, California , USA.
(6)f Institute for Health Promotion & Disease Prevention Research , University of
Southern California , Los Angeles, California , USA.
(7)g Division of Biostatistics, Department of Preventive Medicine , University of
Southern California , Los Angeles, California , USA.
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.
DOI: 10.1080/10790268.2017.1313931
PMCID: PMC6340272 [Available on 2020-01-01]
PMID: 28414254
