Mike Carlson1, Cheryl L P Vigen1, Salah Rubayi2, Erna Imperatore Blanche1, Jeanine Blanchard1, Michal Atkins2, Barbara Bates-Jensen3, Susan L Garber4, Elizabeth A Pyatak1, Jesus Diaz1, Lucia I Florindez1, Joel W Hay5, Trudy Mallinson1, Jennifer B Unger6, Stanley Paul Azen7, Michael Scott2, Alison Cogan1, Florence Clark1. 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.
Abstract
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.
RCT Entities:
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.
Authors: L Diane Parham; Ellen S Cohn; Susan Spitzer; Jane A Koomar; Lucy Jane Miller; Janice P Burke; Barbara Brett-Green; Zoe Mailloux; Teresa A May-Benson; Susanne Smith Roley; Roseann C Schaaf; Sarah A Schoen; Clare A Summers Journal: Am J Occup Ther Date: 2007 Mar-Apr
Authors: Jeanne Jackson; Mike Carlson; Salah Rubayi; Michael D Scott; Michal S Atkins; Erna I Blanche; Clarissa Saunders-Newton; Stephanie Mielke; Mary Kay Wolfe; Florence A Clark Journal: Disabil Rehabil Date: 2010 Impact factor: 3.033
Authors: C A Salzberg; D W Byrne; C G Cayten; P van Niewerburgh; J G Murphy; M Viehbeck Journal: Am J Phys Med Rehabil Date: 1996 Mar-Apr Impact factor: 2.159
Authors: Susanne Coleman; Jane Nixon; Justin Keen; Lyn Wilson; Elizabeth McGinnis; Carol Dealey; Nikki Stubbs; Amanda Farrin; Dawn Dowding; Jos M G A Schols; Janet Cuddigan; Dan Berlowitz; Edward Jude; Peter Vowden; Lisette Schoonhoven; Dan L Bader; Amit Gefen; Cees W J Oomens; E Andrea Nelson Journal: J Adv Nurs Date: 2014-03-31 Impact factor: 3.187
Authors: Alix G Sleight; Alison M Cogan; Valerie A Hill; Elizabeth A Pyatak; Jesus Díaz; Lucía I Floríndez; Jeanine Blanchard; Cheryl Vigen; Susan L Garber; Florence A Clark Journal: Top Spinal Cord Inj Rehabil Date: 2019
Authors: Lucía I Floríndez; Mike E Carlson; Elizabeth Pyatak; Jeanine Blanchard; Alison M Cogan; Alix G Sleight; Valerie Hill; Jesus Diaz; Erna Blanche; Susan L Garber; Florence A Clark Journal: Disabil Rehabil Date: 2019-01-08 Impact factor: 2.439