Lifestyle intervention for adults with spinal cord injury: Results of the USC–RLANRC Pressure Ulcer Prevention Study

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

Keywords:

• Pressure ulcer
• Pressure injury
• Spinal cord injuries
• Risk reduction behavior
• Randomized controlled trial
• Occupational therapy

Acknowledgements

This work was supported by grant R01HD056267 from the National Center for Medical Rehabilitation Research (NCMRR) within the Eunice Kennedy Shriver National Institute of Child Health & Human Development, National Institutes of Health to the University of Southern California.

Conflict of interest: No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the authors or upon any organization with which the authors are associated.

The Pressure Ulcer Prevention Study is registered at ClinicalTrials.gov (NCT01999816).

The authors thank Michael Weinrich, MD and Louis Quatrano, PhD from the NICHD National Center for Medical Rehabilitation Research (NCMRR) for their programmatic assistance for this project. In addition, the investigators thank those who served on the Data Safety and Monitoring Board for their ongoing guidance and support: Richard (Sal) Salcido, MD, EdD (Chair); Tom Belin, PhD; Joy Hammel, PhD, OTR; Forrest Pendleton; Denise G. Tate, PhD; and Louis Quatrano, PhD. Finally, the PUPS investigators acknowledge all trial participants, without whom the study would not be possible.

Consultants: Marcus J. Fuhrer, PhD; Nancy Gibbs, MD. Interveners: Arameh Anvarizadeh, OTD, OTR/L; Mark Armstrong, RN; Jane Baumgarten, BS, OTR/L; Delphine O. Mangan, BSN, RN, CWCN; Annee Deering-Fitzgerald, MS, RN; Celso Delgado, Jr, OTD, OTR/L; Yvette Ngann, BSN, RN, WOCN, CRRN; Kelly Peck, RN, MSN; Clarissa Saunders-Newton, PhD, OTR/L; Jenna Trammel, MS, RN; Lisbeth Vega, OTD, OTR/L; Ana Verran, MA, OTR/L, CDRS. Project staff: Daniella Florindez, MPH; Samruddhi Ghaisas, OTD, OTR/L; Kiley Hanish, OTD, OTR/L; Cynthia L. Kushi, OTR/L; Jeremy Seip, OTD, OTR/L; Michael Tien, MS, MPH; Ashwini Vaishampayan, OTD, OTR. Ulcer data reconciliation team: Jingwen Claire Li, BS, OTD, OTR; Brooke Bianco, MSN, RN; Robert Maxwell, MSN, RN; Tina Wayne, RN, MPH. Assessment team: Jardine Cordero-Pagunsan, NP-C; Hilda Diaz, RN, MSN, ACNP; Donald Fogelberg, PhD, OTR/L; Jinpei Hong, RN; German Sanchez, RN; Alison J. Stoneham, LVN. Rancho Los Amigos National Rehabilitation Center (RLANRC) site support: Deandra Pedroza, BA; Angie Rivera. Fiscal administration: Patricia H. Gutierrez, Janis Wise. Manuscript preparation: Erin Rice, BA; Sarah Gleason, BA; Stephanie Mielke, OTD, OTR/L.

ORCID

Cheryl LP Vigen http://orcid.org/0000-0002-9789-1502

Erna Imperatore Blanche http://orcid.org/0000-0003-0177-6073

Barbara Bates-Jensen http://orcid.org/0000-0001-8490-4012

Elizabeth A Pyatak http://orcid.org/0000-0003-3280-8912

Trudy Mallinson http://orcid.org/0000-0002-4888-5579

Jennifer B Unger http://orcid.org/0000-0001-9064-6603

Alison Cogan http://orcid.org/0000-0002-6800-1988

Florence Clark http://orcid.org/0000-0001-7401-0824