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Pressure Ulcer Prevention Study

Version
V0
Resource Type
Dataset : clinical data, event/transaction data, experimental data
Creator
  • Clark, Florence (University of Southern California)
Publication Date
2019-01-04
Funding Reference
  • NCMRR, NICHD
    • Award Number: R01HD056267
Free Keywords
pressure ulcer; pressure injury; rct; occupational therapy; spinal cord injury; risk reduction behavior
Description
  • Abstract

    Medically serious pressure ulcers (MSPrUs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. The study objective was to test the efficacy of a lifestyle-based intervention designed to reduce the incidence of MSPrUs in an at-risk population of adults with SCI. We conducted a single-site, single-blind, randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. Recruitment and ongoing medical treatment were undertaken at Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. Adults with SCI who had one or more prior MSPrUs over the past 2 years were enrolled and evaluated: N=82 in randomized intervention (RI), N=84 in randomized control (RC), N=66 in nonrandomized no-contact control (NCC). The Pressure Ulcer Prevention Program was a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. In the RI and RC groups, study nurses, blind to the participants’ condition assignments, conducted skin checks at baseline, 12 months and 24 months. In addition, trained interviewers (also blind to condition assignments) administered an assessment battery including questionnaires to measure health-related quality of life (Adapted RAND 36-Item Health Survey 1.0 (SF-36)), life satisfaction (Satisfaction with Life Scale (SWLS)), depression (Quasi-Adaptive Short Form for the Patient Reported Outcomes Measurement Information System (PROMIS) Version 1 Depression Item Bank), social support (Interpersonal Support Evaluation List (ISEL)), drug and alcohol use (Adapted Cut Down, Annoyed, Guilty, and Eye Opener (CAGE) Questionnaire), knowledge of ulcer prevention (Pressure Ulcer Knowledge Test), performance of preventive behaviors (Garber Procedure for Assessing Performance of Preventive Behaviors), and self-efficacy (Adapted Moorong Self Efficacy Scale), at study baseline, 12 months and 24 months. At baseline a set of eligibility and background variables were also measured. The NCC group received an abbreviated assessment including eligibility, background and social support, drug and alcohol use, and depression questionnaires, and were not followed beyond 12 months. The primary outcome for the study was the annualized MSPrU incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. MSPrUs were classified as either serious (stages 3 and 4, unstageable and suspected deep tissue injury) or non-serious (stages 1 and 2). Secondary outcomes included number of surgeries and various quality-of-life measures assessed by the questionnaires.



  • Technical Information

    Response Rates: 387 people were assessed for eligibility; 170 (44%) were randomized. 166 (98%) of those randomized were evaluable for the primary endpoint at 12 months. 158 (93%) were evaluable at 24 months.
  • Technical Information

    Presence of Common Scales: Adapted RAND 36-Item Health Survey 1.0 (SF-36)

    Satisfaction with Life Scale (SWLS)

    Quasi-Adaptive Short Form for the Patient Reported Outcomes Measurement Information System (PROMIS) Version 1 Depression Item Bank

    Interpersonal Support Evaluation List (ISEL)

    Pressure Ulcer Knowledge Test

    Garber, et al., Procedure for Assessing Performance of Preventive Behaviors2 with the
    addition of caregiver experience

    Adapted Moorong Self Efficacy Scale

    Adapted Cut Down, Annoyed, Guilty, and Eye Opener (CAGE) Questionnaire

Temporal Coverage
  • 2009-02-01 / 2014-02-28
    Time Period: Sun Feb 01 00:00:00 EST 2009--Fri Feb 28 00:00:00 EST 2014
  • 2009-02-01 / 2014-02-28
    Collection Date(s): Sun Feb 01 00:00:00 EST 2009--Fri Feb 28 00:00:00 EST 2014
Geographic Coverage
  • Los Angeles, CA
Sampled Universe
Adults with spinal cord injury and a history of medically serious pressure injury
Smallest Geographic Unit: N/A
Sampling
Prospective participants for this study were adults (≥ 18 years of age) with SCI (paraplegia or tetraplegia) who had a history of at least one stage 3 or stage 4 PrI in the past five years, were currently utilizing RLANRC services, and had an existing medical chart at the facility. Additional inclusion criteria were: (1) English- or Spanish-speaking; (2) contactable by telephone or cell phone; (3) cognitively intact (based on unadjusted score ≥ 7 on the Short Portable Mental Status Questionnaire [SPMSQ]); (4) willing to undertake recommended lifestyle changes for MSPrI prevention; and (5) residing within 100 miles of RLANRC. Participants were excluded if they: (1) were ambulatory; (2) were less than 6 months post-injury; (3) had an unstable or worsening stage 3, or any stage 4, PrI present; or (4) participated in any of our prior research studies.


Collection Mode
  • coded on-site observation~~cognitive assessment test~~face-to-face interview~~mixed mode~~on-site questionnaire~~paper and pencil interview (PAPI)~~record abstracts~~telephone interview~~

    RI - randomized intervention - data collected at baseline, 12 months and 24 months
    RC - randomized control - data collected at baseline, 12 months and 24 months
    NCC - no-contact control - data collected at baseline and 12 months

Availability
Download
Publications
  • Clark, F, EA Pyatak, and M Carlson. “Implementing Trials of Complex Interventions in Community Settings: The USC-Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS).” Clinical Trials 12, no. 2 (2014).
  • Pyatak, EA, EI Blanche, and SL Garber. “Conducting Intervention Research among Underserved Carlson et Al. Lifestyle Intervention for Adults with Spinal Cord Injury 16 The Journal of Spinal Cord Medicine 2017 1565 1570 1575 1580 1585 1590 1595 1600 1605 1610 1615 1620 1625 1630 1635 1640 1645 1650 1655 1660 Populations: Lessons Learned and Recommendations for Researchers.” Arch Phys Med Rehabil 94, no. 6 (2013).
  • Pyatak, EA, EI Blanche, and SL Garber. “Conducting Intervention Research among Underserved Carlson et Al. Lifestyle Intervention for Adults with Spinal Cord Injury 16 The Journal of Spinal Cord Medicine 2017 1565 1570 1575 1580 1585 1590 1595 1600 1605 1610 1615 1620 1625 1630 1635 1640 1645 1650 1655 1660 Populations: Lessons Learned and Recommendations for Researchers.” Arch Phys Med Rehabil 94, no. 6 (2013).

Update Metadata: 2019-10-04 | Issue Number: 2 | Registration Date: 2019-10-04

Clark, Florence (2019): Pressure Ulcer Prevention Study. Version: V0. ICPSR - Interuniversity Consortium for Political and Social Research. Dataset. https://doi.org/10.3886/E100595