Implementing trials of complex interventions in community settings: The USC–Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with re...

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Bibliographic Details
Published in:Clinical trials (London, England) England), 2014-04, Vol.11 (2), p.218-229
Main Authors: Clark, Florence, Pyatak, Elizabeth A, Carlson, Mike, Blanche, Erna Imperatore, Vigen, Cheryl, Hay, Joel, Mallinson, Trudy, Blanchard, Jeanine, Unger, Jennifer B, Garber, Susan L, Diaz, Jesus, Florindez, Lucia I, Atkins, Michal, Rubayi, Salah, Azen, Stanley Paul
Format: Article
Language:English
Subjects:
Clinical trials
Delivery of Health Care
Female
Humans
Male
Patient Selection
Pressure Ulcer - economics
Pressure Ulcer - etiology
Pressure Ulcer - prevention & control
Randomized Controlled Trials as Topic - methods
Randomized Controlled Trials as Topic - standards
Recruitment
Residence Characteristics
Spinal cord injuries
Spinal Cord Injuries - complications
Ulcers
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Summary:Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Methods Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. Limitations We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Conclusions Overcoming challenges has re
ISSN:1740-7745
1740-7753
DOI:10.1177/1740774514521904