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

Clin Trials, 2014 · DOI: 10.1177/1740774514521904 · Published: April 1, 2014

Spinal Cord Injury Rehabilitation Dermatology

Simple Explanation

This study addresses the challenges of conducting a randomized controlled trial (RCT) for a complex health intervention (Pressure Ulcer Prevention Program - PUPP) delivered in community settings to individuals with spinal cord injuries. The study aims to assess the effectiveness of the PUPP intervention in preventing pressure ulcers and related complications in this vulnerable population. The intervention includes both fixed and customizable elements to incorporate pressure ulcer prevention practices into daily routines.

Study Duration

12 Months

Participants

170 adults with spinal cord injury

Evidence Level

Level I, Randomized Controlled Trial

Key Findings

1
The study successfully recruited 170 participants and maintained a high treatment adherence rate of 90%.
2
Methodological challenges were encountered in recruitment, retention, intervention delivery, fidelity, randomization, and assessment.
3
A five-pronged recruitment approach, increased staff time for intervention delivery, and rigorous monitoring ensured treatment fidelity and replicability.

Research Summary

The University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS) aims to assess the efficacy of a lifestyle intervention in preventing medically serious pressure ulcers and related surgeries in adults with spinal cord injury. The study encountered challenges in recruitment, retention, intervention delivery and fidelity, randomization, assessment, and potential inadvertent contamination of the control group. Overcoming these challenges required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

Practical Implications

Clinical Practice

The study emphasizes the importance of individualized, multi-component interventions for pressure ulcer prevention in community settings.

Research Methodology

The study provides valuable insights into the challenges and solutions for conducting rigorous RCTs of complex interventions with underserved populations.

Health Policy

The findings highlight the need for cost-effective interventions to reduce the human and economic burden of pressure ulcers among individuals with spinal cord injuries.

Study Limitations

1
The challenges encountered are most relevant to similarly complex trials and less germane to straightforward treatment protocols.
2
The demographic characteristics of the study population may limit the generalizability of the findings to more advantaged populations.
3
Some challenges and solutions may not apply to trials conducted in other settings.

Your Feedback

Was this summary helpful?

Back to Spinal Cord Injury