Advanced pressure ulcers are a common and medically serious complication of spinal cord injury (SCI) and are associated with extremely high treatment costs and reduced quality of life. However, preventive interventions that address this problem have received very little research attention. To address this gap, PUPS investigated the efficacy of a promising lifestyle intervention designed to prevent pressure ulcers among at-risk members of the SCI population. The six-year study involved collaboration between researchers from the University of Southern California (USC) and Rancho Los Amigos National Rehabilitation Center (RLANRC), who have developed the intervention based on the results of a qualitative investigation of lifestyle and ulcer risk among adults with SCI. The long-term objective of this project was the identification of an intervention option that can enhance the health and life quality of the population of adults with SCI while simultaneously diminishing the heavy healthcare burden that results from the problem of SCI-related pressure ulcers.
Division faculty members Stanley Azen and Erna Blanche were key collaborators. Additional USC collaborators included Clinical Pharmacy and Pharmaceutical Economics & Policy Professor Joel Hay, Professor of Preventive Medicine Jennifer Unger, and from Rancho Los Amigos National Rehabilitation Hospital (RLANRH), Salah Rubayi and Michael Scott.
Journal Articles
Ghaisas, S., Pyatak, E. A., Blanche, E., Blanchard, J., & Clark, F. (2015). Lifestyle changes and pressure ulcer prevention in adults with spinal cord injury in the Pressure Ulcer Prevention Study Lifestyle Intervention. American Journal of Occupational Therapy, 69(1), 6901290020p1-6901290020p10. https://doi.org/10.5014/ajot.2015.012021 Show abstract
Pressure ulcers (PrUs) are a major burden to patients with spinal cord injury (SCI), affecting their psychological, physical, and social well-being. Lifestyle choices are thought to contribute to the risk of developing PrUs. This article focuses on the interaction between lifestyle choices and the development of PrUs in community settings among participants in the University of Southern California-Rancho Los Amigos National Rehabilitation Center Pressure Ulcer Prevention Study (PUPS II), a randomized controlled trial of a lifestyle intervention for adults with SCI. We conducted a secondary cross-case analysis of treatment notes of 47 PUPS II participants and identified four patterns relating PrU development to lifestyle changes: positive PrU changes (e.g., healing PrUs) with positive lifestyle changes, negative or no PrU changes with positive lifestyle changes, positive PrU changes with minor lifestyle changes, and negative or no PrU changes with no lifestyle changes. We present case studies exemplifying each pattern.
Clark, F., Pyatak, E. A., Carlson, M., Blanche, E. I., Vigen, C., Hay, J., Mallinson, T., Blanchard, J., Unger, J. B., Garber, S. L., Díaz, J., Floríndez, L. I., Atkins, M., Rubayi, S., & Azen, S. P. (2014). Implementing trials of complex interventions in community settings: The USC-Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS). Clinical Trials, 11(2), 218-229. https://doi.org/10.1177/1740774514521904 Show abstract
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 required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.
Pyatak, E. A., Blanche, E. I., Garber, S. L., Díaz, J., Blanchard, J., Floríndez, L., & Clark, F. A. (2013). Conducting intervention research among underserved populations: Lessons learned and recommendations for researchers. Archives of Physical Medicine and Rehabilitation, 94(6), 1190-1198. https://doi.org/10.1016/j.apmr.2012.12.009 Show abstract
Randomized controlled trials (RCTs) are considered the criterion standard in research design for establishing treatment efficacy. However, the rigorous and highly controlled conditions of RCTs can be difficult to attain when conducting research among individuals living with a confluence of disability, low socioeconomic status, and being a member of a racial/ethnic minority group, who may be more likely to have unstable life circumstances. Research on effective interventions for these groups is urgently needed, because evidence regarding approaches to reduce health disparities and improve health outcomes is lacking. In this methodologic article, we discuss the challenges and lessons learned in implementing the Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury study among a highly disadvantaged population. These issues are discussed in terms of strategies to enhance recruitment, retention, and intervention relevance to the target population. Recommendations for researchers seeking to conduct RCTs among socioeconomically disadvantaged, ethnically diverse populations are provided.
Blanche, E. I., Fogelberg, D., Díaz, J., Carlson, M. E., & Clark, F. A. (2011). Manualization of occupational therapy interventions: Illustrations from the Pressure Ulcer Prevention Research Program. American Journal of Occupational Therapy, 65(6), 711-719. https://doi.org/10.5014/ajot.2011.001172 Show abstract
The manualization of a complex occupational therapy intervention is a crucial step in ensuring treatment fidelity for both clinical application and research purposes. Toward the latter end, intervention manuals are essential for ensuring trustworthiness and replicability of randomized controlled trials that aim to provide evidence of the effectiveness of occupational therapy. In this article, we review the literature on the process of intervention manualization. We then illustrate the prescribed steps through our experience in implementing the University of Southern California/Rancho Los Amigos National Rehabilitation Center's collaborative Pressure Ulcer Prevention Project. In this research program, qualitative research provided the initial foundation for manualization of a multifaceted occupational therapy intervention designed to reduce the incidence of medically serious pressure ulcers in adults with spinal cord injury.
Vaishampayan, A., Clark, F. A., Carlson, M. E., & Blanche, E. I. (2011). Preventing pressure ulcers in people with spinal cord injury: Targeting risky life circumstances through a community-based interventions. Advances in Skin and Wound Care, 24(6), 275-284. https://doi.org/10.1097/01.ASW.0000398663.66530.46 Show abstract
Objective. The objectives of the study were to sensitize practitioners working with individuals with spinal cord injury (SCI) to the complex life circumstances that are implicated in the development of pressure ulcers (PrUs) and to document the ways that interventions can be adapted to target individual needs.
Methods. This study was a content analysis of weekly fidelity/quality control meetings that were undertaken as part of a lifestyle intervention for PrU prevention in community-dwelling adults with SCI.
Results. Four types of lifestyle-relevant challenges to ulcer prevention were identified: risk-elevating life circumstances, communication difficulties, equipment problems, and individual personality issues. Intervention flexibility was achieved by changing the order of treatment modules, altering the intervention content or delivery approach, or going beyond the stipulated content.
Conclusion. Attention to recurrent types of individual needs, along with explicit strategies for tailoring interventions published in a manual, has the potential to enhance PrU prevention efforts for adults with SCI.
Fogelberg, D., Atkins, M., Blanche, E. I., Carlson, M. E., & Clark, F. A. (2009). Decisions and dilemmas in everyday life: Daily use of wheelchairs by individuals with spinal cord injury and the impact on pressure ulcer risk. Topics in Spinal Cord Injury Rehabilitation, 15(2), 16-32. https://doi.org/10.1310/sci1502-16 Show abstract
Individuals with spinal cord injury (SCI) use wheelchairs for mobility and for full participation in their daily activities. The use of wheelchairs, however, can increase the risk of pressure ulcers. This study focused on wheelchair users’ perceptions of the interplay between their wheeled mobility and the development of pressure ulcers by performing a secondary analysis of data gathered during a 2-year ethnographic study of 20 community-dwelling adults with SCI. Data from a subset of these individuals are described; each of these stories contains a pressure ulcer risk episode related to wheeled mobility or cushion use. Identified risk episodes were associated with wheelchair selection, wheelchair adjustment, habituation to new equipment, lifestyle choices, and challenging life contexts. Examples highlighted the crucial relationship between individuals’ minute-to-minute decision-making and pressure ulcer risk.
