Systems intervention to promote colon cancer screening in safety net settings: protocol for a community-based participatory randomized controlled trial

Implementation Science

Graham A Colditz²  Enola K Proctor³  Jean S Wang⁴  Veronica Richardson¹  Aimee S James² 

[1] Grace Hill Health Centers, Quality Improvement and Corporate Compliance, 1717 Biddle Street, St. Louis, MO 63106, USA;Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110, USA;Brown School, Washington University, St. Louis, MO 63110, USA;Division of Gastroenterology, Department of Medicine, Washington University School of Medicine, 660 S. Euclid Avenue, Campus Box 8124, Saint Louis, MO 63110, USA

关键词: Community-based participatory research;    Implementation strategy;    Multi-level intervention;    Intervention studies;    Randomized controlled trial;    Screening;    Healthcare disparities;    Colon cancer;   

Others  :  813623
DOI  :  10.1186/1748-5908-8-58

 received in 2013-03-13, accepted in 2013-05-29,  发布年份 2013

【 摘 要 】

Background

Colorectal cancer is a leading cause of cancer mortality. Screening can be effective but is underutilized. System- or multi-level interventions could be effective at increasing screening, but most have been implemented and evaluated in higher-resource settings such as health maintenance organizations. Given the disparities evident for colorectal cancer and the potential for screening to improve outcomes, there is a need to expand this work to include diverse settings, including those who treat economically disadvantaged patients. This paper describes the study protocol for a trial designed to increase colorectal cancer screening in those ‘safety-net’ health centers that serve underinsured and uninsured patients. This trial was designed and is being implemented using a community-based participatory approach.

Methods/design

We developed a practical clinical cluster-randomized controlled trial. We will recruit 16 community health centers to this trial. This systems-level intervention consists of a menu of evidence-based implementation strategies for increasing colorectal cancer screening. Health centers in the intervention arm then collaborate with the study team to tailor strategies to their own setting in order to maximize fit and acceptability. Data are collected at the organizational level through interviews, and at the provider and patient levels through surveys. Patients complete a survey about their healthcare and screening utilization at baseline, six months, and twelve months.

Outcomes

The primary outcome is colorectal cancer screening by patient self-report, supplemented by a chart-audit in a subsample of patients. Implementation outcomes informed by the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) conceptual framework will be measured at patient, provider, and practice levels.

Discussion

Our study is one of the first to integrate community participatory strategies to a randomized controlled trial in a healthcare setting. The multi-level approach will support the ability of the intervention to affect screening through multiple avenues. The participatory approach will strengthen the chance that implementation strategies will be maintained after study completion and, supports external validity by increasing health center interest and willingness to participate.

Trial registration

NCT01299493

【 授权许可】

   
2013 James et al.; licensee BioMed Central Ltd.

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