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Contemp Clin Trials. 2014 Jul;38(2):344-9. doi: 10.1016/j.cct.2014.06.006. Epub 2014 Jun 14.

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial.

Author information

1
The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR 97227, USA. Electronic address: Gloria.d.coronado@kpchr.org.
2
The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR 97227, USA. Electronic address: William.vollmer@kpchr.org.
3
The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR 97227, USA. Electronic address: Amanda.f.petrik@kpchr.org.
4
National Cancer Institute, Process of Care Research Branch, Behavioral Research Program, Division of Cancer Control and Population Sciences, 9609 Medical Center Drive, Bethesda, MD 20892-9760, USA. Electronic address: Taplins@mail.nih.gov.
5
OCHIN, Inc., 1881 SW Naito Parkway, Portland, OR 97201, USA; Department of Family Medicine Oregon Health & Sciences University, 4411 SW Vermont Street, Portland, OR 97219, USA. Electronic address: burdickt@ochin.org.
6
The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR 97227, USA. Electronic address: Richard.meenan@kpchr.org.
7
Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, USA. Electronic address: Green.b@ghc.org.

Abstract

BACKGROUND:

Colorectal cancer is the second-leading cause of cancer deaths in the United States. The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics. The study will assess the effectiveness of a system-based intervention designed to improve the rates of colorectal-cancer screening using fecal immunochemical testing (FIT) in federally qualified health centers in Oregon and Northern California.

MATERIAL AND METHODS:

STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics. Clinics will be randomized to one of two arms. Clinics in the intervention arm (1) will use an automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits (with pictographic instructions) to them; (2) will conduct an improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program. Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits. The primary outcomes are: proportion of age- and screening-eligible patients completing a FIT within 12months; and cost, cost-effectiveness, and return on investment of the intervention.

CONCLUSIONS:

This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients, including many with historically low colorectal-cancer screening rates. If successful, the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01742065.

KEYWORDS:

Cluster-randomized study; Colorectal cancer screening; Fecal immunochemical test; Pragmatic study

PMID:
24937017
PMCID:
PMC4226652
DOI:
10.1016/j.cct.2014.06.006
[Indexed for MEDLINE]
Free PMC Article

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