title: Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial.
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.
  
  
  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.
authors.affiliation: The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR 97227, USA. Electronic address: Gloria.d.coronado@kpchr.org.
authors.forename: Gloria D
authors.initials: GD
authors.lastname: Coronado
authors.affiliation: The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR 97227, USA. Electronic address: William.vollmer@kpchr.org.
authors.forename: William M
authors.initials: WM
authors.lastname: Vollmer
authors.affiliation: The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR 97227, USA. Electronic address: Amanda.f.petrik@kpchr.org.
authors.forename: Amanda
authors.initials: A
authors.lastname: Petrik
authors.affiliation: 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.
authors.forename: Stephen H
authors.initials: SH
authors.lastname: Taplin
authors.affiliation: 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.
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Burdick
authors.affiliation: The Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR 97227, USA. Electronic address: Richard.meenan@kpchr.org.
authors.forename: Richard T
authors.initials: RT
authors.lastname: Meenan
authors.affiliation: Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, USA. Electronic address: Green.b@ghc.org.
authors.forename: Beverly B
authors.initials: BB
authors.lastname: Green
mesh_terms: D000368:Aged; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D055088:Early Detection of Cancer / Q000379:methods*; D057286:Electronic Health Records; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009780:Occult Blood; D012107:Research Design; D012307:Risk Factors; D064876:Safety-net Providers / Q000458:organization & administration*; D016037:Single-Blind Method
keywords: Cluster-randomized study; Colorectal cancer screening; Fecal immunochemical test; Pragmatic study