title: Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve adherence to colorectal cancer screening among patients cared for in a community health center.
abstract: BACKGROUND
  Colorectal cancer (CRC) is common and leads to significant morbidity and mortality. Although screening with fecal occult blood testing (FOBT) or endoscopy has been shown to decrease CRC mortality, screening rates remain suboptimal. Screening rates are particularly low for people with low incomes and members of underrepresented minority groups. FOBT should be done annually to detect CRC early and to reduce CRC mortality, but this often does not occur. This paper describes the design of a multifaceted intervention to increase long-term adherence to FOBT among poor, predominantly Latino patients, and the design of a randomized controlled trial (RCT) to test the efficacy of this intervention compared to usual care.
  
  
  METHODS
  In this RCT, patients who are due for repeat FOBT are identified in the electronic health record (EHR) and randomized to receive either usual care or a multifaceted intervention. The usual care group includes multiple point-of-care interventions (e.g., standing orders, EHR reminders), performance measurement, and financial incentives to improve CRC screening rates. The intervention augments usual care through mailed CRC screening test kits, low literacy patient education materials, automated phone and text message reminders, in-person follow up calls from a CRC Screening Coordinator, and communication of results to patients along with a reminder card highlighting when the patient is next due for screening. The primary outcome is completion of FOBT within 6 months of becoming due.
  
  
  CONCLUSIONS
  The main goal of the study is to determine the comparative effectiveness of the intervention compared to usual care. Additionally, we want to assess whether or not it is possible to achieve high rates of adherence to CRC screening with annual FOBT, which is necessary for reducing CRC mortality. The intervention relies on technology that is increasingly widespread and declining in cost, including EHR systems, automated phone and text messaging, and FOBTs for CRC screening. We took this approach to ensure generalizability and allow us to rapidly disseminate the intervention through networks of community health centers (CHCs) if the RCT shows the intervention to be superior to usual care.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01453894.
authors.forename: David W
authors.initials: DW
authors.lastname: Baker
authors.forename: Tiffany
authors.initials: T
authors.lastname: Brown
authors.forename: David R
authors.initials: DR
authors.lastname: Buchanan
authors.forename: Jordan
authors.initials: J
authors.lastname: Weil
authors.forename: Kenzie A
authors.initials: KA
authors.lastname: Cameron
authors.forename: Lauren
authors.initials: L
authors.lastname: Ranalli
authors.forename: M Rosario
authors.initials: MR
authors.lastname: Ferreira
authors.forename: Quinn
authors.initials: Q
authors.lastname: Stephens
authors.forename: Kate
authors.initials: K
authors.lastname: Balsley
authors.forename: Shira N
authors.initials: SN
authors.lastname: Goldman
authors.forename: Michael S
authors.initials: MS
authors.lastname: Wolf
mesh_terms: D000368:Aged; D003113:Colonoscopy / Q000706:statistics & numerical data; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000517:prevention & control*; D003151:Community Health Centers / Q000458:organization & administration; D057186:Comparative Effectiveness Research / Q000379:methods; D055088:Early Detection of Cancer / Q000379:methods / Q000706:statistics & numerical data; D006801:Humans; D008875:Middle Aged; D009780:Occult Blood; D010349:Patient Compliance / Q000706:statistics & numerical data; D010353:Patient Education as Topic / Q000379:methods; D012107:Research Design