title: Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.
abstract: Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations).
  
  
  
  This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results.
  
  
  
  The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial.
authors.affiliation: Arizona State University, College of Nursing and Health Innovation, 550 N 3rd Street, Phoenix, AZ 85004, United States. Electronic address: Linda.Larkey@asu.edu.
authors.forename: Linda
authors.initials: L
authors.lastname: Larkey
authors.affiliation: The University of Arizona, College of Nursing, 1305 N. Martin, Tucson, AZ 85721, United States.
authors.forename: Laura
authors.initials: L
authors.lastname: Szalacha
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, United States.
authors.forename: Patricia
authors.initials: P
authors.lastname: Herman
authors.affiliation: Arizona State University, College of Nursing and Health Innovation, 550 N 3rd Street, Phoenix, AZ 85004, United States.
authors.forename: Julie
authors.initials: J
authors.lastname: Gonzalez
authors.affiliation: The University of Arizona, College of Nursing, 1305 N. Martin, Tucson, AZ 85721, United States.
authors.forename: Usha
authors.initials: U
authors.lastname: Menon
mesh_terms: D001741:Black or African American; D000368:Aged; D001213:Asian; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D055088:Early Detection of Cancer; D005006:Ethnicity; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D007198:Indians, North American; D008297:Male; D017057:Medically Uninsured; D008875:Middle Aged; D008913:Minority Groups; D010349:Patient Compliance; D010353:Patient Education as Topic / Q000379:methods*; D062526:Patient Navigation / Q000379:methods*; D011203:Poverty; D012017:Referral and Consultation