title: Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients.
  
  
  METHODS
  We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening.
  
  
  CONCLUSIONS
  This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02054598.
authors.affiliation: Cecil Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, 725 Martin Luther King Jr Boulevard, Campus Box 7590, Chapel Hill, NC 27599-7590, USA. alison.brenner@unc.edu.
authors.forename: Alison T
authors.initials: AT
authors.lastname: Brenner
authors.forename: Christina M
authors.initials: CM
authors.lastname: Getrich
authors.forename: Michael
authors.initials: M
authors.lastname: Pignone
authors.forename: Robert L
authors.initials: RL
authors.lastname: Rhyne
authors.forename: Richard M
authors.initials: RM
authors.lastname: Hoffman
authors.forename: Andrew
authors.initials: A
authors.lastname: McWilliams
authors.forename: Brisa Urquieta
authors.initials: BU
authors.lastname: de Hernandez
authors.forename: Mark A
authors.initials: MA
authors.lastname: Weaver
authors.forename: Hazel
authors.initials: H
authors.lastname: Tapp
authors.forename: Khalil
authors.initials: K
authors.lastname: Harbi
authors.forename: Daniel
authors.initials: D
authors.lastname: Reuland
mesh_terms: D000069:Acculturation; D000368:Aged; D002985:Clinical Protocols; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000208:ethnology / Q000473:pathology / Q000523:psychology; D003661:Decision Support Techniques; D055088:Early Detection of Cancer / Q000379:methods / Q000523:psychology*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology; D006630:Hispanic or Latino / Q000523:psychology; D006801:Humans; D019458:Insurance Coverage; D007348:Insurance, Health; D007802:Language; D008297:Male; D008875:Middle Aged; D009516:New Mexico / Q000453:epidemiology; D009657:North Carolina / Q000453:epidemiology; D009780:Occult Blood; D010353:Patient Education as Topic; D062526:Patient Navigation; D011237:Predictive Value of Tests; D012107:Research Design; D014741:Video Recording; D035862:Vulnerable Populations / Q000208:ethnology / Q000523:psychology*