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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

Alison T Brenner1*, Christina M Getrich2, Michael Pignone13, Robert L Rhyne4, Richard M Hoffman456, Andrew McWilliams7, Brisa Urquieta de Hernandez7, Mark A Weaver8, Hazel Tapp7, Khalil Harbi1 and Daniel Reuland13

Author Affiliations

1 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

2 Department of Anthropology, University of Maryland, College Park, MD, USA

3 Division of General Internal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA

4 Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA

5 Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA

6 University of New Mexico Cancer Center, Albuquerque, NM, USA

7 Department of Family Medicine, Carolinas HealthCare System, Charlotte, USA

8 Departments of Medicine and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

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Trials 2014, 15:275  doi:10.1186/1745-6215-15-275

Published: 8 July 2014



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.


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.


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.

Clinical trial registration NCT02054598.

colon cancer; colonic neoplasms; decision aids; early detection of cancer; Hispanic Americans; minority health; patient navigation; vulnerable populations