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Original Investigation
July 2017

Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient PopulationA Randomized Clinical Trial

Author Affiliations
  • 1Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill
  • 2Division of General Medicine & Clinical Epidemiology, University of North Carolina School of Medicine, Chapel Hill
  • 3Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill
  • 4Department of Medicine, University of Iowa Carver College of Medicine, Iowa City
  • 5University of Iowa Holden Comprehensive Cancer Center, University of Iowa, Iowa City
  • 6Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque
  • 7Department of Family Medicine, Carolinas HealthCare System, Charlotte, North Carolina
  • 8University of New Mexico Comprehensive Cancer Center, Albuquerque
  • 9Department of Anthropology, University of Maryland, College Park
  • 10Department of Biostatistics, University of North Carolina, Chapel Hill
  • 11Department of Internal Medicine, University of Texas Dell Medical School, Austin
JAMA Intern Med. 2017;177(7):967-974. doi:10.1001/jamainternmed.2017.1294
Key Points

Question  Compared with usual care, what is the effect of an intervention combining a colorectal cancer (CRC) screening decision aid and patient navigation on CRC screening completion in a diverse, vulnerable primary care population?

Findings  In this randomized clinical trial that included 265 patients, the rate of CRC screening completion at 6 months was greater in the intervention arm (68%) than in the control arm (27%), a significant difference.

Meaning  Given the substantial effect on screening, efforts to understand how this kind of intervention can be more broadly implemented are warranted.


Importance  Colorectal cancer (CRC) screening is underused, especially among vulnerable populations. Decision aids and patient navigation are potentially complementary interventions for improving CRC screening rates, but their combined effect on screening completion is unknown.

Objective  To determine the combined effect of a CRC screening decision aid and patient navigation compared with usual care on CRC screening completion.

Design, Setting, and Participants  In this randomized clinical trial, data were collected from January 2014 to March 2016 at 2 community health center practices, 1 in North Carolina and 1 in New Mexico, serving vulnerable populations. Patients ages 50 to 75 years who had average CRC risk, spoke English or Spanish, were not current with recommended CRC screening, and were attending primary care visits were recruited and randomized 1:1 to intervention or control arms.

Interventions  Intervention participants viewed a CRC screening decision aid in English or Spanish immediately before their clinician encounter. The decision aid promoted screening and presented colonoscopy and fecal occult blood testing as screening options. After the clinician encounter, intervention patients received support for screening completion from a bilingual patient navigator. Control participants viewed a food safety video before the encounter and otherwise received usual care.

Main Outcomes and Measures  The primary outcome was CRC screening completion within 6 months of the index study visit assessed by blinded medical record review.

Results  Characteristics of the 265 participants were as follows: their mean age was 58 years; 173 (65%) were female, 164 (62%) were Latino; 40 (15%) were white non-Latino; 61 (23%) were black or of mixed race; 191 (78%) had a household income of less than $20 000; 101 (38%) had low literacy; 75 (28%) were on Medicaid; and 91 (34%) were uninsured. Intervention participants were more likely to complete CRC screening within 6 months (68% vs 27%); adjusted-difference, 40 percentage points (95% CI, 29-51 percentage points). The intervention was more effective in women than in men (50 vs 21 percentage point increase, interaction P = .02). No effect modification was observed across other subgroups.

Conclusions and Relevance  A patient decision aid plus patient navigation increased the rate of CRC screening completion in compared with usual care invulnerable primary care patients.

Trial Registration  clinicaltrials.gov Identifier: NCT02054598