Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening
Completed · Not applicable
Conditions studied: Colorectal Cancer
In brief
Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel computer-based decision aid facilitates several components of SDM from both the patient and provider perspective, there is a reluctance among providers to acquiesce to patient preferences for a particular screening strategy when its differs from their own. The overall objective of this study is to assess whether risk stratification for advanced colorectal neoplasia influences clinical decision-making related to screening test selection and adherence within a SDM framework. Eligible subjects will be randomized to either an experimental arm, in which they will be asked to complete a 6-item risk assessment questionnaire known as the "Advanced Colorectal Neoplasia Index \[ACNI\]" after reviewing a web-based decision aid, or a control arm, in which they will only review the decision aid. Both interventions will take place just before a prearranged office visit with their provider. The primary outcome will be screening test ordered; secondary outcomes will include test completion rates, concordance between test preference and test ordered,, patient satisfaction with decision-making process, screening intentions, 6-month test completion rates and provider satisfaction. Outcomes will be evaluated using computerized tracking systems or validated instruments.
Key facts
- Study ID
- NCT01596582
- Run by
- Boston Medical Center
- People needed
- 352
- Starts
- 2012-04-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2017-03-21
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- English-speaking "average-risk" patients 50 to 75 years of age;
- Due for CRC screening based on current recommendations (i.e. no prior screening or > 1year since last fecal occult blood testing [FOBT], > 3 years since last stool DNA test, > 5 years since last flexible sigmoidoscopy, virtual colonoscopy or double-contrast barium enema [DCBE], or > 10 years since last colonoscopy);
- Under the direct care of a staff (attending) primary care provider or physician extender;
- Absence of major co-morbidities that preclude CRC screening.
You may not qualify if…
- High-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or polyps involving one or more first degree relatives < 60 years of age, chronic inflammatory bowel disease);
- Presence of "alarm" gastrointestinal symptoms, including rectal bleeding, recent change in bowel habits, abdominal pain, unexplained weight loss and iron deficiency anemia;
- Comorbidities that preclude CRC screening by any method;
- Lack of fluency in written and spoken English (since decision aid and personalized risk assessment tool will be in English only due to funding issues).
Where it is running
- Boston Medical center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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