N/A
N=352
Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01596582 ↗Enrolled (actual)
352
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Concordance Between Patient Preference and Test Ordered — 148; 147 Participants — p=0.40
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Risk Assessment (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concordance Between Patient Preference and Test Ordered |
148; 147 | 0.40 |
| SECONDARY Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients |
86; 61 | 0.51 |
| SECONDARY Satisfaction With Decision-making Process (SDMP) |
52.0; 48.9 | <0.001 sig |
| SECONDARY Screening Intentions |
4.6; 4.0 | <0.001 sig |
| SECONDARY Screening Test Completion |
109; 7 | 0.004 sig |
| SECONDARY Provider Satisfaction |
4.0; 3.9; 3.2; 3.6; 3.8; 3.8 | >0.05 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT01596582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.