Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Impact of Risk Stratification on Shared Decision-Making for Colorectal Cancer Screening|
- Concordance between patient and provider test preferences [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Test-specific concordance for high vs. low risk patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Satisfaction with decision-making process [ Time Frame: One month ] [ Designated as safety issue: No ]
- Screening intentions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Screening test completion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Provider satisfaction [ Time Frame: Two years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Study Completion Date:||June 2016|
|Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
No Intervention: Standard Care
Subjects randomized to the control arm reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com)just prior to a scheduled visit with their provider.
Experimental: Risk Assessment
Subjects randomized to the experimental arm will complete the ACNI risk assessment tool and then reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com)just prior to a scheduled office visit with their provider.
Behavioral: Risk Assessment
Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age, sex (male/female), race/ethnicity (black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never).
Other Name: ACNI
Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States. Screening by any of at least 6 different methods is a cost-effective yet underutilized strategy for reducing both CRC incidence and mortality. Because these methods differ with respect to risks and benefits and because existing evidence fails to identify a single best strategy, most authoritative groups advocate a shared decision-making (SDM) approach when selecting an appropriate screening strategy. SDM is a sequential, interactive process involving information exchange, values clarification, decision-making and mutual agreement. To facilitate this process, patient-oriented decision aids have been developed to enable patients to identify a preferred strategy based on personal values and empower them to participate in the decision-making process. Our recent studies to date find that although decision aids enable patients to make informed choices, providers are often unwilling to acquiesce to patient preferences when they differ from their own. Since accurate risk assessment is a critical component of effective clinical decision-making, the investigators postulate that risk stratification for the point prevalence of advanced colorectal neoplasia will enable providers to incorporate objective risk-based criteria in their decision-making when considering patient preferences for screening. To that end, the investigators have recently developed and validated the so-called "Advanced Colorectal Neoplasia Index [ACNI]" that stratifies patients into low versus intermediate/high risk categories based on available clinical data, including age, sex, race/ethnicity, smoking history, daily alcohol intake and use of non-steroidal anti-inflammatory drugs. The overall objective of this study is to determine whether risk stratification using the ACNI influences clinical decision-making related to screening test selection and adherence to screening within a SDM framework.
Hypothesis: Providers who incorporate risk estimates of ACN in their decision-making when recommending screening tests are more likely to consider patient preferences for options other than colonoscopy than providers lacking this information.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596582
|United States, Massachusetts|
|Boston Medical center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Paul C Schroy III, MD, MPH||Boston Medical Center|