Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Risk Assessment
Intervention type(s): Behavioral
Intervention description(s): 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 (50-59, 60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic 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). The index represents a prototype version of the Advanced Colorectal Neoplasia Index (Am J Gastroenterol 2015;110:1062-71).
Other intervention name(s): ACNI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colorectal cancer screening; Shared decision-making; Patient preferences; Risk assessment; Advanced colorectal neoplasia