Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - 75
Updated:3/22/2017
Start Date:April 2012
End Date:June 2016

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Impact of Risk Stratification on Shared Decision-Making for Colorectal Cancer Screening

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.

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.

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).
We found this trial at
1
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Boston, Massachusetts 02118
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Boston, MA
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