Clinical trial NCT01596582: Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening
Official title: Impact of Risk Stratification on Shared Decision-Making for Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer screening
Shared decision-making
Patient preferences
Risk assessment
Advanced colorectal neoplasia
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 352
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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).

Primary outcomes:
measure: Concordance Between Patient Preference and Test Ordered
timeFrame: 3 months
Secondary outcomes:
measure: Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients
timeFrame: 3 months
measure: Satisfaction With Decision-making Process (SDMP)
timeFrame: One month
measure: Screening Intentions
timeFrame: 3 months
measure: Screening Test Completion
timeFrame: 6 months
measure: Provider Satisfaction
timeFrame: Two years
Other outcomes:
measure: Concordance Between Patient Preference for Colonoscopy and Test Ordered
timeFrame: 3 months
measure: Concordance Between Patient Preferences for Screening Tests Other Than Colonoscopy and Test Ordered
timeFrame: 3 months
measure: Concordance Between Patient Preference for Colonoscopy and Test Ordered for High Versus Low Risk Patients
timeFrame: 3 months
measure: Concordance Between Patient Preferences for a Screening Tests Other Than Colonoscopy and Test Ordered for High Versus Low Risk Patients
timeFrame: 3 months
Locations:
city: Boston
country: United States
facility: Boston Medical center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Paul C Schroy III, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schroy PC 3rd, Emmons K, Peters E, Glick JT, Robinson PA, Lydotes MA, Mylvanaman S, Evans S, Chaisson C, Pignone M, Prout M, Davidson P, Heeren TC. The impact of a novel computer-based decision aid on shared decision making for colorectal cancer screening: a randomized trial. Med Decis Making. 2011 Jan-Feb;31(1):93-107. doi: 10.1177/0272989X10369007. Epub 2010 May 18.
citation: Schroy PC 3rd, Mylvaganam S, Davidson P. Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making. Health Expect. 2014 Feb;17(1):27-35. doi: 10.1111/j.1369-7625.2011.00730.x. Epub 2011 Sep 8.
citation: Schroy PC 3rd, Caron SE, Sherman BJ, Heeren TC, Battaglia TA. Risk assessment and clinical decision making for colorectal cancer screening. Health Expect. 2015 Oct;18(5):1327-38. doi: 10.1111/hex.12110. Epub 2013 Jul 30.
citation: Schroy PC 3rd, Wong JB, O'Brien MJ, Chen CA, Griffith JL. A Risk Prediction Index for Advanced Colorectal Neoplasia at Screening Colonoscopy. Am J Gastroenterol. 2015 Jul;110(7):1062-71. doi: 10.1038/ajg.2015.146. Epub 2015 May 26.
citation: Schroy PC 3rd, Duhovic E, Chen CA, Heeren TC, Lopez W, Apodaca DL, Wong JB. Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2016 May;36(4):526-35. doi: 10.1177/0272989X15625622. Epub 2016 Jan 19.