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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01596582
First received: May 7, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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]" before 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, value concordance, patient satisfaction with decision-making process and provider satisfaction. Outcomes will be evaluated using computerized tracking systems or validated instruments.


Condition Intervention
Colorectal Cancer
Behavioral: Risk Assessment

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Screening test ordered [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Screening test completion rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Concordance between patient and patients test preference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Satisfaction with decision-making process [ Time Frame: One month ] [ Designated as safety issue: No ]
  • Provider satisfaction [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: April 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  • without 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596582

Locations
United States, Massachusetts
Boston Medical center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Paul C Schroy III, MD, MPH Boston Medical Center
  More Information

Publications:
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01596582     History of Changes
Other Study ID Numbers: NCI-CA131197, 1R01CA131197
Study First Received: May 7, 2012
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Colorectal cancer screening
Shared decision-making
Patient preferences
Risk assessment
Advanced colorectal neoplasia

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014