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

NCT01596582 | Completed Results

• 1 other identifier: NCI-CA131197
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer screening; Shared decision-making; Patient preferences; Risk assessment; Advanced colorectal neoplasia

Outcome Measures

Primary Outcomes (1)

• Concordance Between Patient Preference and Test Ordered

  Concordance is a measure of the agreement between the patient's test preference and actual test ordered for standard care vs. risk assessment patients. It is defined as the number of patients who had their preferred test ordered.

  3 months

Secondary Outcomes (5)

• Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients

  3 months

• Satisfaction With Decision-making Process (SDMP)

  One month

• Screening Intentions

  3 months

• Screening Test Completion

  6 months

• Provider Satisfaction

  Two years

Other Outcomes (4)

• Concordance Between Patient Preference for Colonoscopy and Test Ordered

  3 months

• Concordance Between Patient Preferences for Screening Tests Other Than Colonoscopy and Test Ordered

  3 months

• Concordance Between Patient Preference for Colonoscopy and Test Ordered for High Versus Low Risk Patients

  3 months

Study Arms (2)

Standard Care

NO INTERVENTION

Subjects randomized to the control arm will review the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.

Risk Assessment

EXPERIMENTAL

Subjects randomized to the experimental arm will complete the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.

Behavioral: Risk Assessment

Interventions

Risk Assessment BEHAVIORAL

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).

Also known as: ACNI

Risk Assessment

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical center

Boston, Massachusetts, 02118, United States

Location

Related Publications (5)

• 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.

  PMID: 20484090 BACKGROUND

• 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.

  PMID: 21902773 BACKGROUND

• 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.

  PMID: 23905546 BACKGROUND

• 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.

  PMID: 26010311 BACKGROUND

• 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.

  PMID: 26785715 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Patient Preference

Interventions

Risk Assessment

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Risk Management; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Limitations and Caveats

Single institution setting; lack of provider education about the utility of risk stratification into their decision-making.

Results Point of Contact

• Title: Paul C. Schroy III, MD, MPH
• Organization: Boston Medical Center

paul.schroy@bmc.org

671-638-8335

Study Officials

• Paul C Schroy III, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BMC Attending Physician

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 11, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 21, 2017
• Results First Posted: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)