Decision Aid to Technologically Enhance Shared Decision Making

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Colorectal Web

• Registration Number: NCT01514786
• Lead Sponsor: University of Michigan

Brief Summary

Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.

Detailed Description

This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Study Start: 2012-05
• Primary Completion: 2014-09
• Study Completion: 2015-04
• Results First Submitted: 2017-03-14
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-10
• Last Update Submitted: 2017-09-10
• Results First Posted: 2017-09-15
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• 50-75 years of age
• not current with colorectal cancer screening
• scheduled for HME, Health Maintenance Exam, or chronic care visit with participating physician
• able to read English
• current contact information

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Exclusion Criteria

• history of colon cancer or adenomatous polyps
• history of dementia or psychosis
• contraindication to CRCS

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention with Colorectal Website	Colorectal Web	Intervention website includes an interactive component including preferences and risk assessment.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits	6 months following intervention a chart audit will be conducted to determine if CRCS was completed.	Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.

Trial Locations

Locations (14)

Children's and Family Medical Clinic; 🇺🇸 Allen Park, Michigan, United States

Downriver Internists; 🇺🇸 Allen Park, Michigan, United States

University of Michigan Family Medicine at Domino's; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan Briarwood Family Medicine; 🇺🇸 Ann Arbor, Michigan, United States

Dua Family Practice; 🇺🇸 Canton, Michigan, United States

George C. Hawrot, MD; 🇺🇸 Dearborn, Michigan, United States

Andrew Thomas, MD; 🇺🇸 Detroit, Michigan, United States

Morang Chester Clinic; 🇺🇸 Detroit, Michigan, United States

David Williams, MD; 🇺🇸 Detroit, Michigan, United States

IPC - Livonia Internal Medicine; 🇺🇸 Livonia, Michigan, United States

Rice Lanzilote & Egan; 🇺🇸 Detroit, Michigan, United States

Lonnie Joe Jr. MD; 🇺🇸 Southfield, Michigan, United States

Mark W. Sawka, MD; 🇺🇸 Woodhaven, Michigan, United States

University of Michigan Family Medicine at Corner Health Center; 🇺🇸 Ypsilanti, Michigan, United States