Decision Aid to Technologically Enhance Shared Decision Making

Colorectal Cancer Clinical Trial

— DATES  

Official title:

Decision Aid to Technologically Enhance Shared Decision Making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514786
• Other study ID #: HUM00044733
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: September 10, 2017
• Start date: May 2012
• Est. completion date: April 2015

Study information

• Verified date: September 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: April 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Exclusion Criteria:

• history of colon cancer or adenomatous polyps

• history of dementia or psychosis

• contraindication to CRCS

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Colorectal Web
The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS

Locations

Country	Name	City	State
United States	Children's and Family Medical Clinic	Allen Park	Michigan
United States	Downriver Internists	Allen Park	Michigan
United States	University of Michigan Briarwood Family Medicine	Ann Arbor	Michigan
United States	University of Michigan Family Medicine at Domino's	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	David Williams, MD	Detroit	Michigan
United States	Morang Chester Clinic	Detroit	Michigan
United States	Rice Lanzilote & Egan	Detroit	Michigan
United States	IPC - Livonia Internal Medicine	Livonia	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits	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.	6 months following intervention a chart audit will be conducted to determine if CRCS was completed.