Decision Aid to Technologically Enhance Shared Decision Making (DATES)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Colorectal Web

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.

• Study Type: Interventional
• Enrollment (Actual): 570
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Allen Park, Michigan, United States, 48101
      • Children's and Family Medical Clinic
    • Allen Park, Michigan, United States, 48101
      • Downriver Internists
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan Family Medicine at Domino's
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan Briarwood Family Medicine
    • Canton, Michigan, United States, 48187
      • Dua Family Practice
    • Dearborn, Michigan, United States, 48124
      • George C. Hawrot, MD
    • Detroit, Michigan, United States, 48201
      • Andrew Thomas, MD
    • Detroit, Michigan, United States, 48224
      • Morang Chester Clinic
    • Detroit, Michigan, United States, 48227
      • Rice Lanzilote & Egan
    • Detroit, Michigan, United States, 48235
      • David Williams, MD
    • Livonia, Michigan, United States, 48152
      • IPC - Livonia Internal Medicine
    • Southfield, Michigan, United States, 48075
      • Lonnie Joe Jr. MD
    • Woodhaven, Michigan, United States, 48183
      • Mark W. Sawka, MD
    • Ypsilanti, Michigan, United States, 48197
      • University of Michigan Family Medicine at Corner Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
Active Comparator: Intervention with Colorectal Website; Intervention website includes an interactive component including preferences and risk assessment.	Behavioral: Colorectal Web; The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Masahito Jimbo, MD, PhD, MPH, University of Michigan

Publications and helpful links

General Publications

• Jimbo M, Sen A, Plegue MA, Hawley S, Kelly-Blake K, Rapai M, Zhang M, Zhang Y, Xie X, Ruffin MT 4th. Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT. Am J Prev Med. 2019 Jul;57(1):77-86. doi: 10.1016/j.amepre.2019.03.004. Epub 2019 May 23.
• Jimbo M, Kelly-Blake K, Sen A, Hawley ST, Ruffin MT 4th. Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial. Trials. 2013 Nov 11;14:381. doi: 10.1186/1745-6215-14-381.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 10, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Screening; Prevention; Colorectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HUM00044733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data is still being analyzed and papers written