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Decision Aid to Technologically Enhance Shared Decision Making (DATES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01514786
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Colorectal Cancer 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Decision Aid to Technologically Enhance Shared Decision Making
Study Start Date : May 2012
Primary Completion Date : September 2014
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514786


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Masahito Jimbo, MD, Clinical Associate Professor, Family Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01514786     History of Changes
Other Study ID Numbers: HUM00044733
First Posted: January 23, 2012    Key Record Dates
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is still being analyzed and papers written

Keywords provided by Masahito Jimbo, MD, University of Michigan:
Colorectal Cancer
Screening
Prevention

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