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Decision Aid to Technologically Enhance Shared Decision Making (DATES)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colorectal Web
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal Cancer, Screening, Prevention

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's and Family Medical Clinic
  • Downriver Internists
  • University of Michigan Family Medicine at Domino's
  • University of Michigan Briarwood Family Medicine
  • Dua Family Practice
  • George C. Hawrot, MD
  • Andrew Thomas, MD
  • Morang Chester Clinic
  • Rice Lanzilote & Egan
  • David Williams, MD
  • IPC - Livonia Internal Medicine
  • Lonnie Joe Jr. MD
  • Mark W. Sawka, MD
  • University of Michigan Family Medicine at Corner Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention with Colorectal Website

Arm Description

Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.

Intervention website includes an interactive component including preferences and risk assessment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2012
Last Updated
September 10, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01514786
Brief Title
Decision Aid to Technologically Enhance Shared Decision Making
Acronym
DATES
Official Title
Decision Aid to Technologically Enhance Shared Decision Making
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, Screening, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
Arm Title
Intervention with Colorectal Website
Arm Type
Active Comparator
Arm Description
Intervention website includes an interactive component including preferences and risk assessment.
Intervention Type
Behavioral
Intervention Name(s)
Colorectal Web
Intervention Description
The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
Primary Outcome Measure Information:
Title
Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits
Description
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.
Time Frame
6 months following intervention a chart audit will be conducted to determine if CRCS was completed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masahito Jimbo, MD, PhD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's and Family Medical Clinic
City
Allen Park
State/Province
Michigan
ZIP/Postal Code
48101
Country
United States
Facility Name
Downriver Internists
City
Allen Park
State/Province
Michigan
ZIP/Postal Code
48101
Country
United States
Facility Name
University of Michigan Family Medicine at Domino's
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Briarwood Family Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Dua Family Practice
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Facility Name
George C. Hawrot, MD
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Andrew Thomas, MD
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Morang Chester Clinic
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48224
Country
United States
Facility Name
Rice Lanzilote & Egan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48227
Country
United States
Facility Name
David Williams, MD
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
IPC - Livonia Internal Medicine
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Lonnie Joe Jr. MD
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Mark W. Sawka, MD
City
Woodhaven
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
University of Michigan Family Medicine at Corner Health Center
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is still being analyzed and papers written
Citations:
PubMed Identifier
31128959
Citation
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.
Results Reference
derived
PubMed Identifier
24216139
Citation
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.
Results Reference
derived

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Decision Aid to Technologically Enhance Shared Decision Making

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