Decision Aid to Technologically Enhance Shared Decision Making (DATES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Masahito Jimbo, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01514786
First received: January 17, 2012
Last updated: December 9, 2013
Last verified: December 2013

January 17, 2012
December 9, 2013
May 2012
September 2014   (final data collection date for primary outcome measure)
The measurement of the impact of Colorectal Web on patient uptake of CRCS on patient determinants/preference/intention before the patient-physician encounter, and on SDM, concordance and patient intention during and after the patient-physician encounter. [ Time Frame: 6 months following intervention a chart audit will be conducted to determine if CRCS was completed. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01514786 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Decision Aid to Technologically Enhance Shared Decision Making
Decision Aid to Technologically Enhance Shared Decision Making

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Colorectal Cancer
Behavioral: Colorectal Web
The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
  • 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.
    Intervention: Behavioral: Colorectal Web
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
630
October 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
Yes
Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu
United States
 
NCT01514786
HUM00044733
Yes
Masahito Jimbo, MD, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Masahito Jimbo, MD, PhD, MPH University of Michigan
University of Michigan
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP