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Decision Aid to Technologically Enhance Shared Decision Making (DATES)

This study is not yet open for participant recruitment.
Verified March 2012 by University of Michigan Health System
Sponsor:
Information provided by (Responsible Party):
Masahito Jimbo, MD, University of Michigan Health System
ClinicalTrials.gov Identifier:
NCT01514786
First received: January 17, 2012
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Colorectal Cancer
 Behavioral: Colorectal Web

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Decision Aid to Technologically Enhance Shared Decision Making

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan Health System:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 630
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Active Comparator: Intervention with Colorectal Website Behavioral: Colorectal Web
The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50-75 years of age
  • not current with colorectal cancer screening
  • scheduled for HME 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514786

Contacts
Contact: Laurie Fortlage, MS, RD 734-998-7120 ext 266 lfort@umich.edu

Locations
United States, Michigan
Downriver Internists Not yet recruiting
Allen Park, Michigan, United States, 48101
Contact: Laurie Fortlage, MS, RD     734-998-7120 ext 266     lfort@umich.edu    
Children's and Family Medical Clinic Not yet recruiting
Allen Park, Michigan, United States, 48101
Contact: Laurie Fortlage, MS,RD     734-998-7120 ext 266     lfort@umich.edu    
Dua Family Practice Not yet recruiting
Canton, Michigan, United States, 48187
Contact: Laurie Fortlage, MS,RD     734-998-7120 ext 266     lfort@umich.edu    
Associated Physicians of Dearborn Not yet recruiting
Dearborn, Michigan, United States, 48126
Contact: Laurie Fortlage, MS, RD     734-998-7120 ext 266     lfort@umich.edu    
Morang Chester Clinic Not yet recruiting
Detroit, Michigan, United States, 48224
Contact: Laurie Fortlage, MS, RD     734-998-7120 ext 266     lfort@umich.edu    
IPC - Livonia Internal Medicine Not yet recruiting
Livonia, Michigan, United States, 48152
Contact: Laurie Fortlage, MS, RD     734-998-7120 ext 266     lfort@umich.edu    
Mark W. Sawka, MD Not yet recruiting
Woodhaven, Michigan, United States, 48183
Contact: Laurie Fortlage, MS, RD     734-998-7120 ext 266     lfort@umich.edu    
Sponsors and Collaborators
University of Michigan Health System
Investigators
Principal Investigator: Masahito Jimbo, MD, PhD, MPH University of Michigan Health System
  More Information

No publications provided

Responsible Party: Masahito Jimbo, MD, Clinical Associate Professor, Family Medicine, University of Michigan Health System
ClinicalTrials.gov Identifier: NCT01514786     History of Changes
Other Study ID Numbers: HUM00044733
Study First Received: January 17, 2012
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Health System:
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

ClinicalTrials.gov processed this record on May 21, 2013