Decision Aid to Technologically Enhance Shared Decision Making (DATES)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Masahito Jimbo, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01514786
First received: January 17, 2012
Last updated: December 1, 2014
Last verified: December 2014
  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:


Further study details as provided by University of Michigan:

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: May 2012
Estimated Study Completion Date: April 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Briarwood Family Medicine
Ann Arbor, Michigan, United States, 48108
University of Michigan Family Medicine at Domino's
Ann Arbor, Michigan, United States, 48106
Dua Family Practice
Canton, Michigan, United States, 48187
George C. Hawrot, MD
Dearborn, Michigan, United States, 48124
David Williams, MD
Detroit, Michigan, United States, 48235
Morang Chester Clinic
Detroit, Michigan, United States, 48224
Rice Lanzilote & Egan
Detroit, Michigan, United States, 48227
Andrew Thomas, MD
Detroit, Michigan, United States, 48201
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

No publications provided by University of Michigan

Additional 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
Study First Received: January 17, 2012
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Colorectal Cancer
Screening
Prevention

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on April 16, 2015