Decision Aid to Technologically Enhance Shared Decision Making (DATES)
This study is currently recruiting participants.
Verified May 2013 by University of Michigan
Sponsor:
University of Michigan
Information provided by (Responsible Party):
Masahito Jimbo, MD, University of Michigan Health System
ClinicalTrials.gov Identifier:
NCT01514786
First received: January 17, 2012
Last updated: May 22, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Cancer
Choosing a Doctor or Health Care Service
Colorectal Cancer
Talking With Your Doctor
U.S. FDA Resources
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: | October 2014 |
| Estimated 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 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: Mary Rapai, MA | 734-998-7120 ext 343 | mrapai@umich.edu |
Locations
| United States, Michigan | |
| Downriver Internists | Recruiting |
| Allen Park, Michigan, United States, 48101 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| Children's and Family Medical Clinic | Recruiting |
| Allen Park, Michigan, United States, 48101 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| University of Michigan Family Medicine at Domino's | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Mary Rapai, MA 734-998-7120 mrapai@umich.edu | |
| University of Michigan Briarwood Family Medicine | Recruiting |
| Ann Arbor, Michigan, United States, 48108 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| Dua Family Practice | Recruiting |
| Canton, Michigan, United States, 48187 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| George C. Hawrot, MD | Recruiting |
| Dearborn, Michigan, United States, 48124 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| Morang Chester Clinic | Recruiting |
| Detroit, Michigan, United States, 48224 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| David Williams, MD | Recruiting |
| Detroit, Michigan, United States, 48235 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| Andrew Thomas, MD | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| Rice Lanzilote & Egan | Recruiting |
| Detroit, Michigan, United States, 48227 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| IPC - Livonia Internal Medicine | Recruiting |
| Livonia, Michigan, United States, 48152 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| Lonnie Joe Jr. MD | Recruiting |
| Southfield, Michigan, United States, 48075 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| Mark W. Sawka, MD | Recruiting |
| Woodhaven, Michigan, United States, 48183 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
| University of Michigan Family Medicine at Corner Health Center | Recruiting |
| Ypsilanti, Michigan, United States, 48197 | |
| Contact: Mary Rapai, MA 734-998-7120 ext 343 mrapai@umich.edu | |
Sponsors and Collaborators
University of Michigan
Investigators
| Principal Investigator: | Masahito Jimbo, MD, PhD, MPH | University of Michigan |
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: | May 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on June 18, 2013