Decision Aid to Technologically Enhance Shared Decision Making
DATES
1 other identifier
interventional
570
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started May 2012
Typical duration for not_applicable colorectal-cancer
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
September 15, 2017
CompletedSeptember 15, 2017
September 1, 2017
2.3 years
January 17, 2012
March 14, 2017
September 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months following intervention a chart audit will be conducted to determine if CRCS was completed.
Study Arms (2)
Control
NO INTERVENTIONSame information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
Intervention with Colorectal Website
ACTIVE COMPARATORIntervention website includes an interactive component including preferences and risk assessment.
Interventions
The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- history of colon cancer or adenomatous polyps
- history of dementia or psychosis
- contraindication to CRCS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Children's and Family Medical Clinic
Allen Park, Michigan, 48101, United States
Downriver Internists
Allen Park, Michigan, 48101, United States
University of Michigan Family Medicine at Domino's
Ann Arbor, Michigan, 48106, United States
University of Michigan Briarwood Family Medicine
Ann Arbor, Michigan, 48108, United States
Dua Family Practice
Canton, Michigan, 48187, United States
George C. Hawrot, MD
Dearborn, Michigan, 48124, United States
Andrew Thomas, MD
Detroit, Michigan, 48201, United States
Morang Chester Clinic
Detroit, Michigan, 48224, United States
Rice Lanzilote & Egan
Detroit, Michigan, 48227, United States
David Williams, MD
Detroit, Michigan, 48235, United States
IPC - Livonia Internal Medicine
Livonia, Michigan, 48152, United States
Lonnie Joe Jr. MD
Southfield, Michigan, 48075, United States
Mark W. Sawka, MD
Woodhaven, Michigan, 48183, United States
University of Michigan Family Medicine at Corner Health Center
Ypsilanti, Michigan, 48197, United States
Related Publications (2)
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.
PMID: 31128959DERIVEDJimbo 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.
PMID: 24216139DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Masahito Jimbo
- Organization
- UMichigan
Study Officials
- PRINCIPAL INVESTIGATOR
Masahito Jimbo, MD, PhD, MPH
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor, Family Medicine
Study Record Dates
First Submitted
January 17, 2012
First Posted
January 23, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2014
Study Completion
April 1, 2015
Last Updated
September 15, 2017
Results First Posted
September 15, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Data is still being analyzed and papers written