A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis
January 2, 2024 updated by: Henry Ford Health System
The purpose of this study is to determine patient variables, physician presenter variables, and information variables that might affect clinical decision making in asymptomatic carotid stenosis.
The hypothesis is that information variables are the most significant determinant of clinical decision making.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- No known history of carotid stenosis
Exclusion Criteria:
- History of dementia
- Unable to read English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Video presentation absolute risk
absolute risk
|
|
|
Active Comparator: Video presentation absolute event-free survival
absolute event-free survival
|
|
|
Active Comparator: Video presentation annualized absolute risk
annualized absolute risk
|
|
|
Active Comparator: Video presentation relative risk
relative risk
|
|
|
Active Comparator: Video presentation qualitative description
qualitative description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decision regarding surgery
Time Frame: Approximately 2 minutes
|
Subjects are asked to make a choice regarding surgery after watching a 30 second video.
|
Approximately 2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
March 14, 2011
First Submitted That Met QC Criteria
March 14, 2011
First Posted (Estimated)
March 15, 2011
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACSCDM-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.