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

  • United States
    • 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
Other: One of 6 video presentation by one of 4 presenters
Active Comparator: Video presentation absolute event-free survival
absolute event-free survival
Other: One of 6 video presentation by one of 4 presenters
Active Comparator: Video presentation annualized absolute risk
annualized absolute risk
Other: One of 6 video presentation by one of 4 presenters
Active Comparator: Video presentation relative risk
relative risk
Other: One of 6 video presentation by one of 4 presenters
Active Comparator: Video presentation qualitative description
qualitative description
Other: One of 6 video presentation by one of 4 presenters

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

Henry Ford Health System

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

Keywords

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.

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