Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis

April 7, 2016 updated by: Brian Silver, Rhode Island Hospital

A Randomized Trial of Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis

Background: In a previous study, information verbally presented as relative risk (e.g. "50% less likely") or qualitative risk (e.g. "significantly less likely") resulted in many more people (66%) choosing a surgical procedure for narrowing or artery in the neck than people presented with absolute risk (e.g. "11% versus 5% over 5 years"), annualized risk (e.g. "2% versus 1% per year for 5 years") and event-free survival (e.g. "95% versus 89% over 5 years") (33%).

Objectives: The purpose of this study is to determine whether the same observations are true for information that is presented visually as a bar graph. In addition, the investigators also seek to determine whether subjects feel that they understand the information better when presented visually as compared with verbally.

Methods: 450 subjects will be approached in the neurology clinic as they are waiting for their office visit. If the subject agrees to participate in this 10 minute study, they will be taken to a quiet room where they will watch a 1 minute video on a laptop. The video will feature an acting physician. The presenter will be the same for all experiment groups. The presenter will describe a hypothetical medical situation in which a narrowing of one of the carotid (neck) arteries is present. The presenter will then describe the risk of a stroke related to that condition if the subject chooses medical therapy versus medical and surgical therapy. The presentation of risk will vary and may be presented in one of 3 different ways including a qualitative description, an absolute risk reduction over a fixed time period, and a relative risk reduction. These three risk groups will be presented either verbally or visually through bar graphs. In the visual subject groups, the presenter will be holding up a graph and remain silent while the graph is shown. The amount of time allotted for the graph on the video will be equal to the amount of time it takes the presenter to say the information in the auditory subject groups. Given that there will be 2 sensory modalities (verbal of visual) and 3 different presentation formats, there will be a total of 6 different videos. After the video is complete, the subject will be asked to complete a 1 page survey which will ask about the patient's age, gender, educational level, reason for the medical visit, and final decision about choice of treatment. The subjects will also answer how well they understood the data by making a mark on a 10 cm horizontal line.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Background: A previous randomized study found that verbal presentation of benefit of surgery in asymptomatic carotid stenosis expressed as qualitative or relative risk resulted in a higher proportion (66% versus 33%) of subjects choosing surgery as compared to subjects presented absolute risk, yearly risk, or event-free survival. Other variables that increased the choice of surgery were male gender, younger age, and higher level of education. Nevertheless, presentation format was the strongest predictor of treatment choice.

Objective/Hypothesis: To determine whether presentation format affects visual representation of information. The investigators hypothesis is that visual representation of both positive and negative outcomes in a single bar graph will result in less subjects favoring surgery as compared to those only shown relative information in a bar graph. The investigators also hypothesize that subjects shown visual information will express a greater understanding of information presented to them as compared to those given verbal information.

Specific Aims: 1) To determine whether presentation format affects visual representation of information. 2) To determine whether subjects given visual representations of information express a greater understanding of the information as compared with subjects given verbal representations of information.

Study Design: 450 subjects will be approached in the neurology clinic as they are waiting for their office visit. Subjects without carotid stenosis will be approached randomly by the principal investigator or one of the co-investigators. They will be asked to participate in the study after completing their office visit with their physician. In the event that the patient is expecting longer than a 30 minute delay to see their physician, they will be asked to participate in the study prior to the office visit. If the subject agrees to participate in this 10 minute study, they will be taken to a quiet room where they will watch a 1 minute video on a laptop. The video will feature an acting physician. The presenter will be the same for all experiment groups. The presenter will describe a hypothetical medical situation in which a narrowing of one of the carotid arteries is present. The presenter will then describe the risk of a stroke related to that condition if the subject chooses medical therapy versus medical and surgical therapy. The presentation of risk will vary and may be presented in one of 3 different ways including a qualitative description, an absolute risk reduction over a fixed time period, and a relative risk reduction. These three risk groups will be presented either verbally or visually through bar graphs. In the visual subject groups, the presenter will be holding up a graph and remain silent while the graph is shown. The amount of time allotted for the graph on the video will be equal to the amount of time it takes the presenter to say the information in the auditory subject groups. Given that there will be 2 sensory modalities (verbal of visual) and 3 different presentation formats, there will be a total of 6 different videos. Randomization will be performed by selecting a video number from an opaque envelope. The subject will be allowed to watch the video up to 3 times, if requested. After the video is complete, the subject will be asked to complete a 1 page survey which will ask about the patient's age, gender, educational level, reason for the medical visit, and final decision about choice of treatment. The subjects will also answer how well they understood the data by making a mark on a 10 cm horizontal line. A mark further to the right signifies better understanding than a mark placed to the left. Data will be entered into a spreadsheet which will then be used to analyze aggregate data.

Study Type

Interventional

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
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or greater

Exclusion Criteria:

  • No history or carotid stenosis
  • No history of dementia

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

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Auditory qualitative
Other: Video
Video of physician
Other: Auditory absolute risk
Other: Video
Video of physician
Other: Auditory relative risk
Other: Video
Video of physician
Other: Visual qualitative
Other: Video
Video of physician
Other: Visual relative risk
Other: Video
Video of physician
Other: Visual absolute risk
Other: Video
Video of physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision to have surgery
Time Frame: 6 months
Subjects will complete a survey immediately after watching the video. The completed surveys will then be analyzed after enrollment is complete.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Principal Investigator: Brian Silver, MD, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2012

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 13, 2012

Study Record Updates

Last Update Posted (Estimate)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASPFACS-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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