Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis



Status:Withdrawn
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2012
End Date:May 2012

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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.

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.

Inclusion Criteria:

- Age 18 or greater

Exclusion Criteria:

- No history or carotid stenosis

- No history of dementia
We found this trial at
1
site
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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mi
from
Providence, RI
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