Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis
A Randomized Trial of Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedApril 11, 2016
April 1, 2016
3 months
February 6, 2012
April 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decision to have surgery
Subjects will complete a survey immediately after watching the video. The completed surveys will then be analyzed after enrollment is complete.
6 months
Study Arms (6)
Auditory qualitative
OTHERAuditory absolute risk
OTHERAuditory relative risk
OTHERVisual qualitative
OTHERVisual relative risk
OTHERVisual absolute risk
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Age 18 or greater
You may not qualify if:
- No history or carotid stenosis
- No history of dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Related Publications (1)
Silver B, Zaman IF, Ashraf K, Majed Y, Norwood EM, Schuh LA, Smith BJ, Smith RE, Schultz LR. A randomized trial of decision-making in asymptomatic carotid stenosis. Neurology. 2012 Jan 31;78(5):315-21. doi: 10.1212/WNL.0b013e31824528df. Epub 2012 Jan 4.
PMID: 22218277BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Silver, MD
Rhode Island Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Stroke Center
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 13, 2012
Study Start
February 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 11, 2016
Record last verified: 2016-04