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Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Brian Silver, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01531868
First received: February 6, 2012
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Carotid Stenosis
Other: Video

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized Trial of Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Decision to have surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Subjects will complete a survey immediately after watching the video. The completed surveys will then be analyzed after enrollment is complete.


Estimated Enrollment: 450
Study Start Date: February 2012
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Auditory qualitative Other: Video
Video of physician
Other Name: Video
Auditory absolute risk Other: Video
Video of physician
Other Name: Video
Auditory relative risk Other: Video
Video of physician
Other Name: Video
Visual qualitative Other: Video
Video of physician
Other Name: Video
Visual relative risk Other: Video
Video of physician
Other Name: Video
Visual absolute risk Other: Video
Video of physician
Other Name: Video

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or greater

Exclusion Criteria:

  • No history or carotid stenosis
  • No history of dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531868

Contacts
Contact: Brian Silver, MD 401-444-8806

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Brian Silver, MD Rhode Island Hospital
  More Information

Publications:
Responsible Party: Brian Silver, Director, Stroke Center, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01531868     History of Changes
Other Study ID Numbers: ASPFACS-1
Study First Received: February 6, 2012
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Decision making
Carotid stenosis

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathological Conditions, Anatomical
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014