Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis

• ClinicalTrials.gov Identifier: NCT01531868
• Recruitment Status: Withdrawn
• First Posted: February 13, 2012
• Last Update Posted: April 11, 2016
• Sponsor: Rhode Island Hospital
• Information provided by (Responsible Party): Brian Silver, Rhode Island Hospital

Tracking Information

• First Submitted Date: February 6, 2012
• First Posted Date: February 13, 2012
• Last Update Posted Date: April 11, 2016
• Study Start Date: February 2012
• Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 8, 2012)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis
• Official Title: A Randomized Trial of Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator)
• Condition: Carotid Stenosis

Intervention

Other: Video

Video of physician

Study Arms

• Auditory qualitative
  Intervention: Other: Video
• Auditory absolute risk
  Intervention: Other: Video
• Auditory relative risk
  Intervention: Other: Video
• Visual qualitative
  Intervention: Other: Video
• Visual relative risk
  Intervention: Other: Video
• Visual absolute risk
  Intervention: Other: Video

• Publications *: 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.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 7, 2016): 0
• Original Estimated Enrollment (submitted: February 8, 2012): 450
• Estimated Study Completion Date: May 2012
• Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age 18 or greater

Exclusion Criteria:

• No history or carotid stenosis
• No history of dementia

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01531868
• Other Study ID Numbers: ASPFACS-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Brian Silver, Rhode Island Hospital
• Study Sponsor: Rhode Island Hospital
• Collaborators: Not Provided

Investigators

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

• PRS Account: Rhode Island Hospital
• Verification Date: April 2016