Carotid StenosisNCT01531868
Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis
A study testing Video in people with Carotid Stenosis, run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or greater
Who cannot join
- No history or carotid stenosis
- No history of dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: 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.
Read the 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.
- Conditions
- Carotid Stenosis
- Being tested
- Video
- Keywords
- Decision making, Carotid stenosis
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
Video of physician
VideoOther
Video of physician
VideoOther
Video of physician
VideoOther
Video of physician
VideoOther
Video of physician
VideoOther
Video of physician
| Study group | Role | What they receive |
|---|---|---|
| Auditory qualitative | Other | Not described Receives: Other: Video |
| Auditory absolute risk | Other | Not described Receives: Other: Video |
| Auditory relative risk | Other | Not described Receives: Other: Video |
| Visual qualitative | Other | Not described Receives: Other: Video |
| Visual relative risk | Other | Not described Receives: Other: Video |
| Visual absolute risk | Other | Not described Receives: Other: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Silver, Rhode Island Hospital
- Investigators
- Brian Silver, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531868
- Sponsor's protocol ID
- ASPFACS-1
- Status last verified
- Apr 2016
- First submitted
- 6 Feb 2012
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22218277
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Alternative Sensory Presentation Formats in Asymptomatic Carotid Stenosis
- ClinicalTrials.gov ID
- NCT01531868
- Acronym / sponsor ID
- ASPFACS-1
- Conditions
- Carotid Stenosis
- Keywords
- Decision making, Carotid stenosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Auditory qualitative | Other | Other: Video |
| Auditory absolute risk | Other | Other: Video |
| Auditory relative risk | Other | Other: Video |
| Visual qualitative | Other | Other: Video |
| Visual relative risk | Other | Other: Video |
| Visual absolute risk | Other | Other: Video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 or greater
Key exclusion criteria (2 listed)
- No history or carotid stenosis
- No history of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoVideo of physician | Other | Auditory qualitative |
| VideoVideo of physician | Other | Auditory absolute risk |
| VideoVideo of physician | Other | Auditory relative risk |
| VideoVideo of physician | Other | Visual qualitative |
| VideoVideo of physician | Other | Visual relative risk |
| VideoVideo of physician | Other | Visual absolute risk |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Background: PubMed 22218277Silver 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Silver, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video in people with Carotid Stenosis, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision to have surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01531868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.