StrokeMeDSNCT01202318
Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers
An observational study of Stroke, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911 call suggestive of stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2012
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The target study population consists of all 911 callers with symptoms suggestive of stroke in the participating county. Specifically, the accessible population for this study is the group of patients whose 911 calls are answered and interrogated by the emergency medical dispatchers at the County Communication Center, Santa Clara.
Who may be able to join
- All 911 calls transferred by local Public Service Answering Points (PSAPs) to the County Communication center of Santa Clara County where the emergency medical dispatchers complete the interrogation using MPDS protocols.
- All 911 calls received directly at the County Communication center of Santa Clara County where emergency medical dispatchers complete the interrogation using the MPDS protocols.
- All 911 calls received from subjects (patient) aged > 18 years or second party calls (by-stander or family who are in close proximity to the patient and can administer the tool) by subjects > 18 years of age.
Who cannot join
- All calls that require immediate response (ECHO level determinant for life threatening conditions) and emergency medical dispatchers cannot complete Card 28
- Calls answered by emergency medical dispatchers who have not completed training on the use of Cincinnati Stroke Scale.
- Calls originating from the cities of Palo Alto, Mountain View, Sunnyvale, Santa Clara, and San Jose that are not interrogated by the County Communication Center for Santa Clara County.
- 911 calls with no available outcomes in the final discharge database.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Prospective Cohort to Determine the Comparative Diagnostic Accuracy of Card 28 to Card 28 and Cincinnati Stroke Scale.
This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911 call suggestive of stroke.
The authors hypothesize that a combination of Card 28 plus the Cincinnati Stroke Scale (CSS) will improve the diagnostic accuracy of emergency medical dispatchers for stroke.
- Conditions
- Stroke
- Keywords
- Cerebrovascular Accident, Stroke,Acute
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The study design was changed to a prospective cohort study due to difficulties in using a randomized approach in an emergency setting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prasanthi Govindarajan, MBBS, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202318
- Sponsor's protocol ID
- H60373-35400-01
- Acronym
- MeDS
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2010
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Prospective Cohort to Determine the Comparative Diagnostic Accuracy of Card 28 to Card 28 and Cincinnati Stroke Scale.
- ClinicalTrials.gov ID
- NCT01202318
- Acronym / sponsor ID
- MeDS / H60373-35400-01
- Conditions
- Stroke
- Keywords
- Cerebrovascular Accident, Stroke,Acute
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study design was changed to a prospective cohort study due to difficulties in using a randomized approach in an emergency setting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Sep 2010 (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.
This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911 call suggestive of stroke.
The authors hypothesize that a combination of Card 28 plus the Cincinnati Stroke Scale (CSS) will improve the diagnostic accuracy of emergency medical dispatchers for stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target study population consists of all 911 callers with symptoms suggestive of stroke in the participating county. Specifically, the accessible population for this study is the group of patients whose 911 calls are answered and interrogated by the emergency medical dispatchers at the County Communication Center, Santa Clara.
Key inclusion criteria (3 listed)
- All 911 calls transferred by local Public Service Answering Points (PSAPs) to the County Communication center of Santa Clara County where the emergency medical dispatchers complete the interrogation using MPDS protocols.
- All 911 calls received directly at the County Communication center of Santa Clara County where emergency medical dispatchers complete the interrogation using the MPDS protocols.
- All 911 calls received from subjects (patient) aged > 18 years or second party calls (by-stander or family who are in close proximity to the patient and can administer the tool) by subjects > 18 years of age.
Key exclusion criteria (5 listed)
- All calls that require immediate response (ECHO level determinant for life threatening conditions) and emergency medical dispatchers cannot complete Card 28
- Calls answered by emergency medical dispatchers who have not completed training on the use of Cincinnati Stroke Scale.
- Calls originating from the cities of Palo Alto, Mountain View, Sunnyvale, Santa Clara, and San Jose that are not interrogated by the County Communication Center for Santa Clara County.
- 911 calls with no available outcomes in the final discharge database.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 15 Jun 2012.
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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.
Prasanthi Govindarajan, MBBS, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of California, San Francisco 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 3 inclusion and 5 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 15 Jun 2012. 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.
Where can I read the original study information?
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 15 Jun 2012.