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ISRCTN
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ISRCTN41456865
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ClinicalTrials.gov identifier
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Public title
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Implementation of pre-hospital emergency pathway for stroke - a cluster randomised trial
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Scientific title
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Acronym
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IMPLICA
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Serial number at source
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N/A
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Study hypothesis
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Adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Suspected stroke in pre-hospital and emergency
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Participants - inclusion criteria
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Participants included are all the professionals working in the Emergency Medical Services dealing with patients with suspected stroke
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/02/2005
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Anticipated end date
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31/08/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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About 152 physicians, 280 nurses, 50 drivers will be trained on the contents of the clinical pathway. We estimated that around 750 patients will be met by the services in the 6 months of observation.
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Interventions
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The professionals working in the Emergency Medical Services will be randomised to receive training on the evidence-based critical pathway for stroke or to current practice
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Primary outcome measure(s)
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Added as of 14/03/2008:
Proportion of patients with a positive CT for ischaemic stroke and symptoms onset <= 6 hour admitted to the stroke unit
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Secondary outcome measure(s)
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Added as of 14/03/2008:
1. Proportion of patients with a positive CT for hemorrhagic stroke and symptoms onset <= 6 hour admitted to a neurosurgical ward
2. Proportion of patients with a positive CT for hemorrhagic or ischaemic stroke or symptoms onset >6 hour admitted to the nearest hospital
3. Proportion of ICD9CM code for stroke in emergency setting confirmed in the hospital discharge data
4. Proportion of patients with stroke confirmed by CT results
5. Proportion of patients with ischaemic stroke receiving treatment within 6 hour of symptoms onset
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Sources of funding
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Agency for Public Health, Lazio Region
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Trial website
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Publications
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Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/16219099
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Contact name
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Dr
Assunta
De Luca
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Address
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Agency for Public health, Lazio Region
Via di Santa Costanza, 53
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City/town
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Rome
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Zip/Postcode
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00198
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Country
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Italy
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Tel
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+39 (0)6 83060446
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Fax
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+39 (0)6 83060463
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Email
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deluca@asplazio.it
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Sponsor
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Agency for Public Health, Lazio Region (Agenzia di Sanità Pubblica della Regione Lazio)(Italy)
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Address
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Via di Santa Costanza, 53
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City/town
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Rome
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Zip/Postcode
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00198
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Country
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Italy
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Tel
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+39 (0)6 83060 493
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Fax
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+ 39 (0)6 83060 463
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Email
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deluca@asplazio.it
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Date applied
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03/11/2004
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Last edited
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14/03/2008
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Date ISRCTN assigned
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08/12/2004
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