Contact information
Type
Scientific
Primary contact
Dr Assunta De Luca
ORCID ID
Contact details
Agency for Public health
Lazio Region
Via di Santa Costanza
53
Rome
00198
Italy
+39 (0)6 83060446
deluca@asplazio.it
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Implementation of pre-hospital emergency pathway for stroke - a cluster randomised trial
Acronym
IMPLICA
Study hypothesis
Adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients
Ethics approval
Not provided at time of registration
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Suspected stroke in pre-hospital and emergency
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/02/2005
Overall trial end date
31/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants included are all the professionals working in the Emergency Medical Services dealing with patients with suspected stroke
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
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.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2005
Recruitment end date
31/08/2005
Locations
Countries of recruitment
Italy
Trial participating centre
Agency for Public health, Lazio Region
Rome
00198
Italy
Sponsor information
Organisation
Agency for Public Health, Lazio Region (Agenzia di Sanità Pubblica della Regione Lazio)(Italy)
Sponsor details
Via di Santa Costanza
53
Rome
00198
Italy
+39 (0)6 83060 493
deluca@asplazio.it
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
Agency for Public Health, Lazio Region
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/16219099
Publication citations
-
Study protocol
Ferri M, De Luca A, Giorgi Rossi P, Lori G, Guasticchi G, Does a pre-hospital emergency pathway improve early diagnosis and referral in suspected stroke patients?--Study protocol of a cluster randomised trial [ISRCTN41456865]., BMC Health Serv Res, 2005, 5, 66, doi: 10.1186/1472-6963-5-66.