Implementation of pre-hospital emergency pathway for stroke - a cluster randomised trial

ISRCTN	ISRCTN41456865
DOI	https://doi.org/10.1186/ISRCTN41456865
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Agency for Public Health, Lazio Region (Agenzia di Sanità Pubblica della Regione Lazio)(Italy)
Funder	Agency for Public Health, Lazio Region

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Assunta De Luca
Scientific

Agency for Public health, Lazio Region
Via di Santa Costanza, 53
Rome
00198
Italy

Phone	+39 (0)6 83060446
Email	deluca@asplazio.it

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Implementation of pre-hospital emergency pathway for stroke - a cluster randomised trial
Study acronym	IMPLICA
Study objectives	Adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/08/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	750
Key inclusion criteria	Participants included are all the professionals working in the Emergency Medical Services dealing with patients with suspected stroke
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/2005
Date of final enrolment	31/08/2005

Agency for Public health, Lazio Region

Rome
00198
Italy

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/01/2009	01/11/2022	Yes	No
Protocol article	Study protocol	11/10/2005		Yes	No

01/11/2022: Publication reference added.
06/11/2019: Internal review.