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

ISRCTN	ISRCTN41456865
DOI	https://doi.org/10.1186/ISRCTN41456865

Submission date: 03/11/2004
Registration date: 08/12/2004
Last edited: 01/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	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 study start date	01/02/2005
Completion date	31/08/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	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.
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

Locations

Countries of recruitment

Italy

Study participating centre

Agency for Public health, Lazio Region

Rome
00198
Italy

Sponsor information

Agency for Public Health, Lazio Region (Agenzia di Sanità Pubblica della Regione Lazio)(Italy)
Government

Via di Santa Costanza, 53
Rome
00198
Italy

Phone	+39 (0)6 83060 493
Email	deluca@asplazio.it

Funders

Funder type

Not defined

Agency for Public Health, Lazio Region

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

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

Editorial Notes

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