Condition category
Circulatory System
Date applied
03/11/2004
Date assigned
08/12/2004
Last edited
14/03/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Randomised 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 measures

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

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

Results - basic reporting

Publication summary

Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/16219099

Publication citations

  1. 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.

Additional files

Editorial Notes