Mobile Stroke Unit for Pre-hospital Emergency Care

Stroke, Acute Clinical Trial

— AMSU  

Official title:

Advanced Mobile Stroke Unit for Pre-hospital Emergency Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330715
• Other study ID #: 292195
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2022
• Source: East of England Ambulance Service NHS Trust
• Contact: Daniel Phillips
• Phone: +447971059148
• Email: daniel.phillips[@]eastamb.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Emergency department overcrowding is a major challenge in medicine, leading to a delay in diagnosis and treatment for the patient due to long waiting times. This is very relevant for diseases like acute stroke and other emergencies. The Advanced Mobile Stroke Unit is an ambulance equipped with additional devices to diagnose and treat patients at the emergency site. Patients with less severe conditions can be diagnosed and safely left at home. The objectives of this project are to investigate whether the Advanced Mobile Stroke Unit compared to a normal ambulance enables more accurate triage of patients (treatment at home vs hospital vs specialist vs A&E). The Advanced Mobile Stroke Unit ambulance will be used in a random order of weeks and this will be compared to weeks with normal ambulances. The study will be carried out by the East of England Ambulance Service NHS Trust in collaboration with the East Suffolk and North Essex NHS Foundation Trust in the East of England. The project is a collaboration with Saarland University, Germany,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 836
• Est. completion date: March 31, 2024
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute emergency patients 18 years or older, who are identified via the national emergency telephone number 999 or 111with suspected severe medical emergency condition, which is categorised as: breathing problem, seizure, falls with head trauma, headache, sick person with suspected infection, stroke, unconsciousness

• calls Monday to Friday 9am to 5 pm

• written informed consent

Exclusion Criteria:

• terminally ill patients

• pregnant patients

• patients in cardiac arrest

• patients in custody of Her Majesty's prison service

Related Conditions & MeSH terms

• Emergencies
• Stroke
• Stroke, Acute

Intervention

Other:
• Management
Comparison if different strategies to manage acute emergencies in the pre-hospital setting.

Locations

Country	Name	City	State
United Kingdom	East of England Ambulance Service NHS Trust	Melbourn

Sponsors (3)

Lead Sponsor	Collaborator
Daniel Phillips	East Suffolk and North Essex NHS Foundation Trust, Universität des Saarlandes

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoints	Mortality rate within 90 days	90 days
Other	Safety endpoints	Number of patients with re-contact to EMS within 24h after emergency call	24 hours
Other	Safety endpoints	Number of patients with (serious) adverse events within 90 days	90 days
Other	Health economic analysis	Incremental cost-effectiveness ratio (ICER), treatment costs and health states will be evaluated for each therapy option, for the acute phase (within 12 hours)	acute phase related to the emergency call (12 hours)
Other	Health economic analysis	Incremental cost-effectiveness ratio (ICER), treatment costs and health states will be evaluated for each therapy option after 1 year	1 year after the acute emergency call
Primary	Number of patients requiring hospital attendance within 4h of acute emergency situation	Patient attendance at hospital related to the emergency call (within 4hours) will be assessed	acute emergency situation (4 hours)
Secondary	Emergency management metrics	Time metrics related to the emergency call treatment (within 4 hours after call)	acute emergency situation (within 4 hours after call)
Secondary	Clinical Outcome on day 90	modified Rankin for patients with brain disease	90 days
Secondary	Clinical Outcome on day 90	EQ-5D5L	90 days