Mobile Stroke Unit for Pre-hospital Emergency Care (AMSU)

Advanced Mobile Stroke Unit for Pre-hospital Emergency Management

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,

Study Overview

• Status: Recruiting
• Conditions: Emergencies; Stroke, Acute
• Intervention / Treatment: Other: Management

• Study Type: Interventional
• Enrollment (Anticipated): 836
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Phillips; Phone Number: +447971059148; Email: daniel.phillips@eastamb.nhs.uk
• Study Contact Backup: Name: Klaus Fassbender, Prof; Phone Number: +4968411624103; Email: klaus.fassbender@uks.eu

Study Locations

• United Kingdom
  • Melbourn, United Kingdom
    • Recruiting
    • East of England Ambulance Service NHS Trust
    • Contact: Daniel Phillips; Email: daniel.phillips@eastamb.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Advanced Mobile Stroke Unit; Prehospital treatment of patients with an advanced Mobile Stroke Unit. The advanced Mobile Stroke Unit is an ambulance equipped with a computed tomography scanner, and additional diagnostic devices, such as point-of-care-laboratory and telemedicine to enable the team to diagnose and initiated specialised treatment of emergency patients at the emergency site.	Other: Management; Comparison if different strategies to manage acute emergencies in the pre-hospital setting.
Other: Conventional ambulance; Prehospital emergency care with conventional ambulances.	Other: Management; Comparison if different strategies to manage acute emergencies in the pre-hospital setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency management metrics	Time metrics related to the emergency call treatment (within 4 hours after call)	acute emergency situation (within 4 hours after call)
Clinical Outcome on day 90	modified Rankin for patients with brain disease	90 days
Clinical Outcome on day 90	EQ-5D5L	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints	Mortality rate within 90 days	90 days
Safety endpoints	Number of patients with re-contact to EMS within 24h after emergency call	24 hours
Safety endpoints	Number of patients with (serious) adverse events within 90 days	90 days
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)
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

Collaborators and Investigators

• Sponsor: Daniel Phillips
• Collaborators: Universität des Saarlandes; East Suffolk and North Essex NHS Foundation Trust
• Investigators: Principal Investigator: Silke Walter, Prof, Universität des Saarlandes, EEAST

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): September 29, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Stroke; Emergencies
• Other Study ID Numbers: 292195

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No