Mobile Stroke Unit for Pre-hospital Emergency Care

Study Overview
=================
Brief 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,

Official Title
-----------------
Advanced Mobile Stroke Unit for Pre-hospital Emergency Management

Conditions
-----------------
Stroke, Acute, Emergencies

Intervention / Treatment
-----------------
* Other: Management


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Advanced Mobile Stroke Unit<br>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<br>* Comparison if different strategies to manage acute emergencies in the pre-hospital setting.<br>|
| Other: Conventional ambulance<br>Prehospital emergency care with conventional ambulances. | Other: Management<br>* Comparison if different strategies to manage acute emergencies in the pre-hospital setting.<br>|

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 |