AMSU: Mobile Stroke Unit for Pre-hospital Emergency Care

Sponsor
Daniel Phillips (Other)
Overall Status
Recruiting
CT.gov ID
NCT05330715
Collaborator
Universität des Saarlandes (Other), East Suffolk and North Essex NHS Foundation Trust (Other)
836
1
2
36.1
23.2

Study Details

Study Description

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,

Condition or Disease Intervention/Treatment Phase
  • Other: Management
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
836 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Advanced Mobile Stroke Unit for Pre-hospital Emergency Management
Actual Study Start Date :
Mar 29, 2021
Anticipated Primary Completion Date :
Sep 29, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of patients requiring hospital attendance within 4h of acute emergency situation [acute emergency situation (4 hours)]

    Patient attendance at hospital related to the emergency call (within 4hours) will be assessed

Secondary Outcome Measures

  1. Emergency management metrics [acute emergency situation (within 4 hours after call)]

    Time metrics related to the emergency call treatment (within 4 hours after call)

  2. Clinical Outcome on day 90 [90 days]

    modified Rankin for patients with brain disease

  3. Clinical Outcome on day 90 [90 days]

    EQ-5D5L

Other Outcome Measures

  1. Safety endpoints [90 days]

    Mortality rate within 90 days

  2. Safety endpoints [24 hours]

    Number of patients with re-contact to EMS within 24h after emergency call

  3. Safety endpoints [90 days]

    Number of patients with (serious) adverse events within 90 days

  4. Health economic analysis [acute phase related to the emergency call (12 hours)]

    Incremental cost-effectiveness ratio (ICER), treatment costs and health states will be evaluated for each therapy option, for the acute phase (within 12 hours)

  5. Health economic analysis [1 year after the acute emergency call]

    Incremental cost-effectiveness ratio (ICER), treatment costs and health states will be evaluated for each therapy option after 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 East of England Ambulance Service NHS Trust Melbourn United Kingdom

Sponsors and Collaborators

  • Daniel Phillips
  • Universität des Saarlandes
  • East Suffolk and North Essex NHS Foundation Trust

Investigators

  • Principal Investigator: Silke Walter, Prof, Universität des Saarlandes, EEAST

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel Phillips, Clinical Lead, East of England Ambulance Service NHS Trust
ClinicalTrials.gov Identifier:
NCT05330715
Other Study ID Numbers:
  • 292195
First Posted:
Apr 15, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022