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

Primary Purpose

Stroke, Acute, Emergencies

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Management
Sponsored by
Daniel Phillips
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East of England Ambulance Service NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Advanced Mobile Stroke Unit

Conventional ambulance

Arm Description

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.

Prehospital emergency care with conventional ambulances.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2022
Last Updated
April 10, 2022
Sponsor
Daniel Phillips
Collaborators
Universität des Saarlandes, East Suffolk and North Essex NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05330715
Brief Title
Mobile Stroke Unit for Pre-hospital Emergency Care
Acronym
AMSU
Official Title
Advanced Mobile Stroke Unit for Pre-hospital Emergency Management
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Phillips
Collaborators
Universität des Saarlandes, East Suffolk and North Essex NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Emergencies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
836 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced Mobile Stroke Unit
Arm Type
Other
Arm Description
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.
Arm Title
Conventional ambulance
Arm Type
Other
Arm Description
Prehospital emergency care with conventional ambulances.
Intervention Type
Other
Intervention Name(s)
Management
Intervention Description
Comparison if different strategies to manage acute emergencies in the pre-hospital setting.
Primary Outcome Measure Information:
Title
Number of patients requiring hospital attendance within 4h of acute emergency situation
Description
Patient attendance at hospital related to the emergency call (within 4hours) will be assessed
Time Frame
acute emergency situation (4 hours)
Secondary Outcome Measure Information:
Title
Emergency management metrics
Description
Time metrics related to the emergency call treatment (within 4 hours after call)
Time Frame
acute emergency situation (within 4 hours after call)
Title
Clinical Outcome on day 90
Description
modified Rankin for patients with brain disease
Time Frame
90 days
Title
Clinical Outcome on day 90
Description
EQ-5D5L
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Safety endpoints
Description
Mortality rate within 90 days
Time Frame
90 days
Title
Safety endpoints
Description
Number of patients with re-contact to EMS within 24h after emergency call
Time Frame
24 hours
Title
Safety endpoints
Description
Number of patients with (serious) adverse events within 90 days
Time Frame
90 days
Title
Health economic analysis
Description
Incremental cost-effectiveness ratio (ICER), treatment costs and health states will be evaluated for each therapy option, for the acute phase (within 12 hours)
Time Frame
acute phase related to the emergency call (12 hours)
Title
Health economic analysis
Description
Incremental cost-effectiveness ratio (ICER), treatment costs and health states will be evaluated for each therapy option after 1 year
Time Frame
1 year after the acute emergency call

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Phillips
Phone
+447971059148
Email
daniel.phillips@eastamb.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus Fassbender, Prof
Phone
+4968411624103
Email
klaus.fassbender@uks.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silke Walter, Prof
Organizational Affiliation
Universität des Saarlandes, EEAST
Official's Role
Principal Investigator
Facility Information:
Facility Name
East of England Ambulance Service NHS Trust
City
Melbourn
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Phillips
Email
daniel.phillips@eastamb.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

Mobile Stroke Unit for Pre-hospital Emergency Care

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