Berlin PRehospital Or Usual Delivery of Acute Stroke Care

Study Overview
=================
Brief Summary
-----------------
Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest cost-effectiveness. However, scientific proof of improved functional outcome compared to usual care is still lacking. The objective of this trial is to show improved functional outcomes after deployment of the Stroke Emergency Mobile (STEMO) compared to regular care.

Detailed Description
-----------------
This is a pragmatic, prospective, multi-center trial with blinded outcome assessment of treatment candidates three months after stroke. Treatment candidates will be defined as patients with final discharge diagnosis of cerebral ischemia, and onset-to-alarm time ≤4 hours, symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. These patients will be included if their emergency call from a predefined catchment area in Berlin, Germany, caused a stroke alarm at the dispatch center during STEMO hours (7am-11pm, Monday-Sunday). About 45% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group. B_PROUD uses data from the B-SPATIAL registry. The B-SPATIAL registry has started recruitment in January 2016. However, B_PROUD recruits patients with symptom onset October 1st, 2016 or later (because data access at the dispatch center had to be established first).

Official Title
-----------------
Berlin PRehospital Or Usual Delivery of Acute Stroke Care - Functional Outcomes After Advanced Prehospital Stroke Care

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: STEMO
* Procedure: Regular care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Suspected acute stroke according to the dispatcher stroke identification algorithm during STEMO hours (7am-11pm, Monday-Sunday) and within the STEMO catchment area Inclusion criteria for primary study population: Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (ICD 10: G45 except G45.4) Confirmed onset-to-alarm time ≤ 4 hours at dispatch Pre-stroke modified Rankin scale ≤ 3 (being able to ambulate, in routine clinical care, patients with mRS up to 3 are usually deemed suitable for tissue plasminogen activator treatment) Exclusion criteria: Symptom remission until arrival of emergency medical service Malignant or other severe primary disease with life expectancy < 1 year Exclusion criteria for primary study population: Major surgery within 4 weeks before study inclusion Confirmed stroke within 3 months before study inclusion Absolute contraindications for thrombolysis AND thrombectomy

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEMO deployment<br>STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support. | Procedure: STEMO<br>* STEMO, the intervention, includes prehospital neurological emergency assessment with the option to perform CT and CT-angiography, start specialized treatment at the door-step of the patient's house, including thrombolysis with tissue Plasminogen Activator and blood pressure Management (choice of drug at discretion of treating physician), use telemedicine for further expertise as well as results of point-of-care laboratory, prenotification (e.g. for endovascular treatment), triage and transport.<br>|
| Active Comparator: Regular care<br>Regular prehospital care consists of an ambulance. In suspected life-threatening cases an emergency physician is sent to the emergency scene in parallel. | Procedure: Regular care<br>* A regular ambulance, the comparator intervention, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale | Assessment of functional outcome over the entire range of the modified Rankin Scale | 3 months | 
| Co-primary 3-Month Outcome | The co-primary 3-month outcome includes the following range of outcomes: mRS 1-3 if available mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke) death. We will run a sensitivity analysis with the co-primary outcome and calculating all patients with missing mRS but still living under private address as mRS 1-3. The latter will help us to include information of patients still living at home but without mRS follow-up. All outcomes will be calculated with ordinal logistic regression. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombolysis rate |  | 3 months | 
| Thrombectomy rate |  | 3 months | 
| Diagnosis and treatment times (A) | Onset-to-treatment time | 3 months | 
| Diagnosis and treatment times (B) | onset-to-reperfusion time (for thrombectomy) | 3 months | 
| Diagnosis and treatment times (C) | alarm-to-imaging time | 3 months | 
| Diagnosis and treatment times (D) | alarm-to-treatment time | 3 months | 
| Diagnosis and treatment times (E) | imaging-to-treatment time | 3 months | 
| Cost-effectiveness (A) | Additional costs due to implementation and running of STEMO | 3 months | 
| Cost-effectiveness (B) | duration of hospital stay regarding acute treatment and rehabilitation | 3 months | 
| Cost-effectiveness (C) | hospital related costs | 3 months | 
| Cost-effectiveness (D) | costs of long-term care | 3 months | 
| Cost-effectiveness (E) | Additional costs due to implementation and running of STEMO, duration of hospital stay regarding acute treatment and rehabilitation, hospital related costs, costs of long-term care | 3 months | 
| Quality of life | Assessment with European Quality of Life - 5 Dimensions (EQ-5D) in yearly intervals over 5 years to follow-up | Up to 5 years | 
| Modified Rankin Scale shift analyses | Shift analyses for mRS ≤ 1 at 3 months in patients ≤ 80 years of age living at home without disability and mRS ≤ 2 at 3 months in patients > 80 years of age living at home with help or living in an institution | 3 months | 
| In-hospital mortality | Frequency of patients dying within the duration of the hospital stay after admission for stroke. | 7 days | 
| Death rate over time | Deaths over time will be determined and compared between groups using a Kaplan-Meier plot | 3 months | 
| Discharge status | Including in-hospital mortality among patients not included in the primary study population (patients with intracranial hemorrhages as well as patients receiving thrombolysis in stroke mimics) | 3 months | 
| Modified Rankin Scale in patients with intracranial hemorrhages | Assessment of functional outcome among patients with intracranial hemorrhages | 3 months | 
| Rate of emergency medical service deliveries to specialized facilities | Assessment for patients with acute ischemic stroke to hospitals with Stroke Unit, for patients with cerebral artery occlusion (internal carotid artery, M1 or proximal M2 segment of middle cerebral artery) to hospitals with thrombectomy facility, and for patients with intracerebral hemorrhage to hospitals with neurosurgery department. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, prehospital, telemedicine, thrombolysis, thrombectomy, endovascular treatment, functional outcome