Berlin PRehospital Or Usual Delivery of Acute Stroke Care
- Conditions
- Stroke
- Interventions
- Procedure: Regular careProcedure: STEMO
- Registration Number
- NCT02869386
- Lead Sponsor
- Charite University, Berlin, Germany
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regular care Regular care Regular prehospital care consists of an ambulance. In suspected life-threatening cases an emergency physician is sent to the emergency scene in parallel. STEMO deployment STEMO STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
- Primary Outcome Measures
Name Time Method Modified Rankin Scale 3 months Assessment of functional outcome over the entire range of the modified Rankin Scale
Co-primary 3-Month Outcome 3 months The co-primary 3-month outcome includes the following range of outcomes:
1. mRS 1-3 if available
2. mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke)
3. 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.
- Secondary Outcome Measures
Name Time Method Thrombolysis rate 3 months Thrombectomy rate 3 months Cost-effectiveness (D) 3 months costs of long-term care
Modified Rankin Scale in patients with intracranial hemorrhages 3 months Assessment of functional outcome among patients with intracranial hemorrhages
Diagnosis and treatment times (D) 3 months alarm-to-treatment time
Cost-effectiveness (E) 3 months 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
Quality of life Up to 5 years Assessment with European Quality of Life - 5 Dimensions (EQ-5D) in yearly intervals over 5 years to follow-up
Death rate over time 3 months Deaths over time will be determined and compared between groups using a Kaplan-Meier plot
Discharge status 3 months 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)
Rate of emergency medical service deliveries to specialized facilities 3 months 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.
Diagnosis and treatment times (A) 3 months Onset-to-treatment time
Diagnosis and treatment times (B) 3 months onset-to-reperfusion time (for thrombectomy)
Diagnosis and treatment times (E) 3 months imaging-to-treatment time
Cost-effectiveness (A) 3 months Additional costs due to implementation and running of STEMO
In-hospital mortality 7 days Frequency of patients dying within the duration of the hospital stay after admission for stroke.
Diagnosis and treatment times (C) 3 months alarm-to-imaging time
Cost-effectiveness (B) 3 months duration of hospital stay regarding acute treatment and rehabilitation
Cost-effectiveness (C) 3 months hospital related costs
Modified Rankin Scale shift analyses 3 months 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
Trial Locations
- Locations (1)
Charite
🇩🇪Berlin, Germany