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.
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).
- STEMO Procedure
Intervention Desc: 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. ARM 1: Kind: Experimental Label: STEMO deployment Description: STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
- Regular care Procedure
Intervention Desc: 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. ARM 1: Kind: Experimental Label: Regular care Description: Regular prehospital care consists of an ambulance. In suspected life-threatening cases an emergency physician is sent to the emergency scene in parallel.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin Scale||3 months||No|
|Secondary||Thrombolysis rate||3 months||No|
|Secondary||Thrombectomy rate||3 months||No|
|Secondary||Diagnosis and treatment times (A)||3 months||No|
|Secondary||Diagnosis and treatment times (B)||3 months||No|
|Secondary||Diagnosis and treatment times (C)||3 months||No|
|Secondary||Diagnosis and treatment times (D)||3 months||No|
|Secondary||Diagnosis and treatment times (E)||3 months||No|
|Secondary||Cost-effectiveness (A)||3 months||No|
|Secondary||Cost-effectiveness (B)||3 months||No|
|Secondary||Cost-effectiveness (C)||3 months||No|
|Secondary||Cost-effectiveness (D)||3 months||No|
|Secondary||Cost-effectiveness (E)||3 months||No|
|Secondary||Quality of life||Up to 5 years||No|
|Secondary||Modified Rankin Scale shift analyses||3 months||No|
|Secondary||In-hospital mortality||7 days||Yes|
|Secondary||Death rate over time||3 months||Yes|
|Secondary||Discharge status||3 months||No|
|Secondary||Modified Rankin Scale in patients with intracranial hemorrhages||3 months||No|
|Secondary||Rate of emergency medical service deliveries to specialized facilities||3 months||No|
|Primary||Co-primary 3-Month Outcome||3 months|