Stroke
Conditions
Keywords
stroke, prehospital, telemedicine, thrombolysis, endovascular treatment, functional outcome
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 a 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, disabling 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 50% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group. Because of several organisational issues during the transition of the STEMO service into provisional regular care, the B\_PROUD 1.0 evaluation has been defined as implementation study and will be complemented by the B\_PROUD 2.0 study. B\_PROUD 2.0. recruits patients with index event after May 1st, 2019. B\_PROUD uses data from the Berlin - SPecific Acute Treatment in ischemic and hemorrhagIc Stroke with longterm outcome (B-SPATIAL) registry. The B-SPATIAL registry started recruitment in January 2016.
Interventions
PROCEDURESTEMO
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 of telemedicine for image transfer as well as results of point-of-care laboratory, prenotification (e.g. for endovascular treatment), triage and transport.
PROCEDURERegular care
A regular ambulance, the comparator, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.
Sponsors
Center for Stroke Research Berlin
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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: 2. Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (Transient Ischemic Attack, ICD 10: G45 except G45.4) 3. Confirmed onset-to-alarm time ≤ 4 hours at dispatch 4. 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
1. Remission of disabling symptoms until arrival of emergency medical service 2. Malignant or other severe primary disease with life expectancy \< 1 year Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | 3 months | Assessment of functional outcome over the entire range of the modified Rankin Scale. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
| 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 or living at home (information according registration office at 4 month after stroke) 2. mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke) 3. death. The co-primary outcome will only be used if the mRS follow-up rate remains below 91%. This will help to include valuable information for patients without concrete mRS follow-up information. All outcomes will be calculated with ordinal logistic regression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombectomy rate | 3 months | — |
| Diagnosis and treatment times (D) | 3 months | alarm-to-treatment time |
| 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 (C) | 3 months | alarm-to-imaging time |
| 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 |
| Cost-effectiveness (B) | 3 months | duration of hospital stay regarding acute treatment and rehabilitation |
| Cost-effectiveness (C) | 3 months | hospital related costs |
| Death rate over time | 3 months | Deaths over time will be determined and compared between groups using a Kaplan-Meier plot |
| 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 based on projections |
| Quality of life | 3 months | Assessment with European Quality of Life - 5 Dimensions (EQ-5D) |
| 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 or living at home with help or living in an Institution. For a detailed description of the modified Rankin Scale (mRS) see 1. |
| In-hospital mortality | 7 days | Frequency of patients dying within the duration of the hospital stay after admission for stroke. |
| 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) |
| Modified Rankin Scale in patients with intracranial hemorrhages | 3 months | Assessment of functional outcome among patients with intracranial hemorrhages. For a detailed description of the modified Rankin Scale (mRS) see 1. |
| Rate of secondary 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. |
| Symptomatic hemorrhage (A) | 3 months | According to clinical categorisation as documented in discharge letters within 36 hours of treatment in patients receiving thrombolysis or thrombectomy |
| Cost-effectiveness (D) | 3 months | costs of long-term care based on projections |
| Thrombolysis rate | 3 months | — |
Countries
Germany
Outcome results
None listed