Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient Safety Clinical Trial
— STREAMOfficial title:
Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) - Multicentric Prospective Interventional Study for the Improvement of Acute Stroke Care
| Verified date | June 2019 |
| Source | Johann Wolfgang Goethe University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Acute stroke care is highly time critical for thrombolysis as well as thrombectomy. In both
scenarios, each minute lost reduces the therapeutic efficacy. Therefore, an optimal
implementation of these effective therapies into daily clinical practice is of utmost
importance for the translation of the evidence from clinical trials into good clinical
outcomes in routine care. In acute stroke therapy, the patient is cared for by an
interdisciplinary team and often has to undergo several handovers between different
caregivers with possible interface problems.
To facilitate a smooth workflow, the investigator developed an interdisciplinary stroke team
algorithm and implemented regular simulation-based team trainings at the investigators
institution. This multimodal intervention markedly improved the "door-to-needle" time for
thrombolysis (time from the patient's arrival in the emergency department to the start of the
tissue plasminogen activator (tPA) infusion) which is the most relevant benchmark parameter
for acute stroke care. The investigators monthly stroke team training had a positive effect
on the perceived degree of safety and staff satisfaction among the employees of the
investigators departments.
The investigator plans to investigate the benefits of the multimodal intervention of a stroke
team algorithm with regular stroke team simulation training in a controlled prospective
pretest-posttest trial design at seven leading stroke centers in Germany. The investigator
hypothesize that the implementation of a stroke team algorithm (defined team, defined tasks)
and regular stroke team training with a focus on efficient team work and communication will
improve process times, patient safety and staff satisfaction.
In the pretest period, the participating seven centers (tertiary care university hospitals
with thrombectomy capacity 24/7/365) record the data of all consecutive patients receiving
thrombolysis and/or thrombectomy during a three month period. Afterwards 3-4 leading
employees of different professional backgrounds (e.g. senior neurologist of the stroke unit,
neurointerventionalist, head nurse of emergency department) will be invited to a joint
"train-the-trainer" seminar at the sponsors institution where the participating centers
present their algorithm to the participants of all seven stroke centers for discussion to
invite suggestions for streamlining and improvement and a train-the-trainer course of stroke
simulation. After the seminar, the principal investigator and stroke team trainer will visit
all centers for one in situ stroke team simulation training and provide teaching materials.
Afterwards, each center will be invited to schedule two additional stroke team trainings a
with stroke team trainer that will be led by e.g. the senior neurologist from the respective
stroke unit with the aim of permanently starting up regular stroke team simulation. In the
posttest period, the participating seven centers again record the data of all consecutive
patients receiving thrombolysis and/or thrombectomy during a three month time period.
| Status | Completed |
| Enrollment | 379 |
| Est. completion date | March 31, 2019 |
| Est. primary completion date | March 11, 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - thrombolysis/thrombectomy in one of the seven participating stroke centers following EMS referral - written informed consent from the patient and/or his/her legal representative. Exclusion Criteria: - in-hospital stroke - referred for thrombectomy by another Hospital. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum Augsburg | Augsburg | |
| Germany | Charite - Universitätsmedizin Berlin, Campus Benjamin Franklin | Berlin | |
| Germany | Universitätsklinikum Hamburg-Eppendorf (UKE) | Hamburg | |
| Germany | Universitätsklinikum Heidelberg | Heidelberg | |
| Germany | Uniklinik Köln | Köln | |
| Germany | Klinikum der Universität München, Klinikum Großhadern | München | |
| Germany | Universitätsklinikum Tübingen | Tübingen | Baden-Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| Johann Wolfgang Goethe University Hospital | Stryker Neurovascular |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Safety: Hemorrhagic transformation of the infarct on follow-up CT | up to 48 hours | ||
| Other | Staff (stroke team) satisfaction | to recognize an improvement of the staff statisfaction, the members of the stroke Team are asked about their opinion and specific markers for staff satisfaction (investigators pre-designed questionnaire) | up to 6 month | |
| Primary | Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation | up to 1 hour | ||
| Secondary | Median thrombectomy process times of patients receiving thrombectomy in a before-after observation | up to 2 hours |