Clinical trial NCT03228251: Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) Trial
Official title: Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) - Multicentric Prospective Interventional Study for the Improvement of Acute Stroke Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient Safety
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Stryker Neurovascular
First posted: 2017-07-24
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Thrombolysis/thrombectomy in one of the seven participating stroke centers following Emergency Medical Service (EMS) referral. All consecutive patients treated during the two observation periods will be recorded after obtaining written informed consent from the patient and/or his/her legal representative. The investigator will not record patients who suffered an in-hospital stroke or who were referred for thrombectomy by another Hospital.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation
timeFrame: up to 1 hour
Secondary outcomes:
measure: Median thrombectomy process times of patients receiving thrombectomy in a before-after observation
timeFrame: up to 2 hours
Other outcomes:
measure: Safety: Hemorrhagic transformation of the infarct on follow-up CT
timeFrame: up to 48 hours
measure: Staff (stroke team) satisfaction
timeFrame: up to 6 month
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charite - Universitätsmedizin Berlin, Campus Benjamin Franklin
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE)
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Köln
country: Germany
facility: Uniklinik Köln
city: München
country: Germany
facility: Klinikum der Universität München, Klinikum Großhadern
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Waltraud Pfeilschifter, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bohmann FO, Gruber K, Kurka N, Willems LM, Herrmann E, du Mesnil de Rochemont R, Scholz P, Rai H, Zickler P, Ertl M, Berlis A, Poli S, Mengel A, Ringleb P, Nagel S, Pfaff J, Wollenweber FA, Kellert L, Herzberg M, Koehler L, Haeusler KG, Alegiani A, Schubert C, Brekenfeld C, Doppler CEJ, Onur OA, Kabbasch C, Manser T, Steinmetz H, Pfeilschifter W; STREAM Trial investigators. Simulation-based training improves process times in acute stroke care (STREAM). Eur J Neurol. 2022 Jan;29(1):138-148. doi: 10.1111/ene.15093. Epub 2021 Oct 21.
citation: Bohmann FO, Kurka N, du Mesnil de Rochemont R, Gruber K, Guenther J, Rostek P, Rai H, Zickler P, Ertl M, Berlis A, Poli S, Mengel A, Ringleb P, Nagel S, Pfaff J, Wollenweber FA, Kellert L, Herzberg M, Koehler L, Haeusler KG, Alegiani A, Schubert C, Brekenfeld C, Doppler CEJ, Onur OA, Kabbasch C, Manser T, Pfeilschifter W; STREAM Trial Investigators. Simulation-Based Training of the Rapid Evaluation and Management of Acute Stroke (STREAM)-A Prospective Single-Arm Multicenter Trial. Front Neurol. 2019 Sep 11;10:969. doi: 10.3389/fneur.2019.00969. eCollection 2019.