- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03228251
Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) Trial (STREAM)
Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) - Multicentric Prospective Interventional Study for the Improvement of Acute Stroke Care
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Augsburg, Germany, 86156
- Klinikum Augsburg
-
Berlin, Germany, 12203
- Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
-
Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf (UKE)
-
Heidelberg, Germany, 69120
- Universitatsklinikum Heidelberg
-
Köln, Germany, 50937
- Uniklinik Köln
-
München, Germany, 81377
- Klinikum der Universität München, Klinikum Großhadern
-
-
Baden-Württemberg
-
Tübingen, Baden-Württemberg, Germany, 72076
- Universitätsklinikum Tübingen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observation Group 1
all stroke patients receiving thrombolysis and/or thrombectomy in a time period of three months before stroke team simulation training
|
|
Observation Group 2
all stroke patients receiving thrombolysis and/or thrombectomy in a time period of three months after stroke team simulation training
|
The participating centers identify 3-4 senior staff of different professional backgrounds (e.g. senior neurologist, neurointerventionalist, head nurse) who will design a stroke team algorithm tailored to the local circumstances of the stroke center.
The centers will be invited to a joint "train-the-trainer" seminar at the sponsor's institution where they present their algorithm to the participants of all seven stroke centers for discussion to invite suggestions for streamlining and improvement.
The teams will be introduced to the concept of simulation-based stroke team training.
After the seminar, the principal investigator and the stroke team trainer will visit all centers for one on-site stroke team training and provide teaching materials.
Afterwards, each center will be invited to schedule two additional stroke team trainings with the stroke team trainer that will be led by e.g. the senior neurologist from the stroke unit with use of a simulation manikin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation
Time Frame: up to 1 hour
|
up to 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Median thrombectomy process times of patients receiving thrombectomy in a before-after observation
Time Frame: up to 2 hours
|
up to 2 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: Hemorrhagic transformation of the infarct on follow-up CT
Time Frame: up to 48 hours
|
up to 48 hours
|
|
Staff (stroke team) satisfaction
Time Frame: up to 6 month
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Waltraud Pfeilschifter, Prof. Dr., Johann Wolfgang Goethe University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STREAM Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient Safety
-
LiquidGoldConceptUniversity of MichiganCompletedBreastfeeding | Patient Simulation | High Fidelity Simulation TrainingUnited States
-
Groupe Hospitalier de Bretagne SudCompletedPatient Simulation | High Fidelity Simulation Training | Instructional Virtual Realities | Weightlessness Simulation | Space SimulationFrance
-
Yuksek Ihtisas UniversitySaglik Bilimleri UniversitesiCompletedAnxiety | Self Efficacy | Patient Simulation | Pediatric Nursing | High Fidelity Simulation TrainingTurkey
-
Hospices Civils de LyonUnknownTime | Benefit of in Situ Simulation for This Kind of Training | Installation of the Patient Until the PercutaneousFrance
-
University of PittsburghCompletedStroke | Adherence, Patient | Strategy TrainingUnited States
-
Centre Hospitalier Universitaire DijonCompletedPatient With Symptomatic Cerebral Infarction | Patient Who Has Had a Mechanical ThrombectomyFrance
Clinical Trials on Stroke team simulation training
-
University of AarhusCentral Denmark RegionActive, not recruitingMedical Education | Pediatrics | Patient OutcomesDenmark
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Ontario Ministry of Health and... and other collaboratorsCompleted
-
National University Hospital, SingaporeCompleted
-
University of LeicesterOpen UniversityActive, not recruiting
-
Dorothy BreenUniversity of Ulster; Health Research Board, Ireland; Cork University Hospital; Health Service Executive, Ireland and other collaboratorsRecruitingAdverse EventsIreland
-
University Hospital, GenevaRecruiting
-
Zonguldak Bulent Ecevit UniversityNurten Taşdemir Assoc. Prof. PhD.UnknownCardiopulmonary Resuscitation | Nurse's Role | Simulation TrainingTurkey
-
Bogomolets National Medical UniversityCompletedCritical Illness | Intubation; Difficult or Failed | Educational ProblemsUkraine
-
University of OxfordCompleted
-
Hadassah Medical OrganizationClalit Health Services; Israel Center for Medical Simulation (MSR); The Samuel...UnknownEnd of Life ProcessIsrael