Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient SafetySTREAMNCT03228251
Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) Trial
An observational study of Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient Safety, run by Johann Wolfgang Goethe University Hospital at 7 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient Safety
- What is being tested?
- Stroke team simulation training
- How many people
- 379 participants
- Where
- 7 sitesGermany
- Study dates
- 16 Oct 2017to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- in-hospital stroke
- referred for thrombectomy by another Hospital.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Klinikum Augsburg
Augsburg, 86156
Charite - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203
Uniklinik Köln
Cologne, 50937
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
Universitätsklinikum Heidelberg
Heidelberg, 69120
Klinikum der Universität München, Klinikum Großhadern
München, 81377
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
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
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.
Read more
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.
- Being tested
- Stroke team simulation training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke team simulation trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Stroke team simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation
Measured: up to 1 hour
Secondary outcomes (1)
Median thrombectomy process times of patients receiving thrombectomy in a before-after observation
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start16 Oct 2017
- Primary completion11 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Neurovascular
- Responsible party
- Principal investigator, Dr. Waltraud Pfeilschifter, Johann Wolfgang Goethe University Hospital
- Investigators
- Waltraud Pfeilschifter, Prof. Dr., Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228251
- Sponsor's protocol ID
- STREAM Trial
- Acronym
- STREAM
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2017
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34478596Bohmann 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.
PubMed 31572288
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03228251
- Acronym / sponsor ID
- STREAM / STREAM Trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Stryker Neurovascular
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Stroke team simulation trainingall stroke patients receiving thrombolysis and/or thrombectomy in a time period of three months after stroke team simulation training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- in-hospital stroke
- referred for thrombectomy by another Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroke team simulation trainingThe 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. | Other | Observation Group 2 |
Primary outcome
Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation
Time frame: up to 1 hour
1 secondary outcome
Median thrombectomy process times of patients receiving thrombectomy in a before-after observation
Time frame: up to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Derived from this study: PubMed 34478596Bohmann 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.
- Derived from this study: PubMed 31572288Bohmann 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waltraud Pfeilschifter, Prof. Dr. principal investigator
Johann Wolfgang Goethe University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient Safety, run by Johann Wolfgang Goethe University Hospital at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228251, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.