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Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) Trial (STREAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228251
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Dr. Waltraud Pfeilschifter, Johann Wolfgang Goethe University Hospital

Tracking Information
First Submitted Date June 26, 2017
First Posted Date July 24, 2017
Last Update Posted Date June 28, 2019
Actual Study Start Date October 16, 2017
Actual Primary Completion Date March 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2017)
Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation [ Time Frame: up to 1 hour ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 20, 2017)
Median thrombectomy process times of patients receiving thrombectomy in a before-after observation [ Time Frame: up to 2 hours ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 20, 2017)
  • Safety: Hemorrhagic transformation of the infarct on follow-up CT [ Time Frame: 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient Safety
Intervention Other: 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.
Study Groups/Cohorts
  • 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
    Intervention: Other: Stroke team simulation training
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2019)
379
Original Estimated Enrollment
 (submitted: July 20, 2017)
800
Actual Study Completion Date March 31, 2019
Actual Primary Completion Date March 11, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03228251
Other Study ID Numbers STREAM Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Waltraud Pfeilschifter, Johann Wolfgang Goethe University Hospital
Study Sponsor Johann Wolfgang Goethe University Hospital
Collaborators Stryker Neurovascular
Investigators
Principal Investigator: Waltraud Pfeilschifter, Prof. Dr. Johann Wolfgang Goethe University Hospital
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date June 2019