ESCAPE (Evaluating Surge Capacity And PrEparedness) (ESCAPE)

November 27, 2023 updated by: Prof. Dr. med. B. Zwissler, Ludwig-Maximilians - University of Munich

ESCAPE (Evaluating Surge Capacity And PrEparedness): a Multicenter Study on Recruiting Students as Surge Capacity Workforce in the Event of a Pandemic

The ESCAPE study intends to assess the possibility of recruiting students as surge capacity work force in hospitals in the event of a major medical incident such as an epidemic or pandemic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The ESCAPE study intends to assess the possibility of recruiting students as surge capacity work force in hospitals in event of a major medical incident such as an epidemic or pandemic. The study consists of two parts:

  • To identify the need for student surge capacity work force in relevant departments most affected by major medical incidents (e.g. Emergency Department, Intensive Care Unit, etc.). This part also raises the question of which tasks can be delegated to such a surge capacity workforce and which training may be required to prepare for such tasks.
  • To identify and quantify the willingness of students to enroll as surge capacity workforce, identifying which tasks they would be willing to perform and which organisational framework is required for their work (training, insurance, pay, etc.).

Both subparts as planned as questionnaires to be completed voluntarily and anonymously.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • Department of Anaesthesiology of the University Hospital of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • Heads of departments typically affected by major medical incidents. These include: Emergency Department, Intensive Care Units, Intermediate Care Units, Medical and Surgical wards, Department for Microbiology, Department for Infectious Diseases, Department for Laboratory Medicine, Antibiotic Stewardship Team, Department for Tropical Medicine, Max-von-Pettenkofer Institute, Institute for Emergency Medicine, Faculty Dean's office. Included were: heads of departments and other members of leadership from the medical staff, nursing staff and other supporting staff.
  • Medical students (aged 18 and over) in any year, currently studying at any of the 38 medical faculties in Germany.

Description

Inclusion Criteria:

  • Medical experts (heads of departements and other management positions) working in selected departments that are typically affected by major medical incidents at the time of questionnaire roll-out.
  • Medical students >18 years of age of any year enrolled in the year 2023-2024 in any of the 38 medical faculties in Germany

Exclusion Criteria:

  • none, as questionnaire participation was achieved by invitation of eligible volunteers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Medical experts in departments at risk
Expert healthcare workers at the Munich University Hospital within departments potentially affected by a major medical incident that could benefit from student surge capacity workforce. The following departments are included: Emergency Department, Intensive Care Units, Intermediate Care Units, Medical and Surgical wards, Department for Microbiology, Department for Infectious Diseases, Department for Laboratory Medicine, Antibiotic Stewardship Team, Department for Tropical Medicine, Max-von-Pettenkofer Institute, Institute for Emergency Medicine, Faculty Dean's office.
Behavioral: Answering questionnaire
A questionnaires for each group has been developped and will be distributed for voluntary and anonymous completion.
Students
Medical students from all medical faculties in Germany to be questioned on their willingness to partake in clinical work as surge capacity work force in the context of a potential major medical incident.
Behavioral: Answering questionnaire
A questionnaires for each group has been developped and will be distributed for voluntary and anonymous completion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Student surge capacity workforce needed
Time Frame: baseline
Is the general opinion that a student workforce would be beneficial in the context of a major medical incident?
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Student willingness to work as student surge capacity workforce
Time Frame: baseline
Are medical students willing to be involved as surge capacity workforce?
baseline
Tasks to be delegated to surge capacity workforce
Time Frame: baseline
What tasks can be delegated to a student workforce and what training is required to safely delegate these?
baseline
Organisational framework in which to embed surge capacity workforce
Time Frame: baseline
What organisational aspects need to be addressed in setting up a student surge capacity workforce?
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ludwig-Maximilians - University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernhard Zwissler, Prof, MD, Ludwigs-Maximilians-University Munich
  • Principal Investigator: Martin Fischer, Prof, MD, Ludwigs-Maximilians-University Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Klinikum Großhadern

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings