Non-urgent EmergenciesEPICS-8NCT03036969
EPICS-8: Reasons for Emergency Department Utilization by Patients With Non-urgent Conditions
An observational study of Non-urgent Emergencies, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions: Emergency Departments (EDs) are an important interface between primary and secondary health care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. Read more about this study
- Who is it for?
- Ages 18 to 115 years
- Conditions the study is for
- Non-urgent Emergencies
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Jun 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 to 115 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult men and women who are discharged after emergency treatment (outpatients) with an initial Manchester Triage Category of blue, green or yellow.
Who may be able to join
- Age>= 18 years
- Outpatients
- MTS-Triage category blue, green or yellow
- Treatment in one of the two participating EDs
- Eligibility to understand the study purposes and give written informed consent
Who cannot join
- Dementia
- no sufficient German language skills
- patients with legal representatives
Trial locations and contacts
1 site in 1 country.
Martin Möckel, MD contact
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin - Berlin
Berlin, 13353
Martin Möckel, MD, martin.moeckel@charite.de
Johann Frick, M A, 004930450553027, johann.frick@charite.de
About this study
Official title: Emergency Processes in Clinical Structures - EPICS-8: Gründe für Die Inanspruchnahme Der Notaufnahme Durch Patienten Mit Blauer, grüner Oder Gelber Triagekategorie Und Ambulantem Behandlungsbedarf
EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:
Emergency Departments (EDs) are an important interface between primary and secondary health care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be investigated in this project.
Read the detailed description
EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:
Emergency Departments (EDs) are an important interface between primary and the secondary health care system in Germany. The number of outpatient visits in the ED´s is still increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be explored in this project.
EPICS-8 is a pilot study to establish a research structure for the linkage of ED-data with data of the primary health care sector. Data linkage will be conducted for patients with the Manchester Triage System categories blue, green and yellow. A secondary aim of the EPICS-8 study is to develop a valid questionnaire for the assessment of reasons for ED utilization by non-urgent patients.
Primary objective:
Establishing of a research structure for the linkage of inhospital-data with data from the primary health care System. Records of 5,000 patients who attended one of the two EDs at the Charité University Medicine Berlin will be linked to Primary health care data.
Secondary objectives:
- Development and testing of a questionaire for the identification of reasons for emergency department utilization by patients with non-urgent conditions (n=100)
- Characterization and quantification of non-urgent emergencies
- Explorative analysis of patient pathways and influencing factors for ED-visits with non-urgent conditions.
- Conditions
- Non-urgent Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-urgent emergencies | Outpatients in the Emergency Department with the MTS-Triage category blue, green or yellow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with linkable records
The Primary outcome will be the proportion of patients with successful record linkage.
Measured: 05/2016 - 05/2018
Secondary outcomes (5)
Valid Questionnaire
A patients questionnaire for the assessment of Emergency Department utilization by non-urgent patients will be developed. The outcome of this work package will be a valid patient questionnaire.
Measured: 05/2016 - 05/2017
Demographic characteristics of non-urgent ED patients
Descriptive analysis of demographic characteristics of ED patients with non-urgent conditions
Measured: During the study period
Clinical characteristics of non-urgent ED patients
Descriptive analysis of clinical characteristics of ED patients with non-urgent conditions
Measured: During the study period
Patient pathways for ED-Visits
Explorative analysis of patient pathways for ED-visits with non-urgent conditions
Measured: 10/2017 - 05/2018
Influencing factors for ED-Visits
Explorative analysis of influencing factors for ED-visits with non-urgent conditions
Measured: 10/2017 - 05/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-urgent EmergenciesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Zentralinstitut für die Kassenärztliche Versorgung in Deutschland
- Responsible party
- Principal investigator, Martin Moeckel, Charite University, Berlin, Germany
- Investigators
- Martin Möckel, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036969
- Sponsor's protocol ID
- EPICS-8
- Acronym
- EPICS-8
- Status last verified
- Jul 2018
- First submitted
- 24 Jan 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Processes in Clinical Structures - EPICS-8: Gründe für Die Inanspruchnahme Der Notaufnahme Durch Patienten Mit Blauer, grüner Oder Gelber Triagekategorie Und Ambulantem Behandlungsbedarf
- ClinicalTrials.gov ID
- NCT03036969
- Acronym / sponsor ID
- EPICS-8 / EPICS-8
- Conditions
- Non-urgent Emergencies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Zentralinstitut für die Kassenärztliche Versorgung in Deutschland
- Study start
- May 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- 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.
EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:
Emergency Departments (EDs) are an important interface between primary and secondary health care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be investigated in this project.
Detailed description
EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:
Emergency Departments (EDs) are an important interface between primary and the secondary health care system in Germany. The number of outpatient visits in the ED´s is still increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be explored in this project.
EPICS-8 is a pilot study to establish a research structure for the linkage of ED-data with data of the primary health care sector. Data linkage will be conducted for patients with the Manchester Triage System categories blue, green and yellow. A secondary aim of the EPICS-8 study is to develop a valid questionnaire for the assessment of reasons for ED utilization by non-urgent patients.
Primary objective:
Establishing of a research structure for the linkage of inhospital-data with data from the primary health care System. Records of 5,000 patients who attended one of the two EDs at the Charité University Medicine Berlin will be linked to Primary health care data.
Secondary objectives:
- Development and testing of a questionaire for the identification of reasons for emergency department utilization by patients with non-urgent conditions (n=100)
- Characterization and quantification of non-urgent emergencies
- Explorative analysis of patient pathways and influencing factors for ED-visits with non-urgent conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-urgent emergencies | – | –Outpatients in the Emergency Department with the MTS-Triage category blue, green or yellow |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women who are discharged after emergency treatment (outpatients) with an initial Manchester Triage Category of blue, green or yellow.
Key inclusion criteria (5 listed)
- Age>= 18 years
- Outpatients
- MTS-Triage category blue, green or yellow
- Treatment in one of the two participating EDs
- Eligibility to understand the study purposes and give written informed consent
Key exclusion criteria (3 listed)
- Dementia
- no sufficient German language skills
- patients with legal representatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with linkable records
Time frame: 05/2016 - 05/2018
The Primary outcome will be the proportion of patients with successful record linkage.
5 secondary outcomes
Valid Questionnaire
Time frame: 05/2016 - 05/2017
Demographic characteristics of non-urgent ED patients
Time frame: During the study period
Clinical characteristics of non-urgent ED patients
Time frame: During the study period
Patient pathways for ED-Visits
Time frame: 10/2017 - 05/2018
Influencing factors for ED-Visits
Time frame: 10/2017 - 05/2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Martin Möckel, MD contact
Martin Möckel, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-urgent Emergencies, run by Charite University, Berlin, Germany at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Möckel, MD (martin.moeckel@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with linkable records (time frame: 05/2016 - 05/2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2018.