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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03036969
Other study ID # EPICS-8
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2016
Est. completion date June 2019

Study information

Verified date July 2018
Source Charite University, Berlin, Germany
Contact Martin Möckel, MD
Email martin.moeckel@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be investigated in this project.


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:

1. Development and testing of a questionaire for the identification of reasons for emergency department utilization by patients with non-urgent conditions (n=100)

2. Characterization and quantification of non-urgent emergencies

3. Explorative analysis of patient pathways and influencing factors for ED-visits with non-urgent conditions.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date June 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 115 Years
Eligibility Eligibility criteria for record linkage:

- Age>= 18 years

- Outpatients

- MTS-Triage category blue, green or yellow

- Treatment in one of the two participating EDs

Eligibility criteria for questionnaire pretest:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Dementia

- no sufficient German language skills

- patients with legal representatives

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Charité Universitätsmedizin - Berlin Berlin

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany Zentralinstitut für die Kassenärztliche Versorgung in Deutschland

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with linkable records The Primary outcome will be the proportion of patients with successful record linkage. 05/2016 - 05/2018
Secondary 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. 05/2016 - 05/2017
Secondary Demographic characteristics of non-urgent ED patients Descriptive analysis of demographic characteristics of ED patients with non-urgent conditions During the study period
Secondary Clinical characteristics of non-urgent ED patients Descriptive analysis of clinical characteristics of ED patients with non-urgent conditions During the study period
Secondary Patient pathways for ED-Visits Explorative analysis of patient pathways for ED-visits with non-urgent conditions 10/2017 - 05/2018
Secondary Influencing factors for ED-Visits Explorative analysis of influencing factors for ED-visits with non-urgent conditions 10/2017 - 05/2018