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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03224078
Other study ID # EA4/086/17
Secondary ID
Status Recruiting
Phase N/A
First received June 23, 2017
Last updated July 19, 2017
Start date May 1, 2017
Est. completion date April 30, 2020

Study information

Verified date July 2017
Source Charite University, Berlin, Germany
Contact Martin Möckel, Prof. Dr.
Phone 0049 30 450 550472
Email martin.moeckel@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall aim of INDEED is to facilitate trans-sectoral and interdisciplinary health services research of emergency care in Germany.

Clinical hospital data from 15 to 20 emergency departments in Germany will be linked to routine ambulatory health care data provided by the Association of Statutory Health Insurance Physicians (Kassenärztliche Vereinigung, KV). INDEED will identify health care gaps and inadequate resource allocation as well as develop strategies for adaptations of the health care system to existing demands.


Description:

B a c k g r o u n d:

Emergency departments nationally and internationally are challenged by a continuously increasing number and complexity of patients and consequent crowding. International studies showed that crowding is associated with unfavourable outcomes. Emergency departments are an important interface between the outpatient and inpatient health care sectors. Health care sectors in Germany are not organisationally cross-linked and data linkage for analysis of the health care system is not generally performed. Hence, there is a lack of data to trans-sectorally describe and monitor patients' pathways and patterns of care in the health care system.

RESEARCH AIMS:

The overall aim of INDEED is to facilitate trans-sectoral and interdisciplinary health services research of emergency care in Germany.

The primary objective of the project is to assess the trans-sectoral utilization of health care services of patients 2 years prior and 1 year after treatment in an emergency department. Patterns of adequate, inadequate and potentially avoidable care will be examined.

The secondary aim is to identify patient clusters with comparable needs of health care provision. Within clusters and for all patients combined INDEED will examine health care needs and gaps as well as factors that influence emergency department visits, disease progression, comorbidities and mortality.

METHODS:

Clinical hospital data from 15 to 20 emergency departments in Germany will be linked to routine ambulatory health care data provided by the Association of Statutory Health Insurance Physicians (Kassenärztliche Vereinigung, KV).

A secondary data analysis of linked routinely collected hospital information system and health insurance data of all adult patients that were treated with any condition in one of the participating emergency departments in 2016 (n≈680.000 cases) will be performed. Data analysis will cover the pattern of utilization of health care, identification of subgroups with comparable need of health care provision, of factors that influence emergency department visits and factors for ambulatory care sensitive conditions (ACSC) or inpatient treatment. Study results will be evaluated considering age, multimorbidity and gender aspects as well as the health system and health economic perspective. Thereby INDEED will identify health care gaps and inadequate resource allocation as well as develop strategies for adaptations of the health care system to existing demands.


Recruitment information / eligibility

Status Recruiting
Enrollment 680000
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult ED patients who attended one of the participating EDs in 2016

- patients with public health insurance

Exclusion Criteria:

- no exclusion criteria are applied

Study Design


Related Conditions & MeSH terms


Intervention

Other:
data extraction
No Special interventions except from data extraction form the respective routine data sources are planned .

Locations

Country Name City State
Germany Charité Universitätsmedizin - Berlin Berlin

Sponsors (7)

Lead Sponsor Collaborator
Charite University, Berlin, Germany OFFIS - Institut für Informatik, Technische Universität Berlin, Technologie- und Methodenplattform für die vernetzte medizinische Forschung (TMF), University of Magdeburg, Wissenschaftliches Institut der AOK (WIdO), Zentralinstitut für die Kassenärztliche Versorgung in Deutschland

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of adequate, inadequate and avoidable ED-visits Prevalence of adequate, inadequate and avoidable ED-visits will be operationalized by a) patients with low utilization of primary health care, b) low urgency, c) preventable conditions, d) chronic diseases that could have been adequately controlled, e) frequent-users, f) patients without contact to a physician in the ED ("left without being seen"). Baseline
Secondary Characterization of health care resource utilization before and after an ED-visit Descriptive analysis of number of visits to primary care physicians before and after the ED visit. The utilization of primary health care will be assessed two years before and one year after the year of the ED visit. ED-visits will be analyzed for the year 2016, this outcome measure will be analyzed for the years 2014-2017. from 2 years before until 1 year after ED-visit (2014-2017)
Secondary influencing factors on avoidable ED-visits influencing factors: sex, age, number of contacts to primary care physician, day and time of ED-admission, diagnoses, medication, admission mode, urgency. from 2 years before until 1 year after ED-visit (2014-2017)
Secondary influencing factors on adequate ED-visits influencing factors: sex, age, number of contacts to primary care physician, day and time of ED-admission, diagnoses, medication, admission mode, urgency. from 2 years before until 1 year after ED-visit (2014-2017)
Secondary influencing factors on inadequate ED-visits influencing factors: sex, age, number of contacts to primary care physician, day and time of ED-admission, diagnoses, medication, admission mode, urgency. from 2 years before until 1 year after ED-visit (2014-2017)
Secondary Exploratory analysis of influencing factors on increased health care costs. influencing factors: sex, age, number of contacts to primary care physician, day and time of ED-admission, diagnoses, medication, admission mode, urgency. Outcome will be treatment costs in the ambulatory sector as well as in-hospital diagnosis related group (DRG) for hospitalized patients from 2 years before until 1 year after ED-visit (2014-2017)
Secondary Exploratory analysis of influencing factors on patient-related mortality influencing factors: sex, age, number of contacts to primary care physician, day and time of ED-admission, diagnoses, medication, admission mode, urgency. Outcome measure: mortality two years after the year of the ED-visit. from 2 years before until 1 year after ED-visit (2014-2017)
Secondary Exploratory analysis of influencing factors on morbidity influencing factors: sex, age, number of contacts to primary care physician, day and time of ED-admission, diagnoses, medication, admission mode, urgency. Outcome measure: morbidity two years after the year of the ED-visit. from 2 years before until 1 year after ED-visit (2014-2017)
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