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Broad Consent in the Emergency Department "BC-ED" Collaborative Data Exchange and Usage - CODEX+

Broad Consent in the Emergency Department "BC-ED" Collaborative Data Exchange and Usage - CODEX+ - BC-ED

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030054
Enrollment
400
Registered
2022-10-25
Start date
2022-09-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binary outcomes (consent yes/no) and usual patient-relevant parameters are collected. There will be no investigation of diseases in this study. The content of the study is the (hypothetical) consent itself.

Interventions

Group 1: Within the availability of study staff, approaching and offering study participation to every fifth patient measured by administrative intake in the emergency department will potentially begi

Sponsors

Notfall- und Akutmedizin Charité Campi Nord
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 115 Years

Inclusion criteria

Inclusion criteria: Age of majority, ability to consent

Exclusion criteria

Exclusion criteria: Minor, incapable of giving consent, lack of sufficient linguistic competence

Design outcomes

Primary

MeasureTime frame
Success rate of consents from patients approached for recruitment in the emergency department overall and stratified by urgency, age, and gender.

Secondary

MeasureTime frame
- Selection bias: patient characteristics of patients who consented to the BC of MI-I vs. patient characteristics of patients who did not consent. - Selection bias: patient-related reasons for participation in / refusal of the BC or, in the case of no statement by the patient, assessment of the reasons by the educator - Time to first contact between study team and patient after administrative admission in the emergency department. - Time to consent of the patient after administrative admission in the emergency department. - Understanding of the content and voluntariness of the BC.

Countries

Germany

Contacts

Public ContactAntje Fischer-Rosinský

Charité Notfallmedizinische Versorgungsforschung

antje.fischer-rosinsky@charite.de030 450 553037

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026