Barriers in the Process of Achieving Informed Consent From Critically Ill Patients

Completed

• Conditions: Critically Ill; Ethics; Study Recruitment; Informed Consent

• Registration Number: NCT03405766
• Lead Sponsor: Oslo University Hospital

Brief Summary

The study will explore barriers in the process of achieving informed consent from critically ill patients

Detailed Description

The barriers will be divided into four major categories:

* Practical barriers

* Medical barriers

* Legal barriers

* Ethical barriers

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-23
• Study Start: 2018-05-02
• Status Verified: 2018-11
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-20
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients considered for inclusion in the NORIDES study

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study recruitment barriers, Medical	2018-2022	Number (%) of patients unable to give consent or to sign
Study recruitment barriers, Ethical	2018-2022	Number (%) of patients not asked to give consent due to ethical issues

Secondary Outcome Measures

Name	Time	Method
Study recruitment barriers, Practical	2018-2022	Number (%) of cases where practical reasons made consent impossible
Study recruitment barriers, Legal	2018-2022	Number (%) of patients where legal issues made consent impossible

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway