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

November 29, 2018 updated by: Sigrid Beitland, Oslo University Hospital
The study will explore barriers in the process of achieving informed consent from critically ill patients

Study Overview

Status

Completed

Conditions

Detailed Description

The barriers will be divided into four major categories:

  • Practical barriers
  • Medical barriers
  • Legal barriers
  • Ethical barriers

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0540
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Intensive care unit patients

Description

Inclusion Criteria:

  • Patients considered for inclusion in the NORIDES study

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study recruitment barriers, Medical
Time Frame: 2018-2022
Number (%) of patients unable to give consent or to sign
2018-2022
Study recruitment barriers, Ethical
Time Frame: 2018-2022
Number (%) of patients not asked to give consent due to ethical issues
2018-2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study recruitment barriers, Practical
Time Frame: 2018-2022
Number (%) of cases where practical reasons made consent impossible
2018-2022
Study recruitment barriers, Legal
Time Frame: 2018-2022
Number (%) of patients where legal issues made consent impossible
2018-2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2018

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 29, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 2017/1254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planned to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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