CompletedNCT03405766Updated Nov 30, 2018

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

An observational study in Critically Ill, Ethics and Informed Consent, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-30.

Sponsored by Oslo University Hospital · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 70
Ages: 18 Years and older
Sex: All

Study summary

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

Read the detailed description

The barriers will be divided into four major categories:

Practical barriers
Medical barriers
Legal barriers
Ethical barriers

Conditions studied

Critically Ill
Ethics
Informed Consent
Study Recruitment

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Critical Illness 1,780

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's enrollment of 70 is below the median of 140 across 814 observational studies indexed under Critical Illness.

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Lead sponsor

Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Intensive care unit patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients considered for inclusion in the NORIDES study

Exclusion criteria

Exclusion Criteria:

None

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 70 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Oslo University Hospital
Oslo, 0540, Norway

References and documents

Publications

Dahlberg J, Eriksen C, Robertsen A, Beitland S. Barriers and challenges in the process of including critically ill patients in clinical studies. Scand J Trauma Resusc Emerg Med. 2020 Jun 8;28(1):51. doi: 10.1186/s13049-020-00732-x. PubMed 32513204 ↗

Individual participant data

Plan to share: No — Not planned to share data

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Nov 2018, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 13, 2017
First posted: Jan 23, 2018
StartActual: May 2, 2018
Primary completionActual: Nov 20, 2018
CompletionActual: Nov 20, 2018
Last update: Nov 30, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03405766
Lead sponsor: Oslo University Hospital
Collaborators: University Hospital, Akershus, University of Oslo
Responsible party: Sigrid Beitland (Principal investigator, Oslo University Hospital) — Principal investigator
First posted: Jan 23, 2018
Start date: May 2, 2018
Primary completion: Nov 20, 2018
Completion: Nov 20, 2018
Last update: Nov 30, 2018

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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