Critically IllNCT03405766
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
An observational study of Critically Ill and Ethics, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study will explore barriers in the process of achieving informed consent from critically ill patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Ethics, Informed Consent
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 2 May 2018to 20 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care unit patients
Who may be able to join
- Patients considered for inclusion in the NORIDES study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
- Critically Ill, Ethics, Informed Consent, Study Recruitment
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Study recruitment barriers, Medical
Number (%) of patients unable to give consent or to sign
Measured: 2018-2022
Study recruitment barriers, Ethical
Number (%) of patients not asked to give consent due to ethical issues
Measured: 2018-2022
Secondary outcomes (2)
Study recruitment barriers, Practical
Number (%) of cases where practical reasons made consent impossible
Measured: 2018-2022
Study recruitment barriers, Legal
Number (%) of patients where legal issues made consent impossible
Measured: 2018-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start2 May 2018
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, University of Oslo
- Responsible party
- Principal investigator, Sigrid Beitland, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405766
- Sponsor's protocol ID
- REK 2017/1254
- Status last verified
- Nov 2018
- First submitted
- 13 Dec 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned to share data
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03405766
- Acronym / sponsor ID
- REK 2017/1254
- Conditions
- Critically Ill, Ethics, Informed Consent, Study Recruitment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, University of Oslo
- Study start
- 2 May 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients
Key inclusion criteria (1 listed)
- Patients considered for inclusion in the NORIDES study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study recruitment barriers, Medical
Time frame: 2018-2022
Number (%) of patients unable to give consent or to sign
Study recruitment barriers, Ethical
Time frame: 2018-2022
Number (%) of patients not asked to give consent due to ethical issues
2 secondary outcomes
Study recruitment barriers, Practical
Time frame: 2018-2022
Study recruitment barriers, Legal
Time frame: 2018-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Derived from this study: PubMed 32513204Dahlberg 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.
- Individual participant dataSharing planned: No. Not planned to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Ethics, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study recruitment barriers, Medical (time frame: 2018-2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.