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

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ClinicalTrials.gov Identifier: NCT03405766
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborators:
University Hospital, Akershus
University of Oslo
Information provided by (Responsible Party):
Sigrid Beitland, Oslo University Hospital

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

Condition or disease
Critically Ill Ethics Informed Consent Study Recruitment

Detailed Description:

The barriers will be divided into four major categories:

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

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : November 20, 2018



Primary Outcome Measures :
  1. Study recruitment barriers, Medical [ Time Frame: 2018-2022 ]
    Number (%) of patients unable to give consent or to sign

  2. Study recruitment barriers, Ethical [ Time Frame: 2018-2022 ]
    Number (%) of patients not asked to give consent due to ethical issues


Secondary Outcome Measures :
  1. Study recruitment barriers, Practical [ Time Frame: 2018-2022 ]
    Number (%) of cases where practical reasons made consent impossible

  2. Study recruitment barriers, Legal [ Time Frame: 2018-2022 ]
    Number (%) of patients where legal issues made consent impossible



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intensive care unit patients
Criteria

Inclusion Criteria:

  • Patients considered for inclusion in the NORIDES study

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405766


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0540
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
University of Oslo

Responsible Party: Sigrid Beitland, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03405766     History of Changes
Other Study ID Numbers: REK 2017/1254
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planned to share data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes