ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03405766
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 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
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
Estimated Study Start Date : February 2, 2018
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : August 20, 2022



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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


Contacts
Contact: Sigrid Beitland, MD, PhD +4722119585 sigrid.beitland@medisin.uio.no

Locations
Norway
Oslo University Hospital Not yet recruiting
Oslo, Norway, 0540
Contact: Sigrid Beitland, MD, PhD    +4722117387    sigrid.beitland@medisin.uio.no   
Principal Investigator: Sigrid Beitland, MD, PhD         
Sub-Investigator: Annette Robertsen, MD         
Sub-Investigator: Jørgen Dahleberg, MD         
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: January 23, 2018
Last Verified: January 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