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Understanding Decision Making in the Intensive Care Unit: a National Study

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ClinicalTrials.gov Identifier: NCT03850847
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

Given how central Substitute Decision Makers (SDMs) are to the process leading to end of life decisions and sometimes, organ donation, it is striking how poorly understood this decision-making process is. A 2017 scoping review on the topic of soliciting SDM consent to organ donation reported on more than 168 studies covering a broad range of topics, including: SDM characteristics and predictors of consent; the process of soliciting consent; and the effect of the decision on subsequent process of care and on family well-being. An unexplored area, however, is factors - including modifiable factors - that influence SDM decision making at the end of life, which organ donation is part of, such as: responses to stress, support from extended families and friends, and personal beliefs about the ongoing medical conditions. This project seeks to fill this clear and important gap.

In the ICU, at the end of life, SDMs are under incredible emotional distress, have often not eaten or slept properly for days preceding discussions about end of life and organ donation, and are also in the midst of grieving for their loved one. The time pressure poses challenges for SDMs' decision making. Thus, this study will investigate novel, potentially modifiable reasons for end of life decision so that we may better support this personally challenging and important decision, especially if organ donation decision interferes with the decision process.

Primary objective: To investigate beliefs and experiences of SDMs involved in the decision-making process around withdrawal of life sustaining therapies .

Secondary objective: To inform efforts to improve support for SDMs with the aim of improving the decision-making process end-of-life decisions, including when organ donation is involved.


Condition or disease Intervention/treatment
Organ Donation Other: Step 1: Semi-structured Interviews Other: Step 2: National Telephone Survey

Detailed Description:
A national multicenter multi-methods study with SDMs will be conducted in two steps. In Step 1, a semi-structured interviews with SDMs will be conducted. The sampling frame will balance interviews with those that were approached or not for organ donation, and consented or not to organ donation. Interviews will be informed by two complementary theoretical frameworks. Building on Step 1 results, in Step 2 a national telephone survey of SDMs will be conducted to test which factors are associated with end-of-life decisions.

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Study Type : Observational
Estimated Enrollment : 292 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Understanding Decision Making in the Intensive Care Unit: a National Study
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Group/Cohort Intervention/treatment
Multi-Methods Study

Step 1: Semi-structured Interviews

Step 2: National Telephone Survey

Other: Step 1: Semi-structured Interviews
  1. Cover SDMs' experience around:

    • withdrawal of life sustaining therapies
    • organ donation among those who were approached (including with the medical team and the organ donation organisation)
    • understanding of the situation
    • views on any gaps in the quantity or quality of information and discussion they received concerning their loved one's end-of-life care or donation process
  2. Explore factors they perceived to influence their decision to consent to organ donation or not (or that would have influenced their decision for those not approached), and how such factors may have changed over the course of making this decision and since the decision (or since the event for those not approached).

Other: Step 2: National Telephone Survey
Explore SDM's beliefs and experiences around end of life and assess which beliefs are associated with the decision taken at the end of life, including decision to donate organs or not (and the strength of this association)




Primary Outcome Measures :
  1. SDM's beliefs and experiences around end of life [ Time Frame: 6 weeks to 2 months after patient's hospitalisation in the intensive care unit ]
    Assess which beliefs and experiences are associated with the decision to donate organs using open-ended questions. The responses obtained from the interviews will be analysed and classified based on the Leventhal's Common Sense Self-Regulation Model and the theoretical domain Framework. The most significant domains will help inform the creation of a larger scale national survey to help investigate what domains affect decision-making around end of life.



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:   Non-Probability Sample
Study Population
Surogate decision makers of critically ill deceased patients, potential organ donors. Are included all SDMs, whether the patient donated organs or not, or were approached for organ donation or not, thus providing a global view of the decision making at the end of life and how it is affected by organ donation, or how it affects organ donation when appropriate.
Criteria

Inclusion Criteria:

  • Substitute decision maker (SDM) and patients with at least 18 years old
  • SDM(s) of patients in the ICU with or without brain injury for whom withdrawal of life-sustaining therapies is considered or has been discussed.
  • SDM(s) of patients for whom death is expected to occur within approximately 1 hour after withdrawal of life-sustaining therapies
  • English or French speakers SDM(s)
  • SDM(s) reachable in ICU

Exclusion Criteria:

  • SDM is not reachable after pre-consent in ICU (after 5 initial attempts within a 3-week period).
  • SDM asks to postpone the interview more than 3 times.
  • SDM unable to provide informed verbal consent for any reason.

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): NCT03850847


Contacts
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Contact: Michael Chassé, MD PhD FRCPC 514-890-8000 ext 30816 michael.chasse.chum@ssss.gouv.qc.ca
Contact: Livia Pinheiro Carvalho, PhD 4384966700 ext 30748 livia.pinheiro-carvalho.chum@ssss.gouv.qc.ca

Locations
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Canada, Alberta
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada
Canada, Manitoba
Winnipeg Health Sciences Centre Not yet recruiting
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montreal, Quebec, Canada
Hôpital du Sacré-Cœur de Montréal Not yet recruiting
Montreal, Quebec, Canada
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada
CHU de Québec - Université Laval Recruiting
Quebec City, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Michael Chassé, MD PhD FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03850847    
Other Study ID Numbers: CE 18.323
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Neurological Determination of Death
Organ Donation
Determination of Death
Understanding Decision Making
Substitute Decision Maker