Clinical trial NCT03850847: Understanding Decision Making in the Intensive Care Unit: a National Study
Official title: Understanding Decision Making in the Intensive Care Unit: a National Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Organ Donation
Keywords: Neurological Determination of Death
Organ Donation
Determination of Death
Understanding Decision Making
Substitute Decision Maker
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ottawa Hospital Research Institute
First posted: 2019-02-22
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: SDM's beliefs and experiences around end of life
timeFrame: 6 weeks to 2 months after patient's hospitalisation in the intensive care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Michael Chassé, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crawshaw J, Presseau J, van Allen Z, Pinheiro Carvalho L, Jordison K, English S, Fergusson DA, Lauzier F, Turgeon AF, Sarti AJ, Martin C, D'Aragon F, Li AH, Knoll G, Ball I, Brehaut J, Burns KEA, Fortin MC, Weiss M, Meade M, Marsolais P, Shemie S, Zaabat S, Dhanani S, Kitto SC, Chasse M; Canadian Donation and Transplantation Research Program and the Canadian Critical Care Trials Group. Exploring the experiences and perspectives of substitute decision-makers involved in decisions about deceased organ donation: a qualitative study protocol. BMJ Open. 2019 Dec 23;9(12):e034594. doi: 10.1136/bmjopen-2019-034594.