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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Organ Donation
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 292

Contacts and Locations

• Study Contact: Name: Michael Chassé, MD PhD FRCPC; Phone Number: 30816 514-890-8000; Email: michael.chasse.chum@ssss.gouv.qc.ca
• Study Contact Backup: Name: Polina Titova, BA; Phone Number: 30748 4384966700; Email: polina.titova.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Foothills Medical Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Winnipeg Health Sciences Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital
  • Quebec
    • Montreal, Quebec, Canada
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
    • Quebec City, Quebec, Canada
      • CHU de Québec - Université Laval
    • Sherbrooke, Quebec, Canada
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Multi-Methods Study; Step 1: Semi-structured Interviews Step 2: National Telephone Survey

Other: Step 1: Semi-structured Interviews; Cover SDMs' experience around:withdrawal of life sustaining therapiesorgan donation among those who were approached (including with the medical team and the organ donation organisation)understanding of the situationviews 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SDM's beliefs and experiences around end of life	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.	6 weeks to 2 months after patient's hospitalisation in the intensive care unit

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Canadian Institutes of Health Research (CIHR); Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Michael Chassé, MD PhD FRCPC, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Organ Donation; Neurological Determination of Death; Determination of Death; Understanding Decision Making; Substitute Decision Maker
• Other Study ID Numbers: CE 18.323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No