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

NCT03850847 | Active Not Recruiting

• 1 other identifier: CE 18.323
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 9

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.

Conditions

Organ Donation

Keywords

Neurological Determination of Death; Organ Donation; Determination of Death; Understanding Decision Making; Substitute Decision Maker

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Multi-Methods Study

Step 1: Semi-structured Interviews Step 2: National Telephone Survey

Other: Step 1: Semi-structured Interviews; Other: Step 2: National Telephone Survey

Interventions

Step 1: Semi-structured Interviews OTHER

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).

Multi-Methods Study

Step 2: National Telephone Survey OTHER

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)

Multi-Methods Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Ottawa Hospital Research Institute: collaborator

Study Sites (9)

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Location

CHU de Québec - Université Laval

Québec, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 31874899 DERIVED

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Chassé, MD PhD FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 22, 2019
• Study Start: August 1, 2019
• Primary Completion: March 31, 2025
• Study Completion: August 31, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)