Organ DonationNCT03850847
Understanding Decision Making in the Intensive Care Unit: a National Study
An observational study of Organ Donation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Donation
- What is being tested?
- Step 1: Semi-structured Interviews and Step 2: National Telephone Survey
- How many people
- 292 participants
- Where
- 9 sitesCanada
- Study dates
- 1 Aug 2019to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Foothills Medical Centre
Calgary, Alberta
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
London Health Sciences Centre
London, Ontario, N6A 5W9
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario
CHU de Québec - Université Laval
Québec, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Winnipeg Health Sciences Centre
Winnipeg, Manitoba
About this 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.
Read more
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.
Read the 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.
- Conditions
- Organ Donation
- Being tested
- Step 1: Semi-structured Interviews, Step 2: National Telephone Survey
- Keywords
- Neurological Determination of Death, Organ Donation, Determination of Death, Understanding Decision Making, Substitute Decision Maker
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1: Semi-structured InterviewsOther
- 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
- 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).
Step 2: National Telephone SurveyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Multi-Methods Study | Step 1: Semi-structured Interviews
Step 2: National Telephone Survey Receives: Other: Step 1: Semi-structured Interviews; Other: Step 2: National Telephone Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks to 2 months after patient's hospitalisation in the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Aug 2019
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organ DonationStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Michael Chassé, MD PhD FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850847
- Sponsor's protocol ID
- CE 18.323
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2019
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31874899
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Decision Making in the Intensive Care Unit: a National Study
- ClinicalTrials.gov ID
- NCT03850847
- Acronym / sponsor ID
- CE 18.323
- Conditions
- Organ Donation
- Keywords
- Neurological Determination of Death, Organ Donation, Determination of Death, Understanding Decision Making, Substitute Decision Maker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ottawa Hospital Research Institute
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Methods Study | – | Other: Step 1: Semi-structured Interviews, Other: Step 2: National Telephone SurveyStep 1: Semi-structured Interviews Step 2: National Telephone Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step 1: Semi-structured Interviews1. 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 | Multi-Methods Study |
| Step 2: National Telephone SurveyExplore 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) | Other | Multi-Methods Study |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 31874899Crawshaw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Chassé, MD PhD FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Donation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03850847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.