Decision MakingNCT04034979
Evaluation of a Decision Aid About Life-sustaining Therapies
A study testing decision aid in people with Decision Making and Resuscitation, run by Laval University at 1 site in Canada.
Trial summary
Introduction: Clinical practice guidelines recommend shared decision making (SDM) to facilitate goals-of-care discussions. This study will train clinicians about how to use a context-adapted decision aid (DA) and SDM to conduct goals-of-care discussions with the elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Decision Making, Resuscitation, Intensive Care Unit
- What is being tested?
- decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 23 May 2017to 22 Jan 2018
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 and older,
- capable of making their own healthcare decisions as determined by the attending intensivist's clinical judgment,
- in need of a discussion about goals of care as determined by the attending intensivist's clinical judgment.
Who cannot join
- intubated patients,
- patients facing urgent decisions,
- patients cared by the principal investigator,
- patients who do not read or speak French.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche de l'Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3Z1
About this study
Official title: Evaluation of a Context-adapted Decision Aid Supporting Critically Ill Patients' Decisions About Life-sustaining Therapies - a Pilot Project
Introduction: Clinical practice guidelines recommend shared decision making (SDM) to facilitate goals-of-care discussions. This study will train clinicians about how to use a context-adapted decision aid (DA) and SDM to conduct goals-of-care discussions with the elderly. The objectives of this study are to: 1) determine if the use of the DA and SDM training program: a) increase clinicians' engagement of patients in decision making regarding their goals of care; b) increase adoption of evidence-based behaviours regarding goals-of-care decision making; and 2) identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the skills in goals-of-care decision making.
Methods: This study will have three phases. Phase I (May-June 2017) will be a baseline evaluation of the current goals-of-care decision making process with elderly patients in a single ICU setting (Levis, Quebec). Phase II (July-August 2017) will be an evaluation of the goals-of-care decision making process in the same ICU using a DA. Phase III (September-December 2017) will be the delivery of an online and in-person training session about the use of the DA and about how to conduct discussions about goals-of-care. The study will then evaluate the goals-of-care decision making process after completion of the training program and using the DA. The investigators will observe and audio- or video-record all eligible elderly-intensivist dyads discussing goals of care during each phase. Two investigators will analyse the recordings using the OPTION 12 scale (measuring the extent that clinicians engage patients in SDM) and the ACCEPT quality indicators (measuring the extent to which intensivists engage in best practice goals-of-care discussions). The investigators will conduct qualitative content analysis of the video and audio records to identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.
Deliverables: This study will produce evidence regarding the impact of a context-adapted DA and training program on clinicians' adoption of SDM and other best practice behaviors regarding goals-of-care decision making with the elderly, and evidence regarding the most frequent patients' incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.
- Conditions
- Decision Making, Resuscitation, Intensive Care Unit, Goals-of-care, Shared-decision Making
- Being tested
- decision aid
- Keywords
- decision aid, ICU, goals-of-care, videotaping, shared-decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decision aidBehavioural
Also called training session
One hour online training about shared-decision making about goals-of-care and best practices regarding goals-of-care discussions and decision-making. One hour debriefing in presence.
| Study group | Role | What they receive |
|---|---|---|
| Phase I-Baseline evaluation | No intervention | The first two months of the investigator's project will be a baseline evaluation of the current decision making process about goals-of-care in a local ICU setting (Levis, Quebec). A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) dyads of physicians and newly admitted elderly patients discussing goals-of-care. |
| Phase II-Impact of the decision aid | Experimental | The two following months will be an evaluation of the decision making process about goals-of-care in the same local ICU setting using only the decision aid without any training. A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) new dyads of physicians and newly admitted elderly patients discussing goals-of-care, whether the physician chooses to use the context-adapted decision-aid or not. Receives: Behavioral: decision aid |
| Phase III- Impact of the decision aid and the | Experimental | This phase will be an evaluation of the decision making process about goals-of-care in the same local ICU setting after intensivists complete the training program and using the DA. A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) new dyads of physicians and newly admitted elderly patients discussing goals-of-care using the context-adapted decision aid and the new skills learned in the training program. Receives: Behavioral: decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observing Patient Involvement in Decision Making (OPTION) scale
The OPTION scale (12 items) measures the extent that clinicians engage patients in shared decision making. For each item, a score 0 (The behaviour is not observed) to 4 (The behaviour is observed and executed to a high standard) is given. Adding each item's score will arrive at a number between 0 (minimum) and 48 (maximum). The OPTION scale will be measured by two observers rating audio- or video-recordings of goals-of-care discussions conducted by intensivists with their patients at the earliest possible time during the patients intensive care stay. These discussions will be held at the discretion of the attending intensivist when deemed appropriate. Most often these discussions are held at the time of patient admission (first 24 hours) or whenever the patient is capable of engaging in a goals of care discussion (eg., after the patient is extubated and weaned off mechanical ventilation).
Measured: The OPTION scale will be measured at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion).
Score based on the quality indicators from the Audit of Communication, Care Planning, and Documentation (ACCEPT) study
This measure will be based on 7 of the 34 (ACCEPT) quality indicators that measure the quality of end-of-life communication and decision making: written information provided before discussion about goals of care, poor prognosis shared with patient during the discussion, verification with patient about prior discussions or written documents about the use of life-sustaining treatments, use of information by intensivist about about goals of care to support the decision, verification by the intensivist prior to the discussion of any written advanced directives in the patient's medical record, documentation of the goals of care discussed in medical record after discussion, goals of care documented in the medical chart after discussion consistent with patient's stated preferences. Indicators will be measured by two observers rating audio- or video-recordings. Score is the sum of the quality indicator items divided by the sum of highest possible values of these items on a scale 0% to 100%.
Measured: The quality indicators will be measured at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion.
Secondary outcomes (1)
Qualitative content analysis
Each audio or video recording will be content analysed by a doctoral student and a research assistant using the R language Qualitative Data Analysis (RQDA) package for Qualitative Data Analysis. The aim of this content analysis will be to identify: 1) patients' most frequent incomprehension, concerns, questions and 2) clinicians' opportunities to improve their skills in goals-of-care discussions and decision making.
Measured: The audio and video recordings will be done at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start23 May 2017
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 4 phases
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network
- Responsible party
- Principal investigator, Patrick Archambault, Laval University
- Investigators
- Patrick M Archambault, MD, MSc., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034979
- Sponsor's protocol ID
- Catalyst-2017-001
- Status last verified
- Jul 2019
- First submitted
- 24 Feb 2018
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sinuff T, Dodek P, You JJ, Barwich D, Tayler C, Downar J, Hartwick M, Frank C, Stelfox HT, Heyland DK. Improving End-of-Life Communication and Decision Making: The Development of a Conceptual Framework and Quality Indicators. J Pain Symptom Manage. 2015 Jun;49(6):1070-80. doi: 10.1016/j.jpainsymman.2014.12.007. Epub 2015 Jan 24.
PubMed 25623923Heyland DK, Barwich D, Pichora D, Dodek P, Lamontagne F, You JJ, Tayler C, Porterfield P, Sinuff T, Simon J; ACCEPT (Advance Care Planning Evaluation in Elderly Patients) Study Team; Canadian Researchers at the End of Life Network (CARENET). Failure to engage hospitalized elderly patients and their families in advance care planning. JAMA Intern Med. 2013 May 13;173(9):778-87. doi: 10.1001/jamainternmed.2013.180.
PubMed 23545563Heyland D, Cook D, Bagshaw SM, Garland A, Stelfox HT, Mehta S, Dodek P, Kutsogiannis J, Burns K, Muscedere J, Turgeon AF, Fowler R, Jiang X, Day AG; Canadian Critical Care Trials Group; Canadian Researchers at the End of Life Network. The Very Elderly Admitted to ICU: A Quality Finish? Crit Care Med. 2015 Jul;43(7):1352-60. doi: 10.1097/CCM.0000000000001024.
PubMed 25901550Kon AA, Davidson JE, Morrison W, Danis M, White DB; American College of Critical Care Medicine; American Thoracic Society. Shared Decision Making in ICUs: An American College of Critical Care Medicine and American Thoracic Society Policy Statement. Crit Care Med. 2016 Jan;44(1):188-201. doi: 10.1097/CCM.0000000000001396.
PubMed 26509317Legare F, Stacey D, Turcotte S, Cossi MJ, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2014 Sep 15;(9):CD006732. doi: 10.1002/14651858.CD006732.pub3.
PubMed 25222632Evans R, Edwards A, Brett J, Bradburn M, Watson E, Austoker J, Elwyn G. Reduction in uptake of PSA tests following decision aids: systematic review of current aids and their evaluations. Patient Educ Couns. 2005 Jul;58(1):13-26. doi: 10.1016/j.pec.2004.06.009.
PubMed 15950832White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461.
PubMed 17353493Plaisance A, Turgeon J, Souza LG, Legare F, Turcotte S, Germain N, Jean T, Dionne M, Fortier FA, Plante P, Tapp D, Gelinas V, Belanger E, Ebell MH, Chabot C, van de Belt TH, Turgeon AF, Archambault PM. Exploring the Impact of a Context-Adapted Decision Aid and Online Training About Shared Decision Making About Goals of Care with Elderly Patients in the Intensive Care Unit: A Mixed-Methods Study. Patient. 2026 Jan;19(1):145-160. doi: 10.1007/s40271-025-00761-7. Epub 2025 Sep 25.
PubMed 40999300
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Context-adapted Decision Aid Supporting Critically Ill Patients' Decisions About Life-sustaining Therapies - a Pilot Project
- ClinicalTrials.gov ID
- NCT04034979
- Acronym / sponsor ID
- Catalyst-2017-001
- Conditions
- Decision Making, Resuscitation, Intensive Care Unit, Goals-of-care, Shared-decision Making
- Keywords
- decision aid, ICU, goals-of-care, videotaping, shared-decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Frailty Network
- Study start
- 23 May 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 29 Jul 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.
Introduction: Clinical practice guidelines recommend shared decision making (SDM) to facilitate goals-of-care discussions. This study will train clinicians about how to use a context-adapted decision aid (DA) and SDM to conduct goals-of-care discussions with the elderly. The objectives of this study are to: 1) determine if the use of the DA and SDM training program: a) increase clinicians' engagement of patients in decision making regarding their goals of care; b) increase adoption of evidence-based behaviours regarding goals-of-care decision making; and 2) identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the skills in goals-of-care decision making.
Methods: This study will have three phases. Phase I (May-June 2017) will be a baseline evaluation of the current goals-of-care decision making process with elderly patients in a single ICU setting (Levis, Quebec). Phase II (July-August 2017) will be an evaluation of the goals-of-care decision making process in the same ICU using a DA. Phase III (September-December 2017) will be the delivery of an online and in-person training session about the use of the DA and about how to conduct discussions about goals-of-care. The study will then evaluate the goals-of-care decision making process after completion of the training program and using the DA. The investigators will observe and audio- or video-record all eligible elderly-intensivist dyads discussing goals of care during each phase. Two investigators will analyse the recordings using the OPTION 12 scale (measuring the extent that clinicians engage patients in SDM) and the ACCEPT quality indicators (measuring the extent to which intensivists engage in best practice goals-of-care discussions). The investigators will conduct qualitative content analysis of the video and audio records to identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.
Deliverables: This study will produce evidence regarding the impact of a context-adapted DA and training program on clinicians' adoption of SDM and other best practice behaviors regarding goals-of-care decision making with the elderly, and evidence regarding the most frequent patients' incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 4 phases
| Arm | Type | Receives |
|---|---|---|
| Phase I-Baseline evaluation | No intervention | –The first two months of the investigator's project will be a baseline evaluation of the current decision making process about goals-of-care in a local ICU setting (Levis, Quebec). A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) dyads of physicians and newly admitted elderly patients discussing goals-of-care. |
| Phase II-Impact of the decision aid | Experimental | Behavioral: decision aidThe two following months will be an evaluation of the decision making process about goals-of-care in the same local ICU setting using only the decision aid without any training. A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) new dyads of physicians and newly admitted elderly patients discussing goals-of-care, whether the physician chooses to use the context-adapted decision-aid or not. |
| Phase III- Impact of the decision aid and the | Experimental | Behavioral: decision aidThis phase will be an evaluation of the decision making process about goals-of-care in the same local ICU setting after intensivists complete the training program and using the DA. A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) new dyads of physicians and newly admitted elderly patients discussing goals-of-care using the context-adapted decision aid and the new skills learned in the training program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- aged 65 and older,
- capable of making their own healthcare decisions as determined by the attending intensivist's clinical judgment,
- in need of a discussion about goals of care as determined by the attending intensivist's clinical judgment.
Key exclusion criteria (4 listed)
- intubated patients,
- patients facing urgent decisions,
- patients cared by the principal investigator,
- patients who do not read or speak French.
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 |
|---|---|---|
| decision aidAlso: training sessionOne hour online training about shared-decision making about goals-of-care and best practices regarding goals-of-care discussions and decision-making. One hour debriefing in presence. | Behavioural | Phase II-Impact of the decision aid, Phase III- Impact of the decision aid and the |
Primary outcome
Observing Patient Involvement in Decision Making (OPTION) scale
Time frame: The OPTION scale will be measured at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion).
The OPTION scale (12 items) measures the extent that clinicians engage patients in shared decision making. For each item, a score 0 (The behaviour is not observed) to 4 (The behaviour is observed and executed to a high standard) is given. Adding each item's score will arrive at a number between 0 (minimum) and 48 (maximum). The OPTION scale will be measured by two observers rating audio- or video-recordings of goals-of-care discussions conducted by intensivists with their patients at the earliest possible time during the patients intensive care stay. These discussions will be held at the discretion of the attending intensivist when deemed appropriate. Most often these discussions are held at the time of patient admission (first 24 hours) or whenever the patient is capable of engaging in a goals of care discussion (eg., after the patient is extubated and weaned off mechanical ventilation).
Score based on the quality indicators from the Audit of Communication, Care Planning, and Documentation (ACCEPT) study
Time frame: The quality indicators will be measured at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion.
This measure will be based on 7 of the 34 (ACCEPT) quality indicators that measure the quality of end-of-life communication and decision making: written information provided before discussion about goals of care, poor prognosis shared with patient during the discussion, verification with patient about prior discussions or written documents about the use of life-sustaining treatments, use of information by intensivist about about goals of care to support the decision, verification by the intensivist prior to the discussion of any written advanced directives in the patient's medical record, documentation of the goals of care discussed in medical record after discussion, goals of care documented in the medical chart after discussion consistent with patient's stated preferences. Indicators will be measured by two observers rating audio- or video-recordings. Score is the sum of the quality indicator items divided by the sum of highest possible values of these items on a scale 0% to 100%.
1 secondary outcome
Qualitative content analysis
Time frame: The audio and video recordings will be done at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Background: PubMed 25623923Sinuff T, Dodek P, You JJ, Barwich D, Tayler C, Downar J, Hartwick M, Frank C, Stelfox HT, Heyland DK. Improving End-of-Life Communication and Decision Making: The Development of a Conceptual Framework and Quality Indicators. J Pain Symptom Manage. 2015 Jun;49(6):1070-80. doi: 10.1016/j.jpainsymman.2014.12.007. Epub 2015 Jan 24.
- Background: PubMed 23545563Heyland DK, Barwich D, Pichora D, Dodek P, Lamontagne F, You JJ, Tayler C, Porterfield P, Sinuff T, Simon J; ACCEPT (Advance Care Planning Evaluation in Elderly Patients) Study Team; Canadian Researchers at the End of Life Network (CARENET). Failure to engage hospitalized elderly patients and their families in advance care planning. JAMA Intern Med. 2013 May 13;173(9):778-87. doi: 10.1001/jamainternmed.2013.180.
- Background: PubMed 25901550Heyland D, Cook D, Bagshaw SM, Garland A, Stelfox HT, Mehta S, Dodek P, Kutsogiannis J, Burns K, Muscedere J, Turgeon AF, Fowler R, Jiang X, Day AG; Canadian Critical Care Trials Group; Canadian Researchers at the End of Life Network. The Very Elderly Admitted to ICU: A Quality Finish? Crit Care Med. 2015 Jul;43(7):1352-60. doi: 10.1097/CCM.0000000000001024.
- Background: PubMed 26509317Kon AA, Davidson JE, Morrison W, Danis M, White DB; American College of Critical Care Medicine; American Thoracic Society. Shared Decision Making in ICUs: An American College of Critical Care Medicine and American Thoracic Society Policy Statement. Crit Care Med. 2016 Jan;44(1):188-201. doi: 10.1097/CCM.0000000000001396.
- Background: PubMed 25222632Legare F, Stacey D, Turcotte S, Cossi MJ, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2014 Sep 15;(9):CD006732. doi: 10.1002/14651858.CD006732.pub3.
- Background: PubMed 15950832Evans R, Edwards A, Brett J, Bradburn M, Watson E, Austoker J, Elwyn G. Reduction in uptake of PSA tests following decision aids: systematic review of current aids and their evaluations. Patient Educ Couns. 2005 Jul;58(1):13-26. doi: 10.1016/j.pec.2004.06.009.
- Background: PubMed 17353493White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461.
- Derived from this study: PubMed 40999300Plaisance A, Turgeon J, Souza LG, Legare F, Turcotte S, Germain N, Jean T, Dionne M, Fortier FA, Plante P, Tapp D, Gelinas V, Belanger E, Ebell MH, Chabot C, van de Belt TH, Turgeon AF, Archambault PM. Exploring the Impact of a Context-Adapted Decision Aid and Online Training About Shared Decision Making About Goals of Care with Elderly Patients in the Intensive Care Unit: A Mixed-Methods Study. Patient. 2026 Jan;19(1):145-160. doi: 10.1007/s40271-025-00761-7. Epub 2025 Sep 25.
- 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.
Patrick M Archambault, MD, MSc. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decision aid in people with Decision Making and Resuscitation, run by Laval University at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Observing Patient Involvement in Decision Making (OPTION) scale (time frame: The OPTION scale will be measured at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion).). The study lists 2 primary outcomes in all. 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 NCT04034979, which also lists 8 linked publications.
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 30 Jul 2019.