Goals of CareASKMEGOCNCT06002113
Eliciting Informed Goals of Care in Elderly Patients
A study testing GOCD Tool in people with Goals of Care and Patient Preference, run by Royal Victoria Hospital, Canada at 1 site in Canada.
Trial summary
Patient-centered medical care considers a patient's values and goals for their health and well-being. Healthcare providers use this information to formulate a medical care plan that is aligned with these expectations. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Goals of Care, Patient Preference, End of Life
- What is being tested?
- GOCD Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalized patients ≥ 80 years old with an acute medical or surgical condition admitted to any hospital ward
- Previously or currently documented CODE STATUS preferences include any life sustaining therapies
- Duration of admission ≥ 24 hours
- English speaking, or translator present
- Competent patient or substitute decision maker
Who cannot join
- Treating physician, patient, or substitute decision maker declines
- Documented resuscitation preferences for comfort or supportive care
- New diagnosis of life-limiting illness on this hospital admission, for example, new diagnosis of metastatic cancer
- Clinically unstable, admitted to an intensive care unit, or currently receiving acute life support treatment (mechanical ventilation, acute dialysis, or inotropic/vasopressor support)
- Readmission after index hospitalization
- Pre-existing need for chronic mechanical ventilation (invasive mechanical ventilation via tracheostomy > 90 days) or maintenance dialysis (peritoneal or hemodialysis > 90 days)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M6M2
Kelly Cruise, BSc, cruisek@rvh.on.ca
About this study
Official title: Assessment of Shared Decision-making Tool for Eliciting Informed Goals of Care in the Hospitalized Elderly (ASKMEGOC): A Randomized Clinical Trial
Patient-centered medical care considers a patient's values and goals for their health and well-being. Healthcare providers use this information to formulate a medical care plan that is aligned with these expectations. This shared-decision making process should occur with every medical decision, but it is especially important whenever decisions about end-of-life care are being considered. Eliciting patient preferences about resuscitation and life-support treatments in the event of life-threatening illnesses are considered to be a standard of excellent and appropriate medical care. Unfortunately, these discussions don't happen consistently and even when they do occur, are rarely ideal. The consequences can be devastating, often resulting in the delivery of unwanted medical care that can be associated with significant physical and mental suffering among patients and their families. In response to this problem, the investigators developed a novel tool to help guide these difficult conversations between healthcare providers and patients. The investigators previously tested this tool in a small group of hospitalized patients who found it acceptable and helpful. In this larger study, the investigators will compare how effective this tool is compared to usual care in ensuring hospitalized patients have their treatment preferences identified, documented and result in end-of-life care that is consistent with their preferences.
Read the detailed description
Objectives:
- To determine the impact of facilitated Goals of Care Discussions (GOCDs) on the number of ICU, ventilator, and dialysis days during the index hospitalization (or until death) (composite).
- To determine the impact of facilitated GOCDs on the number of ICU, ventilator, and dialysis days after the index hospitalization until 12 months post-admission from the index hospitalization (or until death) (composite).
- To determine the impact of f-GOCDs on the final treatment preferences for life sustaining treatments (LSTs) documented in CODE STATUS.
- To determine the impact of facilitated GOCDs on other outcomes including decisional conflict and quality of communication, patient satisfaction with the encounter, and place of death.
- To determine the difference in direct patient hospital costs
- To determine the barriers and facilitators to the implementation of GOCDs.
Design:
A prospective, single-centre, stratified, parallel group, allocation concealed, analyst-masked, randomized, pragmatic, mixed-method, comparative effectiveness trial in hospitalized elderly patients 80 years and older.
Participants:
This study will include all elderly patients admitted to the Royal Victoria Regional Health Centre in Barrie, Ontario, Canada, with an acute medical or surgical diagnosis who fulfill all the inclusion criteria and for whom none of the exclusion criteria exist.
- Conditions
- Goals of Care, Patient Preference, End of Life
- Being tested
- GOCD Tool, Usual care
- Medical subject headings
- Patient Preference, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOCD ToolOther
Web-based tool with 4 components; pre-admission health status; current illness prognosis for hospital survival; in-hospital cardiorespiratory arrest prognosis; values and goals of care
Usual careOther
Attending physicians responsible for GOCD during hospitalization using their usual approaches
| Study group | Role | What they receive |
|---|---|---|
| GOCD Tool | Experimental | Intensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool Receives: Other: GOCD Tool |
| usual care | Active comparator | Usual discussions conducted by attending physician with patient Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-related health care utilization
total number of ventilator, ICU, and dialysis days
Measured: From the time of index hospital admission until hospital discharge or death, up to 12 months after the time of index hospital admission
ICU-related health care utilization
total number of hospital, ventilator, ICU, and dialysis days
Measured: 12 months after admission from index hospital admission
Secondary outcomes (11)
CODE STATUS resuscitation preferences
Distribution of resuscitation preferences documented in CODE STATUS
Measured: At the time of index hospital discharge or death during the index hospitalization, up to 12 months after the time of index hospital admission
Change in CODE STATUS preferences
Proportion of patients who change documented CODE STATUS preferences
Measured: At the time of index hospital discharge or death during the index hospitalization, up to 12 months after the time of index hospital admission
Resuscitation level designation
proportion of patients with completed resuscitation preferences identified
Measured: At the time of index hospital discharge or death, up to 12 months after the time of index hospital admission
Distribution of ICU-related days of health care utilization
compare empirical distributions of total days of health care utilization
Measured: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Time required to complete GOCD-facilitated discussion
Total time required to complete intervention
Measured: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Quality of communication
assessment of patient perceptions of quality of goals of care discussion
Measured: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
patient satisfaction with GOCD discussion
patient satisfaction with goals of care discussions
Measured: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Evaluation of GOCD tool
patient's perceptions of quality of web-based tool
Measured: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Patient-provider agreement on resuscitation preferences
decision concordance between patients and providers
Measured: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Death
date and time and place of death during study period
Measured: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Direct hospital costs
Difference in direct hospital costs
Measured: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start3 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (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 Goals of CareStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Victoria Regional Health Centre
- Responsible party
- Principal investigator, Giulio DiDiodato, Royal Victoria Hospital, Canada
- Investigators
- Giulio DiDiodato, MD PhD, Principal investigator, Royal Victoria Regional Health CentreChris Martin, MD, Principal investigator, Royal Victoria Regional Health CentreDoug Austgarden, MD, Principal investigator, Royal Victoria Regional Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002113
- Sponsor's protocol ID
- R22-003
- Acronym
- ASKMEGOC
- Status last verified
- Nov 2025
- First submitted
- 27 Jul 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only upon request, de-identified data may be shared
Publications
Martin C, Cruise K, Aggarwal M, Austgarden D, DiDiodato G. Assessment of shared decision-making tool for eliciting informed goals of care in the hospitalized elderly (ASKmeGOC): protocol for a randomized clinical trial. Trials. 2025 Dec 16;27(1):60. doi: 10.1186/s13063-025-09323-6.
PubMed 41402864
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Shared Decision-making Tool for Eliciting Informed Goals of Care in the Hospitalized Elderly (ASKMEGOC): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06002113
- Acronym / sponsor ID
- ASKMEGOC / R22-003
- Conditions
- Goals of Care, Patient Preference, End of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Royal Victoria Hospital, CanadaUniversity, hospital or other
- Collaborators
- Royal Victoria Regional Health Centre
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Aug 2023 (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.
Patient-centered medical care considers a patient's values and goals for their health and well-being. Healthcare providers use this information to formulate a medical care plan that is aligned with these expectations. This shared-decision making process should occur with every medical decision, but it is especially important whenever decisions about end-of-life care are being considered. Eliciting patient preferences about resuscitation and life-support treatments in the event of life-threatening illnesses are considered to be a standard of excellent and appropriate medical care. Unfortunately, these discussions don't happen consistently and even when they do occur, are rarely ideal. The consequences can be devastating, often resulting in the delivery of unwanted medical care that can be associated with significant physical and mental suffering among patients and their families. In response to this problem, the investigators developed a novel tool to help guide these difficult conversations between healthcare providers and patients. The investigators previously tested this tool in a small group of hospitalized patients who found it acceptable and helpful. In this larger study, the investigators will compare how effective this tool is compared to usual care in ensuring hospitalized patients have their treatment preferences identified, documented and result in end-of-life care that is consistent with their preferences.
Detailed description
Objectives:
- To determine the impact of facilitated Goals of Care Discussions (GOCDs) on the number of ICU, ventilator, and dialysis days during the index hospitalization (or until death) (composite).
- To determine the impact of facilitated GOCDs on the number of ICU, ventilator, and dialysis days after the index hospitalization until 12 months post-admission from the index hospitalization (or until death) (composite).
- To determine the impact of f-GOCDs on the final treatment preferences for life sustaining treatments (LSTs) documented in CODE STATUS.
- To determine the impact of facilitated GOCDs on other outcomes including decisional conflict and quality of communication, patient satisfaction with the encounter, and place of death.
- To determine the difference in direct patient hospital costs
- To determine the barriers and facilitators to the implementation of GOCDs.
Design:
A prospective, single-centre, stratified, parallel group, allocation concealed, analyst-masked, randomized, pragmatic, mixed-method, comparative effectiveness trial in hospitalized elderly patients 80 years and older.
Participants:
This study will include all elderly patients admitted to the Royal Victoria Regional Health Centre in Barrie, Ontario, Canada, with an acute medical or surgical diagnosis who fulfill all the inclusion criteria and for whom none of the exclusion criteria exist.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GOCD Tool | Experimental | Other: GOCD ToolIntensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool |
| usual care | Active comparator | Other: Usual careUsual discussions conducted by attending physician with patient |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Hospitalized patients ≥ 80 years old with an acute medical or surgical condition admitted to any hospital ward
- Previously or currently documented CODE STATUS preferences include any life sustaining therapies
- Duration of admission ≥ 24 hours
- English speaking, or translator present
- Competent patient or substitute decision maker
Key exclusion criteria (6 listed)
- Treating physician, patient, or substitute decision maker declines
- Documented resuscitation preferences for comfort or supportive care
- New diagnosis of life-limiting illness on this hospital admission, for example, new diagnosis of metastatic cancer
- Clinically unstable, admitted to an intensive care unit, or currently receiving acute life support treatment (mechanical ventilation, acute dialysis, or inotropic/vasopressor support)
- Readmission after index hospitalization
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 |
|---|---|---|
| GOCD ToolWeb-based tool with 4 components; pre-admission health status; current illness prognosis for hospital survival; in-hospital cardiorespiratory arrest prognosis; values and goals of care | Other | GOCD Tool |
| Usual careAttending physicians responsible for GOCD during hospitalization using their usual approaches | Other | usual care |
Primary outcome
ICU-related health care utilization
Time frame: From the time of index hospital admission until hospital discharge or death, up to 12 months after the time of index hospital admission
total number of ventilator, ICU, and dialysis days
ICU-related health care utilization
Time frame: 12 months after admission from index hospital admission
total number of hospital, ventilator, ICU, and dialysis days
11 secondary outcomes
CODE STATUS resuscitation preferences
Time frame: At the time of index hospital discharge or death during the index hospitalization, up to 12 months after the time of index hospital admission
Change in CODE STATUS preferences
Time frame: At the time of index hospital discharge or death during the index hospitalization, up to 12 months after the time of index hospital admission
Resuscitation level designation
Time frame: At the time of index hospital discharge or death, up to 12 months after the time of index hospital admission
Distribution of ICU-related days of health care utilization
Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Time required to complete GOCD-facilitated discussion
Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Quality of communication
Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
patient satisfaction with GOCD discussion
Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Evaluation of GOCD tool
Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Patient-provider agreement on resuscitation preferences
Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Death
Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Direct hospital costs
Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 41402864Martin C, Cruise K, Aggarwal M, Austgarden D, DiDiodato G. Assessment of shared decision-making tool for eliciting informed goals of care in the hospitalized elderly (ASKmeGOC): protocol for a randomized clinical trial. Trials. 2025 Dec 16;27(1):60. doi: 10.1186/s13063-025-09323-6.
- Individual participant dataSharing planned: No. Only upon request, de-identified data may be shared
Related trials for Goals of Care
Not yet recruiting
King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
Heart Failure, Cardiac Rehabilitation
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Enrolling by invitation
Improving Goals of Care Conversations Between Doctors and Young Adults With Cancer
Cancer
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Recruiting
Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
Hematopoietic and Lymphatic System Neoplasm
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.
Giulio DiDiodato, MD PhD principal investigator
Royal Victoria Regional Health Centre
Chris Martin, MD principal investigator
Royal Victoria Regional Health Centre
Doug Austgarden, MD principal investigator
Royal Victoria Regional Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOCD Tool in people with Goals of Care and Patient Preference, run by Royal Victoria Hospital, Canada 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulio DiDiodato, MD PhD (7057289090 ext. 45641, didiodatog@rvh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU-related health care utilization (time frame: From the time of index hospital admission until hospital discharge or death, up to 12 months after the time of index hospital admission). 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 NCT06002113, 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 21 Nov 2025.