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RecruitingNCT06002113ASKMEGOCUpdated Nov 21, 2025

Eliciting Informed Goals of Care in Elderly Patients

An interventional study of GOCD Tool and Usual care in Goals of Care, Patient Preference and End of Life, sponsored by Royal Victoria Hospital, Canada. Recruiting at 1 site in Canada. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Royal Victoria Hospital, Canada · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
80 Years and older
Sex
All
01

Study 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. 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:

  1. 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).
  2. 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).
  3. To determine the impact of f-GOCDs on the final treatment preferences for life sustaining treatments (LSTs) documented in CODE STATUS.
  4. 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.
  5. To determine the difference in direct patient hospital costs
  6. 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.

02

Conditions studied

  • Goals of Care
  • Patient Preference
  • End of Life
03

In context

Patient Preference

112 studies on the registry are indexed under Patient Preference; 28 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 134 across 52 interventional studies indexed under Patient Preference.

Browse Patient Preference studies →

Lead sponsor

Royal Victoria Hospital, Canada is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    GOCD Tool

    Intensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool

    Other: GOCD Tool

  • Active comparator
    usual care

    Usual discussions conducted by attending physician with patient

    Other: Usual care

Interventions

  • OtherGOCD Tool

    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

  • OtherUsual care

    Attending physicians responsible for GOCD during hospitalization using their usual approaches

06

What researchers measure

Primary outcomes

  1. ICU-related health care utilization

    total number of ventilator, ICU, and dialysis days

    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

  2. ICU-related health care utilization

    total number of hospital, ventilator, ICU, and dialysis days

    Time frame: 12 months after admission from index hospital admission

Secondary outcomes

  1. CODE STATUS resuscitation preferences

    Distribution of resuscitation preferences documented in CODE STATUS

    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

  2. Change in CODE STATUS preferences

    Proportion of patients who change documented 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

  3. Resuscitation level designation

    proportion of patients with completed resuscitation preferences identified

    Time frame: At the time of index hospital discharge or death, up to 12 months after the time of index hospital admission

  4. Distribution of ICU-related days of health care utilization

    compare empirical distributions of total days of health care utilization

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

  5. Time required to complete GOCD-facilitated discussion

    Total time required to complete intervention

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

  6. Quality of communication

    assessment of patient perceptions of quality of goals of care discussion

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

  7. patient satisfaction with GOCD discussion

    patient satisfaction with goals of care discussions

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

  8. Evaluation of GOCD tool

    patient's perceptions of quality of web-based tool

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

  9. Patient-provider agreement on resuscitation preferences

    decision concordance between patients and providers

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

  10. Death

    date and time and place of death during study period

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

  11. Direct hospital costs

    Difference in direct hospital costs

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No — Only upon request, de-identified data may be shared

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06002113
Lead sponsor
Royal Victoria Hospital, Canada
Collaborators
Royal Victoria Regional Health Centre
Responsible party
Giulio DiDiodato (Chief Research Scientist, Royal Victoria Hospital, Canada) — Principal investigator
First posted
Aug 21, 2023
Start date
Oct 3, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Nov 21, 2025

Study contacts

Giulio DiDiodato, MD PhD
Contact
didiodatog@rvh.on.ca
7057289090 ext. 45641
Kelly Cruise, BHSc
Contact
cruisek@rvh.on.ca
7057289090 ext. 45639
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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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