Recruiting

Observational Study

Sponsor:

Royal Victoria Hospital, Canada

Code:

NCT06002113

Conditions

Goals of Care

Patient Preference

End of Life

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

GOCD Tool

Usual care

Study Details

Brief 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.

Conditions

Goals of Care

Patient Preference

End of Life

Study ID

NCT06002113

Start date

Oct 3, 2023

Status verified date

Nov, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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:

  • 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)

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: GOCD Tool

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

active comparator: usual care

Usual discussions conducted by attending physician with patient

Interventions

GOCD 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

Usual care

Attending physicians responsible for GOCD during hospitalization using their usual approaches

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 ]
  • ICU-related health care utilization [ Time Frame: 12 months after admission from index hospital admission ]

Central Contacts and Locations

Central contacts

Giulio DiDiodato, MD PhD

7057289090didiodatog@rvh.on.ca

Locations

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M6M2

Contacts

Kelly Cruise, BSc

cruisek@rvh.on.ca

More Information

Sponsor

Royal Victoria Hospital, Canada

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Royal Victoria Hospital, Canada on 2025-11-21.