Eliciting Informed Goals of Care in Elderly Patients

NCT ID: NCT06002113

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2027-06-01

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.

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.

Conditions

Goals of Care; Patient Preference; End of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

GOCD Tool

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

Group Type: EXPERIMENTAL

GOCD Tool

Intervention Type: OTHER

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

Usual discussions conducted by attending physician with patient

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Attending physicians responsible for GOCD during hospitalization using their usual approaches

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

Intervention Type: OTHER

Usual care

Attending physicians responsible for GOCD during hospitalization using their usual approaches

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Victoria Regional Health Centre

UNKNOWN

Sponsor Role: collaborator

Royal Victoria Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Giulio DiDiodato

Chief Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giulio DiDiodato, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Regional Health Centre

Chris Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Regional Health Centre

Doug Austgarden, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Regional Health Centre

Locations

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Giulio DiDiodato, MD PhD

Role: CONTACT

didiodatog@rvh.on.ca

7057289090 ext. 45641

Kelly Cruise, BHSc

Role: CONTACT

cruisek@rvh.on.ca

7057289090 ext. 45639

Facility Contacts

Kelly Cruise, BSc

Role: primary

cruisek@rvh.on.ca

Other Identifiers

R22-003

Identifier Type: -

Identifier Source: org_study_id