Eliciting Informed Goals of Care in Elderly Patients

NCT06002113 | Recruiting DMC

• 1 other identifier: R22-003
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• ICU-related health care utilization

  total number of ventilator, ICU, and dialysis days

  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

  12 months after admission from index hospital admission

Secondary Outcomes (11)

• CODE STATUS resuscitation preferences

  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

  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

  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

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

• Time required to complete GOCD-facilitated discussion

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

Study Arms (2)

GOCD Tool

EXPERIMENTAL

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

Other: GOCD Tool

usual care

ACTIVE COMPARATOR

Usual discussions conducted by attending physician with patient

Other: Usual care

Interventions

GOCD Tool 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

GOCD Tool

Usual care OTHER

Attending physicians responsible for GOCD during hospitalization using their usual approaches

usual care

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal Victoria Hospital, Canada: lead
• Royal Victoria Regional Health Centre: collaborator

Study Sites (1)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M6M2, Canada

RECRUITING

Related Publications (1)

• 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. doi: 10.1186/s13063-025-09323-6. Online ahead of print.

  PMID: 41402864 DERIVED

MeSH Terms

Conditions

Patient Preference; Death

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giulio DiDiodato, MD PhD

  Royal Victoria Regional Health Centre

  PRINCIPAL INVESTIGATOR

• Chris Martin, MD

  Royal Victoria Regional Health Centre

  PRINCIPAL INVESTIGATOR

• Doug Austgarden, MD

  Royal Victoria Regional Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulio DiDiodato, MD PhD

CONTACT

7057289090; didiodatog@rvh.on.ca

Kelly Cruise, BHSc

CONTACT

7057289090; cruisek@rvh.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Research Scientist

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 21, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)