Eliciting Informed Goals of Care in Elderly Patients (ASKMEGOC)

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.

Study Overview

• Status: Recruiting
• Conditions: End of Life; Patient Preference; Goals of Care
• Intervention / Treatment: Other: GOCD Tool; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulio DiDiodato, MD PhD; Phone Number: 45641 7057289090; Email: didiodatog@rvh.on.ca
• Study Contact Backup: Name: Kelly Cruise, BHSc; Phone Number: 45639 7057289090; Email: cruisek@rvh.on.ca

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M6M2
      • Recruiting
      • Royal Victoria Regional Health Centre
      • Contact: Kelly Cruise, BSc; Email: cruisek@rvh.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GOCD Tool; Intensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool	Other: 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
Active Comparator: usual care; Usual discussions conducted by attending physician with patient	Other: Usual care; Attending physicians responsible for GOCD during hospitalization using their usual approaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CODE STATUS resuscitation preferences	Distribution of resuscitation preferences documented in CODE STATUS	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	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	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	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	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	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	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	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	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	From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Direct hospital costs	Difference in direct hospital costs	From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

Collaborators and Investigators

• Sponsor: Royal Victoria Hospital, Canada
• Collaborators: Royal Victoria Regional Health Centre
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction; Death; Patient Preference
• Other Study ID Numbers: R22-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only upon request, de-identified data may be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No