Assessment of shared decision-making tool for eliciting informed goals of care in the hospitalized elderly (ASKmeGOC): protocol for a randomized clinical trial.
Chris Martin, Kelly Cruise, Monica Aggarwal...
https://pubmed.ncbi.nlm.nih.gov/41402864Actively Recruiting
Phase Not Applicable
Age: 80Years +
All Genders
ID06002113
Assessment of Shared Decision-making Tool for Eliciting Informed Goals of Care in the Hospitalized Elderly (ASKMEGOC): A Randomized Clinical Trial
Led by Royal Victoria Hospital, Canada · Updated on 2025-11-21
1200
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
R
Royal Victoria Hospital, Canada
Lead Sponsor
R
Royal Victoria Regional Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a shared decision-making tool designed to help elderly hospitalized patients, aged 80 and older, communicate their treatment preferences regarding end-of-life care. The study aims to improve how well patients' wishes about resuscitation and life-support treatments are identified, documented, and respected. This randomized clinical trial compares the new tool with usual care, focusing on hospitalized patients with acute medical or surgical conditions. The study is conducted at a single center and includes patients who have existing or prior documented preferences about life-sustaining treatments. Participants are randomly assigned to one of two groups: one uses an intensive care unit-facilitated goals-of-care discussion supported by a web-based shared decision-making software called the GOCD Tool, which includes components on health status, prognosis, and care goals. The other group receives usual care, where attending physicians conduct discussions using their standard methods. The trial measures how these approaches impact ICU use, ventilator and dialysis days during and after hospitalization, and whether treatment preferences are properly documented and followed. Throughout the study, participants will have their ICU-related healthcare utilization tracked from hospital admission up to 12 months post-admission or until death. Researchers will assess changes in resuscitation preferences, quality of communication, patient satisfaction, and healthcare costs. The study includes evaluations of decision-making conflicts and barriers to implementing the tool. Monitoring includes assessments of treatment preferences recorded in patients' medical records and the time needed to complete the goals-of-care discussions.
CONDITIONS
Brief Title
Eliciting Informed Goals of Care in Elderly Patients
Who Can Participate
Age: 80Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Hospitalized patients aged 80 years or older with an acute medical or surgical condition admitted to any hospital ward
- Previously or currently documented CODE STATUS preferences including any life sustaining therapies
- Hospital admission lasting 24 hours or more
- English speaking or with translator present
- Competent patient or substitute decision maker available
You will not qualify if you...
- Treating physician, patient, or substitute decision maker declines participation
- Documented resuscitation preferences for comfort or supportive care only
- New diagnosis of life-limiting illness on this hospital admission, such as metastatic cancer
- Clinically unstable, admitted to intensive care unit, or currently receiving acute life support (mechanical ventilation, acute dialysis, or inotropic/vasopressor support)
- Readmission after index hospitalization
- Pre-existing need for chronic mechanical ventilation (over 90 days) or maintenance dialysis (over 90 days)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - From hospital admission until discharge or death, up to 12 months
Participants receive facilitated Goals of Care Discussions (GOCDs) using either a web-based shared decision-making tool or usual care by attending physicians during hospitalization.
Visits occur during the hospital stay as part of routine care
Follow-up
Duration - Up to 12 months after hospital admission
Participants are monitored for ICU-related healthcare utilization, treatment preferences, quality of communication, patient satisfaction, and direct hospital costs up to 12 months after hospital admission.
Follow-up assessments may occur during hospitalization and post-discharge up to 12 months
Trial Site Locations
Total: 1 location
1
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M6M2
Actively Recruiting
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Research Team
G
Giulio DiDiodato, MD PhD
K
Kelly Cruise, BHSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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