Eliciting Informed Goals of Care in Elderly Patients (ASKMEGOC)

Royal Victoria Hospital, Canada

Status: Enrolling

Conditions: Patient Preference; Goals of Care; End of Life

Treatments: Other: GOCD Tool; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06002113

R22-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

GOCD Tool

Experimental group

Description:

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

Treatment:

Other: GOCD Tool

usual care

Active Comparator group

Description:

Usual discussions conducted by attending physician with patient

Treatment:

Other: Usual care