Clinical trial NCT06002113: Eliciting Informed Goals of Care in Elderly Patients
Official title: Assessment of Shared Decision-making Tool for Eliciting Informed Goals of Care in the Hospitalized Elderly (ASKMEGOC): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Goals of Care
Patient Preference
End of Life
Lead sponsor: Royal Victoria Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Royal Victoria Regional Health Centre
First posted: 2023-08-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 do not 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)

Primary outcomes:
measure: ICU-related health care utilization
timeFrame: From the time of index hospital admission until hospital discharge or death, up to 12 months after the time of index hospital admission
measure: ICU-related health care utilization
timeFrame: 12 months after admission from index hospital admission
Secondary outcomes:
measure: CODE STATUS resuscitation preferences
timeFrame: At the time of index hospital discharge or death during the index hospitalization, up to 12 months after the time of index hospital admission
measure: Change in CODE STATUS preferences
timeFrame: At the time of index hospital discharge or death during the index hospitalization, up to 12 months after the time of index hospital admission
measure: Resuscitation level designation
timeFrame: At the time of index hospital discharge or death, up to 12 months after the time of index hospital admission
measure: Distribution of ICU-related days of health care utilization
timeFrame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
measure: Time required to complete GOCD-facilitated discussion
timeFrame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
measure: Quality of communication
timeFrame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
measure: patient satisfaction with GOCD discussion
timeFrame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
measure: Evaluation of GOCD tool
timeFrame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
measure: Patient-provider agreement on resuscitation preferences
timeFrame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
measure: Death
timeFrame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
measure: Direct hospital costs
timeFrame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
Study officials:
affiliation: Royal Victoria Regional Health Centre
name: Giulio DiDiodato, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Victoria Regional Health Centre
name: Chris Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Victoria Regional Health Centre
name: Doug Austgarden, MD
role: PRINCIPAL_INVESTIGATOR
References: