Eliciting Informed Goals of Care in Elderly Patients

End of Life Clinical Trial

— ASKMEGOC  

Official title:

Assessment of Shared Decision-making Tool for Eliciting Informed Goals of Care in the Hospitalized Elderly (ASKMEGOC): A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06002113
• Other study ID #: R22-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: October 15, 2025

Study information

• Verified date: August 2023
• Source: Royal Victoria Hospital, Canada
• Contact: Giulio DiDiodato, MD PhD
• Phone: 7057289090
• Email: didiodatog[@]rvh.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

2. To determine the impact of facilitated GOCDs on the number of hospital, ICU, ventilator, and dialysis days after the index hospitalization until 12 months post-discharge (or until death).

3. To determine the impact of facilitated GOCDs on the concordance between documented patient preferences for Life-Sustaining Therapies (LSTs) (during the index hospitalization) and whether these LSTs were received after the index hospitalization until 12 months post-discharge (or until death).

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 barriers and facilitators to the implementation of GOCDs.

Design:

A prospective, single-centre, stratified, parallel group, allocation concealed, statistician-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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patients = 80 years old with an acute medical or surgical condition admitted to any hospital ward

• 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)

Related Conditions & MeSH terms

• Death
• End of Life
• Goals of Care
• Patient Preference

Intervention

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
• Usual care
Attending physicians responsible for GOCD during hospitalization using their usual approaches

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Royal Victoria Hospital, Canada	Alectra, Royal Victoria Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU-related health care utilization	total number of ventilator, ICU, and dialysis days	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Primary	ICU-related health care utilization	total number of ventilator, ICU, and dialysis days	12 months after discharge from index hospital admission
Primary	Goal-concordant care for ICU-related health care utilization	proportion of patients who received goal-concordant care according to resuscitation preferences	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Primary	Goal-concordant care for ICU-related health care utilization	proportion of patients who received goal-concordant care according to resuscitation preferences	12 months after discharge from index hospital admission
Secondary	Resuscitation level designation	proportion of patients with completed resuscitation preferences identified	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Secondary	Distribution of ICU-related days of health care utilization	compare empirical distributions of total days of health care utilization	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Secondary	Time required to complete GOCD-facilitated discussion	Total time required to complete intervention	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Secondary	Quality of communication	assessment of patient perceptions of quality of goals of care discussion	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Secondary	patient satisfaction with GOCD discussion	patient satisfaction with goals of care discussions	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Secondary	Evaluation of GOCD tool	patient's perceptions of quality of web-based tool	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Secondary	Patient-provider agreement on resuscitation preferences	decision concordance between patients and providers	From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
Secondary	Death	date and time and place of death during study period	From date of randomization until death in hospital or after discharge, assessed up to 12 months