Eliciting Informed Goals of Care in Elderly Patients (ASKMEGOC)

• ClinicalTrials.gov Identifier: NCT06002113
• Recruitment Status: Not yet recruiting
• First Posted: August 21, 2023
• Last Update Posted: August 21, 2023
• Sponsor: Royal Victoria Hospital, Canada
• Collaborators: Royal Victoria Foundation; Alectra
• Information provided by (Responsible Party): Giulio DiDiodato, Royal Victoria Hospital, Canada

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Goals of Care; Patient Preference; End of Life	Other: GOCD Tool; Other: Usual care	Not Applicable

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)
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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Assessment of Shared Decision-making Tool for Eliciting Informed Goals of Care in the Hospitalized Elderly (ASKMEGOC): A Randomized Clinical Trial
• Estimated Study Start Date: September 15, 2023
• Estimated Primary Completion Date: October 15, 2024
• Estimated Study Completion Date: October 15, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. ICU-related health care utilization [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   total number of ventilator, ICU, and dialysis days
2. ICU-related health care utilization [ Time Frame: 12 months after discharge from index hospital admission ]
   total number of ventilator, ICU, and dialysis days
3. Goal-concordant care for ICU-related health care utilization [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   proportion of patients who received goal-concordant care according to resuscitation preferences
4. Goal-concordant care for ICU-related health care utilization [ Time Frame: 12 months after discharge from index hospital admission ]
   proportion of patients who received goal-concordant care according to resuscitation preferences

Secondary Outcome Measures :

1. Resuscitation level designation [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   proportion of patients with completed resuscitation preferences identified
2. Distribution of ICU-related days of health care utilization [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   compare empirical distributions of total days of health care utilization
3. Time required to complete GOCD-facilitated discussion [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   Total time required to complete intervention
4. Quality of communication [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   assessment of patient perceptions of quality of goals of care discussion
5. patient satisfaction with GOCD discussion [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   patient satisfaction with goals of care discussions
6. Evaluation of GOCD tool [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   patient's perceptions of quality of web-based tool
7. Patient-provider agreement on resuscitation preferences [ Time Frame: From date of randomization until hospital discharge or death in hospital, assessed up to 12 months ]
   decision concordance between patients and providers
8. Death [ Time Frame: From date of randomization until death in hospital or after discharge, assessed up to 12 months ]
   date and time and place of death during study period

Eligibility Criteria

• Ages Eligible for Study: 80 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: Giulio DiDiodato, MD PhD; 7057289090 ext 45641; didiodatog@rvh.on.ca

Contact: Kelly Cruise, BHSc; 7057289090 ext 45639; cruisek@rvh.on.ca

Sponsors and Collaborators

Royal Victoria Hospital, Canada

Royal Victoria Foundation

Alectra

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

More Information

• Responsible Party: Giulio DiDiodato, Chief Research Scientist, Royal Victoria Hospital, Canada
• ClinicalTrials.gov Identifier: NCT06002113
• Other Study ID Numbers: R22-003
• First Posted: August 21, 2023
• Last Update Posted: August 21, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Only upon request, de-identified data may be shared

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Death; Pathologic Processes