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

Overview

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.

Interventions

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

Primary outcome measures

• ICU-related health care utilization [Time frame: From the time of index hospital admission until hospital discharge or death, up to 12 months after the time of index hospital admission]
• ICU-related health care utilization [Time frame: 12 months after admission from index hospital admission]

Secondary outcome measures (11)

• CODE STATUS resuscitation preferences [Time frame: At the time of index hospital discharge or death during the index hospitalization, up to 12 months after the time of index hospital admission]
• Change in CODE STATUS preferences [Time frame: At the time of index hospital discharge or death during the index hospitalization, up to 12 months after the time of index hospital admission]
• Resuscitation level designation [Time frame: At the time of index hospital discharge or death, up to 12 months after the time of index hospital admission]
• Distribution of ICU-related days of health care utilization [Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months]
• Time required to complete GOCD-facilitated discussion [Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months]
• Quality of communication [Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months]
• patient satisfaction with GOCD discussion [Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months]
• Evaluation of GOCD tool [Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months]
• Patient-provider agreement on resuscitation preferences [Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months]
• Death [Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months]
• Direct hospital costs [Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months]

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 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Canada · 1 center

• Royal Victoria Regional Health Centre — Barrie

Publications

• Martin C, Cruise K, Aggarwal M, Austgarden D, DiDiodato G. Assessment of shared decision-making tool for eliciting informed goals of care in the hospitalized elderly (ASKmeGOC): protocol for a randomized clinical trial. Trials. 2025 Dec 16;27(1):60. doi: 10.1186/s13063-025-09323-6. PMID 41402864

Identifiers

NCT: NCT06002113 · R22-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗