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NCT Number: NCT06002113

Eliciting Informed Goals of Care in Elderly Patients

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.

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Key information

Conditions

Goals of Care Behavior Death End of Life Health Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M6M2, Canada

Location status: Recruiting

Location contact

Kelly Cruise, BSc

CONTACT

[email protected]

About this study

Objectives:

  • 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).
  • 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).
  • To determine the impact of f-GOCDs on the final treatment preferences for life sustaining treatments (LSTs) documented in CODE STATUS.
  • 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.
  • To determine the difference in direct patient hospital costs
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GOCD Tool

Other

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

Other

Attending physicians responsible for GOCD during hospitalization using their usual approaches

Primary outcomes

  1. 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

    total number of ventilator, ICU, and dialysis days

  2. ICU-related health care utilization

    Time frame: 12 months after admission from index hospital admission

    total number of hospital, ventilator, ICU, and dialysis days

Secondary outcomes

  1. 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

    Distribution of resuscitation preferences documented in CODE STATUS

  2. 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

    Proportion of patients who change documented CODE STATUS preferences

  3. 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

    proportion of patients with completed resuscitation preferences identified

  4. 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

    compare empirical distributions of total days of health care utilization

  5. 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

    Total time required to complete intervention

  6. Quality of communication

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

    assessment of patient perceptions of quality of goals of care discussion

  7. patient satisfaction with GOCD discussion

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

    patient satisfaction with goals of care discussions

  8. Evaluation of GOCD tool

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

    patient's perceptions of quality of web-based tool

  9. Patient-provider agreement on resuscitation preferences

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

    decision concordance between patients and providers

  10. Death

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

    date and time and place of death during study period

  11. Direct hospital costs

    Time frame: From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months

    Difference in direct hospital costs

Study contacts

Contact information is provided by the study sponsor or research team.

Giulio DiDiodato, MD PhD

CONTACT

[email protected]

7057289090 ext. 45641

Kelly Cruise, BHSc

CONTACT

[email protected]

7057289090 ext. 45639

Sponsors and collaborators

Lead sponsor

Royal Victoria Hospital, Canada

Other

Collaborators

  • Royal Victoria Regional Health Centre

Registry information

Official study title

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

Acronym: ASKMEGOC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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