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Eliciting Informed Goals of Care in Elderly Patients (ASKMEGOC)

Primary Purpose

Goals of Care, Patient Preference, End of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GOCD Tool
Usual care
Sponsored by
Royal Victoria Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Goals of Care

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    GOCD Tool

    usual care

    Arm Description

    Intensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool

    Usual discussions conducted by attending physician with patient

    Outcomes

    Primary Outcome Measures

    ICU-related health care utilization
    total number of ventilator, ICU, and dialysis days
    ICU-related health care utilization
    total number of ventilator, ICU, and dialysis days
    Goal-concordant care for ICU-related health care utilization
    proportion of patients who received goal-concordant care according to resuscitation preferences
    Goal-concordant care for ICU-related health care utilization
    proportion of patients who received goal-concordant care according to resuscitation preferences

    Secondary Outcome Measures

    Resuscitation level designation
    proportion of patients with completed resuscitation preferences identified
    Distribution of ICU-related days of health care utilization
    compare empirical distributions of total days of health care utilization
    Time required to complete GOCD-facilitated discussion
    Total time required to complete intervention
    Quality of communication
    assessment of patient perceptions of quality of goals of care discussion
    patient satisfaction with GOCD discussion
    patient satisfaction with goals of care discussions
    Evaluation of GOCD tool
    patient's perceptions of quality of web-based tool
    Patient-provider agreement on resuscitation preferences
    decision concordance between patients and providers
    Death
    date and time and place of death during study period

    Full Information

    First Posted
    July 27, 2023
    Last Updated
    August 14, 2023
    Sponsor
    Royal Victoria Hospital, Canada
    Collaborators
    Royal Victoria Foundation, Alectra
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06002113
    Brief Title
    Eliciting Informed Goals of Care in Elderly Patients
    Acronym
    ASKMEGOC
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    October 15, 2024 (Anticipated)
    Study Completion Date
    October 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Royal Victoria Hospital, Canada
    Collaborators
    Royal Victoria Foundation, Alectra

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    Detailed Description
    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) 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). 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). 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Goals of Care, Patient Preference, End of Life

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GOCD Tool
    Arm Type
    Experimental
    Arm Description
    Intensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool
    Arm Title
    usual care
    Arm Type
    Active Comparator
    Arm Description
    Usual discussions conducted by attending physician with patient
    Intervention Type
    Other
    Intervention Name(s)
    GOCD Tool
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Intervention Description
    Attending physicians responsible for GOCD during hospitalization using their usual approaches
    Primary Outcome Measure Information:
    Title
    ICU-related health care utilization
    Description
    total number of ventilator, ICU, and dialysis days
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    ICU-related health care utilization
    Description
    total number of ventilator, ICU, and dialysis days
    Time Frame
    12 months after discharge from index hospital admission
    Title
    Goal-concordant care for ICU-related health care utilization
    Description
    proportion of patients who received goal-concordant care according to resuscitation preferences
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    Goal-concordant care for ICU-related health care utilization
    Description
    proportion of patients who received goal-concordant care according to resuscitation preferences
    Time Frame
    12 months after discharge from index hospital admission
    Secondary Outcome Measure Information:
    Title
    Resuscitation level designation
    Description
    proportion of patients with completed resuscitation preferences identified
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    Distribution of ICU-related days of health care utilization
    Description
    compare empirical distributions of total days of health care utilization
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    Time required to complete GOCD-facilitated discussion
    Description
    Total time required to complete intervention
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    Quality of communication
    Description
    assessment of patient perceptions of quality of goals of care discussion
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    patient satisfaction with GOCD discussion
    Description
    patient satisfaction with goals of care discussions
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    Evaluation of GOCD tool
    Description
    patient's perceptions of quality of web-based tool
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    Patient-provider agreement on resuscitation preferences
    Description
    decision concordance between patients and providers
    Time Frame
    From date of randomization until hospital discharge or death in hospital, assessed up to 12 months
    Title
    Death
    Description
    date and time and place of death during study period
    Time Frame
    From date of randomization until death in hospital or after discharge, assessed up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Giulio DiDiodato, MD PhD
    Phone
    7057289090
    Ext
    45641
    Email
    didiodatog@rvh.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kelly Cruise, BHSc
    Phone
    7057289090
    Ext
    45639
    Email
    cruisek@rvh.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giulio DiDiodato, MD PhD
    Organizational Affiliation
    Royal Victoria Regional Health Centre
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Chris Martin, MD
    Organizational Affiliation
    Royal Victoria Regional Health Centre
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Doug Austgarden, MD
    Organizational Affiliation
    Royal Victoria Regional Health Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

    Learn more about this trial

    Eliciting Informed Goals of Care in Elderly Patients

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