ASKMEGOC: Eliciting Informed Goals of Care in Elderly Patients

Sponsor
Royal Victoria Hospital, Canada (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06002113
Collaborator
Royal Victoria Foundation (Other), Alectra (Other)
1,200
2
25

Study Details

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
  • Other: GOCD Tool
  • Other: Usual care
N/A

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
Anticipated 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
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Oct 15, 2024
Anticipated Study Completion Date :
Oct 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [From date of randomization until hospital discharge or death in hospital, assessed up to 12 months]

    decision concordance between patients and providers

  8. Death [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

Criteria

Ages Eligible for Study:
80 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giulio DiDiodato, Chief Research Scientist, Royal Victoria Hospital, Canada
ClinicalTrials.gov Identifier:
NCT06002113
Other Study ID Numbers:
  • R22-003
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023