Eliciting Informed Goals of Care in Elderly Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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End of Life, Goals of Care, Patient Preference

Intervention / Treatment
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* Other: GOCD Tool
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GOCD Tool<br>Intensive care unit-facilitated goals-of-care discussion using web-based shared-decision making software tool | Other: GOCD Tool<br>* 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<br>|
| Active Comparator: usual care<br>Usual discussions conducted by attending physician with patient | Other: Usual care<br>* Attending physicians responsible for GOCD during hospitalization using their usual approaches<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU-related health care utilization | total number of ventilator, ICU, and dialysis days | From date of randomization until hospital discharge or death in hospital, assessed up to 12 months | 
| ICU-related health care utilization | total number of ventilator, ICU, and dialysis days | 12 months after discharge from index hospital admission | 
| Goal-concordant care for ICU-related health care utilization | proportion of patients who received goal-concordant care according to resuscitation preferences | From date of randomization until hospital discharge or death in hospital, assessed up to 12 months | 
| Goal-concordant care for ICU-related health care utilization | proportion of patients who received goal-concordant care according to resuscitation preferences | 12 months after discharge from index hospital admission | 

Secondary Outcome Measures

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