End of Life, Goals of Care, Patient Preference
Conditions
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: 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
OTHERGOCD 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
OTHERUsual care
Attending physicians responsible for GOCD during hospitalization using their usual approaches
Sponsors
Royal Victoria Regional Health Centre
Royal Victoria Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU-related health care utilization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CODE STATUS preferences | 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 |
| Resuscitation level designation | 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 |
| Distribution of ICU-related days of health care utilization | 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 |
| Time required to complete GOCD-facilitated discussion | From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months | Total time required to complete intervention |
| Quality of communication | 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 |
| CODE STATUS resuscitation preferences | 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 |
| Evaluation of GOCD tool | 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 |
| Patient-provider agreement on resuscitation preferences | From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months | decision concordance between patients and providers |
| Death | 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 |
| Direct hospital costs | From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months | Difference in direct hospital costs |
| patient satisfaction with GOCD discussion | From index hospital admission until hospital discharge or death in hospital, assessed up to 12 months | patient satisfaction with goals of care discussions |
Countries
Canada
Contacts
Primary ContactGiulio DiDiodato, MD PhD
Backup ContactKelly Cruise, BHSc
Outcome results
None listed