Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. This pragmatic clinical trial will be conducted with 48 hospitals at two large U.S. health systems and enroll more than 78,000 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 70% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. The 48 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalist clinicians are trained using the Center to Advance Palliative Care (CAPC) online trainings. This pragmatic, hybrid effectiveness-implementation parallel-cluster RCT will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures, and follows a pilot feasibility study. We will collect Patient-Reported Outcomes (PROs) surveys from a random subset of enrolled patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
78,302
A specialist PC consult is automatically ordered for patients meeting a certain threshold of 1-year mortality risk (dependent on arm). An EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so.
An EHR-based Our Practice Advisory alert asks generalist clinicians to self-report whether they have provided primary PC by clicking which of 4 key PC domains they have addressed or to provide a brief justification as to why not.
High-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. For very high-risk patients (i.e., with a 1-year mortality risk of ≥ 95%), an EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so.
Kaiser Permanente Southern California
Pasadena, California, United States
Trinity Health
Livonia, Michigan, United States
Hospital free days
Count of days from enrollment spent alive outside of an acute care hospital through 182 days.
Time frame: Enrollment- 182 days.
Patient quality of life
Patient or caregiver report of the patient's quality of life using the 15-item McGill Quality of Life survey instrument.
Time frame: 1-month, 3-months, and 6-months post-enrollment
Clinician communication
Patient or caregiver report of how much patients feel heard and understood, using the 4-item CMS-MACRA survey instrument
Time frame: 1-month post-enrollment
Pain management
Patient or caregiver report of whether patients receive desired help for pain, using the 3-item CMS-MACRA survey instrument.
Time frame: 1-month post-enrollment
Goal concordant care
Patient or caregiver report of the patient's perception of whether their treatment matched what they wanted.
Time frame: 1-month post-enrollment
Social interaction
Patient or caregiver report of patient's social support using the 4-item Duke Social Support Index's Social Interaction Sub-scale
Time frame: 1-month post-enrollment
Loneliness
Patient or caregiver report of patient's loneliness using the 3-item Duke UCLA loneliness scale.
Time frame: 1-month post-enrollment
Hospital free days at 3 months
Count of days from enrollment spent alive and not in an acute care hospital through 3 months.
Time frame: Enrollment - 3-months post-enrollment
Institution free days at 3 months
Count of days from enrollment spent alive and not in any care facility through 3 months.
Time frame: Enrollment - 3-months post-enrollment
Institution free days at 6 months
Count of days from enrollment spent alive and not in any care facility through 6 months.
Time frame: Enrollment - 6-months post-enrollment
30-day hospital readmissions
Count of readmissions
Time frame: Enrollment - 30 days post-enrollment
90-day hospital readmissions
Count of readmissions.
Time frame: Enrollment - 90 days post-enrollment
Community-based palliative care use
Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of PC visits.
Time frame: Enrollment - 6-months post-enrollment
Hospice use
Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of hospice.
Time frame: Enrollment - 6-months post-enrollment
Change in code status
Binary indicator of whether code status changed from enrollment.
Time frame: Enrollment- Discharge from hospital (an average of 7 days)
Time to palliative care consult
Time from enrollment until receipt of the first documented inpatient palliative care consultation note.
Time frame: Enrollment- Discharge from hospital (an average of 7 days)
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