NCT Number: NCT07224594
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Kaiser Permanente Southern California, Pasadena, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Enrollment- 182 days.
Count of days from enrollment spent alive outside of an acute care hospital through 182 days.
Time frame: 1-month, 3-months, and 6-months post-enrollment
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 post-enrollment
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
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
Patient or caregiver report of the patient's perception of whether their treatment matched what they wanted.
Time frame: 1-month post-enrollment
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
Patient or caregiver report of patient's loneliness using the 3-item Duke UCLA loneliness scale.
Time frame: Enrollment - 3-months post-enrollment
Count of days from enrollment spent alive and not in an acute care hospital through 3 months.
Time frame: Enrollment - 3-months post-enrollment
Count of days from enrollment spent alive and not in any care facility through 3 months.
Time frame: Enrollment - 6-months post-enrollment
Count of days from enrollment spent alive and not in any care facility through 6 months.
Time frame: Enrollment - 30 days post-enrollment
Count of readmissions
Time frame: Enrollment - 90 days post-enrollment
Count of readmissions.
Time frame: Enrollment - 6-months post-enrollment
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
Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of hospice.
Time frame: Enrollment- Discharge from hospital (an average of 7 days)
Binary indicator of whether code status changed from enrollment.
Time frame: Enrollment- Discharge from hospital (an average of 7 days)
Time from enrollment until receipt of the first documented inpatient palliative care consultation note.
Time frame: 3 months post-patient death
Caregiver report of the patient's end-of-life experience using the 14-item Family Assessment of Treatment at the End of Life Short Form (FATE-S) survey instrument and two additional questions regarding place of death and whether it was their preferred location.
University of Pennsylvania
Other
Acronym: COMPASS-PC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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