NCT Number: NCT06629142
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 feasibility pilot study will be conducted with 6 hospitals at two large U.S. health systems and enroll 540 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 60% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. In this cluster-randomized trial, the 6 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalists are trained using the Center to Advance Palliative Care (CAPC) online trainings. The pilot study will only measure process outcomes to assess the feasibility of a larger clinical trial (e.g., are the interventions working as intended). This pilot feasibility study is the precursor to a much larger pragmatic, hybrid effectiveness-implementation parallel-cluster RCT that will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures.
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Notify Me18 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.
Moderately high-risk patients (e.g., with a 1-year mortality risk between 60% and 94%) will receive usual care. For very high-risk patients (e.g., 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: 36 to 60 hours post admission
Percentage of all Intervention Our Practice Advisory (OPAs) that fired in the correct time window for patients with mortality risk thresholds eligible for each intervention.
Time frame: Enrollment - 1 month post-discharge
Percentage of 1-month PRO surveys completed by alive patients or their surrogate proxies
Time frame: Enrollment - 3 months post-discharge
Percentage of 3-month PRO surveys completed by alive patients or their surrogate proxies
Time frame: 36 hours to 170 hours post admission
Percentage of default specialist PC orders that resulted in an inpatient PC consult before hospital discharge
Time frame: 36 hours to 60 hours post admission
Percentage of default specialist PC orders in which a generalist clinician indicated they did not want the order to proceed.
Time frame: 0 to 60 hours post admission
Percentage of all patient encounters in whom at least one Our Practice Advisory (OPA) fired inappropriately. This includes an OPA firing outside the allowed time window on a patient who is eligible, the firing of the wrong OPA on a patient who is eligible (e.g., firing of the Generalist PC OPA for a patient in the Specialist PC arm), and the firing of any OPA on a patient who is ineligible (e.g., who has an inappropriate mortality risk score or active discharge order at the time enrollment eligibility is assessed).
Time frame: Baseline
Percentage of clinicians eligible for CAPC palliative care training in the Generalist PC arm who complete the 4 required training modules. Partial completion (1-3 required modules) and completion of optional CAPC modules will be secondarily reported.
Time frame: 36 hours to 60 hours post admission
Percentage of clinicians in the Generalist PC arm who say they are addressing patients' PC needs during the current encounter, and of those, the percentage who document at least 1 of 4 PC Domains in the EHR Our Practice Advisory Alert
University of Pennsylvania
Other
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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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