Comparing Optimized Models of Primary And Specialist Services for Palliative Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Default Order, Accountable Justification, Standardized Usual Care.
- Who it may be relevant to
- Registry conditions: Seriously Ill Hospitalized Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Default Order
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. - Behavioral Accountable Justification
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. - Behavioral Standardized Usual Care
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.
Primary outcome measures
- Hospital free days [Time frame: Enrollment- 182 days.]
Secondary outcome measures (12)
- Patient quality of life [Time frame: 1-month, 3-months, and 6-months post-enrollment]
- Clinician communication [Time frame: 1-month post-enrollment]
- Pain management [Time frame: 1-month post-enrollment]
- Goal concordant care [Time frame: 1-month post-enrollment]
- Social interaction [Time frame: 1-month post-enrollment]
- Loneliness [Time frame: 1-month post-enrollment]
- Hospital free days at 3 months [Time frame: Enrollment - 3-months post-enrollment]
- Institution free days at 3 months [Time frame: Enrollment - 3-months post-enrollment]
- Institution free days at 6 months [Time frame: Enrollment - 6-months post-enrollment]
- 30-day hospital readmissions [Time frame: Enrollment - 30 days post-enrollment]
- 90-day hospital readmissions [Time frame: Enrollment - 90 days post-enrollment]
- Community-based palliative care use [Time frame: Enrollment - 6-months post-enrollment]
Eligibility criteria
Inclusion criteria
- Age 18 years of age or older; AND Predicted 1-year mortality risk of 70% or greater; AND Admitted to a study hospital.
Exclusion criteria
- Patients who die or have an active or completed discharge order prior to enrollment time OR
- Readmission within 182 days of an eligible encounter OR
- Ineligible service line, with current admission status labeled as: hospice, acute rehabilitation, skilled nursing facility, long-term acute care, psychiatry, obstetrics
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 2 centers
- Kaiser Permanente Southern California — Pasadena
- Trinity Health — Livonia
Identifiers
NCT: NCT07224594 · 855378 · PLACER-2022C3-30553