Seriously Ill Hospitalized Patients
Conditions
Keywords
Palliative
Brief summary
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.
Interventions
BEHAVIORALDefault 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.
BEHAVIORALAccountable 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.
BEHAVIORALStandardized Usual Care
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.
Sponsors
Duke Clinical Research Institute
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years of age or older; AND * Predicted 1-year mortality risk of 60% 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appropriate Firings of All Our Practice Advisory (OPA) Interventions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PRO Survey Response Rate at 3 months | Enrollment - 3 months post-discharge | Percentage of 3-month PRO surveys completed by alive patients or their surrogate proxies |
| Default Specialist PC Consults | 36 hours to 170 hours post admission | Percentage of default specialist PC orders that resulted in an inpatient PC consult before hospital discharge |
| Default Specialist PC Order Cancellation Rate | 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. |
| Patient-Reported Outcome (PRO) Survey Response Rate at 1 month | Enrollment - 1 month post-discharge | Percentage of 1-month PRO surveys completed by alive patients or their surrogate proxies |
| Generalist PC Training Completion | 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. |
| Generalist PC Domain Completion | 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 |
| Inappropriate Our Practice Advisory (OPA) Firings | 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). |
Countries
United States
Outcome results
None listed