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 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
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
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.
Sponsors
University of Pennsylvania
Duke Clinical Research Institute
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital free days | Enrollment- 182 days. | Count of days from enrollment spent alive outside of an acute care hospital through 182 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient quality of life | 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. |
| Clinician communication | 1-month post-enrollment | Patient or caregiver report of how much patients feel heard and understood, using the 4-item CMS-MACRA survey instrument |
| Pain management | 1-month post-enrollment | Patient or caregiver report of whether patients receive desired help for pain, using the 3-item CMS-MACRA survey instrument. |
| Goal concordant care | 1-month post-enrollment | Patient or caregiver report of the patient's perception of whether their treatment matched what they wanted. |
| Social interaction | 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 |
| Loneliness | 1-month post-enrollment | Patient or caregiver report of patient's loneliness using the 3-item Duke UCLA loneliness scale. |
| Hospital free days at 3 months | Enrollment - 3-months post-enrollment | Count of days from enrollment spent alive and not in an acute care hospital through 3 months. |
| Institution free days at 3 months | Enrollment - 3-months post-enrollment | Count of days from enrollment spent alive and not in any care facility through 3 months. |
| Institution free days at 6 months | Enrollment - 6-months post-enrollment | Count of days from enrollment spent alive and not in any care facility through 6 months. |
| 30-day hospital readmissions | Enrollment - 30 days post-enrollment | Count of readmissions |
| 90-day hospital readmissions | Enrollment - 90 days post-enrollment | Count of readmissions. |
| Community-based palliative care use | 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. |
| Hospice use | 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. |
| Change in code status | Enrollment- Discharge from hospital (an average of 7 days) | Binary indicator of whether code status changed from enrollment. |
| Time to palliative care consult | Enrollment- Discharge from hospital (an average of 7 days) | Time from enrollment until receipt of the first documented inpatient palliative care consultation note. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORScott Halpern, MD, PhD
University of Pennsylvania
PRINCIPAL_INVESTIGATORKatherine Courtright, MD, MS
University of Pennsylvania
Outcome results
None listed