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| ID | Type | Description | Link |
|---|---|---|---|
| PLACER-2022C3-30553 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized Usual Care | Active Comparator | Active control group, where high-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. A specialist PC consult is ordered by default for the very high-risk patients (i.e., 1-year mortality risk ≥ 95%), unless clinicians cancel the order. |
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| Trained Generalist Palliative Care | Experimental | Generalist clinicians trained in PC domains receive an EHR-based alert to document whether or not they have addressed PC domains for high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the very high risk patients (i.e., 1-year mortality risk ≥ 95%) unless clinicians cancel the order. |
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| Specialist Palliative Care | Experimental | A specialist PC consult is ordered by default for all patients with a ≥ 70% 1-year mortality risk ('default order intervention'), unless clinicians cancel the order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Default Order | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital free days | Count of days from enrollment spent alive outside of an acute care hospital through 182 days. | Enrollment- 182 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient quality of life | Patient or caregiver report of the patient's quality of life using the 15-item McGill Quality of Life survey instrument. | 1-month, 3-months, and 6-months post-enrollment |
| Clinician communication |
| Measure | Description | Time Frame |
|---|---|---|
| End-of-Life Care | 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. | 3 months post-patient death |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Halpern, MD, PhD | University of Pennsylvania | Principal Investigator |
| Katherine Courtright, MD, MS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Southern California | Pasadena | California | 91101 | United States | ||
| Trinity Health |
De-identified data (the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes)), and analytic code from a PCORI-funded research project from this PCORI-funded clinical trial will be made available on the Patient-Centered Outcomes Data Repository.
The IPD and supporting information will be available between 3 and 6 months after the study completion date, and will be available on the Patient Centered Outcomes Data Repository in line with PCORI's policies for data retention.
Applicants will follow the guidelines as set out on the Patient Centered Outcomes Data Repository for accessing this data set.
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| Accountable Justification | Behavioral | 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. |
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| Standardized Usual Care | Behavioral | 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. |
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Patient or caregiver report of how much patients feel heard and understood, using the 4-item CMS-MACRA survey instrument
| 1-month post-enrollment |
| Pain management | Patient or caregiver report of whether patients receive desired help for pain, using the 3-item CMS-MACRA survey instrument. | 1-month post-enrollment |
| Goal concordant care | Patient or caregiver report of the patient's perception of whether their treatment matched what they wanted. | 1-month post-enrollment |
| Social interaction | Patient or caregiver report of patient's social support using the 4-item Duke Social Support Index's Social Interaction Sub-scale | 1-month post-enrollment |
| Loneliness | Patient or caregiver report of patient's loneliness using the 3-item Duke UCLA loneliness scale. | 1-month post-enrollment |
| Hospital free days at 3 months | Count of days from enrollment spent alive and not in an acute care hospital through 3 months. | Enrollment - 3-months post-enrollment |
| Institution free days at 3 months | Count of days from enrollment spent alive and not in any care facility through 3 months. | Enrollment - 3-months post-enrollment |
| Institution free days at 6 months | Count of days from enrollment spent alive and not in any care facility through 6 months. | Enrollment - 6-months post-enrollment |
| 30-day hospital readmissions | Count of readmissions | Enrollment - 30 days post-enrollment |
| 90-day hospital readmissions | Count of readmissions. | Enrollment - 90 days post-enrollment |
| Community-based palliative care use | Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of PC visits. | Enrollment - 6-months post-enrollment |
| Hospice use | Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of hospice. | Enrollment - 6-months post-enrollment |
| Change in code status | Binary indicator of whether code status changed from enrollment. | Enrollment- Discharge from hospital (an average of 7 days) |
| Time to palliative care consult | Time from enrollment until receipt of the first documented inpatient palliative care consultation note. | Enrollment- Discharge from hospital (an average of 7 days) |
| Livonia |
| Michigan |
| 48152 |
| United States |