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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG082874-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Medstar Health Research Institute | OTHER |
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This stepped-wedge, cluster randomized pragmatic trial among 9 MedStar hospitals for patients with serious illness and unmet palliative care (PC) needs will test two interventions embedded within the electronic health record (EHR): (1) a PC needs triggered alert to opt-in to PC consults nudging hospital clinicians to order specialty PC consults for eligible inpatients, and (2) a palliative care needs triggered alert with an opt-out to palliative care consults. The trial will compare the interventions effects to usual care, focusing on completed PC consults during the hospital encounter and other secondary outcomes. The trial also includes an embedded mixed methods study to explore factors influencing the effectiveness and equity of intervention implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative care needs information provision | Active Comparator | Clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs |
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| Palliative care needs information provision + default consult order | Active Comparator | The palliative care needs information provision intervention will be supplemented with a default palliative care consult order such that clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs, and offered the choice to cancel the default consult order. |
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| Control/Usual Care | No Intervention | During the control phase, patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care. All hospitals will contribute a minimum of 9 weeks of outcomes data prior to adopting the intervention. The total duration of the control phase will differ for each hospital dependent on their randomly assigned time to adopt Intervention 1 in this stepped-wedge trial design. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative care needs information | Behavioral | clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs |
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| Measure | Description | Time Frame |
|---|---|---|
| Inpatient palliative care consultation | Binary: at least 1 inpatient visit from a PC specialist during the hospital encounter | from enrollment up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hospice enrollment | Binary: hospice enrollment (any level of service) | enrollment through 6 months |
| Hospice duration | Continuous: total days enrolled in hospice (any level of service) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Courtright, MD, MS | University of Pennsylvania | Principal Investigator |
| Michael Harhay, PhD, MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States | ||
Individual participant data will be made available to researchers upon request and approval by the study investigators of a valid research proposal.
Individual participant data generated from this project will be made available no later than 1 year after publication of the primary trial manuscript.
Proposals for data use will be reviewed by Principal Investigator and independent review boards (such as Institutional Review Board, Data Safety and Monitoring Board, and a Stakeholder Advisory Committee). Approved data requestors will need to sign data use agreements to access and use de-identified data.
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| Default consult order | Behavioral | clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs + a choice to cancel the default palliative care consult order |
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| enrollment through 6 months |
| Community palliative care referral | Binary: order for community (home or outpatient clinic) palliative care consultation | enrollment through 6 months |
| Hospital all-cause mortality | Binary: (primary definition) death in the hospital; (secondary/sensitivity definition) death in the hospital or within 1 calendar day of discharge day. | enrollment to 1 day after hospital discharge |
| 30-day hospital readmission | Binary: date of admission to an acute care hospital is within 30 days of hospital discharge | hospital discharge through 30 days |
| Number of readmissions | Count: number of acute care hospital admissions | enrollment through 6 months |
| Hospital-free days | Count: days from enrollment spent alive and not in an acute care hospital through 6 months or death | Enrollment through 6 months |
| Change in code status | Binary; any change in code status order at enrollment and code status order at hospital discharge | from enrollment up to 26 weeks |
| Time to palliative care consult | Continuous (hours): enrollment to documentation timestamp of first inpatient palliative care consult | from enrollment up to 26 weeks |
| Discharge to hospice | Binary: (primary definition) hospital discharge disposition to hospice (any location or level of service); (secondary/sensitivity analysis definition) hospital discharge disposition to hospice or comfort-focused care orders in-hospital | from enrollment up to 26 weeks |
| Hospital length of stay | Continuous: enrollment time to hospital discharge order timestamp. | from enrollment up to 26 weeks |
| MedStar Washington Health Center |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| MedStar Harbor Hospital | Baltimore | Maryland | 21225 | United States |
| MedStar Franklin Square Medical Center | Baltimore | Maryland | 21237 | United States |
| MedStar Good Samaritan Hospital | Baltimore | Maryland | 21239 ยท | United States |
| MedStar Southern Maryland Hospital Center | Clinton | Maryland | 20735 | United States |
| MedStar St. Mary's Hospital | Leonardtown | Maryland | 20650 | United States |
| MedStar Montgomery Medical Center | Olney | Maryland | 20832 | United States |