Palliative Care
Conditions
Keywords
Palliative Care, Pragmatic Trial
Brief summary
This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult specialists (specialty PC) for inpatients at high risk of death within 6 months. The trial will evaluate the intervention's effect compared to usual care on the primary outcome of hospital-free days through 6 months, and other patient-centered, clinical, and economic outcomes. The trial also includes an embedded mixed methods study to understand clinician and hospital contextual factors that influence the intervention's uptake.
Interventions
BEHAVIORALGeneralist + Specialist palliative care
Clinicians are alerted in the EHR to make an active choice whether to provide generalist palliative care themselves, consult PC specialist, or to defer PC at that time.
BEHAVIORALPre-Intervention phase
Patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care.
Sponsors
University of Pennsylvania
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
stepped-wedge cluster (at hospital-level) randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Inpatient or observation admission status at a study hospital * Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher
Exclusion criteria
* Under 18 years of age * Inpatient primary service: hospice, rehabilitation, obstetrics, psychiatry * Patients that have died or been discharged before 0800 on hospital day 3 when the mortality risk is generated and enrollment occurs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-free days | 6 months | Days from enrollment spent alive and not in an acute care hospital through 6 months or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goals of Care (GOC) conversation within a discrete GOC note type | up to 6 weeks | Presence or absence of documented GOC conversation after enrollment detected by natural language programming algorithm or by a discrete GOC note type |
| Pain scores | up to 6 weeks | pain level according to standardized scale across hospitals after enrollment |
| Palliative care consultation note | up to 6 weeks | Presence or absence of signed inpatient palliative care note after enrollment |
| Time to palliative care consult | up to 6 weeks | starts at time of enrollment until receipt of first documented inpatient palliative care consultation note |
| Change in code status found in chart documentation | up to 6 weeks | no change, new limitations on life support (e.g., DNAR, DNI) or discontinued limitations on life support |
| Intensive care unit admission | up to 6 weeks | admitted to any ICU during hospital encounter |
| Hospital length of stay | up to 6 weeks | number of days in hospital staring at enrollment |
| Hospital all-cause mortality | up to 6 weeks | death occurred in the hospital or within 1 day of discharge |
| Hospice enrollment | up to 6 weeks | yes if new hospice enrollment |
| Home or clinic palliative care referral | up to 6 weeks | yes if new home of clinic palliative care order after enrollment |
| Hospital discharge disposition written in discharge order | up to 6 weeks | Discharge to home, other acute facility, skilled nursing facility |
| 30-day hospital readmission | 30 days | readmission within 30 days of discharge |
| 180-day all cause mortality | 180 days | 180 days after enrollment |
| Hospital total costs | up to 6 weeks | continuous hospital costs |
| Future acute care costs | enrollment to 6 months post hospital discharge | acute care costs over the 6 month follow up period |
| Goal-concordant care | enrollment to 6 months post hospital discharge | yes if treatments received over 6 month follow up align with goals documented in the EHR; no if treatments are misaligned with goals, or goals are unclear or undocumented |
| McGill Quality of Life-Revised | 1 month | 14-item survey instrument; score 0-10; continuous |
| CMS-MACRA PC Quality | 1 month | (1) felt heard and understood (4-items); (2) received desired help for pain (3-items); continuous |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine R Courtright, MD, MS
University of Pennsylvania
Outcome results
None listed