Clinical trial NCT06596577: Nudging Effective and Equitable Delivery of Specialty Palliative Care
Official title: Improving the Delivery and Equity of Inpatient Palliative Care: a Hybrid Type I Pragmatic Cluster Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Serious Illness
Palliative
Keywords: Palliative Care
Pragmatic Trial
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Medstar Health Research Institute
First posted: 2024-09-19
Enrollment: 64107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 hospital-free days through 6 months and other secondary outcomes. The trial also includes an embedded mixed methods study to explore factors influencing the effectiveness and equity of intervention implementation.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older; AND
2. Inpatient status; AND
3. Meet or exceed EHR palliative care needs algorithm threshold

Exclusion Criteria:

1. Primary inpatient service: hospice, rehabilitation, psychiatry, obstetrics, neonatal
2. Signed hospital discharge order

Primary outcomes:
measure: Hospital-free days
timeFrame: Enrollment through 6 months
Secondary outcomes:
measure: Hospice enrollment
timeFrame: enrollment through 6 months
measure: Hospice duration
timeFrame: enrollment through 6 months
measure: Community palliative care referral
timeFrame: enrollment through 6 months
measure: 6-month all-cause mortality
timeFrame: enrollment through 6 months
measure: Hospital all-cause mortality
timeFrame: enrollment to 1 day after hospital discharge
measure: 30-day hospital readmission
timeFrame: hospital discharge through 30 days
measure: Number of readmissions
timeFrame: enrollment through 6 months
measure: Palliative care consultation
timeFrame: from enrollment up to 26 weeks
measure: Change in code status
timeFrame: from enrollment up to 26 weeks
measure: Time to palliative care consult
timeFrame: from enrollment up to 26 weeks
measure: Hospice discharge
timeFrame: from enrollment up to 26 weeks
measure: Hospital length of stay
timeFrame: from enrollment up to 26 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Health Center
state: District of Columbia
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: MedStar Harbor Hospital
state: Maryland
city: Baltimore
country: United States
facility: MedStar Franklin Square Medical Center
state: Maryland
city: Baltimore
country: United States
facility: MedStar Good Samaritan Hospital
state: Maryland
city: Clinton
country: United States
facility: MedStar Southern Maryland Hospital Center
state: Maryland
city: Leonardtown
country: United States
facility: MedStar St. Mary's Hospital
state: Maryland
city: Olney
country: United States
facility: MedStar Montgomery Medical Center
state: Maryland
Study officials:
affiliation: University of Pennsylvania
name: Katherine Courtright, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Michael Harhay, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: