Clinical trial NCT05502861: A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients
Official title: A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients: the Palliative Connect Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Palliative Care
Keywords: Palliative Care, Pragmatic Trial
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-08-16
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: stepped-wedge cluster (at hospital-level) randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hospital-free days
timeFrame: 6 months
Secondary outcomes:
measure: Goals of Care (GOC) conversation within a discrete GOC note type
timeFrame: up to 6 weeks
measure: Pain scores
timeFrame: up to 6 weeks
measure: Palliative care consultation note
timeFrame: up to 6 weeks
measure: Time to palliative care consult
timeFrame: up to 6 weeks
measure: Change in code status found in chart documentation
timeFrame: up to 6 weeks
measure: Intensive care unit admission
timeFrame: up to 6 weeks
measure: Hospital length of stay
timeFrame: up to 6 weeks
measure: Hospital all-cause mortality
timeFrame: up to 6 weeks
measure: Hospice enrollment
timeFrame: up to 6 weeks
measure: Home or clinic palliative care referral
timeFrame: up to 6 weeks
measure: Hospital discharge disposition written in discharge order
timeFrame: up to 6 weeks
measure: 30-day hospital readmission
timeFrame: 30 days
measure: 180-day all cause mortality
timeFrame: 180 days
measure: Hospital total costs
timeFrame: up to 6 weeks
measure: Future acute care costs
timeFrame: enrollment to 6 months post hospital discharge
measure: Goal-concordant care
timeFrame: enrollment to 6 months post hospital discharge
measure: McGill Quality of Life-Revised
timeFrame: 1 month
measure: McGill Quality of Life-Revised
timeFrame: 3 months
measure: McGill Quality of Life-Revised
timeFrame: 6 months
measure: CMS-MACRA PC Quality
timeFrame: 1 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine R Courtright, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: