A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients

University of Pennsylvania

Status: Active, not recruiting

Conditions: Palliative Care

Treatments: Behavioral: Generalist + Specialist palliative care; Behavioral: Pre-Intervention phase

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05502861

848497

R01AG073384 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 16,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16,000 participants in 2 patient groups

Intervention

Experimental group

Description:

The study's intervention is a prognostic-triggered EHR alert to nudge clinicians to provide generalist or specialist PC. The alert notifies the clinician that the patient is likely to benefit from PC, and requires clinicians to actively choose to provide generalist PC themselves, consult PC specialist, or to defer PC. If a clinician chooses to consult specialist PC, a second alert will fire that enables them to easily and quickly place the consult order. The alert will trigger for all patients with moderate or higher 6-month mortality risk on second full hospital day at 8AM.

Treatment:

Behavioral: Generalist + Specialist palliative care

Control/Usual Care

Active Comparator group

Description:

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. The length of the control phase will differ at each hospital dependent on the sequence in which hospitals are randomly assigned to switch to the intervention phase. All hospitals contribute a minimum of 15 weeks of outcomes data prior to adopting the intervention.

Treatment:

Behavioral: Pre-Intervention phase