A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients
- Conditions
- Palliative Care
- Interventions
- Behavioral: Generalist + Specialist palliative careBehavioral: Pre-Intervention phase
- Registration Number
- NCT05502861
- Lead Sponsor
- University of Pennsylvania
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 16000
- Age 18 or older
- Inpatient or observation admission status at a study hospital
- Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention Generalist + Specialist palliative care 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. Control/Usual Care Pre-Intervention phase 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.
- Primary Outcome Measures
Name Time Method Hospital-free days 6 months Days from enrollment spent alive and not in an acute care hospital through 6 months or death
- Secondary Outcome Measures
Name Time Method Hospital discharge disposition written in discharge order up to 6 weeks Discharge to home, other acute facility, skilled nursing facility
McGill Quality of Life-Revised 6 months 14-item survey instrument; score 0-10; continuous
Pain scores up to 6 weeks pain level according to standardized scale across hospitals after enrollment
Hospice enrollment up to 6 weeks yes if new hospice enrollment
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
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
Time to palliative care consult up to 6 weeks starts at time of enrollment until receipt of first documented inpatient palliative care consultation note
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
CMS-MACRA PC Quality 1 month (1) felt heard and understood (4-items); (2) received desired help for pain (3-items); continuous
Palliative care consultation note up to 6 weeks Presence or absence of signed inpatient palliative care note after enrollment
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
180-day all cause mortality 180 days 180 days after enrollment
Home or clinic palliative care referral up to 6 weeks yes if new home of clinic palliative care order after enrollment
30-day hospital readmission 30 days readmission within 30 days of discharge
Hospital total costs up to 6 weeks continuous hospital costs
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States