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

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05502861
• Other study ID #: 848497
• Secondary ID: R01AG073384
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 16000
• Est. completion date: June 2026
• Est. primary completion date: November 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• Generalist + 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.
• Pre-Intervention phase
Patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital-free days	Days from enrollment spent alive and not in an acute care hospital through 6 months or death	6 months
Secondary	Goals of Care (GOC) conversation within a discrete GOC note type	Presence or absence of documented GOC conversation after enrollment detected by natural language programming algorithm or by a discrete GOC note type	up to 6 weeks
Secondary	Pain scores	pain level according to standardized scale across hospitals after enrollment	up to 6 weeks
Secondary	Palliative care consultation note	Presence or absence of signed inpatient palliative care note after enrollment	up to 6 weeks
Secondary	Time to palliative care consult	starts at time of enrollment until receipt of first documented inpatient palliative care consultation note	up to 6 weeks
Secondary	Change in code status found in chart documentation	no change, new limitations on life support (e.g., DNAR, DNI) or discontinued limitations on life support	up to 6 weeks
Secondary	Intensive care unit admission	admitted to any ICU during hospital encounter	up to 6 weeks
Secondary	Hospital length of stay	number of days in hospital staring at enrollment	up to 6 weeks
Secondary	Hospital all-cause mortality	death occurred in the hospital or within 1 day of discharge	up to 6 weeks
Secondary	Hospice enrollment	yes if new hospice enrollment	up to 6 weeks
Secondary	Home or clinic palliative care referral	yes if new home of clinic palliative care order after enrollment	up to 6 weeks
Secondary	Hospital discharge disposition written in discharge order	Discharge to home, other acute facility, skilled nursing facility	up to 6 weeks
Secondary	30-day hospital readmission	readmission within 30 days of discharge	30 days
Secondary	180-day all cause mortality	180 days after enrollment	180 days
Secondary	Hospital total costs	continuous hospital costs	up to 6 weeks
Secondary	Future acute care costs	acute care costs over the 6 month follow up period	enrollment to 6 months post hospital discharge
Secondary	Goal-concordant care	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	enrollment to 6 months post hospital discharge
Secondary	McGill Quality of Life-Revised	14-item survey instrument; score 0-10; continuous	1 month
Secondary	McGill Quality of Life-Revised	14-item survey instrument; score 0-10; continuous	3 months
Secondary	McGill Quality of Life-Revised	14-item survey instrument; score 0-10; continuous	6 months
Secondary	CMS-MACRA PC Quality	(1) felt heard and understood (4-items); (2) received desired help for pain (3-items); continuous	1 month