Skip to main content
OpenTrials
Completed

NCT Number: NCT05502861

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Generalist + Specialist palliative care

Behavioral

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.

Other names: Active choice generalist palliative care

Pre-Intervention phase

Behavioral

Patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care.

Other names: Usual care

Primary outcomes

  1. Hospital-free days

    Time frame: 6 months

    Days from enrollment spent alive and not in an acute care hospital through 6 months or death

Secondary outcomes

  1. Goals of Care (GOC) conversation within a discrete GOC note type

    Time frame: 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

  2. Pain scores

    Time frame: up to 6 weeks

    pain level according to standardized scale across hospitals after enrollment

  3. Palliative care consultation note

    Time frame: up to 6 weeks

    Presence or absence of signed inpatient palliative care note after enrollment

  4. Time to palliative care consult

    Time frame: up to 6 weeks

    starts at time of enrollment until receipt of first documented inpatient palliative care consultation note

  5. Change in code status found in chart documentation

    Time frame: up to 6 weeks

    no change, new limitations on life support (e.g., DNAR, DNI) or discontinued limitations on life support

  6. Intensive care unit admission

    Time frame: up to 6 weeks

    admitted to any ICU during hospital encounter

  7. Hospital length of stay

    Time frame: up to 6 weeks

    number of days in hospital staring at enrollment

  8. Hospital all-cause mortality

    Time frame: up to 6 weeks

    death occurred in the hospital or within 1 day of discharge

  9. Hospice enrollment

    Time frame: up to 6 weeks

    yes if new hospice enrollment

  10. Home or clinic palliative care referral

    Time frame: up to 6 weeks

    yes if new home of clinic palliative care order after enrollment

  11. Hospital discharge disposition written in discharge order

    Time frame: up to 6 weeks

    Discharge to home, other acute facility, skilled nursing facility

  12. 30-day hospital readmission

    Time frame: 30 days

    readmission within 30 days of discharge

  13. 180-day all cause mortality

    Time frame: 180 days

    180 days after enrollment

  14. Hospital total costs

    Time frame: up to 6 weeks

    continuous hospital costs

  15. Future acute care costs

    Time frame: enrollment to 6 months post hospital discharge

    acute care costs over the 6 month follow up period

  16. Goal-concordant care

    Time frame: 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

  17. McGill Quality of Life-Revised

    Time frame: 1 month

    14-item survey instrument; score 0-10; continuous

  18. McGill Quality of Life-Revised

    Time frame: 3 months

    14-item survey instrument; score 0-10; continuous

  19. McGill Quality of Life-Revised

    Time frame: 6 months

    14-item survey instrument; score 0-10; continuous

  20. CMS-MACRA PC Quality

    Time frame: 1 month

    (1) felt heard and understood (4-items); (2) received desired help for pain (3-items); continuous

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.