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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Palliative Care
• Intervention / Treatment: Behavioral: Generalist + Specialist palliative care; Behavioral: Pre-Intervention phase

• Study Type: Interventional
• Enrollment (Estimated): 16000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bethany D Sewell, MSW; Phone Number: 215-746-0121; Email: bethany.sewell@pennmedicine.upenn.edu
• Study Contact Backup: Name: Corinne Merlino, BS; Phone Number: 215-573-0779; Email: corinne.merlino@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	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.; Other Names: Active choice generalist palliative care
Active Comparator: Control/Usual Care; 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.	Behavioral: 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.; Other Names: Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital-free days	Days from enrollment spent alive and not in an acute care hospital through 6 months or death	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Palliative care consultation note	Presence or absence of signed inpatient palliative care note after enrollment	up to 6 weeks
Time to palliative care consult	starts at time of enrollment until receipt of first documented inpatient palliative care consultation note	up to 6 weeks
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
Intensive care unit admission	admitted to any ICU during hospital encounter	up to 6 weeks
Hospital length of stay	number of days in hospital staring at enrollment	up to 6 weeks
Hospital all-cause mortality	death occurred in the hospital or within 1 day of discharge	up to 6 weeks
Hospice enrollment	yes if new hospice enrollment	up to 6 weeks
Home or clinic palliative care referral	yes if new home of clinic palliative care order after enrollment	up to 6 weeks
Hospital discharge disposition written in discharge order	Discharge to home, other acute facility, skilled nursing facility	up to 6 weeks
30-day hospital readmission	readmission within 30 days of discharge	30 days
180-day all cause mortality	180 days after enrollment	180 days
Hospital total costs	continuous hospital costs	up to 6 weeks
Future acute care costs	acute care costs over the 6 month follow up period	enrollment to 6 months post hospital discharge
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
Pain scores	pain level according to standardized scale across hospitals after enrollment	up to 6 weeks
McGill Quality of Life-Revised	14-item survey instrument; score 0-10; continuous	1 month
McGill Quality of Life-Revised	14-item survey instrument; score 0-10; continuous	3 months
McGill Quality of Life-Revised	14-item survey instrument; score 0-10; continuous	6 months
CMS-MACRA PC Quality	(1) felt heard and understood (4-items); (2) received desired help for pain (3-items); continuous	1 month

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Katherine R Courtright, MD, MS, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Palliative Care, Pragmatic Trial
• Other Study ID Numbers: 848497; R01AG073384 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie published results will be made available to other researchers, after deidentification.
• IPD Sharing Time Frame: Data will be available beginning 9 months after publication and up to 36 months following publication. After 36 months the data will be available in our University's data warehouse but without support, except for deposited metadata.
• IPD Sharing Access Criteria: Proposals for data use will be reviewed by Principal Investigator and independent review boards (such as Institutional Review Board and Data Safety and Monitoring Board). Approved data requestors will need to sign data use agreements to access and use data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No