Generalist + Specialist Palliative Care for Seriously Ill Inpatients

Overseen By Corinne Merlino, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Under 18, Hospice, Rehabilitation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

16000 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Generalist + Specialist Palliative Care for Seriously Ill Inpatients?

Research shows that specialist palliative care teams in hospitals can improve quality of life and satisfaction with care for patients with advanced diseases. Additionally, early integration of palliative care has been found to improve outcomes for patients with cancer and heart failure. ^{1 2 3 4 5}

How is the Generalist + Specialist palliative care treatment different from other treatments for seriously ill inpatients?

The Generalist + Specialist palliative care treatment is unique because it combines the expertise of generalist healthcare providers with specialist palliative care teams to offer comprehensive support for seriously ill inpatients. This approach aims to improve the quality of life by addressing complex needs through a collaborative, multidisciplinary team, which is not typically found in standard care models. ^{1 3 6 7 8}

What is the purpose of this 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.

Research Team

Katherine R Courtright, MD, MS

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adult patients admitted to participating hospitals who are at high risk of dying within the next 6 months, with a mortality risk predicted to be moderate (≥50%) or higher.

Inclusion Criteria

Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher

I am currently admitted or under observation at a study hospital.

Exclusion Criteria

Patients that have died or been discharged before 0800 on hospital day 3 when the mortality risk is generated and enrollment occurs

I am under 18 years old.

I am currently admitted for hospice, rehabilitation, obstetrics, or psychiatry care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Patients meeting eligibility criteria are enrolled for study data collection without influencing delivery of care

15 weeks

Intervention Phase

A prognostic-triggered EHR alert nudges clinicians to provide generalist or specialist palliative care

6 months

Follow-up

Participants are monitored for hospital-free days and other outcomes after intervention

6 months

Treatment Details

Interventions

• Active control alert
• Generalist + Specialist palliative care

Trial Overview The study tests an electronic health record nudge prompting hospital clinicians to provide palliative care themselves or consult specialists. It compares this approach against usual care, focusing on hospital-free days and other patient-centered outcomes over 6 months.

Participant Groups

Group I: Intervention Experimental Treatment 1 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.

Group II: Control/Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

1. England pubmed.ncbi.nlm.nih.gov

What are the views of hospital-based generalist palliative care professionals on what facilitates or hinders collaboration with in-patient specialist palliative care teams? A systematically constructed narrative synthesis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pro-active Palliative Care for Hospitalized Primary Care Patients. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Specialist palliative care teams and characteristics related to referral rate: a national cross-sectional survey among hospitals in the Netherlands. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Seeking Excellence in End of Life Care (SEE Care): A Multi-Centered Acute Hospitals Service Evaluation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Impact of physician-based palliative care delivery models on health care utilization outcomes: A population-based retrospective cohort study. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

The development of a palliative care team at the Western General Hospital, Edinburgh. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Comparing the effect of a consult model versus an integrated palliative care and medical oncology co-rounding model on health care utilization in an acute hospital - an open-label stepped-wedge cluster-randomized trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Need for additional professional psychosocial and spiritual support in patients with advanced diseases in the course of specialist palliative care - a longitudinal observational study. [2021]