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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how hospital clinicians can improve palliative care (supportive care for serious illnesses) by using electronic health record alerts. These alerts suggest whether doctors should provide general palliative care themselves or consult specialists. The goal is to determine if this approach, which combines generalist and specialist palliative care, helps patients spend more time outside the hospital and improves other health and economic outcomes. Patients admitted to a participating hospital with a high risk of passing away in the next six months might be suitable for this trial. As an unphased trial, this study offers patients the opportunity to contribute to innovative care strategies that could enhance quality of life.

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 prior data suggests that this behavioral intervention is safe for seriously ill inpatients?

Research has shown that palliative care, provided by either general doctors or specialists, is generally safe for patients. One study found that palliative care led to fewer emergency room visits, suggesting it might better manage symptoms and reduce emergencies. Another study compared care by general doctors and specialists, finding both can effectively manage pain and other symptoms for seriously ill patients. These findings suggest that this approach is well-tolerated and does not cause significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it integrates a unique approach using a prognostic-triggered EHR alert system to enhance palliative care for seriously ill inpatients. Unlike traditional methods where palliative care is often initiated based on clinician discretion, this system proactively notifies healthcare providers when a patient is likely to benefit from palliative care. It prompts them to choose between generalist care, consulting a specialist, or deferring the care, ensuring timely and personalized attention. This method aims to streamline care delivery, potentially improving patient outcomes by ensuring that those in need receive appropriate palliative care interventions promptly.

What evidence suggests that this trial's treatments could be effective for seriously ill inpatients?

This trial will compare the effects of combining generalist and specialist palliative care with usual care for seriously ill inpatients. Studies have shown that this combination improves outcomes for these patients. Specifically, research indicates that specialist palliative care can lead to better health results, improve the quality of care, and even shorten hospital stays. Additionally, this approach enhances the overall experience for patients and their families. Evidence suggests that general doctors trained in basic palliative care can provide effective care when guided by specialists. Overall, this combined model increases access to necessary care and supports better health outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Katherine R Courtright, MD, MS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-palliative-care-2023-bd2fb

Generalist + Specialist Palliative Care for Seriously Ill Inpatients 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- ...

2. pcori.org pcori.org/research-results/2023/comparing-palliative-care-delivered-generalist-clinicians-versus-palliative-care-specialists-patients-hospitalized-advanced-illnesses

Comparing Palliative Care Delivered by Generalist ... This study compares the clinical effectiveness of palliative care delivered by generalist clinicians trained in basic palliative care skills ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6483755/

The effectiveness and cost‐effectiveness of inpatient specialist ... A previous systematic review by Higginson 2002 showed that specialist palliative care improved clinical outcomes and quality of care and can reduce hospital ...

4. chibe.upenn.edu chibe.upenn.edu/news/penn-medicine-news-penn-medicine-researchers-awarded-27-5-million-for-large-palliative-care-study/

Penn Medicine Researchers Awarded $27.5 Million for Large ... ... palliative care delivery improves outcomes for seriously ill hospitalized patients. Palliative care also helps patients and their loved ones ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMp1215620

Generalist plus Specialist Palliative Care — Creating a ... This model allows increased access to specialty palliative care consultation and reinforces delivery of primary palliative care by everyone ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11097520/

Generalist, specialist, or expert in palliative care? A cross ... This study aims to explore how HCPs working in palliative care describe themselves in terms of generalist, specialist, and expert

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05502861

A Pragmatic Trial of an Active Choice Nudge for Generalist ... A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients. ClinicalTrials.gov ID NCT05502861.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9022124/

Generalist versus Specialist Palliative Medicine - PMC When it comes to the complicated symptom management, that is where the data show us that specialty palliative care makes the biggest impact. I ...

9. bmj.com bmj.com/content/370/bmj.m2257

Association between palliative care and healthcare ... Palliative care was associated with reduced rates of emergency department visits (crude rate 1.9 (standard deviation 6.2) v 2.9 (8.7) per person year)