Palliative Care Interventions for Serious Illness

(NEEDS-PC Trial)

Enrolling by invitation at 10 trial locations

Overseen By Bethany Sewell, MSW

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Pennsylvania

Disqualifiers: Hospice, Rehabilitation, Psychiatry, Obstetrics, Neonatal

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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 enhance palliative care for patients with serious illnesses who have unmet needs. Researchers are testing two systems to alert hospital staff about these needs using electronic health records. One system suggests a palliative care consult, while the other automatically schedules one unless canceled. The study seeks inpatients at certain hospitals with significant unmet palliative care needs. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients an opportunity to contribute to potentially groundbreaking improvements in palliative care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these palliative care interventions are safe?

Research shows that electronic reminders in hospitals can improve care for patients with serious illnesses. These reminders, sent to doctors through a computer system, encourage consideration of palliative care consultations.

Past studies have generally found these reminders well-received. They gently prompt doctors to focus on comfort care. In one study, this approach led to more patients being referred to hospice care, enhancing their quality of life.

No major safety issues or negative effects have been reported with these electronic reminders. They are considered a safe way to encourage better care without directly altering the patient's medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these palliative care interventions because they leverage technology to improve care delivery for patients with serious illnesses. Unlike traditional palliative care, which often requires a proactive request from clinicians, these interventions use electronic health record (EHR) alerts. One approach informs clinicians about a patient's diagnosis and unmet palliative care needs, while another goes further by including a default consult order that can be canceled. This innovative use of nudges aims to ensure that patients receive timely and appropriate palliative care, potentially leading to more equitable and effective treatment outcomes.

What evidence suggests that these palliative care interventions could be effective for patients with serious illness?

This trial will compare different approaches to delivering palliative care interventions. Studies have shown that palliative care can improve the quality of life for people with serious illnesses, often leading to better patient satisfaction and potentially lowering healthcare costs. In this trial, one arm will provide clinicians with information about patients' unmet palliative care needs, which research indicates can help doctors make better decisions. Another arm will add a standard consult order to this information provision, increasing the chances that patients will receive palliative care. However, some studies found that these orders alone don't shorten hospital stays but do increase the number of palliative care consultations. Overall, these steps aim to ensure patients receive the support they need, potentially leading to better hospital experiences. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Harhay, PhD, MPH

Principal Investigator

University of Pennsylvania

Katherine Courtright, MD, MS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with serious illnesses who have unmet palliative care needs. It's designed to see if certain prompts in the hospital's electronic health record can help these patients receive specialized palliative care more effectively and equitably.

Inclusion Criteria

My records show I need a high level of care for my symptoms.

I am currently hospitalized.

Exclusion Criteria

I have been officially discharged from the hospital.

I am currently admitted for hospice, rehab, psychiatric, obstetric, or neonatal 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

3 months

Intervention Phase

Implementation of EHR alerts for palliative care needs with opt-in and opt-out options for consults

6 months

Follow-up

Participants are monitored for hospital-free days and other secondary outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Nudging Effective and Equitable Delivery of Specialty Palliative Care

Trial Overview The study tests two EHR-based interventions: one that alerts clinicians to opt-in for a specialty palliative care consult, and another that automatically opts patients in unless declined. The effectiveness of these methods will be compared to usual care practices.

How Is the Trial Designed?

Group I: 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. All hospitals will contribute a minimum of 9 weeks of outcomes data prior to adopting the intervention. The total duration of the control phase will differ for each hospital dependent on their randomly assigned time to adopt Intervention 1 in this stepped-wedge trial design.

Group II: Palliative care needs information provision Active Control 1 Intervention

Clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs

Group III: Palliative care needs information provision + default consult order Active Control 1 Intervention

The palliative care needs information provision intervention will be supplemented with a default palliative care consult order such that clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs, and offered the choice to cancel the default consult order.

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+

Medstar Health Research Institute

Collaborator

Trials

202

Recruited

187,000+

Published Research Related to This Trial

A study analyzing 475 serious incident reports in palliative care over 12 years revealed that the most common issues were pressure ulcers (266 reports) and medication errors (91 reports), highlighting significant safety risks in this vulnerable population.

The analysis identified key causes of unsafe care, including lack of palliative care experience and poor service coordination, suggesting that enhancing care delivery and increasing access to specialist support could help reduce these risks and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in palliative care: A mixed-methods study of reports to a national database of serious incidents. Yardley, I., Yardley, S., Williams, H., et al.[2019]

The paper emphasizes the importance of developing robust serious adverse event (SAE) reporting procedures in non-pharmaceutical palliative care trials, as patients often face high risks of hospitalization or death due to their underlying conditions rather than the trial interventions.

Recommendations for improving SAE management include allowing sufficient planning time, defining what constitutes a serious adverse event for the specific study population, and refining reporting procedures throughout the trial to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. Dunleavy, L., Collingridge Moore, D., Korfage, I., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11277722/

The Effectiveness of Palliative Care Interventions in Long ... Another study emphasizes the need for tailored palliative care programs that accommodate the complex needs of long-term care residents, ...

2. scorecard.capc.org scorecard.capc.org/

CAPC's 2024 Serious Illness Scorecard - Explore State Ratings America's Serious Illness Scorecard reviews each state's capacity to deliver high-quality care to people facing serious illness.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590229625000061

What gets measured in palliative care? A review and ... Studies indicate that palliative care improves outcomes and can reduce health care costs for people with serious illness [5]. In the context of well-documented ...

4. who.int who.int/news-room/fact-sheets/detail/palliative-care

Palliative care Palliative care is most effective when considered early in the course of the illness. Early palliative care not only improves quality of life ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2813879

Default Palliative Care Consultation for Seriously Ill ... This cluster randomized trial examines whether the effect of ordering palliative care consultation by default for seriously ill hospitalized ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06596577

NCT06596577 | Nudging Effective and Equitable Delivery ... The trial will compare the interventions effects to usual care, focusing on completed PC consults during the hospital encounter and other secondary outcomes.

7. medstarhealth.org medstarhealth.org/blog/needs-pc-trial-palliative-care-ehr

NEEDS-PC Trial Aims to Improve Access to Palliative Care ... Palliative care improves outcomes for people with serious illnesses. Discover how our research aims to help more people access these ...

8. medstarhealth.org medstarhealth.org/innovation-and-research/medstar-health-research-institute/research-networks/medical-surgical-research-network/palliative-care-research/needs-pc-trial

NEEDS-PC Trial - Palliative Care Research To promote evidence-based delivery of inpatient palliative care for hospitalized adults with any serious illness (at any stage and treatment intent) and unmet ...

9. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/article-abstract/2831393

Nudging Clinicians to Promote Serious Illness ... The comfort-focused treatment alternative nudge led to a significant increase in discharge to hospice (10.9% vs 7.3%) and earlier comfort-care ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12423848/

Critical Care Physicians' Perspectives on Nudging in ... In this study, physicians reported that although use of nudges may be a necessary, effective, and sometimes appropriate mode of communication in ...