Palliative Care Interventions for Serious Illness

(NEEDS-PC Trial)

Recruiting at 8 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

64107 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Nudging Effective and Equitable Delivery of Specialty Palliative Care?

Research shows that palliative care can improve the quality of care for patients with serious illnesses and reduce overall healthcare costs. A region-based palliative care intervention also improved the quality of care and quality of death for patients. ^{1 2 3 4 5}

Is palliative care generally safe for patients?

Palliative care is generally safe, but patients may experience serious adverse events like psychological distress, and medication errors can occur. These incidents are often related to the progression of the patient's illness rather than the care itself. ^{1 6 7 8 9}

How does the treatment Nudging Effective and Equitable Delivery of Specialty Palliative Care differ from other palliative care treatments?

This treatment focuses on improving the delivery of palliative care by training non-specialists to provide care, which is unique compared to traditional models that rely on specialists. It aims to increase access and quality of care by using pragmatic strategies for training and maintaining intervention fidelity. ^{2 5 10 11 12}

What is the purpose of this trial?

This stepped-wedge, cluster randomized pragmatic trial among 9 MedStar hospitals for patients with serious illness and unmet palliative care (PC) needs will test two interventions embedded within the electronic health record (EHR): (1) a PC needs triggered alert to opt-in to PC consults nudging hospital clinicians to order specialty PC consults for eligible inpatients, and (2) a palliative care needs triggered alert with an opt-out to palliative care consults. The trial will compare the interventions effects to usual care, focusing on hospital-free days through 6 months and other secondary outcomes. The trial also includes an embedded mixed methods study to explore factors influencing the effectiveness and equity of intervention implementation.

Research Team

Katherine Courtright, MD, MS

Principal Investigator

University of Pennsylvania

Michael Harhay, PhD, MPH

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: 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 II: 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.

Group III: 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 3 months 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.

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+

Findings from Research

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]

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]

References

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

Incentives for Palliative Care. [2023]

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

Changes in Relatives' Perspectives on Quality of Death, Quality of Care, Pain Relief, and Caregiving Burden Before and After a Region-Based Palliative Care Intervention. [2018]

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

Education and referral criteria: impact on oncology referrals to palliative care. [2018]

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

Palliative care in the era of health care reform. [2015]

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

Methods for improving the quality of palliative care delivery: a systematic review. [2021]

6. England 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. [2021]

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

Patient safety in palliative care: A mixed-methods study of reports to a national database of serious incidents. [2019]

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

Perceptions and utilization of palliative care services in acute care hospitals. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Doctor-Related Medication Safety Incidents on a Specialist Palliative Medicine Inpatient Unit: A Retrospective Analysis of Three Years of Voluntary Reporting. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Interventionist training and intervention fidelity monitoring and maintenance for CONNECT, a nurse-led primary palliative care in oncology trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Early specialized palliative care for patients with metastatic lung cancer receiving chemotherapy: a feasibility study of a nurse-led screening-triggered programme. [2022]

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

Increasing access and quality in Department of Veterans Affairs care at the end of life: a lesson in change. [2022]