NCT06144281

Brief Summary

Home palliative care needs are often under-recognized in patients with End-Stage Renal Disease (ESRD). This pilot study is designed to evaluate the effectiveness of referrals to home palliative care services in improving patient outcomes compared with usual care among patients with ESRD admitted to a Penn hospital. Evaluating the effectiveness of home palliative care services is critical to determine whether increasing access to these services would improve patient-centered outcomes for these high-need patients

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

December 14, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2024

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

November 16, 2023

Last Update Submit

January 22, 2025

Conditions

Keywords

palliativeESRD

Outcome Measures

Primary Outcomes (1)

  • Acute Encounters

    A combined count of hospitalizations, Emergency Department, and Observation visits during the 180-day follow-up period that will be assessed using the electronic health record and administrative data for the tri-state area

    Baseline - 180 days

Secondary Outcomes (8)

  • Hospital-Free Days

    Baseline - 180 days

  • Home Palliative Care Visits

    Baseline - 180 days

  • Time to Home Palliative Care Visit

    Baseline - 180 days

  • Mortality

    Baseline - 180 days

  • Hospice Enrollment

    Baseline - 180 days

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The inpatient care team, including the attending/ordering and covering providers, for participants in this group will receive a message from the research team identifying their patient as appropriate for home palliative care and will be asked to refer their patient for these services.

Behavioral: Nudge for PHPC NP Referral

Usual Care

NO INTERVENTION

Participants in this group will receive usual care upon discharge from the hospital. Their clinical team will not be notified that they are appropriate for home palliative care services, but they may still be referred for those services if their clinicians feel their patient will benefit.

Interventions

The attending and covering providers for inpatients who have been identified according to the study's inclusion criteria as appropriate for home palliative care services upon hospital discharge will be asked to refer their patient for these services.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be an adult (18 years of age or older) hospitalized at a Penn study hospital
  • AND digital signature of ESRD (N18.6) within the last 12 months
  • AND resides in the five-county area surrounding Philadelphia which is served by Penn Palliative Care Nurse Practitioner program
  • AND have one or more of the following markers of potentially unmet needs: (i) existing home care eligibility or referral for home care (but not already receiving PC); (ii) non-ambulatory status determined via nursing assessment; (iii) severe protein-calorie malnutrition; (iv) 2 or more hospitalizations within the prior year

You may not qualify if:

  • Patients with functional kidney transplants
  • Patients discharged to skilled nursing facilities and LTC facilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

December 14, 2023

Primary Completion

November 11, 2024

Study Completion

November 11, 2024

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations