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Clinical Trials/NCT06144281
NCT06144281
Terminated
Not Applicable

Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease (SHEPHERD 2.0)

University of Pennsylvania1 site in 1 country315 target enrollmentDecember 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End-Stage Renal Disease
Sponsor
University of Pennsylvania
Enrollment
315
Locations
1
Primary Endpoint
Acute Encounters
Status
Terminated
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
December 14, 2023
End Date
November 11, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Scott Halpern

Professor of Medicine

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Acute Encounters

Time Frame: Baseline - 180 days

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

Secondary Outcomes

  • Hospice Enrollment(Baseline - 180 days)
  • Symptom Burden(1- and 3-months)
  • Hospital-Free Days(Baseline - 180 days)
  • Mortality(Baseline - 180 days)
  • Quality of Care(1- and 3-months)
  • Home Palliative Care Visits(Baseline - 180 days)
  • Time to Home Palliative Care Visit(Baseline - 180 days)
  • Health-Related Quality of Life(1- and 3-months)

Study Sites (1)

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