Study Stopped
Effectiveness of home palliative care services could not be determined due to lower-than-expected referrals and consults in the intervention arm
Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease
SHEPHERD 2
1 other identifier
interventional
315
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
1 active site
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
CompletedFirst Posted
Study publicly available on registry
November 22, 2023
CompletedStudy Start
First participant enrolled
December 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2024
CompletedJanuary 27, 2025
January 1, 2025
11 months
November 16, 2023
January 22, 2025
Conditions
Keywords
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
EXPERIMENTALThe 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.
Usual Care
NO INTERVENTIONParticipants 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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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