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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06144281
Acronym
SHEPHERD 2
Enrollment
315
Registered
2023-11-22
Start date
2023-12-14
Completion date
2024-11-11
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease

Keywords

palliative, ESRD

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

Interventions

BEHAVIORALNudge for PHPC NP Referral

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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute EncountersBaseline - 180 daysA 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

MeasureTime frameDescription
Home Palliative Care VisitsBaseline - 180 daysThe total number of home palliative care visits during the 180-day follow-up period after hospital discharge will be assessed using the electronic health record.
Time to Home Palliative Care VisitBaseline - 180 daysDays from hospital discharge to the first home palliative care visit.
MortalityBaseline - 180 daysMortality rates will be assessed using the electronic health record after the 180-day follow-up period.
Hospital-Free DaysBaseline - 180 daysThe number of hospital-free days during the 180-day follow-up period will be assessed using the electronic health record and administrative data for the tri-state area.
Health-Related Quality of Life1- and 3-monthsHealth-related quality of life will be assessed by the EQ-5D survey of patients at 1- and 3-months post-hospital discharge time-points.
Symptom Burden1- and 3-monthsSymptom burden will be assessed by the Edmonton Symptom Assessment System survey of patients at 1- and 3-months post-hospital discharge time-points.
Quality of Care1- and 3-monthsQuality of care will be assessed by the CMS-MACRA PC Quality Measures (Received Help for Pain; Felt Heard & Understood) for patients at 1- and 3-months post-hospital discharge time-points.
Hospice EnrollmentBaseline - 180 daysNew hospice enrollment will be assessed using the electronic health record and administrative data for the tristate area.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026