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Clinical Trials/NCT05471622
NCT05471622
Completed
Not Applicable

Study of Home-Embedded Palliative Care for Hemodialysis-Dependent End-Stage Renal Disease

University of Pennsylvania1 site in 1 country285 target enrollmentJuly 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End-Stage Renal Disease
Sponsor
University of Pennsylvania
Enrollment
285
Locations
1
Primary Endpoint
Rate of Home Palliative Care Receipt
Status
Completed
Last Updated
2 years ago

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 feasibility and acceptability of an initiative to enhance referrals to Penn Home Palliative Care compared with usual care among hemodialysis-dependent ESRD patients admitted to a Penn hospital. Results will inform a future pragmatic trial comparing the effectiveness of home palliative care compared with usual care among ESRD patients. 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
July 21, 2022
End Date
December 18, 2023
Last Updated
2 years ago
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 one of two study hospitals
  • Digital signature of ESRD (N18.6) within the last 12 months with an inpatient hemodialysis order
  • Patient resides in the five-county area surrounding Philadelphia which is served by the Penn Home Palliative Care services.
  • Appropriate for home palliative care, defined as:
  • (i) Existing home care eligibility/referral for home care OR (ii) Severe protein malnutrition (E43, E44) OR (iii) Non-ambulatory status determined by a flowsheet completed by nursing on hospital admission with three ambulatory options: (1) non-ambulatory, (2) ambulates with assistance, or (3) ambulates independently. If this information is missing from the electronic health record, the determination will be made using one of the three following options: (1) overall prior home mobility assessment "complete dependence on all aspects," or (2) ambulation or functional transfers domains indicate "dependent," or (3) wheelchair mobility domain was completed (with any non-null/non-empty value).

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rate of Home Palliative Care Receipt

Time Frame: Baseline - 45 days

Receipt of home palliative care will be defined as at least one home palliative care visit within 45 days after hospital discharge, determined via electronic health record review.

Secondary Outcomes

  • Hospital-free days(Baseline - 180 days)
  • Acceptability of home palliative care referral among clinician stakeholders(Baseline - 180 days)
  • Follow-up Home Palliative Care Visits(Baseline - 180 days)
  • Mortality(Baseline - 180 days)

Study Sites (1)

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