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

NCT05471622 | Completed

• 1 other identifier: 851328
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 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 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.

Conditions

End-Stage Renal Disease

Keywords

palliative; ESRD

Outcome Measures

Primary Outcomes (1)

• Rate of Home Palliative Care Receipt

  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.

  Baseline - 45 days

Secondary Outcomes (4)

• Follow-up Home Palliative Care Visits

  Baseline - 180 days

• Mortality

  Baseline - 180 days

• Hospital-free days

  Baseline - 180 days

• Acceptability of home palliative care referral among clinician stakeholders

  Baseline - 180 days

Study Arms (2)

Intervention

EXPERIMENTAL

The lead case manager and covering provider on the inpatient care team 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 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

Nudge for PHPC Referral BEHAVIORAL

The case manager and covering providers for inpatients who have been identified according to the study's inclusion criteria as appropriate for Penn Home Palliative Care (PHPC) upon hospital discharge will be asked to refer their patient for these home palliative care services.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological 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: July 20, 2022
• First Posted: July 25, 2022
• Study Start: July 21, 2022
• Primary Completion: June 18, 2023
• Study Completion: December 18, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)