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

End-Stage Renal Disease Clinical Trial

— SHEPHERD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05471622
• Other study ID #: 851328
• Status: Completed
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: December 18, 2023

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: December 18, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• None

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• Nudge for PHPC Referral
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Follow-up Home Palliative Care Visits	The 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.	Baseline - 180 days
Secondary	Mortality	Mortality rates will be assessed using the electronic health record after the 180-day follow-up period.	Baseline - 180 days
Secondary	Hospital-free days	The 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.	Baseline - 180 days
Secondary	Acceptability of home palliative care referral among clinician stakeholders	Acceptability of home palliative care referral among clinician stakeholders will be measured via survey and focus group questions.	Baseline - 180 days