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

End-Stage Renal Disease Clinical Trial

— SHEPHERD 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144281
• Other study ID #: 851328 (2)
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: Vanessa Madden, BS
• Phone: (215) 746-4923
• Email: vmadden[@]upenn.edu
• 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• 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 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 home care services
• 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Nudge 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.

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	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	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	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	Time to Home Palliative Care Visit	Days from hospital discharge to the first home palliative care visit.	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	Hospice Enrollment	New hospice enrollment will be assessed using the electronic health record and administrative data for the tristate area.	Baseline - 180 days
Secondary	Health-Related Quality of Life	Health-related quality of life will be assessed by the EQ-5D survey of patients at 1- and 3-months post-hospital discharge time-points.	1- and 3-months
Secondary	Symptom Burden	Symptom burden will be assessed by the Edmonton Symptom Assessment System survey of patients at 1- and 3-months post-hospital discharge time-points.	1- and 3-months
Secondary	Quality of Care	Quality 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.	1- and 3-months