Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease (SHEPHERD 2)

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

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

Study Overview

• Status: Recruiting
• Conditions: End-Stage Renal Disease
• Intervention / Treatment: Behavioral: Nudge for PHPC NP Referral

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Madden, BS; Phone Number: (215) 746-4923; Email: vmadden@upenn.edu
• Study Contact Backup: Name: Nicholas Bishop, BA; Phone Number: (215) 573-0779; Email: nicholas.bishop@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Niharika Ganta, MD, MPH; Phone Number: 215-221-2365; Email: Niharika.Ganta@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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.
Experimental: Intervention; The inpatient care team, including the attending/ordering and covering providers, 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rates will be assessed using the electronic health record after the 180-day follow-up period.	Baseline - 180 days
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
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
Time to Home Palliative Care Visit	Days from hospital discharge to the first home palliative care visit.	Baseline - 180 days
Hospice Enrollment	New hospice enrollment will be assessed using the electronic health record and administrative data for the tristate area.	Baseline - 180 days
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
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
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ESRD; palliative
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 851328 (2)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No