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

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06144281
Collaborator
(none)
400
1
2
7
57.2

Study Details

Study Description

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 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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nudge for PHPC NP Referral
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease (SHEPHERD 2.0)
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Acute Encounters [Baseline - 180 days]

    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

Secondary Outcome Measures

  1. Hospital-Free Days [Baseline - 180 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.

  2. Home Palliative Care Visits [Baseline - 180 days]

    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.

  3. Time to Home Palliative Care Visit [Baseline - 180 days]

    Days from hospital discharge to the first home palliative care visit.

  4. Mortality [Baseline - 180 days]

    Mortality rates will be assessed using the electronic health record after the 180-day follow-up period.

  5. Hospice Enrollment [Baseline - 180 days]

    New hospice enrollment will be assessed using the electronic health record and administrative data for the tristate area.

  6. Health-Related Quality of Life [1- and 3-months]

    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.

  7. Symptom Burden [1- and 3-months]

    Symptom burden will be assessed by the Edmonton Symptom Assessment System survey of patients at 1- and 3-months post-hospital discharge time-points.

  8. Quality of Care [1- and 3-months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Scott Halpern, Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT06144281
Other Study ID Numbers:
  • 851328 (2)
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Scott Halpern, Professor of Medicine, University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2023