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

Primary Purpose

End-Stage Renal Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nudge for PHPC Referral
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End-Stage Renal Disease focused on measuring palliative, ESRD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be an adult (18 years of age or older) hospitalized at one of the three 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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2022
Last Updated
July 5, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05471622
Brief Title
Study of Home-Embedded Palliative Care for Hemodialysis-Dependent End-Stage Renal Disease
Acronym
SHEPHERD
Official Title
Study of Home-Embedded Palliative Care for Hemodialysis-Dependent End-Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
June 5, 2023 (Actual)
Study Completion Date
December 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
palliative, ESRD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nudge for PHPC Referral
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Home Palliative Care Receipt
Description
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.
Time Frame
Baseline - 45 days
Secondary Outcome Measure Information:
Title
Follow-up Home Palliative Care Visits
Description
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.
Time Frame
Baseline - 180 days
Title
Mortality
Description
Mortality rates will be assessed using the electronic health record after the 180-day follow-up period.
Time Frame
Baseline - 180 days
Title
Hospital-free days
Description
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.
Time Frame
Baseline - 180 days
Title
Acceptability of home palliative care referral among clinician stakeholders
Description
Acceptability of home palliative care referral among clinician stakeholders will be measured via survey and focus group questions.
Time Frame
Baseline - 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Madden, MS, MPH
Phone
2157464923
Email
vmadden@upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Bishop
Phone
215-573-0779
Email
nicholas.bishop@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niharika Ganta, MD, MPH
Email
Niharika.Ganta@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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