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

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05471622

Collaborator

(none)

114

Enrollment

Location

Arms

14.4

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

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 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.

Condition or Disease	Intervention/Treatment	Phase
End-Stage Renal Disease	Behavioral: Nudge for PHPC Referral	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 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-Dependent End-Stage Renal Disease

Actual Study Start Date :

Jul 21, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	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.
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.

Arm

Intervention/Treatment

Experimental: Intervention

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.

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.

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

Rate of Home Palliative Care Receipt [Baseline - 45 days]
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 [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.
Mortality [Baseline - 180 days]
Mortality rates will be assessed using the electronic health record after the 180-day follow-up period.
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.
Acceptability of home palliative care referral among clinician stakeholders [Baseline - 180 days]
Acceptability of home palliative care referral among clinician stakeholders will be measured via survey and focus group questions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

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:

NCT05471622

Other Study ID Numbers:

851328

First Posted:

Jul 25, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Scott Halpern, Professor of Medicine, University of Pennsylvania

palliative

ESRD

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Study Results

No Results Posted as of Aug 11, 2022