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Completed

NCT Number: NCT05471622

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

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nudge for PHPC Referral

Behavioral

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 outcomes

  1. Rate of Home Palliative Care Receipt

    Time frame: 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 outcomes

  1. Follow-up Home Palliative Care Visits

    Time frame: 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.

  2. Mortality

    Time frame: Baseline - 180 days

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

  3. Hospital-free days

    Time frame: 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.

  4. Acceptability of home palliative care referral among clinician stakeholders

    Time frame: Baseline - 180 days

    Acceptability of home palliative care referral among clinician stakeholders will be measured via survey and focus group questions.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: SHEPHERD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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