End-Stage Renal DiseaseSHEPHERDNCT05471622
Study of Home-Embedded Palliative Care for Hemodialysis-Dependent End-Stage Renal Disease
A study testing Nudge for PHPC Referral in people with End-Stage Renal Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Nudge for PHPC Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- End-Stage Renal Disease
- Being tested
- Nudge for PHPC Referral
- Keywords
- palliative, ESRD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nudge for PHPC ReferralBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Nudge for PHPC Referral |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - 45 days
Secondary outcomes (4)
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.
Measured: Baseline - 180 days
Mortality
Mortality rates will be assessed using the electronic health record after the 180-day follow-up period.
Measured: 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.
Measured: Baseline - 180 days
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.
Measured: Baseline - 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start21 Jul 2022
- Primary completion18 Jun 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Halpern, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471622
- Sponsor's protocol ID
- 851328
- Acronym
- SHEPHERD
- Status last verified
- Feb 2024
- First submitted
- 20 Jul 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Home-Embedded Palliative Care for Hemodialysis-Dependent End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT05471622
- Acronym / sponsor ID
- SHEPHERD / 851328
- Conditions
- End-Stage Renal Disease
- Keywords
- palliative, ESRD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nudge for PHPC ReferralThe 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nudge for PHPC ReferralThe 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. | Behavioural | Intervention |
Primary outcome
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.
4 secondary outcomes
Follow-up Home Palliative Care Visits
Time frame: Baseline - 180 days
Mortality
Time frame: Baseline - 180 days
Hospital-free days
Time frame: Baseline - 180 days
Acceptability of home palliative care referral among clinician stakeholders
Time frame: Baseline - 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge for PHPC Referral in people with End-Stage Renal Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Home Palliative Care Receipt (time frame: Baseline - 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.