End-Stage Renal DiseaseSHEPHERD 2NCT06144281
Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease
A study testing Nudge for PHPC NP 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 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. 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 NP Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 11 Nov 2024
- 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 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 Palliative Care Nurse Practitioner program
- 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
Who cannot join
- Patients with functional kidney transplants
- Patients discharged to skilled nursing facilities and LTC facilities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease (SHEPHERD 2.0)
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
- Conditions
- End-Stage Renal Disease
- Being tested
- Nudge for PHPC NP 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 NP ReferralBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Nudge for PHPC NP 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.
Acute Encounters
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
Measured: Baseline - 180 days
Secondary outcomes (8)
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
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
Time to Home Palliative Care Visit
Days from hospital discharge to the first home palliative care visit.
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
Hospice Enrollment
New hospice enrollment will be assessed using the electronic health record and administrative data for the tristate area.
Measured: Baseline - 180 days
Health-Related Quality of Life
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.
Measured: 1- and 3-months
Symptom Burden
Symptom burden will be assessed by the Edmonton Symptom Assessment System survey of patients at 1- and 3-months post-hospital discharge time-points.
Measured: 1- and 3-months
Quality of Care
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.
Measured: 1- and 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start14 Dec 2023
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Why it stopped: Effectiveness of home palliative care services could not be determined due to lower-than-expected referrals and consults in the intervention arm
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
- 315 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
- NCT06144281
- Sponsor's protocol ID
- 851328 (2)
- Acronym
- SHEPHERD 2
- Status last verified
- Jan 2025
- First submitted
- 16 Nov 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease (SHEPHERD 2.0)
- ClinicalTrials.gov ID
- NCT06144281
- Acronym / sponsor ID
- SHEPHERD 2 / 851328 (2)
- Conditions
- End-Stage Renal Disease
- Keywords
- palliative, ESRD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Effectiveness of home palliative care services could not be determined due to lower-than-expected referrals and consults in the intervention arm
- Enrolment
- 315 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 22 Nov 2023 (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 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
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 NP ReferralThe 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. |
| 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 (4 listed)
- 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 Palliative Care Nurse Practitioner program
- 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
Key exclusion criteria (2 listed)
- Patients with functional kidney transplants
- Patients discharged to skilled nursing facilities and LTC facilities
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 NP ReferralThe 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. | Behavioural | Intervention |
Primary outcome
Acute Encounters
Time frame: 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
8 secondary outcomes
Hospital-Free Days
Time frame: Baseline - 180 days
Home Palliative Care Visits
Time frame: Baseline - 180 days
Time to Home Palliative Care Visit
Time frame: Baseline - 180 days
Mortality
Time frame: Baseline - 180 days
Hospice Enrollment
Time frame: Baseline - 180 days
Health-Related Quality of Life
Time frame: 1- and 3-months
Symptom Burden
Time frame: 1- and 3-months
Quality of Care
Time frame: 1- and 3-months
Results and safety
The study was stopped early (reason given: Effectiveness of home palliative care services could not be determined due to lower-than-expected referrals and consults in the intervention arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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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 NP 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 Jan 2025. 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 was stopped early (reason given: Effectiveness of home palliative care services could not be determined due to lower-than-expected referrals and consults in the intervention arm). Results are not available in the source record.
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?
Acute Encounters (time frame: Baseline - 180 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 27 Jan 2025.