ESRDNCT05011136
Physician Reimbursement Home Patients
An observational study of ESRD, run by Satellite Healthcare at 1 site in United States.
Trial summary
This is an observational study using an online survey to solicit information from nephrologists who care for dialysis patients about the time and effort involved in providing care to home dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Dec 2021
- Phase
- Observational
- 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
Study population: All US nephrologists who care for dialysis patients.
Who may be able to join
- All nephrologists in the US who care for dialysis patients.
Who cannot join
- Nephrologists who have not cared for dialysis patients in the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physician Reimbursement for Home Dialysis: Assessment of Validity of CMS Compensation for Nephrologists
This is an observational study using an online survey to solicit information from nephrologists who care for dialysis patients about the time and effort involved in providing care to home dialysis patients.
Read the detailed description
Physician reimbursement today for care of a home dialysis patient is a capitated reimbursement, defined by the age of the patient and their days on home dialysis. Due to the multiple advantages of home therapy, CMS is working on increasing home dialysis uptake; however, there is little to no data on the time and effort involved in providing care to home dialysis patients.
In this study, we will develop and distribute a survey to capture the components of home dialysis patient care and the perceived time and effort of nephrologists across the US to do so. This will provide data for CMS as they consider the adjustment of their policy values in physician reimbursement for home dialysis patient care, which is currently labeled as misvalued (Centers for Medicare and Medicaid Services, 2021).
- Conditions
- ESRD
- Being tested
- No intervention. This is a qualitative study
- Keywords
- ESRD, Home Dialysis, Compensation
- 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.
No intervention. This is a qualitative studyOther
Also called Survey
US nephrologists who care for dialysis patients will be asked to complete an internet based survey evaluating the time and effort required for home dialysis patient care.
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide data to facilitate a data-driven adjustment of the capitated physician payment for caring for home dialysis patients.
Compilation of survey data from US nephrologists with dialysis patients.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael F Hussein, MBBS, Principal investigator, Satellite Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011136
- Sponsor's protocol ID
- SIH 129
- Status last verified
- May 2022
- First submitted
- 11 Aug 2021
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Reimbursement for Home Dialysis: Assessment of Validity of CMS Compensation for Nephrologists
- ClinicalTrials.gov ID
- NCT05011136
- Acronym / sponsor ID
- SIH 129
- Conditions
- ESRD
- Keywords
- ESRD, Home Dialysis, Compensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Aug 2021 (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.
This is an observational study using an online survey to solicit information from nephrologists who care for dialysis patients about the time and effort involved in providing care to home dialysis patients.
Detailed description
Physician reimbursement today for care of a home dialysis patient is a capitated reimbursement, defined by the age of the patient and their days on home dialysis. Due to the multiple advantages of home therapy, CMS is working on increasing home dialysis uptake; however, there is little to no data on the time and effort involved in providing care to home dialysis patients.
In this study, we will develop and distribute a survey to capture the components of home dialysis patient care and the perceived time and effort of nephrologists across the US to do so. This will provide data for CMS as they consider the adjustment of their policy values in physician reimbursement for home dialysis patient care, which is currently labeled as misvalued (Centers for Medicare and Medicaid Services, 2021).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All US nephrologists who care for dialysis patients.
Key inclusion criteria (1 listed)
- All nephrologists in the US who care for dialysis patients.
Key exclusion criteria (1 listed)
- Nephrologists who have not cared for dialysis patients in the last year.
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 |
|---|---|---|
| No intervention. This is a qualitative studyAlso: SurveyUS nephrologists who care for dialysis patients will be asked to complete an internet based survey evaluating the time and effort required for home dialysis patient care. | Other | – |
Primary outcome
To provide data to facilitate a data-driven adjustment of the capitated physician payment for caring for home dialysis patients.
Time frame: Day 1
Compilation of survey data from US nephrologists with dialysis patients.
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 11 May 2022.
- 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.
Wael F Hussein, MBBS principal investigator
Satellite Healthcare, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD, run by Satellite Healthcare 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 1 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 11 May 2022. 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?
To provide data to facilitate a data-driven adjustment of the capitated physician payment for caring for home dialysis patients. (time frame: Day 1). 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 11 May 2022.