End Stage Renal DiseaseNCT05005572
Treatment Choice and Outcomes for ESRD: Evidence From the First Year of a Nationwide Randomized Evaluation
A study testing Payment adjustment for home dialysis and transplant in people with End Stage Renal Disease, run by Amy Finkelstein at 1 site in United States.
Trial summary
The investigators plan to analyze the first year of a nationwide randomized-controlled trial of end stage renal disease (ESRD) treatment choice model (ETC). This mandatory-participation program was designed by the Centers for Medicare and Medicaid Services and randomization was conducted at the hospital referral… Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Payment adjustment for home dialysis and transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,621 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All Medicare-certified ESRD facilities and Medicare-enrolled managing clinicians located in HRRs in the United States are required to participate.
- Patient is receiving dialysis or other services for ESRD
- Patient is new to dialysis, defined as not having received dialysis for at least 12 months prior to their first observed dialysis claim
- Patient is enrolled in Medicare Part B
Who cannot join
- HRRs in US territories
- HRRs with 20% or more zip codes in Maryland (excluded from randomization)
- Facilities and clinicians with fewer than 11 attributed beneficiaries
- Patient is receiving dialysis only for an acute kidney injury
- Patient is younger than 66 years of age before initiating dialysis
- Patient received a kidney transplant within 12 months prior to the start of dialysis and does not have a kidney transplant failure code
Show all 11Show fewer
- Patient is enrolled in Medicare Advantage, a cost plan, or other Medicare managed care plan
- Patient resides outside of the US or in one of the US territories
- Patient has elected hospice
- Patient has a diagnosis of dementia at any point in the first 90 days or the preceding 12 months before initiating dialysis as identified using Centers for Medicare and Medicaid Services Hierarchical condition categories (CMS-HCC)
- Patient is residing in or receiving dialysis in a skilled nursing facility (SNF)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02142
About this study
Official title: Treatment Choice and Outcomes for End Stage Renal Disease: Evidence From the First Year of a Nationwide Randomized Evaluation
The investigators plan to analyze the first year of a nationwide randomized-controlled trial of end stage renal disease (ESRD) treatment choice model (ETC). This mandatory-participation program was designed by the Centers for Medicare and Medicaid Services and randomization was conducted at the hospital referral region (HRR) level. 95 HRRs were assigned to the treatment group beginning in January 2021. The investigators will study the impact of this program in the first year on treatment modality choice for ESRD and explore heterogeneity in impact across patients and providers.
- Conditions
- End Stage Renal Disease
- Being tested
- Payment adjustment for home dialysis and transplant
- Keywords
- Hemodialysis, Peritoneal Dialysis
- 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.
Payment adjustment for home dialysis and transplantOther
The ETC model makes two types of payment adjustments for facilities and managing clinicians, an adjustment to the reimbursement rate for home dialysis, and a performance adjustment. The first adjustment, Home Dialysis Payment Adjustment (HDPA), raises the reimbursement rate for home dialysis for the first three years of the program; the amount of increase is 3% in 2021, and reduces to 2% in 2022, and 1% in 2023. The second adjustment, Performance Payment Adjustment (PPA), is an increase or decrease in the reimbursement rate based on the home dialysis rate and the transplant rate attributable to the participating facility or clinician.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Payment adjustment for home dialysis and transplant |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Receiving Any Home Dialysis in the First 90 Days
It is defined as the percentage of patients in our baseline sample who have any home dialysis claims within the first 90 days since the start of dialysis treatment.
Measured: The 90-day period beginning on the date of the first dialysis claim.
Secondary outcomes (2)
Percentage of Weeks Receiving Any Home Dialysis in First 90 Days
For each patient, this is the number of weeks the patient received dialysis at home or receiving training for home dialysis within the first 90 days divided by the number of weeks the patient received dialysis in any modality in the first 90 days. For the 13th week since the start of dialysis, only the 6 days that fall within the 90-day period are counted and the week is weighted at 6/7 of the other weeks when computing this measure.
Measured: The 90-day period beginning on the date of the first dialysis claim.
Percentage of Dialysis Sessions at Home in First 90 Days
For each patient, this is the number of dialysis sessions at home divided by the total number of dialysis sessions in the first 90 days, weighting peritoneal dialysis sessions as 3/7 of hemodialysis sessions.
Measured: The 90-day period beginning on the date of the first dialysis claim.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Jan 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18,621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amy Finkelstein
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Sponsor-investigator, Amy Finkelstein, Abdul Latif Jameel Poverty Action Lab
- Investigators
- Amy Finkelstein, PhD, Principal investigator, Massachusetts Institute of TechnologyLiran Einav, PhD, Principal investigator, Stanford UniversityNeale Mahoney, PhD, Principal investigator, Stanford UniversityYunan Ji, BA, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005572
- Sponsor's protocol ID
- JPAL-9512
- Status last verified
- Oct 2022
- First submitted
- 6 Aug 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ji Y, Einav L, Mahoney N, Finkelstein A. Financial Incentives to Facilities and Clinicians Treating Patients With End-stage Kidney Disease and Use of Home Dialysis: A Randomized Clinical Trial. JAMA Health Forum. 2022 Oct 7;3(10):e223503. doi: 10.1001/jamahealthforum.2022.3503.
PubMed 36206005
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Choice and Outcomes for End Stage Renal Disease: Evidence From the First Year of a Nationwide Randomized Evaluation
- ClinicalTrials.gov ID
- NCT05005572
- Acronym / sponsor ID
- JPAL-9512
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,621 participants (actual)
- Lead sponsor
- Amy FinkelsteinUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 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.
The investigators plan to analyze the first year of a nationwide randomized-controlled trial of end stage renal disease (ESRD) treatment choice model (ETC). This mandatory-participation program was designed by the Centers for Medicare and Medicaid Services and randomization was conducted at the hospital referral region (HRR) level. 95 HRRs were assigned to the treatment group beginning in January 2021. The investigators will study the impact of this program in the first year on treatment modality choice for ESRD and explore heterogeneity in impact across patients and providers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Payment adjustment for home dialysis and transplant |
| Control | No intervention | – |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- All Medicare-certified ESRD facilities and Medicare-enrolled managing clinicians located in HRRs in the United States are required to participate.
- Patient is receiving dialysis or other services for ESRD
- Patient is new to dialysis, defined as not having received dialysis for at least 12 months prior to their first observed dialysis claim
- Patient is enrolled in Medicare Part B
Key exclusion criteria (11 listed)
- HRRs in US territories
- HRRs with 20% or more zip codes in Maryland (excluded from randomization)
- Facilities and clinicians with fewer than 11 attributed beneficiaries
- Patient is receiving dialysis only for an acute kidney injury
- Patient is younger than 66 years of age before initiating dialysis
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 |
|---|---|---|
| Payment adjustment for home dialysis and transplantThe ETC model makes two types of payment adjustments for facilities and managing clinicians, an adjustment to the reimbursement rate for home dialysis, and a performance adjustment. The first adjustment, Home Dialysis Payment Adjustment (HDPA), raises the reimbursement rate for home dialysis for the first three years of the program; the amount of increase is 3% in 2021, and reduces to 2% in 2022, and 1% in 2023. The second adjustment, Performance Payment Adjustment (PPA), is an increase or decrease in the reimbursement rate based on the home dialysis rate and the transplant rate attributable to the participating facility or clinician. | Other | Treatment |
Primary outcome
Percentage of Patients Receiving Any Home Dialysis in the First 90 Days
Time frame: The 90-day period beginning on the date of the first dialysis claim.
It is defined as the percentage of patients in our baseline sample who have any home dialysis claims within the first 90 days since the start of dialysis treatment.
2 secondary outcomes
Percentage of Weeks Receiving Any Home Dialysis in First 90 Days
Time frame: The 90-day period beginning on the date of the first dialysis claim.
Percentage of Dialysis Sessions at Home in First 90 Days
Time frame: The 90-day period beginning on the date of the first dialysis claim.
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 2 Nov 2022.
- Results publication: PubMed 36206005Ji Y, Einav L, Mahoney N, Finkelstein A. Financial Incentives to Facilities and Clinicians Treating Patients With End-stage Kidney Disease and Use of Home Dialysis: A Randomized Clinical Trial. JAMA Health Forum. 2022 Oct 7;3(10):e223503. doi: 10.1001/jamahealthforum.2022.3503.
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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.
Amy Finkelstein, PhD principal investigator
Massachusetts Institute of Technology
Liran Einav, PhD principal investigator
Stanford University
Neale Mahoney, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Payment adjustment for home dialysis and transplant in people with End Stage Renal Disease, run by Amy Finkelstein 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 11 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 2 Nov 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?
Percentage of Patients Receiving Any Home Dialysis in the First 90 Days (time frame: The 90-day period beginning on the date of the first dialysis claim.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005572, which also lists 1 linked publication.
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 2 Nov 2022.