Renal DialysisNCT04764435
The Effect of Physician Ownership on Dialysis Outcomes
An observational study of Renal Dialysis and Financial Disclosure, run by University of Southern California.
Trial summary
Many dialysis facilities have financial relationships with nephrologists, including joint venture agreements, where the nephrologist owns a minority share of the dialysis facility. Such agreements could present a conflict of interest with respect to patient care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Financial Disclosure
- What is being tested?
- Physician ownership and Large dialysis organization ownership
- How many people
- 208,213 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2017
- 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
- Adult, Older adult
Study population: The study will include all patient-months between 1/1/2017-12/31/2017 of 100% of patients receiving dialysis for ESRD in free-standing, non-pediatric dialysis facilities in the US. Patients must have at least 12 months of Medicare fee-for-service as the primary payer.
Who may be able to join
- Adult
- Receiving dialysis for ESRD in the US
- Medicare fee for service as primary payer (and had Medicare FFS for at least 12 months prior to the month
- Received dialysis between 1/1/2017-12/31/2017
- Receiving dialysis in a free-standing facility
- No missing data
Who cannot join
- Pediatric (< 18 years)
- Receiving dialysis in hospital-based facility
- Receiving dialysis in a facility that had >= 15% pediatric patient months
About this study
Many dialysis facilities have financial relationships with nephrologists, including joint venture agreements, where the nephrologist owns a minority share of the dialysis facility. Such agreements could present a conflict of interest with respect to patient care. This study will investigate whether these joint venture agreements are associated with differences in the quality of care provided by dialysis facilities.
Read the detailed description
The investigators will use the United States Renal Data System (USRDS), a registry of all patients on dialysis in the US irrespective of payer. The dataset includes patient characteristics (biologic and sociodemographic) within 45 days of initiating dialysis for all patients with ESKD irrespective of insurance coverage, death data for all patients with ESKD irrespective of insurance, dialysis facility characteristics, which are updated annually, longitudinal treatment data submitted by the end-stage renal disease (ESRD) networks for all patients irrespective of insurance, and CROWNWeb clinical data: monthly treatment data (e.g., Kt/V, treatment time, serum hemoglobin, vascular access) submitted by dialysis facilities for all patients irrespective of insurance. The registry is linked to Fee-for-service Medicare claims for all patients with this payer. All data have already been collected (i.e., this is a retrospective study) and deidentified by a data distributor.
The investigators have also obtained a cross-sectional dataset of dialysis facilities and physician owners in 2017 from the Centers for Medicare \& Medicaid Services (CMS) through a Freedom of Information Act request.
In this study, the investigators will link the USRDS to this cross-sectional dataset. The investigators will also link the data to publicly available data from Dialysis Facility Compare (which contains quality performance of each dialysis facility, published by the government on a quarterly basis) and Census data (which contains geographic sociodemographic characteristics).
From this data linkage, the investigators will study differences between facilities that are physician owned and those that are not physician owned. The investigators will study outcomes both at the facility level and the patient level.
All models will have an alpha of 5% and will have 2-sided statistical tests.
For facility level outcomes:
The investigators will construct a facility level dataset and compare physician-owned facilities to non-physician owned facilities adjusting for facility characteristics and regional (zipcode level) sociodemographic characteristics. The investigators will also test the effect of incorporating patient characteristics into the model. For patient characteristics, the investigators will take the average for each facility's population (e.g., average age, % of patients male, etc.). The investigators will use ordinary least squares for continuous outcomes and logistic regression for binary outcomes. The investigators will use robust standard errors.
For patient level outcomes:
The investigators will construct a patient-month panel dataset and compare patients dialyzing at physician-owned facilities to those dialyzing at non-physician owned facilities. The investigators will adjust for patient, facility, and zipcode level sociodemographic characteristics. Since all outcomes are binary, the investigators will use logistic regression for all models. The investigators' primary analysis will be logistic regression, adjusting for patient, facility, zipcode characteristics, with patient-level fixed effects and non-parametric bootstrap standard errors. In order, The investigators will explore the sensitivity of results to the following:
- logistic regression with all adjusters, patient-level fixed effects, and robust standard errors
- ordinary least squares with all adjusters, patient-level fixed effects, cluster-robust standard errors at the facility level
- ordinary least squares with all adjusters, patient-level fixed effects, robust standard errors
The investigators also pre-specify the adjusters below:
Patient characteristics (comorbidities will be obtained using the Chronic Conditions Warehouse software on a 12 month lookback of Medicare fee-for-service claims)
- Age
- Sex
- Race
- Ethnicity
- Prior transplant
- Incident patient (first 120 days of dialysis)
- Years with ESRD
- Dual Eligibility
- Hypertension
- Alzheimers
- Atrial fibrilation
- Prior myocardial infarction
- Asthma
- Breast Cancer
- Cataract
- Chronic obstructive pulmonary disease
- Colorectal Cancer
- Depression
- Diabetes
- Endometrial Cancer
- Glaucoma
- Congestive Heart Failure
- Hip Fracture
- Hyperlipidemia
- Hypertension
- Ischemic heart disease
- Lung cancer
- Osteoporosis
- Prostate Cancer
- Rheumatoid Arthritis / Osteoarthritis
- Prior stroke / transient ischemic attack
- Benign prostatic hyperplasia
Facility characteristics
- For-profit status
- Chain owned
- Number of patients at facility
- Patient:staff ratio
- ESRD Network
Regional (zipcode level) sociodemographic characteristics
- Median Income
- % of zipcode with high school degree
- % of zipcode below poverty line
We pre-specify a subgroup analysis by whether the dialysis facility is owned by a large dialysis organization (i.e., Davita, Fresenius).
- Conditions
- Renal Dialysis, Financial Disclosure
- Being tested
- Physician ownership, Large dialysis organization ownership
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician ownershipOther
The "intervention" or exposure is whether the dialysis facility was owned by a physician in 2017
Large dialysis organization ownershipOther
The "intervention" or exposure is whether the dialysis facility was owned by a large dialysis organization in 2017
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving dialysis at a physician-owned dialysis facility | All adults with Medicare fee-for-service in 2017 who received dialysis at a physician-owned dialysis facility. If a patient received dialysis at more than one facility in 2017, patients will be assigned to the facility that provided the plurality of dialysis in 2017. Receives: Other: Physician ownership | |
| Patients receiving dialysis at a dialysis facility not owned by a physician | All adults with Medicare fee-for-service in 2017 who received dialysis at a dialysis facility not owned by a physician. If a patient received dialysis at more than one facility in 2017, patients will be assigned to the facility that provided the plurality of dialysis in 2017. | |
| Patients receiving dialysis at a facility owned by a large dialysis organization | All adults with Medicare fee-for-service in 2017 who received dialysis at a dialysis facility owned by a large dialysis organization (Davita or Fresenius). If a patient received dialysis at more than one facility in 2017, patients will be assigned to the facility that provided the plurality of dialysis in 2017. Receives: Other: Large dialysis organization ownership | |
| Patients receiving dialysis at a facility NOT owned by a large dialysis organization | All adults with Medicare fee-for-service in 2017 who received dialysis at a dialysis facility NOT owned by a large dialysis organization (Davita or Fresenius). If a patient received dialysis at more than one facility in 2017, patients will be assigned to the facility that provided the plurality of dialysis in 2017. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facility level outcome: Facility 5-star rating
Whether a facility was a "high-quality" facility using the Dialysis Facility Compare aggregate score in 2017. The variable will be dichotomized into:
- High-quality: 4-5 stars
- Low-quality: 1-3 stars
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: % of patient-months with long-term catheter
The fraction of patient-months of a dialysis facility where the patient used a catheter for 3 months or longer in 2017
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: % of patient-months with hemoglobin < 10 g/dL
The fraction of patient-months of a dialysis facility where the patient had a hemoglobin < 10
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: % of patient-months with hemoglobin > 12 g/dL
The fraction of patient-months of a dialysis facility where the patient had a hemoglobin > 12
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: % of patient-months with serum calcium > 10.2 mg/dL
The fraction of patient-months of a dialysis facility where the patient had a serum calcium > 10.2
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: % of patient-months with serum phosphate > 7 mg/dL
The fraction of patient-months of a dialysis facility where the patient had a serum phosphate > 7
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: % of patient-months with Kt/V >= 1.2 (for hemodialysis)
The fraction of patient-months of a dialysis facility where the patient had a Kt/V >= 1.2 (hemodialysis only)
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: % of patient-months with Kt/V >= 1.7 (for peritoneal dialysis)
The fraction of patient-months of a dialysis facility where the patient had a Kt/V >= 1.7 (peritoneal dialysis only)
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: standardized mortality rate
Facility's standardized mortality rate according to Dialysis Facility Compare
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: standardized hospitalization rate
Facility's standardized hospitalization rate according to Dialysis Facility Compare
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: standardized 30-day readmission rate
Facility's standardized 30-day readmission rate according to Dialysis Facility Compare
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: standardized infection ratio
Facility's standardized infection ratio according to Dialysis Facility Compare
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: standardized transfusion rate
Facility's standardized transfusion rate according to Dialysis Facility Compare
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility level outcome: % of patient months where fistula is being used (hemodialysis)
The fraction of patient-months of a dialysis facility where the patient was using a fistula (hemodialysis only)
Measured: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Patient level outcome: mortality
Assess the exact date of death (reported in the administrative dataset)
Measured: For each calendar month in 2017, determine whether the patient was alive or dead (administrative data indicate the exact date of death)
Patient level outcome: home dialysis (peritoneal dialysis or home hemodialysis)
Using claims data (granular at a daily level), determine the dialysis modality used for the plurality of that month
Measured: For each calendar month in 2017, determine whether the patient used home dialysis for the plurality of that month (claims indicate type of dialysis for each calendar day of the month)
Patient level outcome: serum hemoglobin < 10 g/dL
Whether the patient's serum hemoglobin < 10 at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine whether the patient's serum hemoglobin was < 10 at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Patient level outcome: serum hemoglobin > 12 g/dL
Whether the patient's serum hemoglobin was > 12 at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine whether the patient's serum hemoglobin was > 12 at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Patient level outcome: serum calcium > 10.2 mg/dL
Whether the patient's serum calcium was > 10.2 at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine whether the patient's serum calcium > 10.2 at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)h and year
Patient level outcome: serum phosphate > 7 mg/dL
Whether the patient's serum phopshate was > 7 at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine whether the patient's serum phosphate was > 7 at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Patient level outcome: hospitalization in that month
Whether the patient had a hospitalization in a given month, using claims data (claims are granular at a daily level)
Measured: For each calendar month in 2017, determine whether the patient experienced a hospitalization (claims data provide a daily assessment of whether patient was hospitalized)
Patient level outcome: 30-day readmission following a discharge in that month
Whether the patient had a discharge in a given month that was followed by a 30-day readmission, using claims data (claims are granular at a daily level)
Measured: For each calendar month in 2017, determine whether the patient experienced a hospitalization that was later followed by a 30-day readmission (claims data provide a daily assessment of whether patient was hospitalized)
Patient level outcome: unplanned 30-day readmission following a discharge in that month
Whether the patient had a discharge in a given month that was followed by an unplanned 30-day readmission, using claims data (claims are granular at a daily level)
Measured: For each calendar month in 2017, determine whether the patient experienced a hospitalization that was later followed by an unplanned 30-day readmission (claims data provide a daily assessment of whether patient was hospitalized)
Patient level outcome: using a fistula in that month (hemodialysis)
Whether a fistula was used at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine whether the patient was using a fistula at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Patient level outcome: using a catheter in that month (hemodialysis)
Whether a dialysis catheter was used at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine whether the patient was using a dialysis catheter at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Patient level outcome: using a catheter for 3 or more months
Whether a dialysis catheter was used at the end of a given month and at the end of the previous 2 calendar months, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine whether the patient was using a fistula at the end of the calendar month, and at the end of the previous two months (dialysis facilities report to CROWNWeb at the end of each month)
Patient level outcome: using an erythropoietin stimulating agent
The type of erythropoietin stimulating agent in a given month and the total dose administered, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine whether the patient was using an erythropoietin stimulating agent at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Patient level outcome: receipt of a blood transfusion
Whether the patient received a blood transfusion in a given month, using claims data (granular at a daily level)
Measured: For each calendar month in 2017, determine whether the patient received a blood transfusion in the calendar month (claims data report on a daily basis when a patient received a blood transfusion)
Patient level outcome: dose of erythropoietin stimulating agent
The type of erythropoietin stimulating agent in a given month and the total dose administered, using CROWNWeb data (reported at the end of each calendar month)
Measured: For each calendar month in 2017, determine the type of erythropoietin stimulating agent used for that month and the total dose (dialysis facilities report to CROWNWeb at the end of each month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 208,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Eugene Lin, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764435
- Sponsor's protocol ID
- HS-18-00530-1
- Other IDs
- K08DK118213
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data can be obtained from the USRDS. Data cannot be shared per the data use agreement (DUA).
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physician Ownership on Dialysis Outcomes
- ClinicalTrials.gov ID
- NCT04764435
- Acronym / sponsor ID
- HS-18-00530-1
- Conditions
- Renal Dialysis, Financial Disclosure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208,213 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 Feb 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.
Many dialysis facilities have financial relationships with nephrologists, including joint venture agreements, where the nephrologist owns a minority share of the dialysis facility. Such agreements could present a conflict of interest with respect to patient care. This study will investigate whether these joint venture agreements are associated with differences in the quality of care provided by dialysis facilities.
Detailed description
The investigators will use the United States Renal Data System (USRDS), a registry of all patients on dialysis in the US irrespective of payer. The dataset includes patient characteristics (biologic and sociodemographic) within 45 days of initiating dialysis for all patients with ESKD irrespective of insurance coverage, death data for all patients with ESKD irrespective of insurance, dialysis facility characteristics, which are updated annually, longitudinal treatment data submitted by the end-stage renal disease (ESRD) networks for all patients irrespective of insurance, and CROWNWeb clinical data: monthly treatment data (e.g., Kt/V, treatment time, serum hemoglobin, vascular access) submitted by dialysis facilities for all patients irrespective of insurance. The registry is linked to Fee-for-service Medicare claims for all patients with this payer. All data have already been collected (i.e., this is a retrospective study) and deidentified by a data distributor.
The investigators have also obtained a cross-sectional dataset of dialysis facilities and physician owners in 2017 from the Centers for Medicare \& Medicaid Services (CMS) through a Freedom of Information Act request.
In this study, the investigators will link the USRDS to this cross-sectional dataset. The investigators will also link the data to publicly available data from Dialysis Facility Compare (which contains quality performance of each dialysis facility, published by the government on a quarterly basis) and Census data (which contains geographic sociodemographic characteristics).
From this data linkage, the investigators will study differences between facilities that are physician owned and those that are not physician owned. The investigators will study outcomes both at the facility level and the patient level.
All models will have an alpha of 5% and will have 2-sided statistical tests.
For facility level outcomes:
The investigators will construct a facility level dataset and compare physician-owned facilities to non-physician owned facilities adjusting for facility characteristics and regional (zipcode level) sociodemographic characteristics. The investigators will also test the effect of incorporating patient characteristics into the model. For patient characteristics, the investigators will take the average for each facility's population (e.g., average age, % of patients male, etc.). The investigators will use ordinary least squares for continuous outcomes and logistic regression for binary outcomes. The investigators will use robust standard errors.
For patient level outcomes:
The investigators will construct a patient-month panel dataset and compare patients dialyzing at physician-owned facilities to those dialyzing at non-physician owned facilities. The investigators will adjust for patient, facility, and zipcode level sociodemographic characteristics. Since all outcomes are binary, the investigators will use logistic regression for all models. The investigators' primary analysis will be logistic regression, adjusting for patient, facility, zipcode characteristics, with patient-level fixed effects and non-parametric bootstrap standard errors. In order, The investigators will explore the sensitivity of results to the following:
- logistic regression with all adjusters, patient-level fixed effects, and robust standard errors
- ordinary least squares with all adjusters, patient-level fixed effects, cluster-robust standard errors at the facility level
- ordinary least squares with all adjusters, patient-level fixed effects, robust standard errors
The investigators also pre-specify the adjusters below:
Patient characteristics (comorbidities will be obtained using the Chronic Conditions Warehouse software on a 12 month lookback of Medicare fee-for-service claims)
- Age
- Sex
- Race
- Ethnicity
- Prior transplant
- Incident patient (first 120 days of dialysis)
- Years with ESRD
- Dual Eligibility
- Hypertension
- Alzheimers
- Atrial fibrilation
- Prior myocardial infarction
- Asthma
- Breast Cancer
- Cataract
- Chronic obstructive pulmonary disease
- Colorectal Cancer
- Depression
- Diabetes
- Endometrial Cancer
- Glaucoma
- Congestive Heart Failure
- Hip Fracture
- Hyperlipidemia
- Hypertension
- Ischemic heart disease
- Lung cancer
- Osteoporosis
- Prostate Cancer
- Rheumatoid Arthritis / Osteoarthritis
- Prior stroke / transient ischemic attack
- Benign prostatic hyperplasia
Facility characteristics
- For-profit status
- Chain owned
- Number of patients at facility
- Patient:staff ratio
- ESRD Network
Regional (zipcode level) sociodemographic characteristics
- Median Income
- % of zipcode with high school degree
- % of zipcode below poverty line
We pre-specify a subgroup analysis by whether the dialysis facility is owned by a large dialysis organization (i.e., Davita, Fresenius).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients receiving dialysis at a physician-owned dialysis facility | – | Other: Physician ownershipAll adults with Medicare fee-for-service in 2017 who received dialysis at a physician-owned dialysis facility. If a patient received dialysis at more than one facility in 2017, patients will be assigned to the facility that provided the plurality of dialysis in 2017. |
| Patients receiving dialysis at a dialysis facility not owned by a physician | – | –All adults with Medicare fee-for-service in 2017 who received dialysis at a dialysis facility not owned by a physician. If a patient received dialysis at more than one facility in 2017, patients will be assigned to the facility that provided the plurality of dialysis in 2017. |
| Patients receiving dialysis at a facility owned by a large dialysis organization | – | Other: Large dialysis organization ownershipAll adults with Medicare fee-for-service in 2017 who received dialysis at a dialysis facility owned by a large dialysis organization (Davita or Fresenius). If a patient received dialysis at more than one facility in 2017, patients will be assigned to the facility that provided the plurality of dialysis in 2017. |
| Patients receiving dialysis at a facility NOT owned by a large dialysis organization | – | –All adults with Medicare fee-for-service in 2017 who received dialysis at a dialysis facility NOT owned by a large dialysis organization (Davita or Fresenius). If a patient received dialysis at more than one facility in 2017, patients will be assigned to the facility that provided the plurality of dialysis in 2017. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include all patient-months between 1/1/2017-12/31/2017 of 100% of patients receiving dialysis for ESRD in free-standing, non-pediatric dialysis facilities in the US. Patients must have at least 12 months of Medicare fee-for-service as the primary payer.
Key inclusion criteria (6 listed)
- Adult
- Receiving dialysis for ESRD in the US
- Medicare fee for service as primary payer (and had Medicare FFS for at least 12 months prior to the month
- Received dialysis between 1/1/2017-12/31/2017
- Receiving dialysis in a free-standing facility
Key exclusion criteria (3 listed)
- Pediatric (< 18 years)
- Receiving dialysis in hospital-based facility
- Receiving dialysis in a facility that had >= 15% pediatric patient months
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 |
|---|---|---|
| Physician ownershipThe "intervention" or exposure is whether the dialysis facility was owned by a physician in 2017 | Other | Patients receiving dialysis at a physician-owned dialysis facility |
| Large dialysis organization ownershipThe "intervention" or exposure is whether the dialysis facility was owned by a large dialysis organization in 2017 | Other | Patients receiving dialysis at a facility owned by a large dialysis organization |
Primary outcome
Facility level outcome: Facility 5-star rating
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Whether a facility was a "high-quality" facility using the Dialysis Facility Compare aggregate score in 2017. The variable will be dichotomized into: * High-quality: 4-5 stars * Low-quality: 1-3 stars
Facility level outcome: % of patient-months with long-term catheter
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
The fraction of patient-months of a dialysis facility where the patient used a catheter for 3 months or longer in 2017
Facility level outcome: % of patient-months with hemoglobin < 10 g/dL
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
The fraction of patient-months of a dialysis facility where the patient had a hemoglobin < 10
Facility level outcome: % of patient-months with hemoglobin > 12 g/dL
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
The fraction of patient-months of a dialysis facility where the patient had a hemoglobin > 12
Facility level outcome: % of patient-months with serum calcium > 10.2 mg/dL
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
The fraction of patient-months of a dialysis facility where the patient had a serum calcium > 10.2
Facility level outcome: % of patient-months with serum phosphate > 7 mg/dL
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
The fraction of patient-months of a dialysis facility where the patient had a serum phosphate > 7
Facility level outcome: % of patient-months with Kt/V >= 1.2 (for hemodialysis)
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
The fraction of patient-months of a dialysis facility where the patient had a Kt/V >= 1.2 (hemodialysis only)
Facility level outcome: % of patient-months with Kt/V >= 1.7 (for peritoneal dialysis)
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
The fraction of patient-months of a dialysis facility where the patient had a Kt/V >= 1.7 (peritoneal dialysis only)
Facility level outcome: standardized mortality rate
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility's standardized mortality rate according to Dialysis Facility Compare
Facility level outcome: standardized hospitalization rate
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility's standardized hospitalization rate according to Dialysis Facility Compare
Facility level outcome: standardized 30-day readmission rate
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility's standardized 30-day readmission rate according to Dialysis Facility Compare
Facility level outcome: standardized infection ratio
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility's standardized infection ratio according to Dialysis Facility Compare
Facility level outcome: standardized transfusion rate
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
Facility's standardized transfusion rate according to Dialysis Facility Compare
Facility level outcome: % of patient months where fistula is being used (hemodialysis)
Time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)
The fraction of patient-months of a dialysis facility where the patient was using a fistula (hemodialysis only)
Patient level outcome: mortality
Time frame: For each calendar month in 2017, determine whether the patient was alive or dead (administrative data indicate the exact date of death)
Assess the exact date of death (reported in the administrative dataset)
Patient level outcome: home dialysis (peritoneal dialysis or home hemodialysis)
Time frame: For each calendar month in 2017, determine whether the patient used home dialysis for the plurality of that month (claims indicate type of dialysis for each calendar day of the month)
Using claims data (granular at a daily level), determine the dialysis modality used for the plurality of that month
Patient level outcome: serum hemoglobin < 10 g/dL
Time frame: For each calendar month in 2017, determine whether the patient's serum hemoglobin was < 10 at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Whether the patient's serum hemoglobin < 10 at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Patient level outcome: serum hemoglobin > 12 g/dL
Time frame: For each calendar month in 2017, determine whether the patient's serum hemoglobin was > 12 at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Whether the patient's serum hemoglobin was > 12 at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Patient level outcome: serum calcium > 10.2 mg/dL
Time frame: For each calendar month in 2017, determine whether the patient's serum calcium > 10.2 at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)h and year
Whether the patient's serum calcium was > 10.2 at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Patient level outcome: serum phosphate > 7 mg/dL
Time frame: For each calendar month in 2017, determine whether the patient's serum phosphate was > 7 at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Whether the patient's serum phopshate was > 7 at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Patient level outcome: hospitalization in that month
Time frame: For each calendar month in 2017, determine whether the patient experienced a hospitalization (claims data provide a daily assessment of whether patient was hospitalized)
Whether the patient had a hospitalization in a given month, using claims data (claims are granular at a daily level)
Patient level outcome: 30-day readmission following a discharge in that month
Time frame: For each calendar month in 2017, determine whether the patient experienced a hospitalization that was later followed by a 30-day readmission (claims data provide a daily assessment of whether patient was hospitalized)
Whether the patient had a discharge in a given month that was followed by a 30-day readmission, using claims data (claims are granular at a daily level)
Patient level outcome: unplanned 30-day readmission following a discharge in that month
Time frame: For each calendar month in 2017, determine whether the patient experienced a hospitalization that was later followed by an unplanned 30-day readmission (claims data provide a daily assessment of whether patient was hospitalized)
Whether the patient had a discharge in a given month that was followed by an unplanned 30-day readmission, using claims data (claims are granular at a daily level)
Patient level outcome: using a fistula in that month (hemodialysis)
Time frame: For each calendar month in 2017, determine whether the patient was using a fistula at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Whether a fistula was used at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Patient level outcome: using a catheter in that month (hemodialysis)
Time frame: For each calendar month in 2017, determine whether the patient was using a dialysis catheter at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
Whether a dialysis catheter was used at the end of a given month, using CROWNWeb data (reported at the end of each calendar month)
Patient level outcome: using a catheter for 3 or more months
Time frame: For each calendar month in 2017, determine whether the patient was using a fistula at the end of the calendar month, and at the end of the previous two months (dialysis facilities report to CROWNWeb at the end of each month)
Whether a dialysis catheter was used at the end of a given month and at the end of the previous 2 calendar months, using CROWNWeb data (reported at the end of each calendar month)
Patient level outcome: using an erythropoietin stimulating agent
Time frame: For each calendar month in 2017, determine whether the patient was using an erythropoietin stimulating agent at the end of the calendar month (dialysis facilities report to CROWNWeb at the end of each month)
The type of erythropoietin stimulating agent in a given month and the total dose administered, using CROWNWeb data (reported at the end of each calendar month)
Patient level outcome: receipt of a blood transfusion
Time frame: For each calendar month in 2017, determine whether the patient received a blood transfusion in the calendar month (claims data report on a daily basis when a patient received a blood transfusion)
Whether the patient received a blood transfusion in a given month, using claims data (granular at a daily level)
Patient level outcome: dose of erythropoietin stimulating agent
Time frame: For each calendar month in 2017, determine the type of erythropoietin stimulating agent used for that month and the total dose (dialysis facilities report to CROWNWeb at the end of each month)
The type of erythropoietin stimulating agent in a given month and the total dose administered, using CROWNWeb data (reported at the end of each calendar month)
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 16 Mar 2021.
- Individual participant dataSharing planned: No. Individual participant data can be obtained from the USRDS. Data cannot be shared per the data use agreement (DUA).
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Dialysis and Financial Disclosure, run by University of Southern California.
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 6 inclusion and 3 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Facility level outcome: Facility 5-star rating (time frame: Cross-sectional from October 2017 dataset (aggregates quality performance from the calendar year 2016)). The study lists 29 primary outcomes in all. 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 16 Mar 2021.