The Effect of Physician Ownership on Dialysis Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 208,213
- Primary Endpoint
- Facility level outcome: Facility 5-star rating
Study Overview
Brief 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. 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Pediatric (< 18 years)
- •Receiving dialysis in hospital-based facility
- •Receiving dialysis in a facility that had >= 15% pediatric patient months
Outcomes
Primary Outcomes
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 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
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: 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)
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 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 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: 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
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: 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: 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)
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 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)
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 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
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: 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: 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: 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: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Eugene Lin
Assistant Professor
University of Southern California