Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital

This study will investigate whether home dialysis uptake varies by the season of year. We will also investigate whether hospitalizations around the time of dialysis also vary by season of year and whether hospitalizations are associated with reduced home dialysis starts and sustained home dialysis uptake.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis; Dialysis; Hospitalizations
• Intervention / Treatment: Other: Season of Year; Other: Hospitalized 14 days prior to dialysis

• Study Type: Observational
• Enrollment (Actual): 400000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults with fee-for-service Medicare coverage initiating dialysis for end-stage kidney disease in the United States from 12/1/2007-11/30/2017

Description

Inclusion Criteria:

• Started dialysis in the USA for end-stage kidney disease from 12/1/2007-11/30/2017
• No transplant or death prior to day 90 of dialysis
• Medicare Parts A/B as primary payer 30 days prior to starting dialysis
• Valid Medicare Evidence Form (Form 2728)

Exclusion Criteria:

• As above

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients initiating dialysis for end-stage kidney disease; Patients whose start of dialysis is from 12/1/2007-11/30/2017. We use the following inclusion criteria: Adult (>= 18 years old); Did not die or have a transplant prior to the 90th day of dialysis; Valid medical evidence form; Medicare Part A/B as primary payer in the 30 days prior to initiating dialysis; Initiating dialysis in the USA

Other: Season of Year; We stratify patients into 4 groups based on the season of the year (between 12/1/2007-11/30/2017); Winter: December, January, February; Spring: March, April, May; Summer: June, July, August; Fall: September, October, November; Other: Hospitalized 14 days prior to dialysis; We further stratify patients into 3 groups based on whether they were hospitalized within 14 days prior to dialysis; Group 1: No hospitalization prior to dialysis; Group 2: Hospitalized within 14 days prior to dialysis for an acute infectious respiratory condition or one of the following acute cardiac conditions (arrhythmia, myocardial infarction, stroke, or fluid overload); Group 3: Hospitalized within 14 days prior to dialysis for a condition not in Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of dialysis modality at the start of dialysis	Whether patient started with home dialysis or in-center dialysis at the start of dialysis	Day 1 of dialysis
Type of dialysis modality at the end of month 3 of dialysis	Whether patient was using home dialysis or in-center dialysis at the end of month 3 of dialysis (day 84)	End of month 3 of dialysis
Type of dialysis modality at the end of month 6 of dialysis	Whether patient was using home dialysis or in-center dialysis at the end of month 6 of dialysis (day 168)	End of month 6 of dialysis
Type of dialysis modality at the end of month 9 of dialysis	Whether patient was using home dialysis or in-center dialysis at the end of month 9 of dialysis (day 252)	End of month 9 of dialysis
Type of dialysis modality at the end of month 12 of dialysis	Whether patient was using home dialysis or in-center dialysis at the end of month 12 of dialysis (day 336)	End of month 12 of dialysis
Mortality in the first year	Whether the patient died in the first year of dialysis and the number of days the patient survived - Censored for transplantation, loss to follow-up	1 year of dialysis

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2007
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HS-18-00530-2; K08DK118213 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data are protected by a DUA from the United States Renal Data System. Researchers interested in obtaining the data must obtain a DUA. We will share programs to generate the analyses via an open source sharing resource.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No