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

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT04935827

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

400,000

Enrollment

120

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dialysis Peritoneal Dialysis Hospitalizations	Other: Season of Year Other: Hospitalized 14 days prior to dialysis

Study Design

Study Type:

Observational

Actual Enrollment :

400000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Nov 30, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Type of dialysis modality at the start of dialysis [Day 1 of dialysis]
Whether patient started with home dialysis or in-center dialysis at the start of dialysis
Type of dialysis modality at the end of month 3 of dialysis [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)
Type of dialysis modality at the end of month 6 of dialysis [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)
Type of dialysis modality at the end of month 9 of dialysis [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)
Type of dialysis modality at the end of month 12 of dialysis [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)
Mortality in the first year [1 year of dialysis]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Southern California
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

None specified.

Study Documents (Full-Text)

Statistical Analysis Plan - Jun 8, 2021

More Information

Publications

None provided.

Responsible Party:

Eugene Lin, Assistant Professor, University of Southern California

ClinicalTrials.gov Identifier:

NCT04935827

Other Study ID Numbers:

HS-18-00530-2
K08DK118213

First Posted:

Jun 23, 2021

Last Update Posted:

Jun 23, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 23, 2021