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

NCT ID: NCT04935827

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-12-01
• Study Completion Date: 2017-11-30

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.

Conditions

Dialysis; Peritoneal Dialysis; Hospitalizations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Season of Year

Intervention Type: OTHER

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

Hospitalized 14 days prior to dialysis

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Eugene Lin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

K08DK118213

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS-18-00530-2

Identifier Type: -

Identifier Source: org_study_id