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

NCT04935827 | Completed

• 2 other identifiers: HS-18-00530-2K08DK118213
• Study Type: observational
• Target: 400,000
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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; Other: Hospitalized 14 days prior to dialysis

Interventions

Season of Year 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

Patients initiating dialysis for end-stage kidney disease

Hospitalized 14 days prior to dialysis 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

Patients initiating dialysis for end-stage kidney disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• As above

Sponsors & Collaborators

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

MeSH Terms

Interventions

Hospitalization

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: December 1, 2007
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share