Rates of Hospitalization in Home Care Assisted Peritoneal Dialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Sunnybrook Health Sciences Centre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00499213
First received: July 9, 2007
Last updated: February 6, 2009
Last verified: July 2007
  Purpose

We have developed and implemented a program that offers home care assistance to patients wishing to perform home peritoneal dialysis, but are unable to do it for themselves. This study is being conducted to ensure the safety of this dialysis program and specifically, to see if the risk of being hospitalized is increased when this therapy is provided to patients.


Condition Intervention
Rate of Hospitalization
Procedure: Home Care Assisted Peritoneal Dialysis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Home Care Assisted Peritoneal Dialysis: The Impact of Expanding Eligibility for Peritoneal Dialysis on Rates of Hospitalization

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Study Start Date: July 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

The cost of caring for patients with kidney failure is growing at an alarming rate and accounts for up to 7% of health care expenditures in developed countries. The majority of the cost is due to in-centre hemodialysis (HD) because of high operating costs and the capital investment required to build new dialysis units. In recent years, there has been a shortage of in-centre HD beds and it has become a priority to increase the number of patients being treated in their place of residence with therapies like peritoneal dialysis (PD). Unfortunately, many patients are unable to perform their own dialysis at home, a trend that will become more and more common as the population ages. We developed and implemented a program of home care assisted PD at Sunnybrook Health Sciences Centre where health care workers go into the home to assist patients with their treatment. The program has been a success and has garnered national attention. As a result, it has been adopted province-wide as part of the "Provincial PD Joint Initiative" and the Manitoba Renal Program is currently implementing a similar program to increase the use of PD.

However, based on preliminary data, we are concerned that patients treated with home care assisted PD may have higher rates of hospitalization when compared to traditional forms of treatment (23.5 days per year of follow-up compared to 13 days per year of follow-up. If this is true it could have a significant impact on patient quality-of-life, cost-savings associated with PD, and resource allocation and planning in regional dialysis programs. This is of particular concern given that the provincial initiative has a goal of increasing the proportion of patients being treated with PD from the current 18% to 30% by 2010.

The primary objective of this study is to determine if patients treated with home care assisted peritoneal dialysis are more likely to be hospitalized when compared to those treated with in-centre hemodialysis.

The secondary objective of this study is to compare the occurrence of important outcome events including the need for access-related procedures, technique survival, and death in patients on home care assisted peritoneal dialysis compared to in-centre hemodialysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. End-stage kidney disease in the opinion of the attending nephrologist
  3. Deemed eligible for both home assisted PD and traditional in-centre HD following a multidisciplinary assessment, regardless of what therapy is chosen

Exclusion Criteria:

  1. History of kidney transplant or expected to receive a transplant in the next 3 months
  2. Expected to transfer to another regional dialysis program following the initiation of dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499213

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
London Health Sciences Centre
Investigators
Principal Investigator: Robert R Quinn, MD Sunnybrook Health Sciences Centre
Principal Investigator: Matthew J Oliver, MD, MHS Sunnybrook Health Sciences Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00499213     History of Changes
Other Study ID Numbers: 07-22
Study First Received: July 9, 2007
Last Updated: February 6, 2009
Health Authority: Canada: Institutional Ethics Review Board

ClinicalTrials.gov processed this record on August 19, 2014