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Virtual Ward for Home Dialysis (Virtual Ward)

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ClinicalTrials.gov Identifier: NCT01912001
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

Home based renal replacement therapy (RRT), including peritoneal dialysis (PD) and home hemodialysis(HHD), offers enhanced quality of life and clinical advantages compared to conventional in-center hemodialysis. Patients with end stage renal disease, that is failure of the kidneys such that dialysis is required, are at high risk for adverse health events especially during a period of transition following a change in care settings. The investigators aim to implement a Home Dialysis Virtual Ward (HDVW) strategy of telephone follow-up, which is targeted to minimize gaps of care during transitions in care.

The investigators aim to have clinicians follow patients by telephone if they meet one of the following four criteria;

  1. Discharge from hospital.
  2. Having an interventional procedure.
  3. Prescription of an antibiotic.
  4. Completion of Home Dialysis training.

The major goal of this HDVW initiative is to provide appropriate and effective supports to medically complex patients in a targeted window of vulnerability.

Condition or disease Intervention/treatment
End Stage Renal Disease Kidney Failure Home Dialysis Other: Telephone follow-up Other: Sympton Assessment

Detailed Description:

End stage renal disease (ESRD) is kidney disease that requires dialysis or kidney transplant to replace lost kidney function. The most common renal replacement therapy in North America is conventional, in-center hemodialysis (CHD). Home dialysis - including peritoneal dialysis (PD) and home hemodialysis(HHD)offers benefits to quality of life, patient satisfaction and clinical advantages, including better survival compared to CHD. (references 1-11 in the protocol).

Patients with (ESRD) have a high burden of co-morbidity. Periods of transition of care from acute care to other settings are thought to represent times of increased vulnerability. Since patients who require home dialysis have high co-morbidity and have complex medical care issues, the investigators seek to improve transitions of care for these patients with a novel strategy of follow-up.

When patients have been hospitalized, had treatment for an infection, had a procedure, or have just transitioned to home dialysis therapy,the investigators aim to decrease gaps in care by having a clinician follow-up by telephone with these patients in a scheduled way.

During the telephone call the clinician will assess the patients care and symptoms, and make adjustments to prescriptions of medications and dialysis, or referrals to additional care as required. Evaluation of care will include:

  1. Indication for admission to the Virtual Ward.
  2. Dialysis prescription.
  3. Demographic and comorbidity data.
  4. Medication reconciliation.
  5. Symptom Assessment.
  6. Dietary review.

Symptoms will be evaluated using a standardized patient assessment tool,the Charlson Comorbidity Index and the modified Edmonton Symptom Assessment Scale.

At the end of the Virtual Ward follow-up period, patients will be asked to complete a Patient Satisfaction Questionnaire.

Data from a preliminary vanguard pilot phase of 84 assessments done in 21 patients over 2 months indicates that 170 to 200 patients recruited from eight sites during a 10 month period should be sufficient to allow analysis of the data collected.

Each of the participating Investigator's will have input into the study conduct and publication preparation.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care
Study Start Date : September 2013
Primary Completion Date : December 2015
Study Completion Date : March 2016
Arms and Interventions

Arm Intervention/treatment
Telephone follow-up.
A member of the Home Dialysis team will telephone patients to follow-up on their symptoms, dialysis and care.
Other: Telephone follow-up Other: Sympton Assessment

Outcome Measures

Primary Outcome Measures :
  1. The number of care gaps identified. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]

Secondary Outcome Measures :
  1. Dialysis prescription and adherence. [ Time Frame: Up to 24 weeks. ]
    Orders for dialysis treatment and amount of dialysis performed will be recorded.

  2. Morbidity associated with dialysis therapy. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]
    All deaths will be recorded.

  3. Burden associated with travel time for patients. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]
    Travel time for health related visits will be recorded.

  4. Medication reconciliation. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]
    Best possible medication history will be recorded at each interaction.

  5. Symptom management. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]
    Symptom assessment will be done at each interaction.

  6. Adherence with dietary recommendations. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]
    Diet review will be performed at each visit.

  7. Coordination of care among participating providers. [ Time Frame: During virtual ward follow-up. ]
    Referrals and consultations will be tracked.

  8. Patient satisfaction. [ Time Frame: 24 weeks post discharge from the virtual ward. ]
    A satisfaction questionnaire will be mailed to participants at the end of participation.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient in the home dialysis program (PD and HHD)and on of the following:
  • Discharge from hospital following an inpatient admissions
  • Medical procedure (e.g. vascular access procedure).
  • Treatment with antibiotics.
  • Completion of home dialysis training program.

Exclusion Criteria:

  • Decline consent.
  • Unable to participate - (e.g. no phone at home, language barrier)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912001

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2V2
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V6H 0A5
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 1A2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Christopher Chan
Baxter Healthcare Corporation
Vancouver General Hospital
Sunnybrook Health Sciences Centre
St. Paul's Hospital, Canada
University of Alberta
St. Michael's Hospital, Toronto
The Ottawa Hospital
Capital Health Nova Scotia
Principal Investigator: Christopher T Chan, MD University Health Network, Toronto
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Chan, Deputy Director-Nephrology/UHN, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01912001     History of Changes
Other Study ID Numbers: 12-5397-AE
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Christopher Chan, University Health Network, Toronto:
end stage renal disease
kidney failure
home dialysis
peritoneal dialysis
gaps in care
transitions of care settings

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic