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Virtual Ward for Home Dialysis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by University Health Network, Toronto
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Christopher Chan, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01912001
First received: July 22, 2013
Last updated: July 27, 2013
Last verified: July 2013
  Purpose

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 Intervention
End Stage Renal Disease
Kidney Failure
Home Dialysis
Other: Telephone follow-up
Other: Sympton Assessment

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The number of care gaps identified. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dialysis prescription and adherence. [ Time Frame: Up to 24 weeks. ] [ Designated as safety issue: Yes ]
    Orders for dialysis treatment and amount of dialysis performed will be recorded.

  • Morbidity associated with dialysis therapy. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ] [ Designated as safety issue: Yes ]
    All deaths will be recorded.

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

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

  • Symptom management. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ] [ Designated as safety issue: Yes ]
    Symptom assessment will be done at each interaction.

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

  • Coordination of care among participating providers. [ Time Frame: During virtual ward follow-up. ] [ Designated as safety issue: Yes ]
    Referrals and consultations will be tracked.

  • Patient satisfaction. [ Time Frame: 24 weeks post discharge from the virtual ward. ] [ Designated as safety issue: No ]
    A satisfaction questionnaire will be mailed to participants at the end of participation.


Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01912001

Contacts
Contact: Christopher T Chan, MD 416 340-3073 Christopher.Chan@uhn.ca
Contact: Margaret E McGrath-Chong, BScN RN 416 340-4800 ext 2089 Margaret.McGrath-Chong@uhn.ca

Locations
Canada, Ontario
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Principal Investigator: Christopher T Chan, MD         
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
Investigators
Principal Investigator: Christopher T Chan, MD University Health Network, Toronto
  More Information

No publications provided by University Health Network, Toronto

Additional 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
Study First Received: July 22, 2013
Last Updated: July 27, 2013
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014