Virtual Ward for Home Dialysis (Virtual Ward)
|ClinicalTrials.gov Identifier: NCT01912001|
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : May 12, 2016
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;
- Discharge from hospital.
- Having an interventional procedure.
- Prescription of an antibiotic.
- 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||Phase|
|End Stage Renal Disease Kidney Failure Home Dialysis||Other: Telephone follow-up Other: Sympton Assessment||Not Applicable|
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:
- Indication for admission to the Virtual Ward.
- Dialysis prescription.
- Demographic and comorbidity data.
- Medication reconciliation.
- Symptom Assessment.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||March 2016|
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|
- The number of care gaps identified. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]
- Dialysis prescription and adherence. [ Time Frame: Up to 24 weeks. ]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. ]All deaths will be recorded.
- 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.
- Medication reconciliation. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]Best possible medication history will be recorded at each interaction.
- Symptom management. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]Symptom assessment will be done at each interaction.
- Adherence with dietary recommendations. [ Time Frame: Up to 24 weeks post discharge from the virtual ward. ]Diet review will be performed at each visit.
- Coordination of care among participating providers. [ Time Frame: During virtual ward follow-up. ]Referrals and consultations will be tracked.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912001
|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|
|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|
|Principal Investigator:||Christopher T Chan, MD||University Health Network, Toronto|