Virtual Ward for Home Dialysis — Virtual Ward  

End Stage Renal Disease Clinical Trial

Official title: Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• End Stage Renal Disease
• Home Dialysis
• Kidney Diseases
• Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

• NCT number: NCT01912001
• Study type: Interventional
• Source: University Health Network, Toronto
• Contact: Christopher T Chan, MD
• Phone: 416 340-3073
• Email: Christopher.Chan@uhn.ca
• Status: Recruiting
• Phase: N/A
• Start date: September 2013
• Completion date: March 2016