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Virtual Ward for Home Dialysis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01912001
Acronym
Virtual Ward
Enrollment
215
Registered
2013-07-30
Start date
2013-09-30
Completion date
2016-03-31
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Home Dialysis, Kidney Failure

Keywords

end stage renal disease, kidney failure, home dialysis, hemodialysis, peritoneal dialysis, gaps in care, co-morbidity, transitions of care settings

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.

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.

Interventions

OTHERTelephone follow-up
OTHERSympton Assessment

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Vancouver General Hospital
CollaboratorOTHER
Sunnybrook Health Sciences Centre
CollaboratorOTHER
St. Paul's Hospital, Canada
CollaboratorOTHER
University of Alberta
CollaboratorOTHER
Unity Health Toronto
CollaboratorOTHER
The Ottawa Hospital
CollaboratorOTHER
Capital Health Nova Scotia
CollaboratorUNKNOWN
Christopher Chan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
The number of care gaps identified.Up to 24 weeks post discharge from the virtual ward.

Secondary

MeasureTime frameDescription
Morbidity associated with dialysis therapy.Up to 24 weeks post discharge from the virtual ward.All deaths will be recorded.
Burden associated with travel time for patients.Up to 24 weeks post discharge from the virtual ward.Travel time for health related visits will be recorded.
Medication reconciliation.Up to 24 weeks post discharge from the virtual ward.Best possible medication history will be recorded at each interaction.
Dialysis prescription and adherence.Up to 24 weeks.Orders for dialysis treatment and amount of dialysis performed will be recorded.
Adherence with dietary recommendations.Up to 24 weeks post discharge from the virtual ward.Diet review will be performed at each visit.
Coordination of care among participating providers.During virtual ward follow-up.Referrals and consultations will be tracked.
Patient satisfaction.24 weeks post discharge from the virtual ward.A satisfaction questionnaire will be mailed to participants at the end of participation.
Symptom management.Up to 24 weeks post discharge from the virtual ward.Symptom assessment will be done at each interaction.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026