Clinical trial NCT01912001: Virtual Ward for Home Dialysis
Official title: Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Kidney Failure
Home Dialysis
Keywords: end stage renal disease
kidney failure
home dialysis
hemodialysis
peritoneal dialysis
gaps in care
co-morbidity
transitions of care settings
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Vancouver General Hospital
name: Sunnybrook Health Sciences Centre
name: St. Paul's Hospital, Canada
name: University of Alberta
name: Unity Health Toronto
name: The Ottawa Hospital
name: Capital Health Nova Scotia
First posted: 2013-07-30
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: The number of care gaps identified.
timeFrame: Up to 24 weeks post discharge from the virtual ward.
Secondary outcomes:
measure: Dialysis prescription and adherence.
timeFrame: Up to 24 weeks.
measure: Morbidity associated with dialysis therapy.
timeFrame: Up to 24 weeks post discharge from the virtual ward.
measure: Burden associated with travel time for patients.
timeFrame: Up to 24 weeks post discharge from the virtual ward.
measure: Medication reconciliation.
timeFrame: Up to 24 weeks post discharge from the virtual ward.
measure: Symptom management.
timeFrame: Up to 24 weeks post discharge from the virtual ward.
measure: Adherence with dietary recommendations.
timeFrame: Up to 24 weeks post discharge from the virtual ward.
measure: Coordination of care among participating providers.
timeFrame: During virtual ward follow-up.
measure: Patient satisfaction.
timeFrame: 24 weeks post discharge from the virtual ward.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Christopher T Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schachter ME, Bargman JM, Copland M, Hladunewich M, Tennankore KK, Levin A, Oliver M, Pauly RP, Perl J, Zimmerman D, Chan CT. Rationale for a home dialysis virtual ward: design and implementation. BMC Nephrol. 2014 Feb 14;15:33. doi: 10.1186/1471-2369-15-33.