Virtual Ward for Home Dialysis (Virtual Ward)

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Kidney Failure; Home Dialysis
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2V2
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 0A5
      • Vancouver General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Capital District Health Authority
  • Ontario
    • Ottawa, Ontario, Canada, K1H 1A2
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of care gaps identified.	Up to 24 weeks post discharge from the virtual ward.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Christopher Chan
• Collaborators: Sunnybrook Health Sciences Centre; Baxter Healthcare Corporation; University of Alberta; Unity Health Toronto; The Ottawa Hospital; St. Paul's Hospital, Canada; Vancouver General Hospital; Capital Health Nova Scotia
• Investigators: Principal Investigator: Christopher T Chan, MD, University Health Network, Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 27, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: peritoneal dialysis; hemodialysis; kidney failure; end stage renal disease; co-morbidity; home dialysis; gaps in care; transitions of care settings
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 12-5397-AE