Virtual Ward for Home Dialysis

End Stage Renal Disease Clinical Trial

— Virtual Ward  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01912001
• Other study ID #: 12-5397-AE
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2013
• Last updated: December 7, 2015
• Start date: September 2013
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: University Health Network, Toronto
• Contact: Christopher T Chan, MD
• Phone: 416 340-3073
• Email: Christopher.Chan[@]uhn.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Intervention

Other:
• Telephone follow-up

• Sympton Assessment

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Capital District Health Authority	Halifax	Nova Scotia
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (9)

Lead Sponsor	Collaborator
Christopher Chan	Baxter Healthcare Corporation, Capital Health Nova Scotia, St. Michael's Hospital, Toronto, St. Paul's Hospital, Canada, Sunnybrook Health Sciences Centre, The Ottawa Hospital, University of Alberta, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of care gaps identified.		Up to 24 weeks post discharge from the virtual ward.	Yes
Secondary	Dialysis prescription and adherence.	Orders for dialysis treatment and amount of dialysis performed will be recorded.	Up to 24 weeks.	Yes
Secondary	Morbidity associated with dialysis therapy.	All deaths will be recorded.	Up to 24 weeks post discharge from the virtual ward.	Yes
Secondary	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.	Yes
Secondary	Medication reconciliation.	Best possible medication history will be recorded at each interaction.	Up to 24 weeks post discharge from the virtual ward.	Yes
Secondary	Symptom management.	Symptom assessment will be done at each interaction.	Up to 24 weeks post discharge from the virtual ward.	Yes
Secondary	Adherence with dietary recommendations.	Diet review will be performed at each visit.	Up to 24 weeks post discharge from the virtual ward.	Yes
Secondary	Coordination of care among participating providers.	Referrals and consultations will be tracked.	During virtual ward follow-up.	Yes
Secondary	Patient satisfaction.	A satisfaction questionnaire will be mailed to participants at the end of participation.	24 weeks post discharge from the virtual ward.	No