Virtual Ward for Home Dialysis (Virtual Ward)
Primary Purpose
End Stage Renal Disease, Kidney Failure, Home Dialysis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telephone follow-up
Sympton Assessment
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring end stage renal disease, kidney failure, home dialysis, hemodialysis, peritoneal dialysis, gaps in care, co-morbidity, transitions of care settings
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)
Sites / Locations
- University of Alberta
- Vancouver General Hospital
- Capital District Health Authority
- The Ottawa Hospital
- Sunnybrook Health Sciences Centre
- St. Michael's Hospital
- University Health Network
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Telephone follow-up.
Arm Description
A member of the Home Dialysis team will telephone patients to follow-up on their symptoms, dialysis and care.
Outcomes
Primary Outcome Measures
The number of care gaps identified.
Secondary Outcome Measures
Dialysis prescription and adherence.
Orders for dialysis treatment and amount of dialysis performed will be recorded.
Morbidity associated with dialysis therapy.
All deaths will be recorded.
Burden associated with travel time for patients.
Travel time for health related visits will be recorded.
Medication reconciliation.
Best possible medication history will be recorded at each interaction.
Symptom management.
Symptom assessment will be done at each interaction.
Adherence with dietary recommendations.
Diet review will be performed at each visit.
Coordination of care among participating providers.
Referrals and consultations will be tracked.
Patient satisfaction.
A satisfaction questionnaire will be mailed to participants at the end of participation.
Full Information
NCT ID
NCT01912001
First Posted
July 22, 2013
Last Updated
May 10, 2016
Sponsor
Christopher Chan
Collaborators
Baxter Healthcare Corporation, Vancouver General Hospital, Sunnybrook Health Sciences Centre, St. Paul's Hospital, Canada, University of Alberta, Unity Health Toronto, The Ottawa Hospital, Capital Health Nova Scotia
1. Study Identification
Unique Protocol Identification Number
NCT01912001
Brief Title
Virtual Ward for Home Dialysis
Acronym
Virtual Ward
Official Title
Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Chan
Collaborators
Baxter Healthcare Corporation, Vancouver General Hospital, Sunnybrook Health Sciences Centre, St. Paul's Hospital, Canada, University of Alberta, Unity Health Toronto, The Ottawa Hospital, Capital Health Nova Scotia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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;
Discharge from hospital.
Having an interventional procedure.
Prescription of an antibiotic.
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:
Indication for admission to the Virtual Ward.
Dialysis prescription.
Demographic and comorbidity data.
Medication reconciliation.
Symptom Assessment.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone follow-up.
Arm Type
Other
Arm Description
A member of the Home Dialysis team will telephone patients to follow-up on their symptoms, dialysis and care.
Intervention Type
Other
Intervention Name(s)
Telephone follow-up
Intervention Type
Other
Intervention Name(s)
Sympton Assessment
Primary Outcome Measure Information:
Title
The number of care gaps identified.
Time Frame
Up to 24 weeks post discharge from the virtual ward.
Secondary Outcome Measure Information:
Title
Dialysis prescription and adherence.
Description
Orders for dialysis treatment and amount of dialysis performed will be recorded.
Time Frame
Up to 24 weeks.
Title
Morbidity associated with dialysis therapy.
Description
All deaths will be recorded.
Time Frame
Up to 24 weeks post discharge from the virtual ward.
Title
Burden associated with travel time for patients.
Description
Travel time for health related visits will be recorded.
Time Frame
Up to 24 weeks post discharge from the virtual ward.
Title
Medication reconciliation.
Description
Best possible medication history will be recorded at each interaction.
Time Frame
Up to 24 weeks post discharge from the virtual ward.
Title
Symptom management.
Description
Symptom assessment will be done at each interaction.
Time Frame
Up to 24 weeks post discharge from the virtual ward.
Title
Adherence with dietary recommendations.
Description
Diet review will be performed at each visit.
Time Frame
Up to 24 weeks post discharge from the virtual ward.
Title
Coordination of care among participating providers.
Description
Referrals and consultations will be tracked.
Time Frame
During virtual ward follow-up.
Title
Patient satisfaction.
Description
A satisfaction questionnaire will be mailed to participants at the end of participation.
Time Frame
24 weeks post discharge from the virtual ward.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher T Chan, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2V2
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 0A5
Country
Canada
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24528505
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.
Results Reference
derived
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Virtual Ward for Home Dialysis
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