NCT Number: NCT01912001
Virtual Ward for Home Dialysis
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Alberta, Edmonton, Alberta, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Sympton Assessment
OtherPrimary outcomes
-
The number of care gaps identified.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Secondary outcomes
-
Dialysis prescription and adherence.
Time frame: Up to 24 weeks.
Orders for dialysis treatment and amount of dialysis performed will be recorded.
-
Morbidity associated with dialysis therapy.
Time frame: Up to 24 weeks post discharge from the virtual ward.
All deaths will be recorded.
-
Burden associated with travel time for patients.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Travel time for health related visits will be recorded.
-
Medication reconciliation.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Best possible medication history will be recorded at each interaction.
-
Symptom management.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Symptom assessment will be done at each interaction.
-
Adherence with dietary recommendations.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Diet review will be performed at each visit.
-
Coordination of care among participating providers.
Time frame: During virtual ward follow-up.
Referrals and consultations will be tracked.
-
Patient satisfaction.
Time frame: 24 weeks post discharge from the virtual ward.
A satisfaction questionnaire will be mailed to participants at the end of participation.
Sponsors and collaborators
Lead sponsor
Christopher Chan
Other
Collaborators
- Baxter Healthcare Corporation
- Capital Health Nova Scotia
- St. Paul's Hospital, Canada
- Sunnybrook Health Sciences Centre
- The Ottawa Hospital
- Unity Health Toronto
- University of Alberta
- Vancouver General Hospital
Registry information
Official study title
Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care
Acronym: Virtual Ward
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- Jul 30, 2013
- Registry last updated
- May 12, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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