Healthy Transitions in Late Stage Kidney Disease

Study Overview
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Brief Summary
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Improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a Nephrologist's routine patient care.

Official Title
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An Open Label Randomized Controlled Study to Compare the Impact of Patient Centered Nursing Services in Addition to a Nephrologist's Usual Patient Care With Usual Nephrologist's Care in Late Stage Chronic Kidney Disease Patients.

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Education
* Other: Daily weight measurement and monitoring
* Other: Universal Dietary education
* Other: Medication review
* Other: Focused advanced directive program
* Other: Countdown to fistula program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 4-5 Chronic Kidney Disease (CKD), defined as estimated glomerular filtration rate (eGFR) between 0-30 ml/minute 18 years of age or older Exclusion Criteria: Cognitive impairment that is clinically apparent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Transitions Group<br>Additional nursing services will be provided to this group in addition to a usual care by Nephrologist. Daily weight measurement and monitoring Medication review Universal dietary education Focused advanced directive program Countdown to fistula program | Other: Education<br>* Additional education will be provided by nurses to improve communication and reduce fragmentation of care.<br>Other: Daily weight measurement and monitoring<br>* Monitor weight to avoid problems related to hypervolemia.<br>Other: Universal Dietary education<br>* To improve diet and health<br>Other: Medication review<br>* Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.<br>Other: Focused advanced directive program<br>* Education will be provided to increase awareness and encourage patients to have advanced directive.<br>Other: Countdown to fistula program<br>* To reduce the number of patients starting dialysis with catheter in place, comprehensive stepwise intervention will be provided by nurses to ensure arterio-venous (AV) fistula placement in all appropriate patients, with coordinated follow up and failure recovery processes.<br>|
| No Intervention: Usual Care Group<br>Usual care by nephrologist. No additional nursing support services will be provide to this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization rate | Reduction in hospitalization rate in intervention group as compare to control group. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve hemodialysis access rates | Percentage of patients with AVF, AVG or catheters | 18 months | 
| Home dialysis | Increase choice of home dialysis as modality of treatment | 18 months |