Clinical Outcomes and Costs of 4-Week Versus 6-Week Bloodwork for Patients on Hemodialysis

Study Overview
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Brief Summary
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The objective of this quality improvement study was to determine the effect of an institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on the achievement of anemia and chronic kidney disease-mineral and bone disorder (CKD-MBD) targets for patients on chronic hemodialysis.

Detailed Description
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Rationale & Objective: Routine bloodwork for patients on hemodialysis has both financial and opportunity costs, but there is little data on how the frequency of measurement affects patient outcomes. Our objective was to determine the effect of changing from routine bloodwork at four-week intervals to six-week intervals on the achievement of anemia and chronic kidney disease-mineral and bone disorder (CKD-MBD) targets. Study Design: Retrospective interrupted time series from June 1, 2012 to December 31, 2015. Setting & Participants: Tertiary hospital in Ontario, Canada, that provides hemodialysis to 350-400 adult patients. Quality Improvement Activities: Institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on March 24, 2014. Outcomes: Proportion of patients who achieved recommended hemoglobin and phosphate targets. In a 252-day sub-analysis, we also calculated the cost-savings attributable to a change in laboratory testing frequency for hemoglobin, ferritin, iron saturation, calcium, and phosphate. Analytical Approach: Statistical Process Control to analyze variation in the clinical outcomes.

Official Title
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Clinical Outcomes and Costs of 4-Week Versus 6-Week Bloodwork for Patients on Hemodialysis

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Diagnostic Test: Four-week routine bloodwork
* Diagnostic Test: Six-week routine bloodwork


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients who received chronic hemodialysis at the Kingston Health Sciences Center regional hemodialysis program Exclusion Criteria: none
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Four-week routine bloodwork<br>Routine bloodwork every 4-weeks (CBC, electrolytes, iron studies, calcium, phosphate, PTH) from June 1, 2012 to March 23, 2014 | Diagnostic Test: Four-week routine bloodwork<br>* Routine hemodialysis bloodwork done every 4 weeks<br>|
| Six-week routine bloodwork<br>Routine bloodwork every 6-weeks (CBC, electrolytes, iron studies, calcium, phosphate, PTH) from March 25, 2014 to December 31, 2015 | Diagnostic Test: Six-week routine bloodwork<br>* Routine hemodialysis bloodwork done every 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin target achievement | Proportion of patients who achieved hemoglobin (10-12 g/dl) | 650 days | 
| Phosphate target achievement | Proportion of patients who achieved phosphate (2.5-4.6 mg/dl) | 650 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of erythropoietin | Proportion of patients on erythropoietin | 650 days | 
| Calcium target achievement | Proportion of patients with calcium (8.8-10.2 mg/dl) | 650 days | 
| PTH target achievement | Proportion of patients with PTH (94-462 pg/ml) | 650 days | 
| All-cause mortality | All-cause mortality | 650 days |