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

Completed

• Conditions: End Stage Renal Disease
• Interventions: Diagnostic Test: Six-week routine bloodwork; Diagnostic Test: Four-week routine bloodwork

• Registration Number: NCT03659500
• Lead Sponsor: Samuel Silver

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• all patients who received chronic hemodialysis at the Kingston Health Sciences Center regional hemodialysis program

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Six-week routine bloodwork	Six-week routine bloodwork	Routine bloodwork every 6-weeks (CBC, electrolytes, iron studies, calcium, phosphate, PTH) from March 25, 2014 to December 31, 2015
Four-week routine bloodwork	Four-week routine bloodwork	Routine bloodwork every 4-weeks (CBC, electrolytes, iron studies, calcium, phosphate, PTH) from June 1, 2012 to March 23, 2014

Primary Outcome Measures

Name	Time	Method
Phosphate target achievement	650 days	Proportion of patients who achieved phosphate (2.5-4.6 mg/dl)
Hemoglobin target achievement	650 days	Proportion of patients who achieved hemoglobin (10-12 g/dl)

Secondary Outcome Measures

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