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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Diagnostic test: Four-week routine bloodwork; Diagnostic test: Six-week routine bloodwork

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 Type: Observational
• Enrollment (Actual): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients on chronic hemodialysis at a regional hemodialysis program in Kingston, Ontario, Canada, from June 1, 2012 to December 31, 2015

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Four-week routine bloodwork; 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; Routine hemodialysis bloodwork done every 4 weeks
Six-week routine bloodwork; 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; Routine hemodialysis bloodwork done every 6 weeks

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of laboratory tests	Direct costs (in CAD) of hemoglobin ($8.27), ferritin ($14.48), iron saturation ($17.58), serum calcium ($2.59), and serum phosphate ($2.59) based on the Ontario Schedule of Benefits for Laboratory Services	650 days

Collaborators and Investigators

• Sponsor: Samuel Silver
• Collaborators: University of Toronto
• Investigators: Principal Investigator: Samuel A Silver, Queen's University

Publications and helpful links

General Publications

• Silver SA, Alaryni A, Alghamdi A, Digby G, Wald R, Iliescu E. Routine Laboratory Testing Every 4 Versus Every 6 Weeks for Patients on Maintenance Hemodialysis: A Quality Improvement Project. Am J Kidney Dis. 2019 Apr;73(4):496-503. doi: 10.1053/j.ajkd.2018.10.008. Epub 2018 Dec 28.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: HD Lab Frequency 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No