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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659500
• Other study ID #: HD Lab Frequency 1
• Status: Completed
• Start date: June 1, 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Diagnostic Test:
• Four-week routine bloodwork
Routine hemodialysis bloodwork done every 4 weeks
• Six-week routine bloodwork
Routine hemodialysis bloodwork done every 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Samuel Silver	University of Toronto

References & Publications (1)

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.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Hemoglobin target achievement	Proportion of patients who achieved hemoglobin (10-12 g/dl)	650 days
Primary	Phosphate target achievement	Proportion of patients who achieved phosphate (2.5-4.6 mg/dl)	650 days
Secondary	Use of erythropoietin	Proportion of patients on erythropoietin	650 days
Secondary	Calcium target achievement	Proportion of patients with calcium (8.8-10.2 mg/dl)	650 days
Secondary	PTH target achievement	Proportion of patients with PTH (94-462 pg/ml)	650 days
Secondary	All-cause mortality	All-cause mortality	650 days