Clinical trial NCT03659500: Clinical Outcomes and Costs of 4-Week Versus 6-Week Bloodwork for Patients on Hemodialysis
Official title: Clinical Outcomes and Costs of 4-Week Versus 6-Week Bloodwork for Patients on Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2018-09-06
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Hemoglobin target achievement
timeFrame: 650 days
measure: Phosphate target achievement
timeFrame: 650 days
Secondary outcomes:
measure: Use of erythropoietin
timeFrame: 650 days
measure: Calcium target achievement
timeFrame: 650 days
measure: PTH target achievement
timeFrame: 650 days
measure: All-cause mortality
timeFrame: 650 days
Other outcomes:
measure: Cost of laboratory tests
timeFrame: 650 days
Locations:
Study officials:
affiliation: Queen's University
name: Samuel A Silver
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.