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NCT Number: NCT03659500

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Four-week routine bloodwork

Diagnostic Test

Routine hemodialysis bloodwork done every 4 weeks

Six-week routine bloodwork

Diagnostic Test

Routine hemodialysis bloodwork done every 6 weeks

Primary outcomes

  1. Hemoglobin target achievement

    Time frame: 650 days

    Proportion of patients who achieved hemoglobin (10-12 g/dl)

  2. Phosphate target achievement

    Time frame: 650 days

    Proportion of patients who achieved phosphate (2.5-4.6 mg/dl)

Secondary outcomes

  1. Use of erythropoietin

    Time frame: 650 days

    Proportion of patients on erythropoietin

  2. Calcium target achievement

    Time frame: 650 days

    Proportion of patients with calcium (8.8-10.2 mg/dl)

  3. PTH target achievement

    Time frame: 650 days

    Proportion of patients with PTH (94-462 pg/ml)

  4. All-cause mortality

    Time frame: 650 days

    All-cause mortality

Other outcomes

  1. Cost of laboratory tests

    Time frame: 650 days

    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

Sponsors and collaborators

Lead sponsor

Samuel Silver

Other

Collaborators

  • University of Toronto

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 6, 2018
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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