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

• ClinicalTrials.gov Identifier: NCT03659500
• Recruitment Status: Completed
• First Posted: September 6, 2018
• Last Update Posted: June 30, 2021
• Sponsor: Queen's University
• Collaborator: University of Toronto
• Information provided by (Responsible Party): Samuel Silver, Queen's University

Study Description

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.

Condition or disease	Intervention/treatment
End Stage Renal Disease	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 Design

• Study Type: Observational
• Actual Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Clinical Outcomes and Costs of 4-Week Versus 6-Week Bloodwork for Patients on Hemodialysis
• Actual Study Start Date: June 1, 2012
• Actual Primary Completion Date: December 31, 2015
• Actual Study Completion Date: December 31, 2015

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• none

Contacts and Locations

Sponsors and Collaborators

Queen's University

University of Toronto

Investigators

• Principal Investigator: Samuel A Silver; Queen's University

More Information

Publications of Results:

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.

• Responsible Party: Samuel Silver, Assistant Professor, Queen's University
• ClinicalTrials.gov Identifier: NCT03659500
• Other Study ID Numbers: HD Lab Frequency 1
• First Posted: September 6, 2018
• Last Update Posted: June 30, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Kidney Failure, Chronic; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency