Effect of a Quality Improvement Bundle to Standardize the Use of Intravenous Fluids for Hospitalized Pediatric Patients: A Stepped-Wedge, Cluster Randomized Clinical Trial

Abstract

Importance: Given that hypotonic maintenance intravenous fluids (IVF) may cause hospital-acquired harm, in November 2018, the American Academy of Pediatrics released a clinical practice guideline recommending the use of isotonic IVF for patients aged 28 days to 18 years without contraindications. No recommendations were made regarding laboratory monitoring; however, unnecessary laboratory tests may contribute to health care waste and harm patients.

Objective: To examine the effect of a quality improvement intervention bundle on (1) increasing the mean proportion of hours per hospital day with exclusive isotonic IVF use to at least 80% and (2) decreasing the mean proportion of hospital days with laboratory tests obtained.

Design, setting, and participants: This stepped-wedge, cluster randomized clinical trial (Standardization of Fluids in Inpatient Settings [SOFI]) was sponsored by a national quality improvement collaborative and was conducted across 106 US pediatric hospitals. The SOFI intervention period was from September 2019 to March 2020.

Interventions: Hospital sites were exposed to educational materials, a clinical algorithm and order set for IVF use, electronic medical record interventions to reduce laboratory testing, and "harms of overtesting" cards.

Main outcomes and measures: Primary outcomes were mean proportion of hours per hospital day receiving exclusive isotonic IVF and mean proportion of hospital days with laboratory test values obtained. Secondary measures included total IVF duration per hospital day, daily patient weight measurement while receiving IVF, serum sodium testing, and adverse events. Baseline data were collected for 2 months; intervention period data, 7 months. Outcomes were analyzed using linear mixed-effects regression models.

Results: A total of 106 hospitals were randomly assigned to 1 of 3 intervention start dates (wedges), and 100 hospitals (94%) completed the study. In total, 5215 hospitalizations were reviewed before the intervention, and 6724 hospitalizations were reviewed after the intervention. Prior to interventions, the mean (SD) proportion of hours per day with exclusive isotonic IVF use was 88.5% (31.7%). Interventions led to an absolute increase of 5.4% (95% CI, 3.9%-6.9%) above baseline in exclusive isotonic IVF use but did not change the proportion of hospital days during which a laboratory test value was obtained (estimated difference, 0.1%; 95% CI, -1.5% to 1.7%; P = .90), IVF use duration (estimated difference, -1.2%; 95% CI, -2.9% to 0.4%), serum sodium testing, or adverse events. There was an absolute increase of 4.4% (95% CI, 2.6%-6.2%) in the mean proportion of hospital days with a patient weight measurement while receiving IVF.

Conclusions and relevance: In this stepped-wedge, cluster randomized clinical trial, an intervention bundle significantly improved the use of isotonic maintenance IVF without a concomitant increase in adverse events or electrolyte testing. Further work is required to deimplement laboratory testing.

Trial registration: ClinicalTrials.gov Identifier: NCT03924674.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Garber reported being a director for the American Academy of Pediatrics Value in Inpatient Pediatrics network during the conduct of the study; and a stipend to his institution from this network. Dr Tchou reported grants from the PEDSnet Scholars Program outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Standardization of Fluids in Inpatient Settings (SOFI) Study Design

All hospitals collected data for the baseline (before intervention) period from May 2018 to August 2019. At step 1 (September 2019), 37 hospitals randomly assigned to the first wedge began interventions. At step 2 (November 2019), 34 hospitals randomly assigned to the second wedge began interventions. At step 3 (January 2020), 35 hospitals randomly assigned to the third wedge began interventions. All data were collected by hospital in monthly increments throughout all periods.

Figure 2.. Standardization of Fluids in Inpatient Settings (SOFI) Study Flow Diagram

IVF represents intravenous fluids.

Figures 3.. Interrupted Time Series Analyses of Exclusive Use of Isotonic Maintenance Intravenous Fluids (IVF)

A, Exclusive isotonic maintenance IVF use before and after publication of the American Academy of Pediatrics (AAP) guideline. The first dotted vertical line indicates AAP guideline publication in late November 2018; the second dotted vertical line, beginning of the Standardization of Fluids in Inpatient Settings (SOFI) intervention period (September 2019). B, Exclusive isotonic maintenance IVF use for the SOFI study period disaggregated between hospitals exposed and unexposed to the intervention. Vertical lines indicate sequential launch dates by wedge.