NCT03924674

SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients

Official Title:

Standardization of Fluids in Inpatient Settings

Summary

Intravenous fluids (IVF) are used in hospitalized patients to replenish the fluid and electrolyte losses of patients who cannot take adequate hydration by mouth or through their gut. Inappropriate use of IVF may cause serious problems, including abnormalities in blood electrolytes such as sodium, which can lead to serious but rare neurologic harm; pain and discomfort from multiple IV insertions and subsequent complications (e.g., IV infiltration); and inadequate monitoring for adverse effects.

Investigators currently don't know what the most commonly used IVF in hospitalized pediatric patients are, and there are no national benchmark data for IVF use. The American Academy of Pediatrics published a Guideline on maintenance IVF in November 2018, which contains one major recommendation: to use isotonic (having a similar electrolyte concentration to blood plasma) maintenance IVF in medical and surgical patients 28 days to 18 years old without pre-existing serious illnesses.

This project aims to better describe and standardize the use of IVF in inpatient pediatric settings across the U.S. and evaluate the impact of an intervention bundle on maintenance IVF use. This project aims to improve health care value by reducing the number of routine laboratory draws.

In Quality Improvement research, there are three different types of measures - outcome measures, process measures and balancing measures.

In this project, the following will be used as a process measure:

The proportion of daily weight measurements for patients on maintenance IVF.

The following will be used as balancing measures:

1. There will be no increase in the number of floor-to-PICU transfers during hospitalization from baseline.
2. There will be no increase in the number of serum sodium lab results obtained from baseline.
3. There will be no increase in adverse events prompting a change in clinical management from baseline: hypertension or edema requiring a diuretic, hypertension requiring anti-hypertensive medication, and acute kidney injury (AKI) requiring renal replacement therapy (RRT)/dialysis.

Eligibility

Inclusion Criteria:

* Age ≥28 days and ≤18 years old at the time of admission
* Received maintenance IVF (rate greater than 10 ml/h) on hospital day #2 at 12:01 am

Exclusion Criteria:

* ICU (PICU, NICU, CICU, etc.) patients
* Patients who have never gone home from the hospital
* Patients with active adrenal, cardiac, hepatic, neurosurgical, chronic renal, heme/onc, biochemical genetic/metabolic illnesses\* (\*As evidenced by: (1) listing of a condition in these categories in past medical history; and/or (2) active medication related to one of these conditions)
* Patients with diabetes insipidus, DKA, severe burns
* Patients on a psychiatric hold/primary behavioral health reason for admission with no needed medical management
* Patients with voluminous watery diarrhea \> 7 days

Disease(s) and\or Condition(s)

Intravenous Fluids

Fluid and Electrolyte Imbalance

ADH Inappropriate

Primary Purpose
  • OTHER
Intervention/Treatment
    • Type: OTHER
    • Name: Education, clinical decision support tools
    • Description: Interventions will include: 1. Education (webinars) for physicians and nurses regarding AAP IVF guidelines, including evidence on safety of isotonic maintenance IVF 2. Implementation of algorithms, ordersets and checklists to guide choice of IVF and clinical indications to start/stop IVF; 3. Tools to promote discussion about timing and necessity of routine lab draws 4. Education and feedback for physicians regarding costs and harms of routine lab testing
    • Arm Group Labels: Stepped Wedge Group 1: Sept. 2019 Launch, Stepped Wedge Group 2: Nov. 2019 Launch, Stepped Wedge Group 3: Jan. 2020 Launch
Sponsor
  • Seattle Children's Hospital