SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
Condition: Intravenous Fluids; Fluid and Electrolyte Imbalance; ADH Inappropriate
MeSH terms: Inappropriate ADH Syndrome
Study type: Interventional

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.
    

Detailed description: 
      Study Design

      All sites will participate in a stepped wedge cluster randomized trial, with 80-120 sites
      total. This design is helpful when simultaneous implementation of an intervention is not
      feasible or practical, and allows for each site to collect baseline data for comparison with
      post-intervention data. There will be 3 groups (or clusters) of approximately 30-40 sites
      each, with randomization to intervention occurring at 2 month intervals. Randomization will
      be stratified by: geographic region, size and baseline rate of IVF use.
    

Intervention name(s): Education, clinical decision support tools
Intervention type(s): Other
Intervention description(s): Interventions will include:
Education (webinars) for physicians and nurses regarding AAP IVF guidelines, including evidence on safety of isotonic maintenance IVF
Implementation of algorithms, ordersets and checklists to guide choice of IVF and clinical indications to start/stop IVF;
Tools to promote discussion about timing and necessity of routine lab draws
Education and feedback for physicians regarding costs and harms of routine lab testing
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All sites will participate in a stepped wedge cluster randomized trial. This design is helpful when simultaneous implementation of an intervention is not feasible or practical, and allows for each site to collect baseline data for comparison with post-intervention data. There will be 3 groups (or clusters) of approximately 30-40 sites each, with randomization to intervention occurring at 2 month intervals. Randomization will be stratified by: geographic region, size and baseline rate of IVF use. By the end of the project, all sites in all groups will have received the intervention toolkit.
Masking: None (Open Label)
Primary purpose: Other