SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
NCT03924674 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2021-04-29
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.
Conditions
- Intravenous Fluids
- Fluid and Electrolyte Imbalance
- ADH Inappropriate
Interventions
- OTHER
-
Education, clinical decision support tools
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
Sponsors & Collaborators
-
American Academy of Pediatrics
collaborator OTHER -
Seattle Children's Hospital
lead OTHER
Principal Investigators
-
Sahar N Rooholamini, MD, MPH · Seattle Children's Hospital/Univ. of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 28 Days
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-01
- Primary Completion
- 2020-05-31
- Completion
- 2020-05-31
Countries
- United States
Study Locations
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