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

Standardization of Fluids in Inpatient Settings

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.

Study Overview

• Status: Completed
• Conditions: Fluid and Electrolyte Imbalance; Intravenous Fluids; ADH Inappropriate
• Intervention / Treatment: Other: Education, clinical decision support tools

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • California
    • Fresno, California, United States, 93721
      • Community Regional Medical Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Children'S Hospital
    • Los Angeles, California, United States, 90095
      • UCLA Mattel Children's Hospital
    • Los Angeles, California, United States, 90025
      • Harbor - UCLA Medical Center
    • Madera, California, United States, 93636
      • Valley Children's Hospital
    • Pleasanton, California, United States, 94585
      • Stanford HealthCare-ValleyCare
    • San Francisco, California, United States, 94158
      • UCSF Benioff Children's Hospital
    • Van Nuys, California, United States, 91405
      • Valley Presbyterian Hospital
    • Walnut Creek, California, United States, 94598
      • John Muir Medical Center
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours A.I. duPont Hospital for Children
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Wolfson Children's Hosptial
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital
    • Miami, Florida, United States, 33156
      • Holtz Children's Hospital
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Children's Hospital
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Childrens Hospital
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • Tampa, Florida, United States, 33613
      • Advent Health Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta at Egleston
    • Augusta, Georgia, United States, 30912
      • Children's Hospital of Georgia
    • Macon, Georgia, United States, 31201
      • Beverly Knight Olson Children's Hospital, Navicent Health
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital
  • Hawaii
    • Wailuku, Hawaii, United States, 96793
      • Maui Memorial Medical Center
  • Idaho
    • Boise, Idaho, United States, 83706
      • Saint Alphonsus Medical Center
    • Boise, Idaho, United States, 83712
      • St. Luke's Children's
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Health
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60612
      • Rush University Children's Hospital
    • Chicago, Illinois, United States, 60616
      • University of Illinois Hospital
    • Lake Forest, Illinois, United States, 60045
      • Northwestern Lake Forest Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Children's Hospital - Oak Lawn
    • Park Ridge, Illinois, United States, 60068
      • Advocate Children's Hospital
    • Peoria, Illinois, United States, 61637
      • OSF Healthcare Children's Hospital of Illinois
    • Winfield, Illinois, United States, 60190
      • Northwestern Central DuPage Hospital
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Beacon Children's Hospital
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Blank Children's Hospital
  • Kansas
    • Topeka, Kansas, United States, 66604
      • Stormont Vail Health
    • Wichita, Kansas, United States, 67214
      • Wesley Medical Center/Wesley Childrens Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Children's Hospital
  • Maine
    • Portland, Maine, United States, 04102
      • The Barbara Bush Children's Hospital at Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Children's Center
    • Baltimore, Maryland, United States, 60045
      • St. Agnes Hospital
    • Frederick, Maryland, United States, 21701
      • Frederick Memorial Hospital
    • Salisbury, Maryland, United States, 21801
      • Peninsula Regional Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Floating Hospital for Children at Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • St. Joseph Mercy Hospital
    • Ann Arbor, Michigan, United States, 48109
      • C. S. Mott Children's Hospital
    • Lansing, Michigan, United States, 48909
      • Sparrow Hospital
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Children's Hospital
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford West Bloomfield Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center Children's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Children's Hospital-St. Louis
  • New Jersey
    • Long Branch, New Jersey, United States, 07740
      • The Unterberg Children's Hospital
    • Somers Point, New Jersey, United States, 08244
      • Shore Medical Center
    • Vineland, New Jersey, United States, 08360
      • Inspira Medical Center Vineland
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Children's Hospital
  • New York
    • New York, New York, United States, 10029
      • Kravis Children's Hospital, The Mount Sinai Hospital
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
    • Staten Island, New York, United States, 10310
      • Richmond University Medical Center
    • Valhalla, New York, United States, 10595
      • Maria Fareri Children's Hospital at Westchester Medical Center
  • Ohio
    • Youngstown, Ohio, United States, 44511
      • Akron Childrens Mahoning Valley
  • Oregon
    • Portland, Oregon, United States, 97227
      • Randall Children's Hospital
    • Portland, Oregon, United States, 97235
      • Doernbecher Children's Hospital
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Unversity Health Network
    • Mount Lebanon, Pennsylvania, United States, 15243
      • St. Clair Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Children's Hospital at Erlanger
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas
    • El Paso, Texas, United States, 79905
      • El Paso Children's Hospital
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch- Galveston
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • Childrens Memorial Hermann Hospital
    • Lubbock, Texas, United States, 79410
      • Covenant Children's Hospital
    • Sugar Land, Texas, United States, 77479
      • Memorial Hermann Community Hospitals
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Children's Hospital
    • Fishersville, Virginia, United States, 22939
      • Augusta Medical Center
    • Fredericksburg, Virginia, United States, 22401
      • Mary Washington Hospital
    • Norfolk, Virginia, United States, 23507
      • The Children's Hospital of The King's Daughters
    • Roanoke, Virginia, United States, 24014
      • Carilion Children's
  • Washington
    • Tacoma, Washington, United States, 98403
      • Mary Bridge Children's Hospital
    • Wenatchee, Washington, United States, 98801
      • Central Washington Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • St. Mary's Hospital
    • Madison, Wisconsin, United States, 53794
      • American Family Children's Hospital
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin
    • Neenah, Wisconsin, United States, 54956
      • Children's Hospital of Wisconsin - Fox Valley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stepped Wedge Group 1: Sept. 2019 Launch; 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	Other: Education, clinical decision support tools; 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
Active Comparator: Stepped Wedge Group 2: Nov. 2019 Launch; 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	Other: Education, clinical decision support tools; 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
Active Comparator: Stepped Wedge Group 3: Jan. 2020 Launch; 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	Other: Education, clinical decision support tools; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid Tonicity	Increase mean proportion of hours per hospital day with exclusive isotonic IVF use to ≥80% by May 2020.	Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Routine Labs	Decrease number of serum WBC levels (proxy for routine labs) per hospital day by 20% from baseline by May 2020.	Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IVF duration	Decrease proportion of time (hours) on maintenance IVF during hospitalization by 10% from baseline by May 2020.	Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: American Academy of Pediatrics
• Investigators: Principal Investigator: Sahar N Rooholamini, MD, MPH, Seattle Children's Hospital/Univ. of Washington

Publications and helpful links

General Publications

• Rooholamini SN, Clifton H, Haaland W, McGrath C, Vora SB, Crowell CS, Romero H, Foti J. Outcomes of a Clinical Pathway to Standardize Use of Maintenance Intravenous Fluids. Hosp Pediatr. 2017 Dec;7(12):703-709. doi: 10.1542/hpeds.2017-0099.
• Feld LG, Neuspiel DR, Foster BA, Leu MG, Garber MD, Austin K, Basu RK, Conway EE Jr, Fehr JJ, Hawkins C, Kaplan RL, Rowe EV, Waseem M, Moritz ML; SUBCOMMITTEE ON FLUID AND ELECTROLYTE THERAPY. Clinical Practice Guideline: Maintenance Intravenous Fluids in Children. Pediatrics. 2018 Dec;142(6):e20183083. doi: 10.1542/peds.2018-3083.
• Rooholamini SN, Jennings B, Zhou C, Kaiser SV, Garber MD, Tchou MJ, Ralston SL. Effect of a Quality Improvement Bundle to Standardize the Use of Intravenous Fluids for Hospitalized Pediatric Patients: A Stepped-Wedge, Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Jan 1;176(1):26-33. doi: 10.1001/jamapediatrics.2021.4267.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: April 6, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Diseases; Pituitary Diseases; Water-Electrolyte Imbalance; Inappropriate ADH Syndrome
• Other Study ID Numbers: AAP VIP Network SOFI study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All project data will be analyzed by the study team at the aggregate level and site-level data will not be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No