SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
SOFI
Standardization of Fluids in Inpatient Settings
1 other identifier
interventional
106
1 country
89
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 6, 2019
CompletedFirst Posted
Study publicly available on registry
April 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedApril 29, 2021
April 1, 2021
1.2 years
April 6, 2019
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
IVF duration
Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Study Arms (3)
Stepped Wedge Group 1: Sept. 2019 Launch
ACTIVE COMPARATORInterventions 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
Stepped Wedge Group 2: Nov. 2019 Launch
ACTIVE COMPARATORInterventions 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
Stepped Wedge Group 3: Jan. 2020 Launch
ACTIVE COMPARATORInterventions 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- American Academy of Pediatricscollaborator
Study Sites (89)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Community Regional Medical Center
Fresno, California, 93721, United States
Loma Linda University Children's Hospital
Loma Linda, California, 92354, United States
Harbor - UCLA Medical Center
Los Angeles, California, 90025, United States
UCLA Mattel Children's Hospital
Los Angeles, California, 90095, United States
Valley Children's Hospital
Madera, California, 93636, United States
Stanford HealthCare-ValleyCare
Pleasanton, California, 94585, United States
UCSF Benioff Children's Hospital
San Francisco, California, 94158, United States
Valley Presbyterian Hospital
Van Nuys, California, 91405, United States
John Muir Medical Center
Walnut Creek, California, 94598, United States
Nemours A.I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Wolfson Children's Hosptial
Jacksonville, Florida, 32207, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Holtz Children's Hospital
Miami, Florida, 33156, United States
Sacred Heart Children's Hospital
Pensacola, Florida, 32504, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Johns Hopkins All Childrens Hospital
St. Petersburg, Florida, 33701, United States
Advent Health Tampa
Tampa, Florida, 33613, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322, United States
Children's Hospital of Georgia
Augusta, Georgia, 30912, United States
Beverly Knight Olson Children's Hospital, Navicent Health
Macon, Georgia, 31201, United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060, United States
Maui Memorial Medical Center
Wailuku, Hawaii, 96793, United States
Saint Alphonsus Medical Center
Boise, Idaho, 83706, United States
St. Luke's Children's
Boise, Idaho, 83712, United States
Kootenai Health
Coeur d'Alene, Idaho, 83814, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Rush University Children's Hospital
Chicago, Illinois, 60612, United States
University of Illinois Hospital
Chicago, Illinois, 60616, United States
Northwestern Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Advocate Children's Hospital - Oak Lawn
Oak Lawn, Illinois, 60453, United States
Advocate Children's Hospital
Park Ridge, Illinois, 60068, United States
OSF Healthcare Children's Hospital of Illinois
Peoria, Illinois, 61637, United States
Northwestern Central DuPage Hospital
Winfield, Illinois, 60190, United States
Beacon Children's Hospital
South Bend, Indiana, 46601, United States
Blank Children's Hospital
Des Moines, Iowa, 50309, United States
Stormont Vail Health
Topeka, Kansas, 66604, United States
Wesley Medical Center/Wesley Childrens Hospital
Wichita, Kansas, 67214, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, 70808, United States
The Barbara Bush Children's Hospital at Maine Medical Center
Portland, Maine, 04102, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287, United States
St. Agnes Hospital
Baltimore, Maryland, 60045, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48105, United States
C. S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Sparrow Hospital
Lansing, Michigan, 48909, United States
Beaumont Children's Hospital
Royal Oak, Michigan, 48073, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Children's Minnesota
Minneapolis, Minnesota, 55404, United States
University of Mississippi Medical Center Children's Hospital
Jackson, Mississippi, 39216, United States
Mercy Children's Hospital-St. Louis
St Louis, Missouri, 63141, United States
The Unterberg Children's Hospital
Long Branch, New Jersey, 07740, United States
Shore Medical Center
Somers Point, New Jersey, 08244, United States
Inspira Medical Center Vineland
Vineland, New Jersey, 08360, United States
University of New Mexico Children's Hospital
Albuquerque, New Mexico, 87106, United States
Kravis Children's Hospital, The Mount Sinai Hospital
New York, New York, 10029, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla, New York, 10595, United States
Akron Childrens Mahoning Valley
Youngstown, Ohio, 44511, United States
Randall Children's Hospital
Portland, Oregon, 97227, United States
Doernbecher Children's Hospital
Portland, Oregon, 97235, United States
St. Luke's Unversity Health Network
Bethlehem, Pennsylvania, 18015, United States
St. Clair Hospital
Mount Lebanon, Pennsylvania, 15243, United States
Children's Hospital at Erlanger
Chattanooga, Tennessee, 37403, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
El Paso Children's Hospital
El Paso, Texas, 79905, United States
University of Texas Medical Branch- Galveston
Galveston, Texas, 77555, United States
Childrens Memorial Hermann Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Covenant Children's Hospital
Lubbock, Texas, 79410, United States
Memorial Hermann Community Hospitals
Sugar Land, Texas, 77479, United States
University of Virginia Children's Hospital
Charlottesville, Virginia, 22908, United States
Augusta Medical Center
Fishersville, Virginia, 22939, United States
Mary Washington Hospital
Fredericksburg, Virginia, 22401, United States
The Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
Carilion Children's
Roanoke, Virginia, 24014, United States
Mary Bridge Children's Hospital
Tacoma, Washington, 98403, United States
Central Washington Hospital
Wenatchee, Washington, 98801, United States
St. Mary's Hospital
Madison, Wisconsin, 53715, United States
American Family Children's Hospital
Madison, Wisconsin, 53794, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Children's Hospital of Wisconsin - Fox Valley
Neenah, Wisconsin, 54956, United States
Related Publications (3)
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.
PMID: 30478247BACKGROUNDRooholamini 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.
PMID: 29162640BACKGROUNDRooholamini 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.
PMID: 34779837DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sahar N Rooholamini, MD, MPH
Seattle Children's Hospital/Univ. of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 6, 2019
First Posted
April 23, 2019
Study Start
April 1, 2019
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
April 29, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share
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.