SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
NCT ID: NCT03924674
Last Updated: 2021-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2019-04-01
2020-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Stepped Wedge Group 1: Sept. 2019 Launch
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
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
Stepped Wedge Group 2: Nov. 2019 Launch
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
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
Stepped Wedge Group 3: Jan. 2020 Launch
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Received maintenance IVF (rate greater than 10 ml/h) on hospital day #2 at 12:01 am
Exclusion Criteria
* 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
28 Days
18 Years
ALL
No
Sponsors
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American Academy of Pediatrics
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Sahar Rooholamini
Assistant Professor
Principal Investigators
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Sahar N Rooholamini, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital/Univ. of Washington
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Community Regional Medical Center
Fresno, California, United States
Loma Linda University Children's Hospital
Loma Linda, California, United States
Harbor - UCLA Medical Center
Los Angeles, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Stanford HealthCare-ValleyCare
Pleasanton, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Valley Presbyterian Hospital
Van Nuys, California, United States
John Muir Medical Center
Walnut Creek, California, United States
Nemours A.I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Wolfson Children's Hosptial
Jacksonville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Holtz Children's Hospital
Miami, Florida, United States
Sacred Heart Children's Hospital
Pensacola, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Johns Hopkins All Childrens Hospital
St. Petersburg, Florida, United States
Advent Health Tampa
Tampa, Florida, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
Children's Hospital of Georgia
Augusta, Georgia, United States
Beverly Knight Olson Children's Hospital, Navicent Health
Macon, Georgia, United States
WellStar Kennestone Hospital
Marietta, Georgia, United States
Maui Memorial Medical Center
Wailuku, Hawaii, United States
Saint Alphonsus Medical Center
Boise, Idaho, United States
St. Luke's Children's
Boise, Idaho, United States
Kootenai Health
Coeur d'Alene, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Rush University Children's Hospital
Chicago, Illinois, United States
University of Illinois Hospital
Chicago, Illinois, United States
Northwestern Lake Forest Hospital
Lake Forest, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Advocate Children's Hospital - Oak Lawn
Oak Lawn, Illinois, United States
Advocate Children's Hospital
Park Ridge, Illinois, United States
OSF Healthcare Children's Hospital of Illinois
Peoria, Illinois, United States
Northwestern Central DuPage Hospital
Winfield, Illinois, United States
Beacon Children's Hospital
South Bend, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Stormont Vail Health
Topeka, Kansas, United States
Wesley Medical Center/Wesley Childrens Hospital
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, United States
The Barbara Bush Children's Hospital at Maine Medical Center
Portland, Maine, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
St. Agnes Hospital
Baltimore, Maryland, United States
Frederick Memorial Hospital
Frederick, Maryland, United States
Peninsula Regional Medical Center
Salisbury, Maryland, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
C. S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Beaumont Children's Hospital
Royal Oak, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Children's Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center Children's Hospital
Jackson, Mississippi, United States
Mercy Children's Hospital-St. Louis
St Louis, Missouri, United States
The Unterberg Children's Hospital
Long Branch, New Jersey, United States
Shore Medical Center
Somers Point, New Jersey, United States
Inspira Medical Center Vineland
Vineland, New Jersey, United States
University of New Mexico Children's Hospital
Albuquerque, New Mexico, United States
Kravis Children's Hospital, The Mount Sinai Hospital
New York, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla, New York, United States
Akron Childrens Mahoning Valley
Youngstown, Ohio, United States
Randall Children's Hospital
Portland, Oregon, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
St. Luke's Unversity Health Network
Bethlehem, Pennsylvania, United States
St. Clair Hospital
Mount Lebanon, Pennsylvania, United States
Children's Hospital at Erlanger
Chattanooga, Tennessee, United States
Children's Medical Center Dallas
Dallas, Texas, United States
El Paso Children's Hospital
El Paso, Texas, United States
University of Texas Medical Branch- Galveston
Galveston, Texas, United States
Childrens Memorial Hermann Hospital
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
Memorial Hermann Community Hospitals
Sugar Land, Texas, United States
University of Virginia Children's Hospital
Charlottesville, Virginia, United States
Augusta Medical Center
Fishersville, Virginia, United States
Mary Washington Hospital
Fredericksburg, Virginia, United States
The Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Carilion Children's
Roanoke, Virginia, United States
Mary Bridge Children's Hospital
Tacoma, Washington, United States
Central Washington Hospital
Wenatchee, Washington, United States
St. Mary's Hospital
Madison, Wisconsin, United States
American Family Children's Hospital
Madison, Wisconsin, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Children's Hospital of Wisconsin - Fox Valley
Neenah, Wisconsin, United States
Countries
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References
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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, 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.
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.
Other Identifiers
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AAP VIP Network SOFI study
Identifier Type: -
Identifier Source: org_study_id
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