Clinical trial NCT03924674: SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
Official title: Standardization of Fluids in Inpatient Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Fluids
Fluid and Electrolyte Imbalance
ADH Inappropriate
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
First posted: 2019-04-23
Enrollment: 106
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fluid Tonicity
timeFrame: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
measure: Routine Labs
timeFrame: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Secondary outcomes:
measure: IVF duration
timeFrame: Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Children's Hospital
state: California
city: Los Angeles
country: United States
facility: Harbor - UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Mattel Children's Hospital
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Pleasanton
country: United States
facility: Stanford HealthCare-ValleyCare
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Van Nuys
country: United States
facility: Valley Presbyterian Hospital
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center
state: California
city: Wilmington
country: United States
facility: Nemours A.I. duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Wolfson Children's Hosptial
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Miami
country: United States
facility: Holtz Children's Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Children's Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Childrens Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Advent Health Tampa
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
city: Augusta
country: United States
facility: Children's Hospital of Georgia
state: Georgia
city: Macon
country: United States
facility: Beverly Knight Olson Children's Hospital, Navicent Health
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Wailuku
country: United States
facility: Maui Memorial Medical Center
state: Hawaii
city: Boise
country: United States
facility: Saint Alphonsus Medical Center
state: Idaho
city: Boise
country: United States
facility: St. Luke's Children's
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Health
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Rush University Children's Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital
state: Illinois
city: Lake Forest
country: United States
facility: Northwestern Lake Forest Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Children's Hospital - Oak Lawn
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Children's Hospital
state: Illinois
city: Peoria
country: United States
facility: OSF Healthcare Children's Hospital of Illinois
state: Illinois
city: Winfield
country: United States
facility: Northwestern Central DuPage Hospital
state: Illinois
city: South Bend
country: United States
facility: Beacon Children's Hospital
state: Indiana
city: Des Moines
country: United States
facility: Blank Children's Hospital
state: Iowa
city: Topeka
country: United States
facility: Stormont Vail Health
state: Kansas
city: Wichita
country: United States
facility: Wesley Medical Center/Wesley Childrens Hospital
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Children's Hospital
state: Louisiana
city: Portland
country: United States
facility: The Barbara Bush Children's Hospital at Maine Medical Center
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Boston
country: United States
facility: Floating Hospital for Children at Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: C. S. Mott Children's Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Children's Hospital
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Children's Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center Children's Hospital
state: Mississippi
city: Saint Louis
country: United States
facility: Mercy Children's Hospital-St. Louis
state: Missouri
city: Long Branch
country: United States
facility: The Unterberg Children's Hospital
state: New Jersey
city: Somers Point
country: United States
facility: Shore Medical Center
state: New Jersey
city: Vineland
country: United States
facility: Inspira Medical Center Vineland
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Children's Hospital
state: New Mexico
city: New York
country: United States
facility: Kravis Children's Hospital, The Mount Sinai Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Valhalla
country: United States
facility: Maria Fareri Children's Hospital at Westchester Medical Center
state: New York
city: Youngstown
country: United States
facility: Akron Childrens Mahoning Valley
state: Ohio
city: Portland
country: United States
facility: Randall Children's Hospital
state: Oregon
city: Portland
country: United States
facility: Doernbecher Children's Hospital
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Unversity Health Network
state: Pennsylvania
city: Mount Lebanon
country: United States
facility: St. Clair Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Children's Hospital at Erlanger
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: El Paso
country: United States
facility: El Paso Children's Hospital
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch- Galveston
state: Texas
city: Houston
country: United States
facility: Childrens Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Lubbock
country: United States
facility: Covenant Children's Hospital
state: Texas
city: Sugar Land
country: United States
facility: Memorial Hermann Community Hospitals
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Children's Hospital
state: Virginia
city: Fishersville
country: United States
facility: Augusta Medical Center
state: Virginia
city: Fredericksburg
country: United States
facility: Mary Washington Hospital
state: Virginia
city: Norfolk
country: United States
facility: The Children's Hospital of The King's Daughters
state: Virginia
city: Roanoke
country: United States
facility: Carilion Children's
state: Virginia
city: Tacoma
country: United States
facility: Mary Bridge Children's Hospital
state: Washington
city: Wenatchee
country: United States
facility: Central Washington Hospital
state: Washington
city: Madison
country: United States
facility: St. Mary's Hospital
state: Wisconsin
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Neenah
country: United States
facility: Children's Hospital of Wisconsin - Fox Valley
state: Wisconsin
Study officials:
affiliation: Seattle Children's Hospital/Univ. of Washington
name: Sahar N Rooholamini, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.