search
Back to results

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

Primary Purpose

Intravenous Fluids, Fluid and Electrolyte Imbalance, ADH Inappropriate

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education, clinical decision support tools
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intravenous Fluids

Eligibility Criteria

28 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children's Hospital
  • Community Regional Medical Center
  • Loma Linda University Children's Hospital
  • Harbor - UCLA Medical Center
  • UCLA Mattel Children's Hospital
  • Valley Children's Hospital
  • Stanford HealthCare-ValleyCare
  • UCSF Benioff Children's Hospital
  • Valley Presbyterian Hospital
  • John Muir Medical Center
  • Nemours A.I. duPont Hospital for Children
  • Children's National Medical Center
  • Wolfson Children's Hosptial
  • Nicklaus Children's Hospital
  • Holtz Children's Hospital
  • Sacred Heart Children's Hospital
  • Johns Hopkins All Childrens Hospital
  • Sarasota Memorial Hospital
  • Advent Health Tampa
  • Children's Healthcare of Atlanta at Egleston
  • Children's Hospital of Georgia
  • Beverly Knight Olson Children's Hospital, Navicent Health
  • WellStar Kennestone Hospital
  • Maui Memorial Medical Center
  • Saint Alphonsus Medical Center
  • St. Luke's Children's
  • Kootenai Health
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Rush University Children's Hospital
  • University of Illinois Hospital
  • Northwestern Lake Forest Hospital
  • Loyola University Medical Center
  • Advocate Children's Hospital - Oak Lawn
  • Advocate Children's Hospital
  • OSF Healthcare Children's Hospital of Illinois
  • Northwestern Central DuPage Hospital
  • Beacon Children's Hospital
  • Blank Children's Hospital
  • Stormont Vail Health
  • Wesley Medical Center/Wesley Childrens Hospital
  • University of Kentucky
  • Our Lady of the Lake Children's Hospital
  • The Barbara Bush Children's Hospital at Maine Medical Center
  • Anne Arundel Medical Center
  • Johns Hopkins Children's Center
  • St. Agnes Hospital
  • Frederick Memorial Hospital
  • Peninsula Regional Medical Center
  • Floating Hospital for Children at Tufts Medical Center
  • St. Joseph Mercy Hospital
  • C. S. Mott Children's Hospital
  • Sparrow Hospital
  • Beaumont Children's Hospital
  • Henry Ford West Bloomfield Hospital
  • Children's Minnesota
  • University of Mississippi Medical Center Children's Hospital
  • Mercy Children's Hospital-St. Louis
  • The Unterberg Children's Hospital
  • Shore Medical Center
  • Inspira Medical Center Vineland
  • University of New Mexico Children's Hospital
  • Kravis Children's Hospital, The Mount Sinai Hospital
  • Vassar Brothers Medical Center
  • Richmond University Medical Center
  • Maria Fareri Children's Hospital at Westchester Medical Center
  • Akron Childrens Mahoning Valley
  • Randall Children's Hospital
  • Doernbecher Children's Hospital
  • St. Luke's Unversity Health Network
  • St. Clair Hospital
  • Children's Hospital at Erlanger
  • Children's Medical Center Dallas
  • El Paso Children's Hospital
  • University of Texas Medical Branch- Galveston
  • Childrens Memorial Hermann Hospital
  • Texas Children's Hospital
  • Covenant Children's Hospital
  • Memorial Hermann Community Hospitals
  • University of Virginia Children's Hospital
  • Augusta Medical Center
  • Mary Washington Hospital
  • The Children's Hospital of The King's Daughters
  • Carilion Children's
  • Mary Bridge Children's Hospital
  • Central Washington Hospital
  • St. Mary's Hospital
  • American Family Children's Hospital
  • Children's Hospital of Wisconsin
  • Children's Hospital of Wisconsin - Fox Valley

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Stepped Wedge Group 1: Sept. 2019 Launch

Stepped Wedge Group 2: Nov. 2019 Launch

Stepped Wedge Group 3: Jan. 2020 Launch

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Fluid Tonicity
Increase mean proportion of hours per hospital day with exclusive isotonic IVF use to ≥80% by May 2020.
Routine Labs
Decrease number of serum WBC levels (proxy for routine labs) per hospital day by 20% from baseline by May 2020.

Secondary Outcome Measures

IVF duration
Decrease proportion of time (hours) on maintenance IVF during hospitalization by 10% from baseline by May 2020.

Full Information

First Posted
April 6, 2019
Last Updated
April 27, 2021
Sponsor
Seattle Children's Hospital
Collaborators
American Academy of Pediatrics
search

1. Study Identification

Unique Protocol Identification Number
NCT03924674
Brief Title
SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
Acronym
SOFI
Official Title
Standardization of Fluids in Inpatient Settings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
American Academy of Pediatrics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: There will be no increase in the number of floor-to-PICU transfers during hospitalization from baseline. There will be no increase in the number of serum sodium lab results obtained from baseline. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravenous Fluids, Fluid and Electrolyte Imbalance, ADH Inappropriate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepped Wedge Group 1: Sept. 2019 Launch
Arm Type
Active Comparator
Arm Description
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
Arm Title
Stepped Wedge Group 2: Nov. 2019 Launch
Arm Type
Active Comparator
Arm Description
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
Arm Title
Stepped Wedge Group 3: Jan. 2020 Launch
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Education, clinical decision support tools
Intervention Description
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
Primary Outcome Measure Information:
Title
Fluid Tonicity
Description
Increase mean proportion of hours per hospital day with exclusive isotonic IVF use to ≥80% by May 2020.
Time Frame
Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Title
Routine Labs
Description
Decrease number of serum WBC levels (proxy for routine labs) per hospital day by 20% from baseline by May 2020.
Time Frame
Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Secondary Outcome Measure Information:
Title
IVF duration
Description
Decrease proportion of time (hours) on maintenance IVF during hospitalization by 10% from baseline by May 2020.
Time Frame
Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
30478247
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.
Results Reference
background
PubMed Identifier
29162640
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.
Results Reference
background
PubMed Identifier
34779837
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs