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| Name | Class |
|---|---|
| American Academy of Pediatrics | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped Wedge Group 1: Sept. 2019 Launch | Active Comparator | Interventions will include:
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| Stepped Wedge Group 2: Nov. 2019 Launch | Active Comparator | Interventions will include:
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| Stepped Wedge Group 3: Jan. 2020 Launch | Active Comparator | Interventions will include:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education, clinical decision support tools | Other | Interventions will include:
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sahar N Rooholamini, MD, MPH | Seattle Children's Hospital/Univ. of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Community Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30478247 | Background | 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. | |
| 29162640 |
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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.
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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.
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|
| 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 |
| 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. |
| 34779837 | Derived | 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. |
| ID | Term |
|---|---|
| D007177 | Inappropriate ADH Syndrome |
| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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