Standardization of Fluids in Inpatient Settings

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

Sponsors

Lead sponsor: Seattle Children's Hospital

Collaborator: American Academy of Pediatrics

Source Seattle Children's Hospital
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 tested as process measures:

1. By May 2020, the proportion of daily weight measurements will increase by 10% from baseline for patients on maintenance IVF.

2. By May 2020, participants will attend an average of ≥75% of their scheduled sessions with project QI coaches. This will be measured by tracking attendance during coaching phone calls.

The following will be tested 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.

Overall Status Active, not recruiting
Start Date April 1, 2019
Completion Date May 31, 2020
Primary Completion Date May 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Fluid Tonicity Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Routine Labs Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Secondary Outcome
Measure Time Frame
IVF duration Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.
Enrollment 112
Condition
Intervention

Intervention type: Other

Intervention name: Education, clinical decision support tools

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

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

Gender: All

Minimum age: N/A

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sahar N Rooholamini, MD, MPH Principal Investigator Seattle Children's Hospital/Univ. of Washington
Location
facility
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, 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
Johns Hopkins All Childrens Hospital | Saint Petersburg, Florida, 33701, United States
Sarasota Memorial Hospital | Sarasota, Florida, 34239, 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 | Saint 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
Location Countries

United States

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Seattle Children's Hospital

Investigator full name: Sahar Rooholamini

Investigator title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Stepped Wedge Group 1: Sept. 2019 Launch

Arm group type: Active Comparator

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 group label: Stepped Wedge Group 2: Nov. 2019 Launch

Arm group type: Active Comparator

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 group label: Stepped Wedge Group 3: Jan. 2020 Launch

Arm group type: Active Comparator

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

Acronym SOFI
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

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

Masking: None (Open Label)

Source: ClinicalTrials.gov