Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03924674
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2019-04-06
Brief Title:
SOFI A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Standardization of Fluids in Inpatient Settings
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOFI
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 eg IV infiltration and inadequate monitoring for adverse effects
Investigators currently dont 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 US 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 RRTdialysis
Investigators currently dont 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 US 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 RRTdialysis
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None