Developing and Evaluating User-Designed Data Displays
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|ClinicalTrials.gov Identifier: NCT02615808|
Recruitment Status : Withdrawn (Change to study design.)
First Posted : November 26, 2015
Last Update Posted : July 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infant, Premature, Diseases Bronchiolitis||Other: Oxygen saturation data visualization||Not Applicable|
The goal of the study is to evaluate the effectiveness of using user-centered designed data displays in the clinical care of patients admitted to Cincinnati Children's Hospital with respiratory illnesses in two clinical settings.
In the general pediatric floor the investigators will evaluate the effectiveness of user-centered designed data displays in the safe and efficient weaning of oxygen in general pediatric patients hospitalized with bronchiolitis.
In the NICU the investigators will evaluate the effectiveness of user-centered designed data displays in the accurate targeting of oxygen saturation levels among premature infants.
The investigators will address these aims by conducting parallel studies on the Cincinnati Children's Hospital hospital medicine (HM) unit and in the NICU comparing the data visualization application to standard of care. The investigators will examine intervention effectiveness using an adaptation of a quasi-experimental, equivalent time series design with randomization of intervention and control periods. The data visualization will be applied at the unit level and directly affect all the nurses and patients cared for in those units.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Developing and Evaluating User-Designed Data Displays|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Oxygen saturation data visualization
During intervention periods staff in both units will have access to the data visualization tool in the electronic health record.
Other: Oxygen saturation data visualization
The data visualization contains current and recent (over last 4, 8 or 12 hours) pulse oximetry readings and trends as well as the monitor alarm limits and most recently recorded supplemental oxygen content and flow.
No Intervention: Control
During control periods, the staff will not have access to the data visualization and will continue to use standard of care electronic health record and monitor data to understand oxygen status and trends.
- Time on supplemental oxygen (HM) [ Time Frame: 6 months ]
- Percent time within target saturation range (90-95%) (NICU) [ Time Frame: 6 months ]
- Number of pulse oximetry alarms triggered (based on deviations from set range) [ Time Frame: 6 months ]
- Number of changes in oxygen flow or fractional inspired oxygen [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615808
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center Burnet Campus|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Heather C Kaplan, MD, MSCE||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Patrick W Brady, MD, MSc||Children's Hospital Medical Center, Cincinnati|