Developing and Evaluating User-Designed Data Displays
Primary Purpose
Infant, Premature, Diseases, Bronchiolitis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen saturation data visualization
Sponsored by
About this trial
This is an interventional health services research trial for Infant, Premature, Diseases
Eligibility Criteria
Inclusion Criteria:
- patients with bronchiolitis (HM)
- patients with supplemental oxygen need during hospitalization (HM)
- patients <12 months of age (HM)
- patients <32 weeks gestational age (NICU)
- patients with consistent supplemental oxygen need in 48 hours prior to study entry (NICU)
Exclusion Criteria:
- patients with supplemental oxygen need prior to admission (HM)
- hospitalization occurs during the change from intervention to control periods (HM)
- patients with congenital anomalies of the lung (NICU)
- patients who are not in a weaning mode (e.g. on pre-discharge low flow oxygen) (NICU)
Sites / Locations
- Cincinnati Children's Hospital Medical Center Burnet Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oxygen saturation data visualization
Control
Arm Description
During intervention periods staff in both units will have access to the data visualization tool in the electronic health record.
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.
Outcomes
Primary Outcome Measures
Time on supplemental oxygen (HM)
Percent time within target saturation range (90-95%) (NICU)
Secondary Outcome Measures
Number of pulse oximetry alarms triggered (based on deviations from set range)
Number of changes in oxygen flow or fractional inspired oxygen
Full Information
NCT ID
NCT02615808
First Posted
November 24, 2015
Last Updated
July 25, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02615808
Brief Title
Developing and Evaluating User-Designed Data Displays
Official Title
Developing and Evaluating User-Designed Data Displays
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Change to study design.
Study Start Date
undefined (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hospitalized children with respiratory disease are commonly monitored with continuous pulse oximetry and heart rate-respiratory rate monitors. These data streams generate >4,000 unique data points each patient-day, yet only a tiny fraction are used to inform care decisions. Failure to adequately summarize this large amount of data for clinicians may result in suboptimal care because clinicians may miss important data signals and may under- or over-react to individual data points. In children hospitalized with respiratory disease and in need of supplemental oxygen, there are a number of care decisions, currently made without adequate data, which could be informed by intelligent data visualization tools. This study has employed user-centered design to develop data displays that inform nurses' and respiratory therapists' decision-making in supplemental oxygen delivery. The investigators are now evaluating the effectiveness of these displays in the clinical care of patients with two common respiratory conditions-infants with bronchiolitis admitted to the general pediatrics ward and preterm infants requiring supplemental oxygen who are cared for in the neonatal intensive care unit. By reducing patient's time on supplemental oxygen and improving time with optimal oxygen saturations, this work has the potential to lead to a breakthrough innovation that improves both outcomes and value.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Bronchiolitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen saturation data visualization
Arm Type
Experimental
Arm Description
During intervention periods staff in both units will have access to the data visualization tool in the electronic health record.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Oxygen saturation data visualization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time on supplemental oxygen (HM)
Time Frame
6 months
Title
Percent time within target saturation range (90-95%) (NICU)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of pulse oximetry alarms triggered (based on deviations from set range)
Time Frame
6 months
Title
Number of changes in oxygen flow or fractional inspired oxygen
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with bronchiolitis (HM)
patients with supplemental oxygen need during hospitalization (HM)
patients <12 months of age (HM)
patients <32 weeks gestational age (NICU)
patients with consistent supplemental oxygen need in 48 hours prior to study entry (NICU)
Exclusion Criteria:
patients with supplemental oxygen need prior to admission (HM)
hospitalization occurs during the change from intervention to control periods (HM)
patients with congenital anomalies of the lung (NICU)
patients who are not in a weaning mode (e.g. on pre-discharge low flow oxygen) (NICU)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather C Kaplan, MD, MSCE
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick W Brady, MD, MSc
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center Burnet Campus
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
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Developing and Evaluating User-Designed Data Displays
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