Developing and Evaluating User-Designed Data Displays

Bronchiolitis Clinical Trial

Official title:

Developing and Evaluating User-Designed Data Displays

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02615808
• Other study ID #: 2014-4293
• Status: Withdrawn
• Phase: N/A
• First received: November 24, 2015
• Last updated: July 25, 2016
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bronchiolitis
• Infant, Premature, Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center Burnet Campus	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time on supplemental oxygen (HM)		6 months	No
Primary	Percent time within target saturation range (90-95%) (NICU)		6 months	No
Secondary	Number of pulse oximetry alarms triggered (based on deviations from set range)		6 months	No
Secondary	Number of changes in oxygen flow or fractional inspired oxygen		6 months	No