Developing and Evaluating User-Designed Data Displays

NCT02615808 | Withdrawn

• 1 other identifier: 2014-4293
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases; Bronchiolitis

Outcome Measures

Primary Outcomes (2)

• Time on supplemental oxygen (HM)

  6 months

• Percent time within target saturation range (90-95%) (NICU)

  6 months

Secondary Outcomes (2)

• Number of pulse oximetry alarms triggered (based on deviations from set range)

  6 months

• Number of changes in oxygen flow or fractional inspired oxygen

  6 months

Study Arms (2)

Oxygen saturation data visualization

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Oxygen saturation data visualization OTHER

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.

Oxygen saturation data visualization

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center Burnet Campus

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Infant, Premature, Diseases; Bronchiolitis

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Heather C Kaplan, MD, MSCE

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Patrick W Brady, MD, MSc

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research coordinator

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

US (1)