Developing and Evaluating User-Designed Data Displays

July 25, 2016 updated by: Kristen Timmons, Children's Hospital Medical Center, Cincinnati
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center Burnet Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time on supplemental oxygen (HM)
Time Frame: 6 months
6 months
Percent time within target saturation range (90-95%) (NICU)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of pulse oximetry alarms triggered (based on deviations from set range)
Time Frame: 6 months
6 months
Number of changes in oxygen flow or fractional inspired oxygen
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-4293

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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