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Developing and Evaluating User-Designed Data Displays

This study has been withdrawn prior to enrollment.
(Change to study design.)
Sponsor:
Information provided by (Responsible Party):
Kristen Timmons, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT02615808
First received: November 24, 2015
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Infant, Premature, Diseases Bronchiolitis Other: Oxygen saturation data visualization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Developing and Evaluating User-Designed Data Displays

Resource links provided by NLM:


Further study details as provided by Kristen Timmons, Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Time on supplemental oxygen (HM) [ Time Frame: 6 months ]
  • Percent time within target saturation range (90-95%) (NICU) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02615808

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Burnet Campus
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
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
  More Information

Responsible Party: Kristen Timmons, Clinical research coordinator, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02615808     History of Changes
Other Study ID Numbers: 2014-4293
Study First Received: November 24, 2015
Last Updated: July 25, 2016

Additional relevant MeSH terms:
Bronchiolitis
Infant, Premature, Diseases
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 21, 2017