Infant, Premature, DiseasesNCT02615808
Developing and Evaluating User-Designed Data Displays
A study testing Oxygen saturation data visualization in people with Infant, Premature, Diseases and Bronchiolitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Infant, Premature, Diseases, Bronchiolitis
- What is being tested?
- Oxygen saturation data visualization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center Burnet Campus
Cincinnati, Ohio, 45229
About this study
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.
Read the 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.
- Conditions
- Infant, Premature, Diseases, Bronchiolitis
- Being tested
- Oxygen saturation data visualization
- Medical subject headings
- Infant, Premature, Diseases, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen saturation data visualizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time on supplemental oxygen (HM)
Measured: 6 months
Percent time within target saturation range (90-95%) (NICU)
Measured: 6 months
Secondary outcomes (2)
Number of pulse oximetry alarms triggered (based on deviations from set range)
Measured: 6 months
Number of changes in oxygen flow or fractional inspired oxygen
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Change to study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Timmons, Children's Hospital Medical Center, Cincinnati
- Investigators
- Heather C Kaplan, MD, MSCE, Principal investigator, Children's Hospital Medical Center, CincinnatiPatrick W Brady, MD, MSc, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615808
- Sponsor's protocol ID
- 2014-4293
- Status last verified
- Jul 2016
- First submitted
- 24 Nov 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating User-Designed Data Displays
- ClinicalTrials.gov ID
- NCT02615808
- Acronym / sponsor ID
- 2014-4293
- Conditions
- Infant, Premature, Diseases, Bronchiolitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change to study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen saturation data visualization | Experimental | Other: Oxygen saturation data visualizationDuring intervention periods staff in both units will have access to the data visualization tool in the electronic health record. |
| 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. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen saturation data visualizationThe 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. | Other | Oxygen saturation data visualization |
Primary outcome
Time on supplemental oxygen (HM)
Time frame: 6 months
Percent time within target saturation range (90-95%) (NICU)
Time frame: 6 months
2 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Related trials for Infant, Premature, Diseases
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Maximising Maternal Milk for Preterm Infant
Breastfeeding, Prematurity
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather C Kaplan, MD, MSCE principal investigator
Children's Hospital Medical Center, Cincinnati
Patrick W Brady, MD, MSc principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen saturation data visualization in people with Infant, Premature, Diseases and Bronchiolitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time on supplemental oxygen (HM) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.