Preterm BirthNCT03673566
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
A study testing NICU Dashboard in people with Preterm Birth and Low; Birthweight, Extremely (999 Grams or Less), run by Philips Healthcare at 1 site in United States.
Trial summary
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection
- What is being tested?
- NICU Dashboard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 1 Apr 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admission to the NICU
- At least one parent (biological, guardian, or adoptive) involved
- One parent can understand and speak the English language
- Parent aged 14 years or older
- Parent with sufficient mental capacity to provide written informed consent as determined by a RN
- Signed informed consent
Show all 12Show fewer
- Aged 19+ yrs: Signed by parent of NICU baby
- Aged <19 yrs (minor): signed by both parent of NICU baby and parent/guardian of parent
- Employee of institution with direct patient care in the NICU (e.g. physician, NP, RN, therapist)
- Aged 19 years or older
- Expected interaction with the NICU Dashboard
- Signed informed consent
Who cannot join
- Expected discharge from the NICU in <48 hours
- CLINICIANS INTERACTING WITH THE NICU DASHBOARD
- No interaction with the NICU Dashboard
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital and Medical Center, Omaha
Omaha, Nebraska, 68114
About this study
Official title: Clinical Evaluation of the "NICU Clinical Decision Support Dashboard"
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.
Read the detailed description
The current NICU environment can be stressful and overwhelming for parents of babies admitted and for clinicians caring for the babies. There is a wide range of monitors in a very clinical environment that does not take into account the comfort of neonates.
The Dashboard works in parallel with EHR and systems of record, and provides a cohesive view of the patient's status and planned clinical workflow in a single location for both parents and staff. Accessories such as environmental sensors and cameras are used to ensure that the environment is comfortable and promotes optimal development of the baby. Caregivers can educate and coach parents to facilitate integrating them into their infant's care. The NICU Dashboard also supports a family view to facilitate education and assist the family in tracking core measures and developmental milestones.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction, Stress, Chronic Lung Disease
- Being tested
- NICU Dashboard
- Keywords
- NICU, Developmental care, Neuroprotective, Technology
- Medical subject headings
- Premature Birth, Birth Weight, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICU DashboardDevice
Also called Lotus Dashboard
The NICU Dashboard is displayed on a touch screen display mounted to the wall or on a rolling cart that will be placed near the bedside. The Dashboard will integrate information from various hospital/device sources in order to provide clinicians with one location to access and collectively interpret clinical findings and environmental factors. Parents will have their own view on the Dashboard that will allow them view their baby's progress, view educational materials, and have access to other resources at their fingertips.
| Study group | Role | What they receive |
|---|---|---|
| NICU Dashboard: Parent | Experimental | The parental intervention group will have access to the parent application on the NICU Dashboard. Parents will be able to view basic information about their baby's condition, educational material, and track core measures and developmental milestones.
Parents of NICU babies will be asked to complete questionnaires at baseline and within 48 hours of NICU discharge. Receives: Device: NICU Dashboard |
| Standard Care: Parent | No intervention | The Parental Control group will receive standard of care without any study devices. |
| NICU Dashboard: Clinician | Experimental | The Clinician group will have access to the NICU Dashboard, which presents information from the EHR, bedside monitoring, and other systems of record through a pre-released FDA Class 2 clinical decision support rule-based system, to assist the appropriate evidence-based guidelines be integrated with team workflows. Caregivers educate and coach parents to facilitate integrating them into their infant's care.
NICU clinicians will be asked to complete questionnaires 1) prior to clinical go-live of the intervention (baseline), 2) at the study mid-way point, and 3) upon completion of parent recruitment. Receives: Device: NICU Dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
NICU Length of Stay
Days spent in the NICU from admission to discharge
Measured: From date of NICU admission until the date of NICU discharge, assessed up to 365 days
Secondary outcomes (15)
Incidence rate of Chronic Lung Disease
Diagnosis
Measured: Through study completion, an average of 1 year
Rate of Readmission
Number of readmissions (within 7 and 30 days) to a hospital over the number of total babies
Measured: 7 days and 30 days post-hospital discharge
Baby growth velocity
Rate of weight gain
Measured: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
Percent of time noise levels are within range
Hours that noise levels are within range over total patient-time
Measured: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
Rate of neonatal adverse events
Preventable adverse events (e.g. unplanned extubations, medication errors)
Measured: Through study completion, an average of 1 year
Baby to parent skin-to-skin time
Self-reported time parents are performing skin-to-skin (kangaroo care), averaged
Measured: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
Parental Stressor Scale:Newborn Intensive Care Unit (PSS:NICU)
For NICU parents 26-item questionnaire broken down into three constructs (Parental Role Alterations, Sights and Sounds of the Unit, and Infant Behavior and Appearance) designed to measure parental perception of stressors arising from the physical and psychosocial environment of the neonatal intensive care unit.
- = Not at all stressful (the experience did not cause you to feel upset, tense, or anxious)
- = A little stressful
- = Moderately stressful
- = Very stressful
- = Extremely stressful Total score will be calculated by summing each item score and averaged for the group. Each subscale will also be computed by summing the items within the subscale and averaging for each group.
Higher scores represent worse outcomes
Measured: Upon signing informed consent (baseline) and within 48 hours of discharge
Neonatal Index of Parent Satisfaction (NIPS)
For NICU parents 30-item questionnaire measuring parents' satisfaction with the care their newborn child receives while in a neonatal intensive care unit (NICU).
7-point Likert-scale (1) lowest satisfaction to (7) highest satisfaction. Sum item scores to calculate total score, with lower scores corresponding to worse outcomes.
Measured: Within 48 hours of discharge
System Usability Scale (SUS)
For NICU parents and clinicians 10-item questionnaire with 2 constructs: usability and learnability 5-point Likert-scale (1) strongly disagree to (5) strongly agree The participant's scores for each question added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.
Measured: Six months after study initiation (mid-point) and 12 months after study initiation (completion)
The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
For NICU parents 7-item questionnaire assessing communication with doctors (4-items) and nurses (3-items).
4-point Likert-scale: Never, Sometimes, Usually, Always The number of "Always" ratings for each participant is summed then divided by the number of items. The mean is then taken, stratified by group.
Higher scores represent better outcomes.
Measured: Within 48 hours of discharge
Emotional Exhaustion Scale
For Clinicians only 4-item questionnaire about job-related frustrations. 4-point Likert-scale: (1) Disagree strongly to (5) Agree strongly. Item scores are summed and averaged by group. Higher scores represent worse outcomes.
Measured: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
Teamwork Perceptions Questionnaire (T-TPQ)
For Clinicians only 21-item questionnaire measuring 3 constructs: team function, mutual support, and communication 5 - Strongly Agree 4 - Agree 3 - Neutral 2 - Disagree
1 - Strongly A total score is calculated for each teamwork construct. Summing scores in this manner allows for more accurate statistical testing.
High scores indicate better outcomes.
Measured: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
Frequency of Missed Care (MISSCARE)
For Clinicians only 35-item questionnaire assessing the frequency that elements of nursing care are missed by nursing staff on the unit.
- - Always missed
- - Frequently missed
- - Occasionally missed
- - Rarely missed
- - Never missed Scores will be averaged per item, and a total MISSCARE score will be computed per individual by averaging all items.
Higher scores represent better outcomes.
Measured: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
NASA Task Load Index (NASA-TLX)
For Clinicians only 6-item survey that rates perceived workload in order to assess the current workload in the NICU.
Increments of high, medium and low estimates for each point results in 21 gradations on the scales assessing mental demand, physical demand, temporal demand, performance, effort, and frustration.
Averages for each subscale will be computed. Higher scores represent worse outcomes.
Measured: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
Percent of time light levels are within range
Hours that light (lux) levels are within range over total patient-time
Measured: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start20 Mar 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: Business pivot caused termination of study before enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The NICU is divided into two floors. One floor will have the Dashboard installed and serve as the intervention floor, while the other will not have the Dashboard and thus serves as the Control floor. As patients are admitted, they are randomly assigned to a room based on availability. Therefore, intervention and control arms will run in parallel in a quasi-randomized fashion.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital and Medical Center, Omaha, Nebraska
- Responsible party
- Sponsor
- Investigators
- Courtney McLean, MD, Principal investigator, Children's Hospital and Medical Center, Omaha, Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673566
- Sponsor's protocol ID
- PCMS-17-07-18.1-CHMCO
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2018
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: At this moment, Philips has no intention to share IPD with other researchers except those from institutions participating in this clinical investigation.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the "NICU Clinical Decision Support Dashboard"
- ClinicalTrials.gov ID
- NCT03673566
- Acronym / sponsor ID
- PCMS-17-07-18.1-CHMCO
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction, Stress, Chronic Lung Disease
- Keywords
- NICU, Developmental care, Neuroprotective, Technology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business pivot caused termination of study before enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital and Medical Center, Omaha, Nebraska
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 17 Sep 2018 (actual)
- 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.
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.
Detailed description
The current NICU environment can be stressful and overwhelming for parents of babies admitted and for clinicians caring for the babies. There is a wide range of monitors in a very clinical environment that does not take into account the comfort of neonates.
The Dashboard works in parallel with EHR and systems of record, and provides a cohesive view of the patient's status and planned clinical workflow in a single location for both parents and staff. Accessories such as environmental sensors and cameras are used to ensure that the environment is comfortable and promotes optimal development of the baby. Caregivers can educate and coach parents to facilitate integrating them into their infant's care. The NICU Dashboard also supports a family view to facilitate education and assist the family in tracking core measures and developmental milestones.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The NICU is divided into two floors. One floor will have the Dashboard installed and serve as the intervention floor, while the other will not have the Dashboard and thus serves as the Control floor. As patients are admitted, they are randomly assigned to a room based on availability. Therefore, intervention and control arms will run in parallel in a quasi-randomized fashion.
| Arm | Type | Receives |
|---|---|---|
| NICU Dashboard: Parent | Experimental | Device: NICU DashboardThe parental intervention group will have access to the parent application on the NICU Dashboard. Parents will be able to view basic information about their baby's condition, educational material, and track core measures and developmental milestones. Parents of NICU babies will be asked to complete questionnaires at baseline and within 48 hours of NICU discharge. |
| Standard Care: Parent | No intervention | –The Parental Control group will receive standard of care without any study devices. |
| NICU Dashboard: Clinician | Experimental | Device: NICU DashboardThe Clinician group will have access to the NICU Dashboard, which presents information from the EHR, bedside monitoring, and other systems of record through a pre-released FDA Class 2 clinical decision support rule-based system, to assist the appropriate evidence-based guidelines be integrated with team workflows. Caregivers educate and coach parents to facilitate integrating them into their infant's care. NICU clinicians will be asked to complete questionnaires 1) prior to clinical go-live of the intervention (baseline), 2) at the study mid-way point, and 3) upon completion of parent recruitment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Admission to the NICU
- At least one parent (biological, guardian, or adoptive) involved
- One parent can understand and speak the English language
- Parent aged 14 years or older
- Parent with sufficient mental capacity to provide written informed consent as determined by a RN
Key exclusion criteria (3 listed)
- Expected discharge from the NICU in <48 hours
- CLINICIANS INTERACTING WITH THE NICU DASHBOARD
- No interaction with the NICU Dashboard
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 |
|---|---|---|
| NICU DashboardAlso: Lotus DashboardThe NICU Dashboard is displayed on a touch screen display mounted to the wall or on a rolling cart that will be placed near the bedside. The Dashboard will integrate information from various hospital/device sources in order to provide clinicians with one location to access and collectively interpret clinical findings and environmental factors. Parents will have their own view on the Dashboard that will allow them view their baby's progress, view educational materials, and have access to other resources at their fingertips. | Device | NICU Dashboard: Clinician, NICU Dashboard: Parent |
Primary outcome
NICU Length of Stay
Time frame: From date of NICU admission until the date of NICU discharge, assessed up to 365 days
Days spent in the NICU from admission to discharge
15 secondary outcomes
Incidence rate of Chronic Lung Disease
Time frame: Through study completion, an average of 1 year
Rate of Readmission
Time frame: 7 days and 30 days post-hospital discharge
Baby growth velocity
Time frame: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
Percent of time noise levels are within range
Time frame: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
Rate of neonatal adverse events
Time frame: Through study completion, an average of 1 year
Baby to parent skin-to-skin time
Time frame: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
Parental Stressor Scale:Newborn Intensive Care Unit (PSS:NICU)
Time frame: Upon signing informed consent (baseline) and within 48 hours of discharge
Neonatal Index of Parent Satisfaction (NIPS)
Time frame: Within 48 hours of discharge
System Usability Scale (SUS)
Time frame: Six months after study initiation (mid-point) and 12 months after study initiation (completion)
The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
Time frame: Within 48 hours of discharge
Emotional Exhaustion Scale
Time frame: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
Teamwork Perceptions Questionnaire (T-TPQ)
Time frame: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
Frequency of Missed Care (MISSCARE)
Time frame: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
NASA Task Load Index (NASA-TLX)
Time frame: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
Percent of time light levels are within range
Time frame: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
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 24 Sep 2020.
- Individual participant dataSharing planned: No. At this moment, Philips has no intention to share IPD with other researchers except those from institutions participating in this clinical investigation.
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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.
Courtney McLean, MD principal investigator
Children's Hospital and Medical Center, Omaha, Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NICU Dashboard in people with Preterm Birth and Low; Birthweight, Extremely (999 Grams or Less), run by Philips Healthcare 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 12 inclusion and 3 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 24 Sep 2020. 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?
NICU Length of Stay (time frame: From date of NICU admission until the date of NICU discharge, assessed up to 365 days). 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 24 Sep 2020.