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Business pivot caused termination of study before enrollment.
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| Name | Class |
|---|---|
| Children's Hospital and Medical Center, Omaha, Nebraska | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NICU Dashboard | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| NICU Length of Stay | Days spent in the NICU from admission to discharge | From date of NICU admission until the date of NICU discharge, assessed up to 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Chronic Lung Disease | Diagnosis | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hospital Acquired Infections | For example, CLABSI, Sepsis, VAP | From date of NICU admission until the date of NICU discharge, assessed up to 365 days |
| Hand washing compliance rate | Number of events found during audits |
NEONATES AND THEIR PARENTS
Inclusion Criteria:
Exclusion Criteria:
CLINICIANS INTERACTING WITH THE NICU DASHBOARD
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney McLean, MD | Children's Hospital and Medical Center, Omaha, Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital and Medical Center, Omaha | Omaha | Nebraska | 68114 | United States |
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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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001724 | Birth Weight |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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| 7 days and 30 days post-hospital discharge |
| Baby growth velocity | Rate of weight gain | 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 | 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) | 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 | 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.
Higher scores represent worse outcomes | 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. | 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. | 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. | 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. | 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. | 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.
Higher scores represent better outcomes. | 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. | 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 | From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days |
| One year prior to study initiation, and through study completion, an average of one year |
| Cost of care | Hospitalization costs (paid by insurance), costs/# of labs ordered, costs/# of images ordered | One year prior to study initiation, and through study completion, an average of one year |
| D000091642 | Urogenital Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |