Adverse Event, Chronic Lung Disease, Growth Acceleration, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Preterm Birth, Satisfaction, Stress
Conditions
Keywords
NICU, Developmental care, Neuroprotective, Technology
Brief 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. 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.
Interventions
DEVICENICU 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.
Sponsors
Memorial Hospital of South Bend
Philips Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective control data will be collected before the study devices are installed in all the NICU rooms. At the point of clinical go-live, there will be a single intervention group that all parents/clinicians will have the opportunity to participate in.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
NEONATES AND THEIR PARENTS Inclusion Criteria: * Admission to the NICU * At least one parent (biological, guardian, or adoptive) involved * One parent can understand and speak the English language * Parent aged 18 years or older * Parent with sufficient mental capacity to provide written informed consent as determined by a RN * Signed informed consent from the parent
Exclusion criteria
* Expected discharge from the NICU in \<48 hours CLINICIANS INTERACTING WITH THE NICU DASHBOARD Inclusion Criteria: * Employee of institution with direct patient care in the NICU (e.g. physician, NP, RN, therapist) * Expected interaction with the NICU Dashboard * Signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of neonatal adverse events | Through study completion, an average of 1 year | Preventable adverse events (e.g. unplanned extubations, medication errors) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Stressor Scale:NICU (PSS:NICU) | Upon signing informed consent (baseline) and within 96 hours of discharge | 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. 1. = Not at all stressful (the experience did not cause you to feel upset, tense, or anxious) 2. = A little stressful 3. = Moderately stressful 4. = Very stressful 5. = 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 |
| Frequency of Missed Care (MISSCARE) | Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion) | For Clinicians only 35-item questionnaire assessing the frequency that elements of nursing care are missed by nursing staff on the unit. 1. \- Always missed 2. \- Frequently missed 3. \- Occasionally missed 4. \- Rarely missed 5. \- 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. |
| NASA Task Load Index (NASA-TLX) | Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion) | 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. |
| Percent of time light levels are within range | From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days | Hours that light (lux) levels are within range over total patient-time |
| Incidence rate of Chronic Lung Disease | Through study completion, an average of 1 year | Diagnosis |
| Rate of Readmission | 7 days and 30 days post-hospital discharge | Number of readmissions (within 7 and 30 days) to a hospital over the number of total babies |
| Baby growth velocity | From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days | Rate of weight gain |
| Percent of time noise levels are within range | From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days | Hours that noise levels are within range over total patient-time |
| NICU Length of Stay | 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 |
| Baby to parent skin-to-skin time | From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days | Self-reported time parents are performing skin-to-skin (kangaroo care), averaged |
| Neonatal Index of Parent Satisfaction (NIPS) | Within 96 hours of discharge | 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. |
| System Usability Scale (SUS) | Six months after study initiation (mid-point) and 12 months after study initiation (completion) | 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. |
| The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey | Within 96 hours of discharge | 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. |
| Emotional Exhaustion Scale | Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion) | 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. |
| Teamwork Perceptions Questionnaire (T-TPQ) | Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost of care | One year prior to study initiation, and through study completion, an average of one year | Hospitalization costs (paid by insurance), costs/# of labs ordered, costs/# of images ordered |
| Incidence of Hospital Acquired Infections | From date of NICU admission until the date of NICU discharge, assessed up to 365 days | For example, CLABSI, Sepsis, VAP |
| Hand washing compliance rate | One year prior to study initiation, and through study completion, an average of one year | Number of events found during audits |
Countries
United States
Outcome results
None listed