Clinical trial NCT03673579: Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
Official title: Clinical Evaluation of the "NICU Clinical Decision Support Dashboard"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preterm Birth
Low; Birthweight, Extremely (999 Grams or Less)
Neonatal Infection
Satisfaction
Stress
Chronic Lung Disease
Growth Acceleration
Adverse Event
Keywords: NICU
Developmental care
Neuroprotective
Technology
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Memorial Hospital of South Bend
First posted: 2018-09-17
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: OTHER

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.

Eligibility 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

Exclusion Criteria:

* No interaction with the NICU Dashboard

Primary outcomes:
measure: Rate of neonatal adverse events
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Incidence rate of Chronic Lung Disease
timeFrame: Through study completion, an average of 1 year
measure: Rate of Readmission
timeFrame: 7 days and 30 days post-hospital discharge
measure: Baby growth velocity
timeFrame: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
measure: Percent of time noise levels are within range
timeFrame: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
measure: NICU Length of Stay
timeFrame: From date of NICU admission until the date of NICU discharge, assessed up to 365 days
measure: Baby to parent skin-to-skin time
timeFrame: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
measure: Parental Stressor Scale:NICU (PSS:NICU)
timeFrame: Upon signing informed consent (baseline) and within 96 hours of discharge
measure: Neonatal Index of Parent Satisfaction (NIPS)
timeFrame: Within 96 hours of discharge
measure: System Usability Scale (SUS)
timeFrame: Six months after study initiation (mid-point) and 12 months after study initiation (completion)
measure: The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
timeFrame: Within 96 hours of discharge
measure: Emotional Exhaustion Scale
timeFrame: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
measure: Teamwork Perceptions Questionnaire (T-TPQ)
timeFrame: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
measure: Frequency of Missed Care (MISSCARE)
timeFrame: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
measure: NASA Task Load Index (NASA-TLX)
timeFrame: Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)
measure: Percent of time light levels are within range
timeFrame: From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
Other outcomes:
measure: Incidence of Hospital Acquired Infections
timeFrame: From date of NICU admission until the date of NICU discharge, assessed up to 365 days
measure: Hand washing compliance rate
timeFrame: One year prior to study initiation, and through study completion, an average of one year
measure: Cost of care
timeFrame: One year prior to study initiation, and through study completion, an average of one year
Locations:
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
Study officials:
affiliation: Memorial Hospital of South Bend, Mednax
name: Robert White, MD
role: PRINCIPAL_INVESTIGATOR
References: