Study Stopped
Business pivot caused termination of study before enrollment.
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2018
CompletedFirst Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedSeptember 24, 2020
September 1, 2020
1.8 years
September 10, 2018
September 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of neonatal adverse events
Preventable adverse events (e.g. unplanned extubations, medication errors)
Through study completion, an average of 1 year
Secondary Outcomes (15)
Incidence rate of Chronic Lung Disease
Through study completion, an average of 1 year
Rate of Readmission
7 days and 30 days post-hospital discharge
Baby growth velocity
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
From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days
NICU Length of Stay
From date of NICU admission until the date of NICU discharge, assessed up to 365 days
- +10 more secondary outcomes
Other Outcomes (3)
Incidence of Hospital Acquired Infections
From date of NICU admission until the date of NICU discharge, assessed up to 365 days
Hand washing compliance rate
One year prior to study initiation, and through study completion, an average of one year
Cost of care
One year prior to study initiation, and through study completion, an average of one year
Study Arms (3)
NICU Dashboard: Parent
EXPERIMENTALThe 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 INTERVENTIONThe Parental Control group will receive standard of care without any study devices.
NICU Dashboard: Clinician
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Expected discharge from the NICU in \<48 hours
- CLINICIANS INTERACTING WITH THE NICU DASHBOARD
- 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
- No interaction with the NICU Dashboard
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philips Healthcarelead
- Memorial Hospital of South Bendcollaborator
Study Sites (1)
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert White, MD
Memorial Hospital of South Bend, Mednax
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 17, 2018
Study Start
June 14, 2018
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
September 24, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share
At this moment, Philips has no intention to share IPD with other researchers except those from institutions participating in this clinical investigation.