Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB

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.

Study Overview

• Status: Withdrawn
• Conditions: Stress; Preterm Birth; Growth Acceleration; Chronic Lung Disease; Satisfaction; Adverse Event; Low; Birthweight, Extremely (999 Grams or Less); Neonatal Infection
• Intervention / Treatment: Device: NICU 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NICU Dashboard: Parent; 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.	Device: NICU 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.; Other Names: Lotus Dashboard
No Intervention: Standard Care: Parent; The Parental Control group will receive standard of care without any study devices.
Experimental: NICU Dashboard: Clinician; 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.	Device: NICU 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.; Other Names: Lotus Dashboard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of neonatal adverse events	Preventable adverse events (e.g. unplanned extubations, medication errors)	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	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	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
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
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:NICU (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	Upon signing informed consent (baseline) and within 96 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 96 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 96 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.; - 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.	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Philips Healthcare
• Collaborators: Memorial Hospital of South Bend
• Investigators: Principal Investigator: Robert White, MD, Memorial Hospital of South Bend, Mednax

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: NICU; Developmental care; Neuroprotective; Technology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Diseases; Premature Birth; Birth Weight
• Other Study ID Numbers: PCMS-17-07-18.1-MHSB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: At this moment, Philips has no intention to share IPD with other researchers except those from institutions participating in this clinical investigation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No