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

NCT03673566 | Withdrawn FDA Device

• 1 other identifier: PCMS-17-07-18.1-CHMCO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

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

• Rate of neonatal adverse events

  Through study completion, an average of 1 year

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

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.

Device: NICU Dashboard

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.

Device: NICU Dashboard

Interventions

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.

Also known as: Lotus Dashboard

NICU Dashboard: Clinician; NICU Dashboard: Parent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 14 years or older
• Parent with sufficient mental capacity to provide written informed consent as determined by a RN
• Signed informed consent
• Aged 19+ yrs: Signed by parent of NICU baby
• Aged \<19 yrs (minor): signed by both parent of NICU baby and parent/guardian of 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)
• Aged 19 years or older
• Expected interaction with the NICU Dashboard
• Signed informed consent
• No interaction with the NICU Dashboard

Sponsors & Collaborators

• Philips Healthcare: lead
• Children's Hospital and Medical Center, Omaha, Nebraska: collaborator

Study Sites (1)

Children's Hospital and Medical Center, Omaha

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Premature Birth; Birth Weight; Personal Satisfaction

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Courtney McLean, MD

  Children's Hospital and Medical Center, Omaha, Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 17, 2018
• Study Start: March 20, 2019
• 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

Locations

US (1)