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

Philips

Status: Withdrawn

Conditions: Adverse Event; Chronic Lung Disease; Satisfaction; Growth Acceleration; Neonatal Infection; Low; Birthweight, Extremely (999 Grams or Less); Stress; Preterm Birth

Treatments: Device: NICU Dashboard

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03673566

PCMS-17-07-18.1-CHMCO

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

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)
• Aged 19 years or older
• Expected interaction with the NICU Dashboard
• Signed informed consent

Exclusion Criteria:

• No interaction with the NICU Dashboard

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

NICU Dashboard: Parent

Experimental group

Description:

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.

Treatment:

Device: NICU Dashboard

Standard Care: Parent

No Intervention group

Description:

The Parental Control group will receive standard of care without any study devices.

NICU Dashboard: Clinician

Experimental group

Description:

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.

Treatment:

Device: NICU Dashboard