Clinical Evaluation of the "NICU Clinical Decision Support Dashboard"

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2020-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NICU Dashboard

Intervention Type 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.

Standard Care: Parent

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

NICU Dashboard

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Lotus Dashboard

Eligibility Criteria

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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

* 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