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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2020-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03673579

Preterm Birth Low; Birthweight, Extremely (999 Grams or Less) Neonatal Infection +5 more

WITHDRAWN NA

Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

NCT00067613

Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age +2 more

COMPLETED NA

Developmental Impact of NICU Exposures (DINE)

NCT03061890

Prematurity

COMPLETED

A Father-friendly Neonatal Intensive Care Unit

NCT05521620

Stress Self Efficacy Perception, Self

COMPLETED NA

Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

NCT06475976

Bronchopulmonary Dysplasia

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lotus Dashboard

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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