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

Primary Purpose

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

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NICU Dashboard

About this trial

This is an interventional other trial for Preterm Birth focused on measuring NICU, Developmental care, Neuroprotective, Technology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Hospital of South Bend

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

NICU Dashboard: Parent

Standard Care: Parent

NICU Dashboard: Clinician

Arm 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.

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

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.

Outcomes

Primary Outcome Measures

Rate of neonatal adverse events

Preventable adverse events (e.g. unplanned extubations, medication errors)

Secondary Outcome Measures

Incidence rate of Chronic Lung Disease

Diagnosis

Rate of Readmission

Number of readmissions (within 7 and 30 days) to a hospital over the number of total babies

Baby growth velocity

Rate of weight gain

Percent of time noise levels are within range

Hours that noise levels are within range over total patient-time

NICU Length of Stay

Days spent in the NICU from admission to discharge

Baby to parent skin-to-skin time

Self-reported time parents are performing skin-to-skin (kangaroo care), averaged

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

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.

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.

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.

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.

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.

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.

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.

Percent of time light levels are within range

Hours that light (lux) levels are within range over total patient-time

Full Information

NCT ID

NCT03673579

First Posted

September 10, 2018

Last Updated

September 22, 2020

Sponsor

Philips Healthcare

Collaborators

Memorial Hospital of South Bend

1. Study Identification

Unique Protocol Identification Number

NCT03673579

Brief Title

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

Official Title

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard"

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Business pivot caused termination of study before enrollment.

Study Start Date

June 14, 2018 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Healthcare

Collaborators

Memorial Hospital of South Bend

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NICU Dashboard: Parent

Arm Type

Experimental

Arm Description

Arm Title

Standard Care: Parent

Arm Type

No Intervention

Arm Description

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

Arm Title

NICU Dashboard: Clinician

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

NICU Dashboard

Other Intervention Name(s)

Lotus Dashboard

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of neonatal adverse events

Description

Preventable adverse events (e.g. unplanned extubations, medication errors)

Time Frame

Through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Incidence rate of Chronic Lung Disease

Description

Diagnosis

Time Frame

Through study completion, an average of 1 year

Title

Rate of Readmission

Description

Number of readmissions (within 7 and 30 days) to a hospital over the number of total babies

Time Frame

7 days and 30 days post-hospital discharge

Title

Baby growth velocity

Description

Rate of weight gain

Time Frame

From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days

Title

Percent of time noise levels are within range

Description

Hours that noise levels are within range over total patient-time

Time Frame

From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days

Title

NICU Length of Stay

Description

Days spent in the NICU from admission to discharge

Time Frame

From date of NICU admission until the date of NICU discharge, assessed up to 365 days

Title

Baby to parent skin-to-skin time

Description

Self-reported time parents are performing skin-to-skin (kangaroo care), averaged

Time Frame

From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days

Title

Parental Stressor Scale:NICU (PSS:NICU)

Description

Time Frame

Upon signing informed consent (baseline) and within 96 hours of discharge

Title

Neonatal Index of Parent Satisfaction (NIPS)

Description

Time Frame

Within 96 hours of discharge

Title

System Usability Scale (SUS)

Description

Time Frame

Six months after study initiation (mid-point) and 12 months after study initiation (completion)

Title

The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey

Description

Time Frame

Within 96 hours of discharge

Title

Emotional Exhaustion Scale

Description

Time Frame

Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)

Title

Teamwork Perceptions Questionnaire (T-TPQ)

Description

Time Frame

Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)

Title

Frequency of Missed Care (MISSCARE)

Description

Time Frame

Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)

Title

NASA Task Load Index (NASA-TLX)

Description

Time Frame

Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion)

Title

Percent of time light levels are within range

Description

Hours that light (lux) levels are within range over total patient-time

Time Frame

From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days

Other Pre-specified Outcome Measures:

Title

Incidence of Hospital Acquired Infections

Description

For example, CLABSI, Sepsis, VAP

Time Frame

From date of NICU admission until the date of NICU discharge, assessed up to 365 days

Title

Hand washing compliance rate

Description

Number of events found during audits

Time Frame

One year prior to study initiation, and through study completion, an average of one year

Title

Cost of care

Description

Hospitalization costs (paid by insurance), costs/# of labs ordered, costs/# of images ordered

Time Frame

One year prior to study initiation, and through study completion, an average of one year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert White, MD

Organizational Affiliation

Memorial Hospital of South Bend, Mednax

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Hospital of South Bend

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46601

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

At this moment, Philips has no intention to share IPD with other researchers except those from institutions participating in this clinical investigation.

Learn more about this trial

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

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