Clinical Evaluation of the "NICU Clinical Decision Support Dashboard"
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of neonatal adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: NICU Dashboard (Device)
Standard Care: Parent
The Parental Control group will receive standard of care without any study devices.
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.
干预措施: NICU Dashboard (Device)
结局指标
主要结局
Rate of neonatal adverse events
时间窗: Through study completion, an average of 1 year
Preventable adverse events (e.g. unplanned extubations, medication errors)
次要结局
- Baby growth velocity(From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days)
- Baby to parent skin-to-skin time(From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days)
- Incidence rate of Chronic Lung Disease(Through study completion, an average of 1 year)
- NICU Length of Stay(From date of NICU admission until the date of NICU discharge, assessed up to 365 days)
- Emotional Exhaustion Scale(Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion))
- Neonatal Index of Parent Satisfaction (NIPS)(Within 96 hours of discharge)
- The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey(Within 96 hours of discharge)
- Teamwork Perceptions Questionnaire (T-TPQ)(Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion))
- Percent of time light levels are within range(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 Readmission(7 days and 30 days post-hospital discharge)
- System Usability Scale (SUS)(Six months after study initiation (mid-point) and 12 months after study initiation (completion))
- Frequency of Missed Care (MISSCARE)(Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion))
- Parental Stressor Scale:NICU (PSS:NICU)(Upon signing informed consent (baseline) and within 96 hours of discharge)
- NASA Task Load Index (NASA-TLX)(Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion))