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临床试验/NCT03673566
NCT03673566撤回不适用

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard"

Philips Healthcare2 个研究点 分布在 1 个国家开始时间: 2019年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
NICU Length of Stay

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
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

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)
  • Aged 19 years or older
  • Expected interaction with the NICU Dashboard
  • Signed informed consent
  • Exclusion Criteria:
  • No interaction with the NICU Dashboard

结局指标

主要结局

NICU Length of Stay

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

Days spent in the NICU from admission to discharge

次要结局

  • Rate of neonatal adverse events(Through study completion, an average of 1 year)
  • Baby to parent skin-to-skin time(From date of NICU admission until the date of NICU discharge, assessed daily up to 365 days)
  • Parental Stressor Scale:Newborn Intensive Care Unit (PSS:NICU)(Upon signing informed consent (baseline) and within 48 hours of discharge)
  • Neonatal Index of Parent Satisfaction (NIPS)(Within 48 hours of discharge)
  • System Usability Scale (SUS)(Six months after study initiation (mid-point) and 12 months after study initiation (completion))
  • The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey(Within 48 hours of discharge)
  • Emotional Exhaustion Scale(Baseline (before study initiation), six months after study initiation (mid-point) and 12 months after study initiation (completion))
  • Teamwork Perceptions Questionnaire (T-TPQ)(Baseline (before study initiation), 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))
  • NASA Task Load Index (NASA-TLX)(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)
  • Incidence rate of Chronic Lung Disease(Through study completion, an average of 1 year)
  • Rate of Readmission(7 days and 30 days post-hospital discharge)
  • Baby growth velocity(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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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