Close Collaboration and Discharge Readiness

Официальное название

Effects of the Close Collaboration With Parents Intervention on Parents of Newborns

Обзор

This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness. The intervention is planned to be implemented between December 2023 and December 2024. The investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.

Подробное описание

Study period Pre-intervention data collection phase: September 2023 - December 2023 (Planned) Intervention phase: January 2024 - December 2024 (Planned) Post-intervention data collection phase: January 2025 - April 2025 (Planned)

Outcome measures Primary outcome: Quality of family centered care rated by parents Secondary outcomes: Parental anxiety symptoms and parental discharge readiness

Data management Eligible infants and their information will be identified and collected by research team members and entered into the excel file (.xlsx). Data will be pseudonymized when the data is entered into the excel file. All electronic data will be destroyed 10 years after the initiation of the study.

The principal investigator will be responsible for managing access to the data. We do not have a plan to make the data open in the future.

Statistical analysis The comparison between two continuous variables will be carried out by the student t test and, additionally, the multiple linear regression model and the logistic regression model to adjust the effect of the potential confounders. The potential confounders included in the models will be the length of stay and parents' previous mental illness.

R and RStudio will be used to analyze the data.

Вмешательства

• Другое Close Collaboration with Parents
  The Close Collaboration with Parents intervention is an educational model for healthcare staff working in NICUs. It aims to improve the ability of the members of the NICU healthcare team to I) observe the infants' individual behaviors and needs, II) support parents to take the initiative and share their observations and understanding of their infant's behaviors and to collaboratively plan the infant's care with the healthcare staff, III) understand the individual story of the family regarding pa

Первичные конечные точки

• Quality of family centered care rated by parents [Срок оценки: at discharge (about 1 month of age)]

Вторичные конечные точки (2)

• Parental anxiety symptoms [Срок оценки: at discharge (about 1 month of age)]
• Parental discharge readiness [Срок оценки: at discharge (about 1 month of age)]

Критерии участия

Критерии включения

• Infants who have been admitted to the NICU for 2 weeks or longer

Критерии исключения

• Infants whose parent doesn't have Japanese as their mother tongue
• Infants whose parent needs psychiatric consultation after birth

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Япония · 1 центр

• Nagano Children's Hospita — Azumino

Идентификаторы

NCT: NCT06057974 · S-05-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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