The Change Mechanisms of the Close Collaboration With Parents Intervention and the Adaptability of the Intervention in the Estonian Context
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 622
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
The overall aim of the study is to implement an evidence-based intervention called 'Close Collaboration with Parents' in Estonian neonatal units. The goal of the intervention is to educate the whole multi-professional NICU staff and promote a positive change in the family-centered care culture of the units. Thus, the first aim of the study is to implement the intervention in an Estonian NICU context, in three hospitals, and study the fidelity of the intervention. More precisely, the study questions are whether adaptations are needed for the successful implementation of the intervention in the Estonian context and how feasible are the used implementation strategies. Secondly, the aim is to study the effectiveness of the Close Collaboration with Parents intervention in this context by using a quasi-experimental, pre-test - post-test, study design. The questions are whether the implementation of the intervention in the Estonian setting will result in positive effects such as 1) an improved development environment for the infants during hospital stay (less noise, more parental speech, and more parent-infant physical closeness), 2) intensified parental bonding to the infant, and 3) increased parental confidence and emotional well-being at the time of discharge from hospital.
详细描述
Materials and Methods: Design A quasi-experimental, before and after intervention, design is used to test the effect of the intervention, where the impact mechanisms are treated as mediators of the change.
Sample: The subjects are employees of five neonatal units of three Estonian hospitals participating in the Close Collaboration with Parents intervention (hereinafter: staff) and newborns cared for in the units and their parents (hereinafter: families). Three of the units are at Tallinn: West-Tallinn Maternity Hospital (NICU and neonatal unit), the Department of Anesthesiology and Intensive Care (PICU/level IIIB), and the Department of Neonatal and Infant Medicine (NICU/level II) at the Children's Hospital. Another two units are located in Tartu University Hospital: the Department of Neonatal and Pediatric Intensive Care (PNICU, level IIIC) and a step-down unit (level II).
Families are recruited during a four-month period before and after the intervention, with the aim to recruit at least 50 families per participating hospital in both periods. Some newborns may be treated in a different hospital or in different units of the same hospital. In the case of a transfer, the family is asked to fill in only the Family Center questionnaire if the newborn has been in that unit for more than 72 hours.
A log will be kept of all infants discharged home from the unit i.e. to evaluate drop-out rate and biases. The log includes the patient's gestational age, birth weight, diagnosis, type of feeding at discharge, and length of hospital stay. If there is missing information in the log, it is completed with the information from the medical records. A log is also kept to follow the units' restrictions related to Covid-19 and concerning family visitation and participation policies.
Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for the families are:
- •families whose newborns have been hospitalized during the first 28 days of infant life
- •expected length of stay of the newborn is at least three days
- •discharge is planned to happen within a week
- •at least one parent has agreed to participate in the study
- •The exclusion criterion for the families:
- •Not able to communicate in Estonian, Russian, or English.
- •The inclusion criterion for the staff members:
- •The staff working in the units during the entire study period are eligible for the study.
排除标准
- 未提供
结局指标
主要结局
Depression
时间窗: Up to 2 months
The postnatal depressive symptoms of the mothers whose newborn has been cared for in the unit after the intervention are compared with the postnatal depressive symptoms of the mothers whose newborn has been cared for in the unit before the intervention. The symptoms are measured with Edinburgh Postnatal Depression Scale. The 10-question scale includes symptoms such as insomnia, mood, tearfulness, and thoughts of self-harm. The scale asks how a person has felt during the previous week. The minimum score is 0 and the maximum is 30. A high score indicates more depressive symptoms.
次要结局
- Anxiety(Up to 2 months)
研究者
Sari Ahlqvist-Bjorkroth
Associate Professor
University of Turku