Effects of the Close Collaboration in Nagano 2

Family Centered Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057974
• Other study ID #: S-05-49
• Status: Recruiting
• Start date: September 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Nagano Children's Hospital
• Contact: Ryo Itoshima, MD
• Phone: +358-29-450-5000
• Email: ryitos[@]utu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Infants whose parent doesn't have Japanese as their mother tongue

• Infants whose parent needs psychiatric consultation after birth

Related Conditions & MeSH terms

• Family Centered Care

Intervention

Other:
• 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 parenthood through a dialogue with parents, and IV) involve parents in the decision-making about the care of their baby from an early stage of care through to the preparation for discharge. The final goal is to improve the care culture in the NICUs by changing the attitudes of the healthcare staff and the care practices of the unit to be more in line with family-centered care principles. It usually takes 1.5 years for each NICU to complete the intervention.

Locations

Country	Name	City	State
Japan	Nagano Children's Hospita	Azumino	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Nagano Children's Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of family centered care rated by parents	The family centered care provided by the medical professionals in the NICU is assessed by parents using a questionnaire modified from DigiFCC questions. It consists of 9 questions. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 not applicable). A higher score indicates better family centered care received by parents. The average score of all questions will be used.; This is rated by both parents separately.	at discharge (about 1 month of age)
Secondary	Parental anxiety symptoms	Parents' anxiety is assessed using the short version of the State and Trait Anxiety Inventory (Short-STAI). It was developed based on the original STAI which has 40 questions.9 The STAI assesses two different anxiety types at the same time. State anxiety is an emotional response that can change over time according to the situation. Trait anxiety indicates a personal emotional characteristic that a person has. There are 5 questions for each state and trait anxiety and each is scored on a four-point scale (1-4). The total score in each type of anxiety varies from a minimum of 5 to a maximum of 20, and higher scores indicate having more depressive symptoms.; This is rated by both parents separately.	at discharge (about 1 month of age)
Secondary	Parental discharge readiness	The readiness for the discharge is measured with the Readiness for Hospital Discharge Scale (RHDS). The questionnaire includes 23 items. Four attributes of readiness for discharge are measured within the subscales: Personal Status (7 items), Knowledge (7 items), Coping Ability (4 items), and Expected Support (5 items). Answers are on a 10-point scale from 0 to 10 (e.g., not at all, totally). The RHDS has been shown to be a reliable and valid measure of patients' perception of readiness for discharge. We use Japanese version, whose validity and reliability have also been shown.	at discharge (about 1 month of age)