Close Collaboration and Discharge Readiness

NCT06057974 | Recruiting

• 1 other identifier: S-05-49
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Family Centered Care

Keywords

Staff education; Parental anxiety; Parental discharge readiness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Parental anxiety symptoms

  at discharge (about 1 month of age)

• Parental discharge readiness

  at discharge (about 1 month of age)

Study Arms (2)

Pre-intervention

The patient and their parents who are admitted to the NICU before the NICU starts implementing the intervention.

Post-intervention

The patient and their parents who are admitted to the NICU after the NICU implements the intervention.

Other: Close Collaboration with Parents

Interventions

Close Collaboration with Parents OTHER

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.

Post-intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Infants and their parents who need at least 2 weeks of admission to Nagano Children's Hospital NICU, a level IV NICU in Japan.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nagano Children's Hospital: lead

Study Sites (1)

Nagano Children's Hospita

Azumino, Nagano, 39982822, Japan

RECRUITING

Study Officials

• Ryo Itoshima, MD

  Nagano Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryo Itoshima, MD

CONTACT

+358-29-450-5000; ryitos@utu.fi

Arata Oda, MD

CONTACT

+81-263-73-6700; araoda@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: September 28, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)