Close Collaboration and Discharge Readiness
ConditionFamily Centered Care
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNagano Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants who have been admitted to the NICU for 2 weeks or longer
Disqualifiers
Infants whose parent doesn't have Japanese as their mother tongue
Infants whose parent needs psychiatric consultation after birth
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Close Collaboration with Parents
Other interventionThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Pre-intervention0 interventions
Group B: Post-intervention1 intervention
Trial outcomes
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.
Time frame
at discharge (about 1 month of age)Secondary outcomes
1
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.
Time frame
at discharge (about 1 month of age)2
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.
Time frame
at discharge (about 1 month of age)Sponsors and contacts
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Source ClinicalTrials.gov