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National Evaluation of the Close Collaboration With Parents Training (VVME5)

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ClinicalTrials.gov Identifier: NCT04635150
Recruitment Status : Completed
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Liisa Lehtonen, Turku University Hospital

Brief Summary:
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infant's stay in the Neonatal Intensive Care Unit (NICU) and parents' and staff perception on family centered care in the unit. This pre-post intervention study was carried out in nine hospitals in Finland in 2012 through 2018. Data was collected by using daily parental diaries, daily text message questions to parents and an audit interview for the staff.

Condition or disease Intervention/treatment Phase
Parent-Child Relations Parenting Infant, Newborn, Disease Behavioral: Close Collaboration with Parents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 768 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-post intervention study with different cohorts before and after the intervention.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: National Evaluation of the Close Collaboration With Parents Training. Enhancing Parents' Presence and Participation During Neonatal Intensive Care.
Actual Study Start Date : May 30, 2012
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Arm Intervention/treatment
Experimental: Post-intervention parents and staff
An educational intervention for the multidisciplinary staff of a neonatal intensive care unit.
Behavioral: Close Collaboration with Parents
Close Collaboration with Parents Training Program is an educational intervention for multidisciplinary NICU staff initially developed and implemented at Turku University Hospital to promote FCC. The intervention consists of four phases lasting 4 to 5 months each. First the healthcare staff learn to observe infant behavior. This phase aims at identifying the individual needs and features of each infant. After that, the staff observe infant behavior with the parents and learn to actively listen to parents' perceptions about their infant. During the phase III, staff learn to know the individual story of the family and their infant, which supports partnership between staff and parents. Finally, staff learn to integrate parents in decision-making and collaboratively plan the transition to home. The training is delivered through facilitator-network model in which local mentors are trained by the trainer mentors and supervisors.




Primary Outcome Measures :
  1. Parental Closeness Diary of parents' presence [ Time Frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. ]
    Daily Closeness Diary including space for both mothers and fathers to indicate their presence in the neonatal unit (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months).

  2. Parental Closeness Diary of parent-infant skin-to-skin contact [ Time Frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. . ]
    Daily Closeness Diary including space for both mothers and fathers to indicate skin-to-skin contact with their infant (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months). Skin-to-skin contact is defined as the infant is lying naked on a parent's chest.

  3. Daily text message questions to both mothers and fathers/partners about parents' satisfaction to family centered care [ Time Frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. ]
    Both parents received one question (randomly out of 9 questions) every evening at 9 pm to report their satisfaction about the specific issue during that day.

  4. Web questions for the staff about the quality of family centered care they have provided during their work shift [ Time Frame: Three months before and three months after the intervention. ]
    Each staff member responded to one web question (randomly out of 8 questions) after each workshift about the quality of family centered care they had provided that day.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Parents

    Inclusion Criteria for parents:

    • Every parent of an infant estimated to stay in the NICU longer than three days was approached.

    Exclusion Criteria:

    • Infant had major congenital anomalies or syndromes,
    • Parents spoke neither Finnish or Swedish,
    • Family lived outside the catchment area of the hospital.
  2. All staff members working at bedside and leadership.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liisa Lehtonen, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT04635150    
Other Study ID Numbers: K37/12
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liisa Lehtonen, Turku University Hospital:
NICU
Family centered care
Parent-infant closeness
Skin-to-skin
Additional relevant MeSH terms:
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Infant, Newborn, Diseases