Outcomes Following Close Collaboration With Parents Intervention in Neonatal Intensive Care Units: A Nonrandomized Clinical Trial.

Importance: Family-centered care (FCC) in neonatal intensive care units (NICUs) is critical for parental involvement and infant well-being, yet few studies have evaluated the impact of FCC interventions on practice or examined how implementation fidelity may affect these outcomes. Objectives: To evaluate the association between the Close Collaboration With Parents intervention and FCC practices and how implementation fidelity may modify these outcomes. Design, Setting, and Participants: This nonrandomized clinical trial had a before-and-after design. It was conducted between March 2021 and June 2023 at 6 NICUs in Estonia and included the parents of all newborns and all staff. Intervention: Close Collaboration With Parents is an educational intervention for multiprofessional NICU staff including e-learning and bedside practices combined with reflection sessions. It aims to improve FCC culture by developing staff skills in communication and collaboration with parents and parenting support. Main Outcomes and Measures: The quality of FCC was assessed using a 1-time questionnaire for the parents with 9 questions from the Digi Family-Centered Care-Parent version tool, and daily questions for the staff using Digi Family-Centered Care-Nurse version tool. The association between implementation fidelity, defined as the proportion of staff who completed the full education, and the quality of FCC was also analyzed. Results: A total of 186 infants (with responses from 186 mothers and 22 fathers) were included in the preintervention period. The median (IQR) gestational age was 37.4 (34.0-39.9) weeks, 94 infants (50.5%) were male, and the median (IQR) parental age was 32 (28-36) years. A total of 208 infants (with responses from 208 mothers and 55 fathers) were included in the postintervention period. The median (IQR) gestational age was 38.1 (35.4-39.9) weeks, 114 infants (55.1%) were male, and median (IQR) parental age was 32 (27-35) years. From the staff, 7448 and 6717 daily responses were analyzed in the preintervention and postintervention periods, respectively. The total rating was significantly higher after the intervention than before, by both the parents (r = 0.07; P < .001) and the staff (r = 0.10; P < .001). The median ratings did not, however, change: the parents' median (IQR) overall rating before and after was 7.0 (6.0-7.0), and the staff's median (IQR) overall rating was 6.0 (5.0-7.0) before and 6.0 (6.0-7.0) after. Implementation fidelity ranged from 4 of 30 health care professionals (13.3%) to 37 of 45 (82.2%) at the NICUs. The NICUs with high fidelity, as opposed to low fidelity, had significantly greater improvement in FCC ratings by the staff after the intervention (β = 2.1 [95% CI, 0.8-3.4]; P = .002). Conclusions and Relevance: In this nonrandomized clinical trial, FCC practices were rated higher by the staff and parents after the Close Collaboration With Parents intervention. Implementation fidelity was identified as an important factor. Trial Registration: ClinicalTrials.gov Identifier: NCT06258655.