Development and pilot study of an evidence-based clustered care practice guide within the framework of individualized...

Clustered care is a core component of individualized developmental care (IDC) in neonatal intensive care units (NICUs). However, the absence of standardized, evidence-based guidance results in variability in nursing practices, potentially compromising developmental stability and care quality. This study aimed to develop, validate, and pilot an evidence-based Clustered Care Practice Guide to support standardized nursing care in NICUs.

This methodological study followed a de novo guideline development approach (April 2022-June 2025). Multiple data sources were integrated, including a PRISMA-guided and PROSPERO-registered systematic review, a descriptive survey with 122 NICU nurses, clinical observations in two university hospitals, and five focus group interviews with 35 nurses. Synthesized evidence was translated into structured recommendations. Content validity was evaluated by 33 multidisciplinary experts using the Davis technique, and methodological quality was assessed according to AGREE II criteria. A pilot implementation was conducted to evaluate feasibility and clinical applicability.

The final guide comprised 55 items across five sections. All items demonstrated acceptable content validity (I-CVI ≥ 0.78), with excellent overall validity (S-CVI/Ave = 0.96). The guide met AGREE II standards. Pilot testing with five nurses and subsequent evaluation by 25 nurses indicated high acceptability, with 95.8% rating the guide as effective and useful. Thematic analysis revealed improved clinical decision-making, workflow organization, professional confidence, and standardization of care practices.

The Clustered Care Practice Guide demonstrates strong methodological rigor and high clinical applicability. It offers a structured, evidence-based framework to standardize clustered care and enhance developmentally supportive practices in NICUs.