Nurse-led risk-based primary healthcare intervention in midlife women’s health management in Hong Kong: a stepped-wedge cluster randomized controlled trial protocol

Abstract Background Midlife women are facing many healthcare challenges, including unmet needs in screening and preventive care. Nurse-led risk-based model in primary healthcare settings prioritizes preventive care and self-management, potentially increases the use of preventive health services including timely health screenings, chronic disease management and mental health programs, and adequate medical consultations. This study aims to evaluate the effectiveness of a nurse-led risk-based women’s health intervention in enhancing preventive health service utilization and its impacts on self-management, health confidence, quality of life, thereby strengthening primary healthcare for midlife women in the Hong Kong. Methods A stepped-wedge cluster randomized controlled trial in continuous recruitment will be conducted in three social service organizations, each with four exposure phases and a transition period. A total of 1728 eligible women residents aged 45–64 will be enrolled. Participants allocated to the intervention condition will receive the nurse-led risk-based 5As intervention at baseline, 1, 3, and 6 months follow-up; encompassing assessments, risk stratification, personalized education, consultation, referral, and instant messages. Control condition will include identical assessments and general lifestyle modification advice at baseline, 3 and 6 months follow-up. The primary outcome will be a composite measure of preventive health services utilization (timely screenings, chronic disease management and mental health programs, and relevant medical consultations) at 3 months after the baseline nurse-led consultation. Secondary outcomes will be preventive health services utilization at 6 months after baseline; Health Confidence Scale, Self-Management Assessment Scale, EQ-5D-5L with EQ Visual Analogue Scale, and validated evaluation tools for vasomotor symptoms, urinary incontinence, depression, anxiety, osteoporosis, blood pressure problems, and breast, cervical, colorectal cancer at 3 and 6 months after baseline. Within- and between-group effects over time, interviews of participants and nurses on perceptions and attitudes towards this intervention will be analyzed. Discussion This study will provide empirical evidence on the effectiveness, feasibility, and acceptability of the nurse-led risk-based 5As intervention targeting women’s health management in primary healthcare. Such intervention, if effective, can be developed as an innovative preventive care model to increase screenings and overall preventive health service utilization, empower women’s capacity in self-health management, and contribute to their health improvements. Trial registration Registered in Clinicaltrials.gov (NCT06628388) with study entitled “Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong (JCDATAZONEWH)”. Registered on October 4th, 2024.