Social drivers of health (SDOH), such as housing stability, food security and access to transportation, profoundly influence both healthcare access and health outcomes. In pregnancy, screening positively for SDOH domains correlates with poorer perinatal outcomes. While the American college of Obstetricians and Gynaecologists recommends screening for SDOH at every routine prenatal visit, many prenatal practices struggle to systematically screen patients for SDOH. This study evaluates the implementation of a universal SDOH screening and management protocol in prenatal care and aims to bridge the gap between the recommendation for universal SDOH screening in prenatal care and its actual integration by evaluating implementation strategies that can serve as a guide for other prenatal care clinics.

This multi-site, prospective formative implementation evaluation will assess the integration of standardised SDOH screening and management into prenatal care workflows at four prenatal clinic sites within an academic Obstetrics and Gynaecology department. The study employs a concurrent triangulation mixed-methods approach integrating chart-abstracted patient data, staff surveys, and staff and patient semi-structured interviews, guided by established implementation science frameworks (exploration, preparation, implementation and sustainment, consolidated framework for implementation research and implementation outcomes framework). Key implementation strategies include workflow integration, electronic medical record optimisation, role clarification and comprehensive training. Implementation outcomes to be evaluated include feasibility, acceptability, appropriateness, adoption, fidelity and sustainability.

This study was approved by the University of North Carolina at Chapel Hill’s Institutional Review Board (IRB #24-3104). Verbal informed consent will be obtained from all interview participants, and consent will be embedded in staff surveys. Results will be disseminated through peer-reviewed publications, conference presentations, stakeholder meetings and directly to participating clinical sites.

Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.

The SONG trial (NCT 05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.

This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.

NCT05915663.