Primary care is facing multiple crises, including an increase in health misinformation. Digital health messaging by primary care providers has been shown to reach a diverse patient population. With the uptake of Generative Artificial Intelligence (GenAI) usage in healthcare, there is an important opportunity to rapidly create messages that are tailored to different populations and conditions. However, thoroughly assessing artificial intelligence (AI)-generated content is essential, as GenAI raises concerns regarding its accuracy, understandability, actionability and bias perpetuation. We aim to investigate whether digital health messages created by GenAI are evaluated as non-inferior compared with those created by human experts.

The AI-CARE (AI to Create Accessible and Reliable patient Education materials) study is a double-blind, crossover, non-inferiority randomised controlled trial. Data collection began on 30 May 2025, and is expected to be completed at the end of May 2026. Over 12 months, 192 messages on 48 topics will be written: half by primary care and public health experts and half by a GenAI tool (OpenAI’s ChatGPT). Review Panels composed of 24 primary care providers and 24 patients will evaluate these messages using an Evaluation Grid developed to assess the messages’ quality of information, adaptation to the target audience, relevance and usefulness, and readiness to be shared with patients. Evaluations will be completed via online REDCap (Research Electronic Data Capture) surveys and the order in which the 192 messages appear will be randomised and will vary between individuals. Participants and analysts will be blinded to the generation source. The primary outcome will be the Clarity and Understandability score.

The Research Ethics Boards of the Hôpital Montfort (24-25-11-038) and the University of Ottawa (S-12-24-11153) formally approved this study in December 2024. Reported data will be grouped and anonymised for dissemination in peer-reviewed scientific journals and conferences.

NCT06997107.

Accurate arterial pressure monitoring is critical in cardiac surgery to guide haemodynamic management and vasopressor therapy. Radial arterial pressure monitoring may systematically underestimate central aortic pressure compared with femoral monitoring, potentially leading to inappropriate vasopressor escalation and associated complications. Recent evidence demonstrates that excessive norepinephrine exposure is associated with acute kidney injury and increased mortality in cardiac surgery patients.

To determine whether femoral arterial pressure monitoring reduces norepinephrine use compared with radial monitoring in cardiac surgery patients.

This is a prospective, randomised, controlled, single-blind, superiority trial conducted at two French university hospitals (CHU Besancon and CHU Dijon). Adult patients undergoing cardiac surgery with cardiopulmonary bypass will be randomised 1:1 to receive either femoral or radial arterial pressure monitoring. The primary endpoint is the proportion of patients treated with norepinephrine from anaesthetic induction to postoperative day 7. Secondary endpoints include acute kidney injury according to KDIGO criteria, cardiac complications, vasoactive-inotropic scores, duration of vasopressor therapy, vascular complications, and 7-day and 30-day mortality. Sample size calculation indicates 340 patients (170 per group) are needed to detect a 15% absolute reduction in norepinephrine use with 90% power and α=0.05, and an anticipated loss to follow-up rate of 5%.

The study has been approved by the French Ethics Committee (Comité de Protection des Personnes Nord-Ouest II, no. 2024/897) and will be conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in peer-reviewed journals and presented at international conferences.

NCT06952907.