Prospectively investigating the impact of AI onshared decision-making in post kidney transplant care (PRIMA-AI): protocol for a longitudinal qualitative study among patients, their support persons and treating physicians at a tertiary care centre.

introductionAs healthcare is shifting from a paternalistic to a patient-centred approach, medical decision making becomes more collaborative involving patients, their support persons (SPs) and physicians. Implementing shared decision-making (SDM) into clinical practice can be challenging and becomes even more complex with the introduction of artificial intelligence (AI) as a potential actant in the communicative network. Although there is more empirical research on patients' and physicians' perceptions of AI, little is known about the impact of AI on SDM. This study will help to fill this gap. To the best of our knowledge, this is the first systematic empirical investigation to prospectively assess the views of patients, their SPs and physicians on how AI affects SDM in physician-patient communication after kidney transplantation. Using a transdisciplinary approach, this study will explore the role and impact of an AI-decision support system (DSS) designed to assist with medical decision making in the clinical encounter. METHODS AND ANALYSIS: This is a plan to roll out a 2 year, longitudinal qualitative interview study in a German kidney transplant centre. Semi-structured interviews with patients, SPs and physicians will be conducted at baseline and in 3-, 6-, 12- and 24-month follow-up. A total of 50 patient-SP dyads and their treating physicians will be recruited at baseline. Assuming a dropout rate of 20% per year, it is anticipated that 30 patient-SP dyads will be included in the last follow-up with the aim of achieving data saturation. Interviews will be audio-recorded and transcribed verbatim. Transcripts will be analysed using framework analysis. Participants will be asked to report on their (a) communication experiences and preferences, (b) views on the influence of the AI-based DSS on the normative foundations of the use of AI in medical decision-making, focusing on agency along with trustworthiness, transparency and responsibility and (c) perceptions of the use of the AI-based DSS, as well as barriers and facilitators to its implementation into routine care. ETHICS AND DISSEMINATION: Approval has been granted by the local ethics committee of Charité-Universitätsmedizin Berlin (EA1/177/23 on 08 August 2023). This research will be conducted in accordance with the principles of the Declaration of Helsinki (1996). The study findings will be used to develop communication guidance for physicians on how to introduce and sustainably implement AI-assisted SDM. The study results will also be used to develop lay language patient information on AI-assisted SDM. A broad dissemination strategy will help communicate the results of this research to a variety of target groups, including scientific and non-scientific audiences, to allow for a more informed discourse among different actors from policy, science and society on the role and impact of AI in physician-patient communication.