Development and evaluation of a decision aid for family surrogate decision-makers for patients with acute kidney injury requiring renal replacement therapy (RRT) in ICUs: a study protocol

INTRODUCTION: Shared decision making is endorsed by guidelines for both acute kidney injury and critical care medicine. However, there is still a huge need for effective interventions, especially those focusing on decisions about renal replacement therapy for intensive care unit (ICU) patients with acute kidney injury. The decision aids provide evidence-based support for shared decision making, to achieve better decisions through enhanced knowledge of treatment options and treatment aligns with patients’ preferences and values. Therefore, our objectives are to develop and evaluate a decision aid systematically and rigorously for family surrogate decision makers of ICU patients with acute kidney injury who need renal replacement therapy. METHODS AND ANALYSIS: We will use a systematic development process that focuses on user-centred design to develop and evaluate the decision aid in three phases: (1) development of a draft prototype for the decision aid based on extensive literature reviews, interviews with key stakeholders and evidence synthesis; (2) alpha testing (‘near live’ usability) the decision aid during simulated clinical encounters to test its comprehensibility, acceptability and usability and (3) beta testing (‘live’ usability) to examine the aid’s clinical feasibility. User testing will be conducted using mixed-methods approach to support iterative revision of the decision aid. The IPDASi (V.4.0) will be used for following qualitative assessment. All interviews will be analysed by Colaizzi’s seven-step approach to qualitative analysis. The coding scheme will use to analyse user interactions. Questionnaire surveys will be analysed using paired sample t-tests when related to the before-and-after survey, otherwise using one-sample t-test. ETHICS AND DISSEMINATION: Ethical approval for this research was obtained from the Ethics Committee of the First Affiliated Hospital of Army Medical University, PLA (Ref: KY2020104). All participants will sign a formal informed consent form. The findings will be published in peer-reviewed journals and reported in appropriate meetings. TRIAL REGISTRATION NUMBER: ChiCTR2000031613.