Development and Evaluation of Decision Aid for Family Surrogate Decision Makers of Patients with Acute Kidney Injury Requiring Renal Replacement Therapy (RRT) in ICU: A Study Protocol

Abstract

Background Shared decision-making is endorsed by guidelines in both acute kidney injury and critical care medicine. However, there is still a huge need for effective interventions, especially focusing on decisions in renal replacement therapy for ICU patients with acute kidney injury. Decision aid is an evidence-based support to achieve shared decision-making for better decision quality, which not only enhances knowledge of treatment options but also matches patients’ preferences and values.Objectives To develop and evaluate a decision aid for family surrogate decision makers of ICU patients with acute kidney injury who are requiring renal replacement therapy, following a systematic and rigorous process.Methods We will follow the systematic development process combined with user-centered design, to develop and evaluate the decision aid in three phases: (1) development of a decision aid based on extensive literature reviews, key stakeholders’ interviews, evidence synthesis and drafting prototype; (2) alpha-testing (“near-live” usability) during simulated clinical encounters to test the comprehensibility, acceptability and usability; (3) beta-testing (“live” usability) to examine the feasibility in the clinical context. User-testing will be conducted for the iterative revision of the decision aid. The IPDASi (v4.0) will be used for the qualitative assessment.Discussion This study may help family surrogate decision makers make renal replacement treatment decisions that match with their loved one’s preferences and values in ICU context, while helping user-centered design integrate into this complex medical decision making.Trial registration number Chinese Clinical Trial registry (ChiCTR2000031613).