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

Abstract

IntroductionShared 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 analysisWe 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 disseminationEthical 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 numberChiCTR2000031613.

Decision Aids in the ICU: a scoping review

“…Ten studies25–32 were conducted in the USA, followed by Canada33–35 (n=3), and only one study36 was conducted in China. Of the 14 included studies, there were 5 RCTs,27 29 30 32 34 4 mixed-method studies,28 35–37 2 observational studies,26 38 1 qualitative study33 and 2 quasi-experimental studies 25 31. Only one study33 did not evaluate the effect of DA application.…”

“…The earliest study was published in 2012, and the greatest number of studies were published in 2021, with three studies 29 36 38. Six studies28–30 36–38 were published in the last 3 years. Trends are illustrated in figure 2.…”

“…These DAs have primarily focused on end-of-life care and life-sustaining treatments. Six studies focused on goals of care,28–30 34 37 38 three studies developed DAs for CPR,31–33 three studies for prolonged mechanical ventilation,25–27 one study for neonatal parents35 and another study for renal replacement therapy 36…”

“…Six studies focused on goals of care, 28-30 34 37 38 three studies developed DAs for CPR, [31][32][33] three studies for prolonged mechanical ventilation, [25][26][27] one study for neonatal parents 35 and another study for renal replacement therapy. 36 Presentation of DAs in the ICU These tools are primarily based on the Ottawa Decision Support Framework (ODSF) and are available in paperbased or web-based presentations. Three DAs 29 31 32 presented a family-centred video that described the ICU setting and the process of CPR or defibrillation.…”