Development And Application Of A Decision Aid For Implantable Cardioverter Defibrillator Candidates

Background:Sudden cardiac death is a major health problem that threatens human life.Implantable cardioverter defibrillator(ICD)is small batery-powered devices implanted in a person’s chest or abdomen programmed to detect life-threatening cardiac arrhythmias that can lead to sudden cardiac arrest.Numerous reports have shown that ICD reduces sudden cardiac death.Choosing to receive an ICD is considered an elective procedure,and thus,the option to accept or decline must be weighed alongside known benefits and risks.Shared decision-making encourages patients to be active participants when making ICD treatment decisions.Patient decision aids(PtDA)have been developed to facilitate quality decision-making,ensuring congruency between patient values and preferences and the health care interventions.The application of PtDA is rapidly increasing,as an useful support way.But the study of ICD PtDA are barely found in China.Objectives:To constructe ICD decision aids and determine the efficacy of ICD decision aid in implantable cardioverter defibrillator patients decision-making.Methods:Development of the PtDA is guided by the The Ottawa Decision Support Framework(ODSF)and International Patient Decision Aid Standards(IPDAS)quality criteria.The research includes three steps:developing of the draft decision aid synthesizing existing ICD clinical practice guidelines and clinical trials,assessing and revising the decision aid contents using a Delphi process,preliminary acceptability testing in patient-family member dyad who are experienced with the decision(have an ICD).54 consented patients were recruited in the study and were randomized to usual care(n=27)or PtDA intervention(n=27)from June 2018 to January 2019.Feasibility outcomes included decision conflict,knowdge and patient acceptance Survey.Outcomes were measured at the time of treatment decision and/or at 3 months follow-up.Results:The final PtDA content includes seven aspects of decision-making stage:decision needs assessment,information providing,pros and cons analysis,value clarification,support system,decision-making orientation,and decision confirmation.41 items ensure the PtDA is acceptable,simple to complete,and clear.Patients receiving the PtDA intervention had lower decisional conflict scores after exposure to the PtDA prespecialist consult,with a total mean score(SD)of 18.98±8.19 compared to usual care 23.59±7.63(t=2.13,P<0.05).And The PtDA intervention group participants were more knowledgeable after exposure to the PtDA pre-specialist consultation.The mean score of the intervention and usual care groups was 17(16,17)and 12(12,14)(P<0.05)respectively.Conclusion:ICD Patients’ Decision Aid provides a strategy on integrating the best available research evidence and patients preferences and values for promoting the development of shared decision-making.The results show that ICD patients’ decision aids has a positive impact on decision conflict and patient’s knowedge.However,it did not significantly impact patient acceptance.