NCT02668900.

Trial name or title	Decision support for adults facing implantable cardioverter‐defibrillator pulse generator replacement
Methods	RCT
Participants	Inclusion criteria ICD (implantable cardioverter‐defibrillator) battery nearing depletion or at elective replacement indicator Able to speak and read in English Able to provide informed consent; or if incapable of providing informed consent, can be obtained by the patient's appointed substitute decision‐maker or power of attorney for personal care. Exclusion criteria Participants and/or substitute decision maker unable to understand the patient decision aid or decision coaching session due to language barrier or visual impairment Participants with cardiac resynchronization therapy (CRT) or participants eligible for an upgrade to CRT. Participants with conduction system disease who are pacemaker dependent
Interventions	Experimental: decision support Quote: "The decision support intervention includes a patient decision and a decision coaching session. The patient decision aid includes a summary about the ICD's function, and the risks and benefits (including probabilities) associated with the option of replacing or not replacing the ICD. The decision coaching session will be led by a trained, non‐directive decision coach who will provide support that aims to develop patients' skills in thinking about the options, assess their values associated with each option, and prepare them to discuss the decision in a consultation with their physician. The final decision, whether to replace or not replace the ICD, will be made with their treating physician (e.g., cardiologist, electrophysiologist)." No intervention: usual care Quote: "The control group will not receive the decision support intervention prior to consultation with the physician."
Outcomes	Primary outcomes Participant referral/recruitment rate Completion of decision support intervention Key processes to the success Secondary outcomes Knowledge Decisional conflict Values about ICD replacement Preferred option Perceptions of involvement in decision‐making The Medical Outcomes Trust Short Form (SF‐36v2) Acceptability and Usability of Decision Support Other outcomes Actual choice Survival
Starting date	April 2016
Contact information	Krystina B Lewis, RN, MN, kblewis@ottawaheart.ca and David Birnie, MD, 613 696 7269, dbirnie@ottawaheart.ca
Notes