Beth Israel Deaconess Medical Center
This is a prospective cohort study of older patients receiving implantable cardioverter-defibrillators. The purpose of the TRACER-ICD study is to conduct a prospective cohort investigation with the goal of 500 patients age \>65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs). Patients will be followed quarterly for 18 months with interviews, electronic record review, and remote monitoring to characterize clinical and functional trajectories following device implantation, with permission for extended electronic follow-up for up to 10 years (Aim 1). This cohort will support validation and refinement of an established model for predicting personalized outcome profiles for ICD therapies and death (Aim 2). Lastly, we will combine electronic record review with semi-structured interviews with patients and physicians to evaluate physician and patient experiences with a prototype individualized shared decision-making (SDM) tool (Aim 3).
Study Objectives and Design The specific aims, applicable methods, and main hypotheses of the TRACER-ICD study are as follows: Aim 1: To characterize the clinical course of patients aged \>65 after ICD implantation by establishing a multicenter prospective cohort (N=500). Baseline (verbal and in-person) and quarterly (phone, electronic health records \[EHR\], remote monitoring) data collected up to 18 months or death will include: a. geriatric assessments (e.g. frailty, cognition,1 functional status; b. comorbidities; c. quality of life and symptom burden; d. health services use; e. SDM hist…
Patients scheduled for ICD implantation will be identified at participating sites by site staff. Eligibility criteria will include the following, all of which must be met by all participants for participation: 1. Patient receiving new primary prevention ICD (single, dual chamber, or subcutaneous system) 2. Age \>65 years 3. English-speaking (assessment instruments are only available/validated in English) 4. Sufficient cognitive ability to provide consent (i.e. answer simple questions on study participation, purpose and procedures) Candidates meeting the following exclusion criteria at baseli…
500 patients age \>65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs).
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