Clinical trial NCT05116176: TRAjectories and CLinical ExpeRiences of ICD Therapy Study
Official title: TRAjectories and CLinical ExpeRiences of ICD Therapy Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Implantable Defibrillator User
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Hebrew SeniorLife
name: University of Colorado, Denver
name: Emory University
name: Mayo Clinic
name: Saint Luke's Health System
First posted: 2021-11-10
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 (N.B.: 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)

Brief summary: 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).

Detailed description: 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 history; and f. ICD-recorded physical activity (minutes/day).

Factors associated with death and poor quality of life will be identified. Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.

H1: A model integrating frailty and clinical factors will predict (a) death, (b) poor quality of life, and (c) unfavorable functional trajectories after ICD implantation.

Aim 2: To validate a personalized prediction model of treatment outcomes of ICDs. We will apply our established semi-competing risks approach5 to the prospective cohort, enriched by the baseline geriatric assessments, to predict individual patients' probabilities of the following outcome profiles at 6, 12, and 18 months post-implant: a. death without prior shock, b. death with prior shock, c. survival without prior shock, and d. survival with prior shock. The independent contribution of frailty, cognitive dysfunction, baseline quality of life, and functional status (e.g. total deficits in ADL and IADL) to model performance will be evaluated.

H2: Addition of frailty, cognitive dysfunction, quality of life, and functional status to a model with cardiovascular variables will significantly improve model performance as assessed by area under the curve (AUC).

Aim 3: To identify optimal strategies for incorporating personalized outcome profiles into SDM. The main cohort's baseline interview and EHR review will provide quantitative data on past SDM tools used by physicians. We will develop a prototype individualized version of the Colorado SDM tool that incorporates 18-month outcome profiles using our semi-competing risk model. We will perform semi-structured interviews of cardiologists (N=20) as well as patients (N=20) recruited from the main cohort regarding process mapping of SDM from clinic to implant procedure, including timing, content, format preferences, and impressions of the prototype individualized tool.

Eligibility criteria: 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 baseline will be excluded from study participation:

1. Receipt of cardiac resynchronization therapy device
2. Participation in another investigational drug or intervention trial expected to influence any of the outcomes of interest in this study
3. Current drug or alcohol use or dependence that, in the opinion of the Site Principle Investigator, would interfere with adherence to study requirements.

Primary outcomes:
measure: Clinical Trajectories after ICD implantation
timeFrame: Patients will be followed quarterly for 18 months or to death.
measure: Outcomes after ICD Implantation
timeFrame: Up to 18 months
measure: Semi-competing risks model of deaths and/or ICD shocks
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Daniel B Kramer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: