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TRAjectories and CLinical ExpeRiences of ICD Therapy Study (TRACER-ICD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05116176
Recruitment Status : Not yet recruiting
First Posted : November 10, 2021
Last Update Posted : November 10, 2021
Sponsor:
Collaborators:
University of Pennsylvania
Hebrew SeniorLife
University of Colorado, Denver
Emory University
Mayo Clinic
Saint Luke's Health System
Information provided by (Responsible Party):
Dan B. Kramer, Beth Israel Deaconess Medical Center

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).

Condition or disease Intervention/treatment
Implantable Defibrillator User Device: Implantable cardioverter-defibrillators

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TRAjectories and CLinical ExpeRiences of ICD Therapy Study
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Implantable cardioverter-defibrillators
    500 patients age >65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs).


Primary Outcome Measures :
  1. Clinical Trajectories after ICD implantation [ Time Frame: Patients will be followed quarterly for 18 months or to death. ]
    Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.

  2. Outcomes after ICD Implantation [ Time Frame: Up to 18 months ]
    Death/Poor Quality of Life (combined endpoint)

  3. Semi-competing risks model of deaths and/or ICD shocks [ Time Frame: Up to 18 months ]
    Personalized outcome profiles for death +/- ICD shocks



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05116176


Contacts
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Contact: Daniel B. Kramer, MD, MPH 617-667-8800 dkramer@bidmc.harvard.edu
Contact: Lindsay H. Duchesneau, MPA 617-632-7731 lduchesn@bidmc.harvard.edu

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
University of Pennsylvania
Hebrew SeniorLife
University of Colorado, Denver
Emory University
Mayo Clinic
Saint Luke's Health System
Investigators
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Principal Investigator: Daniel B Kramer, MD, MPH Beth Israel Deaconess Medical Center
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Responsible Party: Dan B. Kramer, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05116176    
Other Study ID Numbers: 2021P000054
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No