Developing a Digital Aid to Improve ICD Decisions

Official title

Developing "A Digital Shared Decision-Making Aid to Improve Patient-Centered Outcomes in Implantable Cardioverter-Defibrillator (ICD) Decisions Among Older Patients"

Overview

Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. The study design is best described as a mixed methods evaluation and refinement of a digital app to improve ICD decision-making. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.

Detailed description

Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.

Participants with heart failure who agree to participate will be recorded in a REDCap system database. The investigators will document in a recruitment tracking log all potentially eligible participants found to be ineligible or who decline participation. The reason for ineligibility or reason for decline will be captured along with age, gender, and race/ethnicity. At the time of their enrollment, the investigators will collect additional information from each participant about their employment status (full-time or part-time employment, no employment, retired), education (no postsecondary education, some postsecondary education), household size (living alone, living with at least one other person).

Participants with heart failure will be asked if they are willing to be interviewed, participate in focus groups, or complete surveys to determine their views on 1) which elements of patient outcome questionnaires are important to them; 2) which decision aid components or educational tools they like or find valuable. Interactions with participants will include open-ended interviews, focus groups, and surveys. These interviews, focus groups, and surveys will be conducted by study staff to help develop a patient-centric shared decision making software tool. Development will occur iteratively with new testing after any modifications. The same individuals may be asked to re-test the app following alterations.

Collaborating teams from UC San Francisco (Site PI: Daniel Morin, MD, MPH) and East Carolina University (Site PI: Samuel Sears, PhD) will join the study before the third month of operation. The participation of these clinical sites is not needed in the first steps on digital tool development. By successfully initiating the project at Stanford, the process of initiation at the clinical sites will be facilitated and is consistent with the mandated use of a single IRB for the three sites.

Interventions

• Other Online, patient-facing decision-making aid (app) with personalized risk information.
  The online, patient-facing decision-making aid will have the following features: 1. Clinical Data Input, 2. Introduction via Animated Video, 3. Common Questions, 4. Check-In Quiz, 5. Risk and Values Exploration based on patient specific information, 6. Wrap-Up, 7. Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to
• Device Implantable Cardioverter Defibrillator (ICD)
  Some participants, in their course of medical care unrelated to the study intervention, will undergo implantation of an ICD.
• Other Online, patient-facing decision-making app without personalized risk information.
  The online, patient-facing decision-making aid will have the following features: 1) Clinical Data Input, 2) Introduction via Animated Video, 3) Common Questions, 4) Check-In Quiz, 5) Generic Risk and Values Exploration without patient specific information, 6) Wrap-Up, 7) Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strateg

Primary outcome measures

• Decisional Conflict Scale (DCS) [Time frame: Immediately after decision-making visit as well as at 3 months.]

Eligibility criteria

Developmental Testing will attempt to abide by eligibility criteria identical to the planned criteria for the subsequent RCT, but may strategically deviate from these criteria to enhance the testing and development process.

Inclusion criteria

• Meets or approximates minimal criteria for primary prevention ICD placement. ● Left Ventricular Ejection Fraction (LVEF) <35%.
• Clinical diagnosis of Heart Failure:
• Patients with severe ischemic dilated cardiomyopathy and underlying NYHA
• Class II or III Heart Failure, OR, Patients with severe nonischemic dilated cardiomyopathy and underlying NYHA Class II or III Heart Failure.
• Age ≥ 70 years old.
• Able to consent in English, Mandarin or Spanish and follow study instructions.

Exclusion criteria

The exclusion criteria include any of the following:

• Past ICD implantation (not including pacemakers).
• Any indication for secondary prevention of SCD via ICD implantation.
• History of mechanical valve replacement.
• History of recent myocardial infarction within the last 40 days.
• History of recent revascularization within the past 90 days.
• History of familial or genetic disorders with a high-risk of ventricular arrhythmias, such as the long QT syndrome (LQTS) or hypertrophic cardiomyopathy (HCM).
• Any factors contraindicating ICD placement.
• Less than 6 months life expectancy and other clinical consideration,
• Unwilling or unable to consider ICD,
• Any contraindications to ambulati

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• University of California, San Francisco — San Francisco
• Eastern Carolina University — Greenville

Identifiers

NCT: NCT07084142 · IRB-79108 · R01HL173578

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗