← Back to all trials
Completed
NCT02668900
Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement
Conditions: Death, Sudden, Cardiac, Death, Sudden, Cardiovascular Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Ottawa Heart Institute Research Corporation
Location: University of Ottawa Heart Institute Ottawa Ontario
Summary
The implantable-cardioverter defibrillator (ICD) is a small medical device used to treat dangerously fast and potentially life-threatening heart rates. For patients at risk, the ICD can detect an abnormal rhythm and provide life-saving therapy by delivering a shock. ICD therapy has risks and benefits that should be weighed from each patient's perspective. An ICD battery needs to be surgically replaced 4 to 7 years to ensure ongoing function. At present, the majority of these batteries are automatically changed without eliciting patients' preferences. There is a need for a better way to engage with patients. Patients want to be involved in their healthcare decisions, yet more than half of patients with an ICD do not know that ICD replacement is optional. To ensure that patients are receiving treatment that they value and want, members of the interprofessional team should ensure that treatment decisions align with patients' expectations, values and preferences. This rests on the principle of shared decision making in which members of the healthcare team and patients deliberate together to arrive at a decision which best reflects the preferences and values of the patient. To facilitate the achievement of this goal, a patient decision aid (PDA) can be used. As a result, the investigators developed PDA for ICD replacement. The purpose of this feasibility trial is to collect preliminary data to test the feasibility of conducting a larger trial, and to evaluate the PDA for its acceptability and ease of use. Eligible and consented participants facing ICD replacement will be randomized to receive the decision aid or to usual care. The investigators will assess if this decision aid can improve participants' knowledge on ICD therapy and the replacement surgery, increase patients' perceived involvement in the decision, and determine whether their actual choice reflects their personal values.
Eligibility Criteria
Inclusion Criteria:
* ICD 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
Source: ClinicalTrials.gov (NCT02668900). StuddyBuddy aggregates publicly available trial information.