Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Development of and Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
Brief Summary: Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers high-risk patients a treatment option to reduce the incidence of SCD by delivering an internal shock to restore a normal rhythm, if needed. Definitive evidence has established the effectiveness of the ICD for reducing mortality when used as prophylaxis for SCD (a primary prevention indication). Approximately 3,700 new candidates accrue annually. Practice guidelines define the criteria to determine patient ICD candidacy for primary prevention. However, in addition to SCD risk, ICD candidates may have chronic diseases such as diabetes, renal insufficiency, hypertension, and atrial fibrillation. Thus, balancing the benefits and risks of an ICD can become complex, particularly when competing mortality risks are present. Research has recognized human costs associated with device complications and shocks affecting psychological, health related quality of life (HRQL), and morbidity outcomes. The complexities surrounding the long-term benefits/risks, complications, replacements, and shocks, warrant decision support to prepare patients to make decisions. In Canada, there is no clear framework to support patients' decision-making in the context of ICD treatment options. Decision support, using a decision aid, could moderate treatment related uncertainty and prepare patients to make active, informed, quality decisions.

Objectives: 1) develop a decision aid for ICD candidates to support quality decision-making (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to determine the feasibility of conducting a trial.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Bowel cancer screening decision aid | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Other: Bowel cancer screening decision aid | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Other: Australian Government Bowel Cancer Screening booklet | Intervention Type: OTHER; Name: Bowel cancer screening decision aid; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Bowel cancer screening decision aid; Assigned to Arm(s): 2 | Intervention Type: OTHER; Name: Australian Government Bowel Cancer Screening booklet; Assigned to Arm(s): 3
B: Arm Label: shared decision making; Type: EXPERIMENTAL; Interventions: Behavioral: Shared decision making | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Shared decision making; Assigned to Arm(s): shared decision making
C: Arm Label: Patient Decision Aid for an ICD (primary prevention, non-CRT); Type: EXPERIMENTAL; Interventions: Behavioral: Patient Decision Aid for an ICD (primary prevention, non-CRT) | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Patient Decision Aid for an ICD (primary prevention, non-CRT); Assigned to Arm(s): Patient Decision Aid for an ICD (primary prevention, non-CRT)
D: Intervention Type: BEHAVIORAL; Name: Academic Detailing (Medical Practices)+Decision Aids (Patients); Assigned to Arm(s): N/A

Answer: C