Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator

McMaster University

Status: Completed

Conditions: Sudden Cardiac Death; Cardiovascular Disease

Treatments: Behavioral: Patient Decision Aid for an ICD (primary prevention, non-CRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01876173

119449 Grant number (Other Grant/Funding Number)

12-214

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Referred for consideration of an ICD(non-CRT)for a primary prevention indication
• English speaking
• able to provide informed consent

Exclusion criteria

• unable to understand the decision aid due to a language barrier or visual impairment
• referred for secondary prevention indication

Trial design

82 participants in 2 patient groups

Patient Decision Aid for an ICD (primary prevention, non-CRT)

Experimental group

Description:

The intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician. Values are assessed to reveal which features of each option are important to patients.

Treatment:

Behavioral: Patient Decision Aid for an ICD (primary prevention, non-CRT)

Usual care

No Intervention group

Description:

The control group will not receive the patient decision aid prior to consultation with the physician.