Clinical trial NCT01876173: Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
Official title: Development of and Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Sudden Cardiac Death
Keywords: Sudden cardiac death
implantable cardioverter defibrillator
decision aid
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation.
timeFrame: Phase 1-2 (1- year)
Secondary outcomes:
measure: Pilot RCT (feasibility)
timeFrame: Pre-Post consultation - participants will be followed until consultation is completed and at 3 months post consultation (average of 16 weeks)
measure: Decision quality measures
timeFrame: Pre consultation (baseline visit)
measure: Decisional Conflict Scale (DCS)
timeFrame: Pre and post consultation- (intervention and usual care group, baseline visit + 1 week post consult)
measure: Sure Test
timeFrame: Pre-consultation - baseline visit
measure: The Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Pre consultation - baseline visit (intervention and usual care)
measure: Preparation for Decision Making scale
timeFrame: Post consultation - up to two weeks post baseline visit (intervention group)
measure: The Medical Outcomes Trust Short Form (SF-36v2)
timeFrame: Pre consultation - baseline visit (intervention and usual care)
Other outcomes:
measure: Vital status
timeFrame: 3 months post baseline visit
measure: Implant status
timeFrame: Phase 3, three months post baseline visit
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Sandra L Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carroll SL, Stacey D, McGillion M, Healey JS, Foster G, Hutchings S, Arthur HM, Browne G, Thabane L. Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial. Pilot Feasibility Stud. 2017 Nov 21;3:49. doi: 10.1186/s40814-017-0189-9. eCollection 2017.
citation: Carroll SL, McGillion M, Stacey D, Healey JS, Browne G, Arthur HM, Thabane L. Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial. Trials. 2013 Oct 22;14:346. doi: 10.1186/1745-6215-14-346.