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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876173
• Other study ID #: 12-214
• Secondary ID: 119449 Grant num
• Status: Completed
• Phase: N/A
• First received: May 30, 2013
• Last updated: March 16, 2016
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Intervention

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

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital status	Alive, deceased	3 months post baseline visit	No
Other	Implant status	Device status - implantable defibrillator/no implantable defibrillator, deferred	Phase 3, three months post baseline visit	No
Primary	Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation.	Development of the decision aid will be guided by the Ottawa Decision Support Framework (ODSF). Evaluation will include the Decision Aid Acceptability questionnaire comprised of 10 items including comprehensibility, balance of presentation of information, and overall suitability.	Phase 1-2 (1- year)	No
Secondary	Pilot RCT (feasibility)	In this feasibility RCT, the feasibility regarding processes (referral and recruitment rates, consent), key to the success of a larger study will be assessed. This includes successful delivery of the decision aid in an efficient manner, the monitoring of resources (budget), and study management (trial coordination, human resources). We will assess the proportion of patients who complete the decision aid, quality questionnaires, and missing data.	Pre-Post consultation - participants will be followed until consultation is completed and at 3 months post consultation (average of 16 weeks)	No
Secondary	Decision quality measures	Decision quality, the extent to which patients' decisions are informed (knowledge) and values based (values, preferences, decisional conflict).	Pre consultation (baseline visit)	No
Secondary	Decisional Conflict Scale (DCS)	The Decisional Conflict Scale measures a person's perception of the difficulty in making a decision, the extent to which they feel uncertain about treatment options, are knowledgeable about the risks and benefits of options, clear about personal values, and supported in decision making. The scale has good test-retest reliability (Cronbach's alpha coefficients > 0.78) and predictive validity.	Pre and post consultation- (intervention and usual care group, baseline visit + 1 week post consult)	No
Secondary	Sure Test	The Sure Test is a 4 item decisional conflict screening tool designed for use in clinical practice. The Sure Test is embedded in the decision aid (intervention group).	Pre-consultation - baseline visit	No
Secondary	The Center for Epidemiologic Studies Depression Scale (CES-D)	The CES-D has 20 items that measure depressive symptoms. The CES-D has good reliability and validity across community and clinical settings. Associations between depressive symptoms and decision choice will be assessed.	Pre consultation - baseline visit (intervention and usual care)	No
Secondary	Preparation for Decision Making scale	The Preparation for Decision Making Scale has 10 categorical items assessing the usefulness of the decision aid in preparing patients to communicate with a health professional.	Post consultation - up to two weeks post baseline visit (intervention group)	No
Secondary	The Medical Outcomes Trust Short Form (SF-36v2)	The SF-36 is a reliable and valid generic health related quality of life scale (HRQL) comprised of 36 items. Associations between HRQL and decision choice will be undertaken.	Pre consultation - baseline visit (intervention and usual care)	No

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