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Completed

NCT Number: NCT01876173

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8P 2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Other names: PtDA

Primary outcomes

  1. Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation.

    Time frame: Phase 1-2 (1- year)

    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.

Secondary outcomes

  1. Pilot RCT (feasibility)

    Time frame: Pre-Post consultation - participants will be followed until consultation is completed and at 3 months post consultation (average of 16 weeks)

    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.

  2. Decision quality measures

    Time frame: Pre consultation (baseline visit)

    Decision quality, the extent to which patients' decisions are informed (knowledge) and values based (values, preferences, decisional conflict).

  3. Decisional Conflict Scale (DCS)

    Time frame: Pre and post consultation- (intervention and usual care group, baseline visit + 1 week post consult)

    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.

  4. Sure Test

    Time frame: Pre-consultation - baseline visit

    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).

  5. The Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: Pre consultation - baseline visit (intervention and usual care)

    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.

  6. Preparation for Decision Making scale

    Time frame: Post consultation - up to two weeks post baseline visit (intervention group)

    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.

  7. The Medical Outcomes Trust Short Form (SF-36v2)

    Time frame: Pre consultation - baseline visit (intervention and usual care)

    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.

Other outcomes

  1. Vital status

    Time frame: 3 months post baseline visit

    Alive, deceased

  2. Implant status

    Time frame: Phase 3, three months post baseline visit

    Device status - implantable defibrillator/no implantable defibrillator, deferred

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2013
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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