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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by McMaster University
Sponsor:
Information provided by (Responsible Party):
Sandra Carroll, McMaster University
ClinicalTrials.gov Identifier:
NCT01876173
First received: May 30, 2013
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Sudden Cardiac Death
Behavioral: Patient Decision Aid for an ICD (primary prevention, non-CRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Health Services Research
Official Title: Development of and Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation. [ Time Frame: Phase 1-2 (1- year) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Decision quality measures [ Time Frame: Pre consultation (baseline visit) ] [ Designated as safety issue: No ]
    Decision quality, the extent to which patients' decisions are informed (knowledge) and values based (values, preferences, decisional conflict).

  • Decisional Conflict Scale (DCS) [ Time Frame: Pre and post consultation- (intervention and usual care group, baseline visit + 1 week post consult) ] [ Designated as safety issue: No ]
    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.

  • Sure Test [ Time Frame: Pre-consultation - baseline visit ] [ Designated as safety issue: No ]
    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).

  • The Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Pre consultation - baseline visit (intervention and usual care) ] [ Designated as safety issue: No ]
    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.

  • Preparation for Decision Making scale [ Time Frame: Post consultation - up to two weeks post baseline visit (intervention group) ] [ Designated as safety issue: No ]
    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.

  • The Medical Outcomes Trust Short Form (SF-36v2) [ Time Frame: Pre consultation - baseline visit (intervention and usual care) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Vital status [ Time Frame: 3 months post baseline visit ] [ Designated as safety issue: No ]
    Alive, deceased

  • Implant status [ Time Frame: Phase 3, three months post baseline visit ] [ Designated as safety issue: No ]
    Device status - implantable defibrillator/no implantable defibrillator, deferred


Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: PtDA
No Intervention: Usual care
The control group will not receive the patient decision aid prior to consultation with the physician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876173

Locations
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8P 2X2
Contact: Sandra L. Carroll, PhD    905 525-9140 ext 21752    carroll@mcmaster.ca   
Principal Investigator: Sandra L Carroll, PhD         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Sandra L Carroll, PhD McMaster University
  More Information

Additional Information:
No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sandra Carroll, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01876173     History of Changes
Other Study ID Numbers: 12-214, 119449 Grant number
Study First Received: May 30, 2013
Last Updated: June 24, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Sudden cardiac death
implantable cardioverter defibrillator
decision aid

Additional relevant MeSH terms:
Cardiovascular Diseases
Death
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Death, Sudden

ClinicalTrials.gov processed this record on July 28, 2014