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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Development and feasibility testing of decision support for patients who are candidates for a prophylactic
Sandra L Carroll1, Michael McGillion, Dawn Stacey
1School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada. carroll@mcmaster.ca.
Insights
This study developed and evaluated a decision aid for patients considering an implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death. The pilot trial demonstrated feasibility, informing future large-scale studies on improving patient decision-making.
Area of Science:
- Cardiovascular Medicine
- Health Decision Science
- Medical Device Technology
Background:
- Patients at risk for sudden cardiac death may receive an implantable cardioverter defibrillator (ICD) for primary prevention.
- A lack of structured decision support exists in Canada for patients considering ICDs.
- Decision aids can reduce uncertainty and improve informed decision-making for medical treatments.
Purpose of the Study:
- To develop a patient decision aid for first-time ICD recipients.
- To evaluate the acceptability and feasibility of the developed decision aid.
- To inform the design of a larger multicenter trial on ICD decision support.
Main Methods:
- A development panel including experts and patient representatives informed aid content.
- Evidence synthesis and a modified Delphi process generated data for the aid.
- A pilot randomized controlled trial (RCT) assessed feasibility, decision quality, and quality of life.
Main Results:
- The study successfully developed a decision aid for primary prevention ICD candidates.
- A pilot RCT involving 80 participants evaluated the aid's feasibility and impact on decision quality.
- Results will guide sample size and methodology for a future large-scale trial.
Conclusions:
- The developed decision aid aims to support patients considering their first ICD.
- Decision support prior to specialist consultation can enhance patient-physician-family decision-making for ICDs.
- This pilot trial provides a foundation for a larger study to optimize shared decision-making for life-prolonging devices.
Background:
Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients' decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial.
Methods/Design:
A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making.
Discussion:
Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD.
Trial Registration:
ClinicalTrials.gov: NCT01876173.
