Patients’ decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death

Carroll, Sandra; Strachan, Patricia H.; Laat, Sonya de; Schwartz, Lisa; Arthur, Heather M.

doi:10.1111/j.1369-7625.2011.00703.x

Cited by 42 publications

(82 citation statements)

References 21 publications

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“…Previously, in the Canadian ICD population, a need for decision support was revealed [30], thus the goal of this work is to develop this support. ICDs are life-prolonging medical devices and are an important cardiovascular treatment option for patients who are at risk for sudden cardiac death.…”

Section: Discussionmentioning

confidence: 99%

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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

Carroll

McGillion

Stacey

et al. 2013

Trials

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BackgroundPatients, 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/designA 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.DiscussionOur 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 registrationClinicalTrials.gov: NCT01876173

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Section: Discussionmentioning

confidence: 99%

“…Values item selections will be developed by the core panel based on ICD evidence [30,67], the Delphi, and clinical expertise. We will also measure all patients pre-consultation preferences (get a device, don’t get a device).…”

Section: Methodsmentioning

confidence: 99%

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

Carroll

McGillion

Stacey

et al. 2013

Trials

View full text Add to dashboard Cite

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“…20 However, there were areas in which readability, content, and intended messages could be improved. 20 However, there were areas in which readability, content, and intended messages could be improved.…”

Section: Discussionmentioning

confidence: 99%

“…20 Ethics approval for the study was obtained from all 3 study sites. 20 Ethics approval for the study was obtained from all 3 study sites.…”

Section: Methodsmentioning

confidence: 99%

Readability and Content of Patient Education Material Related to Implantable Cardioverter Defibrillators

Strachan

Laat

Carroll

et al. 2012

Journal of Cardiovascular Nursing

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Print-based patient education materials for ICD candidates are geared to a highly literate population. The focus on positive information to the exclusion of potentially negative aspects of the ICD, or alternatives to accepting 1, could influence and/or confuse patients about the purpose and implications of this medical device. Development of print materials is indicated that includes information about possible problems and that would be relevant for the multicultural and debilitated population who may require ICDs. The findings are highly relevant for nurses who care for primary prevention ICD candidates.

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“…Obtaining consent from a person for treatment requires provision to that person of sufficient, intelligible information to allow them to make an informed choice 31. The information provided to support the process of informed consent should include explanation

of the balance of benefits and harms or burdens of device implantation at the time;

of how the balance of benefits and risks may change in the future;

that a time may come when it is best that the treatment (specifically ICD shocks) stops;

of what ICD deactivation involves, should it be considered in the future.

…”

Section: Legal and Ethical Considerations Regarding Device Deactivmentioning

confidence: 99%

Cardiovascular implanted electronic devices in people towards the end of life, during cardiopulmonary resuscitation and after death: guidance from the Resuscitation Council (UK), British Cardiovascular Society and National Council for Palliative Care

Pitcher

Soar

Hogg

et al. 2016

Heart

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Patients’ decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death

Abstract: Background Patients are offered implantable defibrillators (ICDs) for the prevention of sudden cardiac death (SCD). However, patientsÕ decision-making process (DMP) of whether or not to accept an ICD has not been explored. We asked patients about their decision making when offered an ICD.

Cited by 42 publications

References 21 publications

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

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

Readability and Content of Patient Education Material Related to Implantable Cardioverter Defibrillators

Cardiovascular implanted electronic devices in people towards the end of life, during cardiopulmonary resuscitation and after death: guidance from the Resuscitation Council (UK), British Cardiovascular Society and National Council for Palliative Care

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