Patient decision-making has not been addressed in relation to uptake of ICDs in primary prevention. To our knowledge, this work provides the first evidence addressing how patients came to decide about a defibrillator. These data contribute new knowledge on an important topic associated with an intervention known to prolong life in an increasing number of patients with cardiovascular disease. Making a decision to accept an ICD differs from a decision to initiate preventative medical treatments due to the invasive nature of the intervention and the method in which therapy is delivered (either anti-tachycardia pacing or an internal shock). However, ICD therapy does share similarities to decisions to commence chemotherapy where prolonging survival is the primary goal of treatment (18
). One could argue that the life prolonging aspect of ICD therapy acts as a powerful influence towards acceptance of the device. However, patients may make sense of their personal risk depending on the manner in which the information is presented during medical consultations (19
). Communication that includes statements about prolongation of life and statistical probabilities favouring survival are powerful, and as we discovered, influential when presented in isolation (without a balance of what to expect without the ICD). However, those seeking symptom relief from heart failure, acquiring information that delineates what a single or dual chamber ICD can and cannot deliver (i.e. symptom relief in the absence of cardiac resynchronization) could inform the decision making process regardless of active or passive approach.
A sense of uncertainty was created in patients after learning about their risk for SCD and ICD candidacy. Given the gravity of this information, it is possible that patients will only hear and remember the information that links ICDs to survival. As such, the initial consultation with the EP specialist represents a seminal event where patient decisions to accept or decline are made. EP specialists are able to offer a cardiovascular intervention to reduce the probability of SCD. In this study, few participants took extended time to re-consider or weigh the pros and cons. An overriding sense of urgency ensued after sudden death risk was introduced. Agard et al. (2007) reported similar findings in secondary prevention ICD patients. The authors reported that the ICD was an offer that could not be refused by patients after they had survived a cardiac arrest. In our study population, the threat of such an event proved to be a similarly powerful influence.
ICD ‘candidate’ is a label patients assume when practice guidelines are applied in the culture of evidence-based medicine. The language of candidacy is born out of “candidacy for inclusion in a clinical trial” (12
). In earlier clinical studies, patients became ICD candidates based on eligibility criteria. In our study, for many participants, a health related trigger event brought ICD candidacy and SCD risk to the forefront. The three influential decision-making factors (1) trust, (2) social influences, and (3) participant health states, which emerged from participant interviews, illuminate the components of patient’s lives that are valued and persuasive. These factors bring to light what our participants considered when choosing this intervention.
Participants adopted different approaches to reach decisions; their deliberations fell along a continuum from active to passive. These approaches were similar to those reported by Flynn et al. (2006) who termed patients’ participation levels in health-related decision making as deliberative or non-deliberative (20
). Equivalent to their findings, our patients, for the most part, had the desire to acquire and exchange treatment related information with physicians. Yet, a preference for physicians to make final
treatment choices was apparent among the majority of our participants. The alternative to not
receiving an ICD did not surface as a focal point in conversations shared between our participants and physicians. These findings bring the question of informed consent to light. Do patients who adopt a passive approach truly comprehend what they are consenting or declining to? The alternative to not receiving an ICD may not be as appealing, in fact likely quite the opposite, however treatment alternatives, especially in the context of existing co-morbid health conditions, require discussion. What is more, the complexity of ICD technology demands a level of health literacy (that some patients may not have) also shown to influence health related patient decision-making (21
), but that given the time or technique could be explained to patients’ satisfaction.
In the decision making literature there is discussion promoting autonomy and shared decision-making (10
). Similar to the findings from Agard et al. (2007), we found that although some participants adopted an active decision making approach, many relied on the physician’s recommendations, expertise, and the trust that patients placed in them (23
). Echoing findings reported by Sinding et al. (2010) our participants’ variation in level of participation in treatment decisions was tied to trust, social influences, and health state, all interacting with each other in ways that had an impact on their decision-making process (24
). These social and embodied constraints were also linked to participant’s interactions with physicians, social networks, and their own selves, further revealing the complexity of decision-making. This begs the question of whether autonomous decision-making is truly possible, particularly in the context of ICD technology.
Would a decision aid for this type of intervention be valuable for patients? Whether the application of a decision aid could support patients’ decision-making during consultations is not yet known. Given the complexity of ICD related treatment (as evidenced in the contextual model) and the degree of patient trust in physicians, it is unlikely that patients would rely on an aid to come to a decision autonomously. It may be more likely that a decision aid could help convey patient preferences and values and enhance patient-physician communication during ICD related decision-making to ensure patients are fully informed. This topic, as well as the development of an aid for ICD related decision – making will be explored in future research informed by our findings. In addition, with a larger sample and a different methodology, is would be interesting to follow patients who had accepted or declined an ICD to examine the subsequent health related behavior of those who used active versus passive approaches to decision making
In our study, few participants declined to receive an ICD. It is possible that potential “candidates” did not pursue any treatment information beyond their community physician. It is also possible, that those who attend a consultation for an ICD are more interested in receiving the ICD, than those who do not. For our participants, the prevailing goal was to prolong survival and this meant they chose an ICD, even in the presence of limiting co-morbid health conditions.
This study has strengths and limitations. The use of a qualitative approach enabled us to capture the truth as told by patients through their narratives. In addition, we sampled from three large ICD referral centers and triangulated the data sources. The findings, although not generalizable to all ICD populations, may be transferable to similar patients receiving an ICD for primary prevention. Interviews conducted after ICD insertion and/or after some time had passed when a device was declined, may have been affected by patient recall. Finally, this study took place in a socialized healthcare system where the costs of an ICD are not assumed directly by patients. The results of this study may not be extrapolated to other countries where this is not the case.
The study has implications for practice. First, the findings introduce the first evidence of patient decision making in ICD therapy that describes the influences important to patients. This information can be useful during pre-ICD consultations between healthcare providers and ICD candidates. Second, there was a lack of understanding of the role and function of the ICD related to cardiovascular symptom reduction and prevention of future non-arrhythmic cardiovascular events. This suggests that additional explanation during decision making surrounding (a) the types of medical devices (pacemakers, cardiac resynchronization ICDs, standard single or dual chamber ICDs) and (b) the role and function of the specific device that individual patients are eligible to receive should be tailored to ICD candidates. Clear communication of personal risk for SCD versus the risks associated with existing co-morbid health problems and where appropriate, advancing heart failure is advisable.