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Patients are offered implantable defibrillators (ICDs) for the prevention of sudden cardiac death (SCD). However, patients’ 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.
A grounded theory methodology was employed. Patients were recruited from three ICD centres. Those who received an ICD underwent interviews the first month after implant. Declining patients had interviews at their convenience. In-depth analysis of transcripts was completed. Identified themes were placed along process pathways in a DMP model and tested.
Forty-four patients consented to participate (25% women). Thirty-four accepted an ICD and 10 (23%) declined. Ages ranged from 26 to 87 (mean = 65; SD = 12.5). Participants were retired (65%), had ischemic heart disease (64%) and some post-secondary education (52%). The DMP was triggered when patient’s risk for SCD was communicated. The physician’s recommendation and a new awareness of SCD risk were motivators to accept the ICD. Patient’s decision-making approaches fell along a continuum, from active and engaged to passive and indifferent. Patient’s approaches were influenced most by the following: (i) trust, (ii) social influences, and (iii) health state.
Health-care providers need to recognize the DMP pathways in which ICD candidacy and SCD risk are understood. The factors that influence a patient’s decision warrant discussion pre-implant. It is imperative that patients comprehend the meaning of ICD candidacy to make an informed decision. Participants did not recall alternatives to receiving ICD therapy.
Sudden cardiac death accounts for a significant number of cardiovascular related deaths in Canada, Europe, and the United States (1–3). Definitive evidence supports the use of implantable cardioverter defibrillators (ICD) as a primary prevention intervention to improve survival associated with life threatening cardiac arrhythmias (4–8). Primary prevention is relevant for those who are at risk for, but have never experienced, a potentially lethal arrhythmia. Following the publication of several randomized controlled trials (RCTs) demonstrating the success of the ICD, a steady demand for ICD technology has transpired and practice guidelines established to assist clinicians in selecting those who may benefit from ICD therapy (9).
The success of the ICD has provided new opportunities for cardiovascular patients to receive a potentially life prolonging intervention meant to prevent sudden cardiac death (SCD). In Canada, receiving an ICD for primary prevention is an elective cardiovascular procedure. Patients are generally referred to electrophysiology specialists who determine whether an ICD is warranted based on practice guidelines and clinical expertise. However, the question of how patients come to reach the decision to accept or decline an ICD has not been addressed.
Increasing emphasis for patients to be active participants in their healthcare decisions has led to the development of decision-making models to aid patients in making informed decisions about treatment options (10–13). In practice, treatment decision-making aids are applied in a number of clinical situations to assist with decision-making (14;15). However, these tools have not been used in the context of ICD uptake. Future aids to assist patients to make an informed decision about whether to receive an ICD must be informed by patients’ perspectives. The purpose of this study was to explore the decision making process for patients who accept or decline an ICD for primary prevention of SCD.
Participants were recruited from three academic ICD referral centers in south central Ontario between October 2008 and June 2010. Ethics approval was obtained at all three sites. A grounded theory approach was employed to conduct the study. Inclusion criteria were: patients at least 18 years of age, able to read and speak English, and eligible to receive a single or dual chamber ICD for primary prevention.
Purposive sampling was focused on seeking participants with specific experiences and insights about ICD decision making and included the following criteria: 1) patients who had completed a consultation with an electrophysiologist and accepted and ICD, 2) patients who had completed a consultation with an electrophysiologist and declined an ICD, and 3) representation of both men and women. We did not seek to have equal numbers of men and women since the proportion of men among total referrals is approximately 70% versus approximately 30% for women. At each site, a nurse, research assistant, or in the case of decliners, the electrophysiologist, identified potential participants who fit the inclusion criteria and sought their approval to be contacted about the study by telephone after reviewing the study invitation. Those who agreed were contacted by the research assistant (SdL) who explained the study in detail. Interviews were set up at a mutually convenient place and time.
Semi-structured interviews took place at least one month after ICD implantation so as not to influence patients about their decisions. We wanted to avoid introducing any situation that could create uncertainty in our participants about their decisions. For those declining an ICD, potential participants were approached after they had made a definitive decision with their physician.
Most interviews lasted 50–60 minutes, with some being as short as 40 minutes, while others were over 2 hours. The interview guide was revised 3 times over the course of the data collection period in response to preliminary analysis of the early interviews (16). Some examples from the original and revised interview guides are as follows, “How did you first understand that the ICD was a possibility for you?” Refinement of this line of questioning probed deeper into, who, where, how, and when? We then added questions exploring participant’s personal risk perception. Process related questions followed with, “How did you go about making the decision to have/not have an ICD?” Additional revisions explored questions about the roles of healthcare providers, family, and friends during the process. Finally, we asked participants about the sources of information utilized, “Where did you get information prior to your decision?” Later adding, “What information had the greatest impact?” to the interview guide. In accordance with the constant comparative approach inherent in grounded theory, analysis was ongoing, comparing individual pieces of empirical data with each other and with published reports throughout the research process (17). All interviews were audio-recorded, transcribed verbatim, and anonymized. Participants were sent a summary of the interview (with 1–4 additional questions) to comment on.
Additional data included researcher memos, published literature, participant demographics, and medical history. To manage the data, NVivo7, a qualitative data management program, was utilized. Initial analysis codes were derived from the interview guide. A further, more refined analysis was conducted with additional or more detailed codes inductively derived during team meetings in which transcripts, coded text, and published literature were discussed in relation to each other. As qualitative research is, by nature, non-linear and iterative, the comparison of different data types (interviews, literature, memos, etc.), against deviant cases within the data were constantly tested against any new information. Saturation was achieved when no new coding themes emerged and consensus was reached among three investigators.
Analysis focused on decision-making themes such as influencing factors, information gathering processes, chronology of events leading to a decision, and individual rationales. During the analysis stage, participants’ cases were coded into a pictorial model. Identified themes were then further refined – conflated or expanded – in numerous model designs until deviant cases could be accounted for, and consensus among the researchers was achieved. The final themes were placed along process pathways in the decision-making model and re-tested with the collected cases to ensure a proper reflection of the findings.
Tables 1 and and22 present the number of patients approached, those who declined, and those who completed interviews in the study. Reasons for non-participation included fatigue related to recent medical procedures, and/or a lack of interest in participating in research.
Most participants were retired (65%), had ischemic heart disease (64%). Educational backgrounds for accepters and decliners varied from several years of elementary schooling to post-graduate or professional degrees. Two participants died prior to study completion (one of the two having completed the interview). The majority of participants were married and living with their partner and/or family. Additional participant characteristics are included in Table 3.
A contextual model that reflects the complexity of participants’ described experiences in accepting or declining the ICD can be seen in Figure 1. The model outlines the process and the factors that influenced participants as they progressed toward a decision. For most, their experience began after a health related “trigger” that created a new awareness of SCD risk, prompting discussions about ICD candidacy. The new awareness of ICD candidacy provided an opportunity for participants to internalize and make sense of their SCD risk. The flow of information, embedded within complex rhetoric during sense-making of their risk fluctuated back and forth as patients processed information. To reach a decision and manage uncertainty that arose from the knowledge of candidacy, participants received and sought ICD-related information from physicians, heart specialists, print material, and/or family/friends, some of which was persuasive and had an impact upon their decisions to varying degrees. Three major factors influenced participant’s final decisions, (1) trust, (2) social influences, and (3) health state. The degree to which these factors were important to an individual varied. Participants’ approaches in arriving at a decision could be characterized as being disposed toward an active or passive style. The entire process, from trigger event to decision, took only minutes for some and up to two years for others.
For many, a health related event triggered the identification of participants as candidates to receive an ICD. Trigger events included hospital admissions for heart failure, atrial arrhythmias, myocardial infarctions, non-cardiovascular health events, or a specific severe cardiac event in a family member (e.g., cardiac arrest in a young person). For the majority of participants the trigger event was less dramatic: having had experienced previous myocardial infarctions or open-heart surgery several years earlier, these participants underwent routine follow-up cardiac testing that revealed new information. Carl presents a typical experience:
…as part of his regular check-up he [community cardiologist] does an ultrasound and checks my heart over. Up until then I thought I had 30 % or so with my heart remaining from the two heart attacks and, um, he said he wanted me to go and be tested. And he thought the tests would determine whether I was eligible for the defibrillator. … I went into the hospital and had the test done and went back to his office and, uh, he said I was down to 24% functioning of my heart definitely put me in a category made me eligible for the defibrillator and we briefly discussed it, not a lot of detail. He’d book an appointment with the specialist and I could ask questions there.Carl, 67, accepted ICD
Alternatively, some participants reported changes in cardiac symptoms triggering cardiovascular investigations and assessments. In all cases, these investigations brought new knowledge of “ICD candidacy” and SCD risk to the forefront.
In the context of ICD therapy, patients were labeled as ICD candidates when they were deemed eligible to receive a device based on practice guidelines. The introduction of ICD candidacy and the risk of SCD occurred in different ways. Some were informed of possible candidacy by a community cardiologist; others were presented with the information during initial consultations with an EP. Participants reported that SCD risk was not always explicitly stated; instead, it was presented as risk for a life-threatening event, often coming as a surprise. Regardless of the presentation of SCD risk, participants were required to make sense of the information and rhetoric associated with it. Appreciating their risk for SCD (or severe cardiac event), and associating meaning to it, was a powerful motivator for participants to start the process of decision-making. The duration of time to reach a decision varied with some participants taking very little time after their trigger event and established candidacy, while others spent a greater amount of time moving back and forth during sense making and deliberation. The arrows on either side of the model (Figure 1) represent this variability in time.
Awareness of newfound SCD risk increased uncertainty about the future in participants, their spouses, and other family members. Some participants thought about ICD candidacy in terms of the numerical information received about their personal SCD risk without receiving an ICD or their life expectancy with one. These numbers became a focal point more often when decisions about the ICD took little time to make. When asked about the most influential piece of information received from a physician a participant recalled:
I said well what will it do to me and he said it will give you five more years of life. I said I’ll take it.Leo, 82, accepted ICD
In contrast, another participant reported feeling that choosing to receive the ICD would denote acceptance of her SCD risk, thus she declined the ICD:
I think if (pause) I kinda pull a blanket over my head (laugh). I think if I don’t do anything it’ll be alright or I’m not sick or you know and if I’ve got something in my body that means that I’m sick.Linda, 64, declined ICD.
Others who declined the ICD carefully balanced the perceived risks and benefits, choosing to live out the end of their days without additional interventions because they were satisfied with their current life circumstances.
Participants’ engagement in decision-making fell along a continuum ranging from active to passive. These approaches were not absolutes, but rather ‘more’ or ‘less’ tendencies. The degree of engagement in decision-making was not equated with greater acceptance or refusal of the ICD. Some participants fluctuated in their approach, depending on circumstances that may have changed during decision-making. What made the two ends of the spectrum different was the degree of involvement participants expressed during their decision-making. For instance, one participant at the active end of the decision-making spectrum “talked to six cardiologists, (of) whom four were EPs (electrophysiologists), plus two Fellows, and my family doctor too”. Sheldon, 67, accepted the ICD after doing numerous internet and medical newsletter searches. That extreme case aside, for the most part, more active engagement meant asking questions to physicians, and looking at other sources of information (e.g., internet, manufacturer’s web sites, health related media sources, other physicians, and first hand information from ICD recipients). Active decision makers posed many more questions to physicians; they sought details and simplified explanations regarding the technology. They wanted to comprehend the purpose and function of the device, and trust in it. More active decision makers took time and balanced their perceptions about personal risk of sudden death against the benefits of the ICD. For active participants, deliberation meant considering all of the ICD-related information they had gathered and integrating it with factors that were influential in their lives. For them, the decision to accept or decline an ICD was, for the most part, a well-informed one.
Participants taking a more passive approach – the other end of the continuum – were less likely to report having sought information beyond what was given to them by medical professionals, and would often defer decision-making to the physician or family members. During discussions about device knowledge or the ICD technology, an example of a more passive response would be:
I tried not to think about it too much, I tried to just let the doctors do their thing.Carla, 26, accepted ICD
Likewise, participants left the decision to their loved ones:
He [cardiologist] suggested it’s better I do it [have an ICD implanted], so my wife said fine.Petar, 68, accepted ICD (emphasis added)
In these cases, participants did not see the decision as theirs to make. Once offered, the ICD was accepted without additional need for deliberation, exploration, or additional time for sense making. The physician recommended the ICD and gratitude ensued for the option to receive such a sophisticated form of technology. Very little, if any, notion of the elective option for receiving an ICD surfaced. Participants with more passive tendencies, who declined the ICD, minimized the belief in their personal risk, or stated disinterest in comprehending it, thus leaving the decision in the hands of their family members and physicians. Some expressed fears that prevented them from learning more about their condition or the device. From our interviews, fear and uncertainty were associated with new knowledge of sudden cardiac death risk. Accepting the ICD, based on the recommendation of the patient’s physicians (and sometimes family members as well), became a way to manage fear and uncertainty. Fear in those who passively declined the device, required a certain level of patient acceptance of their risk and cardiac condition. The vast majority of participants at the passive end of the spectrum were people who accepted an ICD. These represented the majority of our study participants. One respondent who passively declined an ICD later accepted one following a MI, while another passively declined after family members expressed concern about a diminished quality of life if he were to experience any shocks. Family members (spouses and/or children) who influenced our participants were active and informed in their approach to seeking ICD-related information. There was a degree of back-and-forth information processing in our participants as they gathered ICD-related information. For those who took a more passive stance, the processing of information was left to family members and physicians.
Three major influential factors during the decision making process surfaced in our participants. These included (1) trust, (2) social influences, and (3) health state. For most, these factors did not present at a single point in time, but rather re-appeared over time, re-influencing patients in a non-linear fashion.
Throughout the decision-making process, an overriding trust in the physician’s knowledge, expertise, years of training, and established patient-physician bonds, emerged as dominant influential factors:
I think it all boils down to if the doctor, if you trust your doctor and he has been taking care of you and then he recommends and gives you valid reasons that you can understand why you should get it, what would happen if you don’t get it…which makes you feel a little more comfortable. Because you don’t want to have to, that’s just I think a psychological thing, but knowing that it’s there and it is going to do that job, I think it is good, helps with a deciding factor.Jeff, 48, accepted ICD
Trust was balanced between community physicians, cardiologists, and EPs. However, final decisions often followed consultations with EPs. To varying degrees, participants trusted the information they gathered from healthcare providers, device manufacturers, family, or other ICD recipients. Some expressed a lack of trust in the physician, particularly when they perceived feelings of disinterest in their case during the consultation and thus deferred decision making to family members or declined the device.
Responsibilities to provide for a spouse, children or grandchildren, or a sense of not wanting to cause emotional harm to family by dying suddenly, or too soon, influenced some participants to accept the ICD. The spouses/partners of ICD recipients were frequently described as the most important influential family member, many of whom provided encouragement to accept the ICD to avoid sudden death.
Because me myself I didn’t care I just I couldn’t see maybe I just don’t understand it enough, I don’t know. I just didn’t care, but they all said, “Please, for our sake, and if you think it will benefit.” So that’s the only reason that I agreed. If it had to be my own, all my decision, I would have probably said, “Don’t bother”, but I went to my family and wife and friends, closest friends and asked and they all pleaded me to have it done. So I said, “Okay.”Jim, 55, accepted ICD
Social networks were sometimes a source of inaccurate information used by participants to make a decision. For instance, some participants discussed pacemakers and ICDs interchangeably, understanding these to be similar forms of treatment. The perceived need for family involvement required to obtain follow-up care also factored into the final decision.
The most commonly reported indicator of health state was the presence of a reduced ejection fraction (LVEF). Some were unaware that a reduced LVEF was associated with an increase risk for SCD; particularly those who reported feeling physically well. Others expressed disbelief that, in the absence of physical symptoms and presence of good health habits, they were at risk for SCD. Participants often understood a reduced LVEF as a “weak heart” which was enough to lead them to seriously consider (and often accept) the ICD.
Participants who experienced heart failure symptoms or non-life threatening arrhythmic events (uncontrolled atrial arrhythmias) tended to (incorrectly) view the ICD as a possible treatment. Several were hopeful that the device would improve overall energy and/or breathing difficulties. It was challenging for many participants who were experiencing symptoms to avoid associating the ICD with symptom relief, when the single or dual chamber ICDs were not intended for that purpose. A poor health state created a sense of urgency in both participants and their families to accept the device.
For the most part participants did not consider their advanced age or co-morbid health problems when accepting the ICD; conversely, several decliners did say that these factors greatly influenced their decision:
You name it I got it. Diabetes, and my osteoporosis, and COPD. I said diabetes, yeah well and then the doctor said with my weak heart, my weak lungs, and my weak kidneys, I don’t have too much going for me.Phyllis, 87, declined ICD
I’ll be 87 in five days. So I’ve had a good life. I don’t care when she [heart] goes okay but I don’t need any help to stay alive after that.Bennett, 86, declined ICD
Two additional participants changed their decision and later accepted an ICD after experiencing a medical crisis or upon finding further information.
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;20;22). 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.
We thank our participants for their generosity regarding their experiences. We also extend our appreciation to Dr. Andrew Krahn, Bonnie Spindler and the Lawson Health Research Institute, London, ON; Dr. Paul Dorian, Emily Little and Zana Mariano at St. Michael’s Hospital, Toronto; Dr. Stuart Connolly, Dr. Jeff Healey, Dr. Girish Nair, Dr. Carlos Morillo, at Hamilton Health Sciences, Population Health Research Institute, Hamilton, ON.
Source of funding
This study received funding from the Canadian Institutes of Health Research (Operating Grant 86741).