To live with heart failure is to live with an uncertain and complex future.1–4 On a daily basis, heart failure patients make concrete choices, such as when to take a diuretic or go to the hospital.5–7 As the illness progresses, treatment decision-making becomes a process of evaluating choices where the outcomes are unclear and the ramifications of the choice may be immediate and/or unfold over time.3 Each heart failure therapy has its own complex care needs and outcomes.3,8 Implantable cardiac defibrillators (ICDs) offset the risk of sudden cardiac death.8,9 Patients eligible for ICD not only face the decision to implant but must consider the effects of shocks, the end of battery life and/or device failure and whether to replace it, and how and when to deactivate the device at the end of life.4,8 Ventricular assist devices (VADs)—implanted as a bridge to transplant for patients who are eligible or as the final or destination therapy for those not eligible for cardiac transplantation (HTx)—are offered to improve survival and quality of life.10,11 However, destination therapy and bridge to transplant patients may have to consider replacement if there is an adverse outcome involving the device and when and whether to deactivate at the end of life.4,8,12 Patients eligible for HTx face the waitlist, deciding whether to accept a donor heart, and must consider the risks of immunosuppressant medication and organ rejection.8
In recognition of these complex decisions, shared decision-making and patient-centered care have been identified as approaches to support patients.8,13 Patient centered care is defined as “respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.”14 Ideally, physicians, nurses, and other clinicians provide the information, resources, and counseling necessary for patients and their family members to make decisions in keeping with their preferences, values, and desired outcomes.8 Clinicians should optimize the timing of new treatments and the discussions that go along with them, as well as revisit decisions.8,15 Additional recommendations include starting discussions earlier in the disease trajectory and at a slower pace.4,11 Although prognostic models can assist in optimizing patient selection and treatment timing, they are challenged by individual level factors and outcome expectations.4 Supporting patients requires recognizing that living with heart failure is not limited to discrete treatment options but also includes a series of transitions within and between therapies.4,8,16,17 Our current knowledge is predominated by studies focused on specific treatments; thus, little is known about the commonalities across complex treatments.
Similar treatment decisions, such as dialysis and transplant, are options for chronic renal failure patients. Through a review and synthesis of qualitative literature, Morton et al18 (2010) identified themes present across multiple chronic renal failure treatments. Following their example, this review aims to examine decision-making through the course of device treatments for patients with heart failure.
Systematic Review of Literature
A qualitative literature review and synthesis relies on a search strategy that is both structured and open, providing adequate definition to discover studies applicable to study aims, while permitting the researcher to make refinements as understanding of the topic develops.19 With this in mind, Ovid MEDLINE, CINAHL, PsycINFO, and Web of Science were searched for studies presenting qualitative data. Studies were included if reported in English with no limits placed on publication date. Each database was searched using the subject terms “heart failure,” “heart assist devices,” or “heart transplantation.” This was combined with subject terms “decision-making” or “advanced care planning.” An example search algorithm from MEDLINE is included (Figure 1). Articles were searched without limit to perspective (ie, patient, caregiver, clinician) or type (clinical or patient). The resulting articles were reviewed for complex treatments defined by ICD, VAD, and/or cardiac transplant. The resulting article titles and abstracts were then reviewed for relevancy, followed by a more thorough review of complete articles. Finally, all applicable study reference lists and authors’ names were searched for additional relevant studies.19 The first author (A.H.) conducted all searches and evaluations for inclusion.
To include all heart failure decision making stakeholders, patients, family members, caregivers, and clinician data were included.8 Data that discussed only clinical decision-making were excluded because the focus was on the decisions made by patients. Studies including concepts other than decision-making, such as quality of life, but that had a decision-making component were retained to ensure pertinent data were not omitted.19 Studies that met inclusion criteria were then assessed, by the first author, using the consolidated criteria for reporting qualitative research.20 Studies were not excluded or ranked on the basis of this assessment.
The trajectory model for qualitative research provided an overall framework throughout data synthesis.19 This model conceptualizes human beings as interactive with others and objects in their environments and within a temporal context.21 This model assists the qualitative researcher in recognizing the biographical and temporal elements within the data.21 The model was also used in selecting the treatments of focus. ICD, VAD, HTx were selected to represent progression through HF therapies. Trajectory and time concepts were considered throughout review and analysis. Synthesis of the research findings followed the process described by Thomas and Harden.22
NVivo23 was used for data extraction, coding, and analysis, which was conducted solely by the first author. Identifying data within a research article is a challenge that is overcome by setting criteria for inclusion in the data set.19 For this review, all texts within the reference section of each article were considered data.22 Participant quotes and researcher statements about participant data were also incorporated into the analysis. Finally, because data are not only confined to the results section, applicable data outside the results sections were analyzed.19
The first step in the synthesis was line-by-line coding of the data.22 In the early stages, codes were developed from the texts. Subsequently, data were added to the previously identified codes, or new codes were added as needed. This continued until at least 1 code was attached to each statement, although many units of data fit multiple codes. The resulting codes were subsequently reviewed to capture the essence of related codes and reduce them to workable descriptive themes.22
Systematic and Critical Review Results
The initial search produced 438 citations (Figure 2), of which 409 studies were excluded upon review of title and abstract. Reasons for exclusion were as follows: interventional studies (n = 7), non-heart failure studies (n = 185), clinical decision-making (n = 40), quantitative study (n = 17), literature review (n = 68), editorial (n = 76), and duplicates (n = 16). Twenty-nine studies remained for full-text review. Of these 19 were eliminated because they were an evaluation of an intervention (n = 1), did not include the population or subject of interest (n = 16), or were exclusively quantitative (n = 2). Two additional studies were uncovered from the author and reference list searches, resulting in 12 studies included in this review.
Quality varied between and within studies as assessed by the consolidated criteria for reporting qualitative research (see Table, Supplemental Digital Content 1, http://links.lww.com/JCN/A46). Only 1 study11 discussed the relationship between researchers and participants or if there were others present during the interviews.25 Few studies described the researchers9,25–28 or their qualifications for conducting the study.9,25,27,29,30 All but 1 study31 reported their data recording methods; only 2 studies discussed field notes.11,27 Descriptions of study design were strongest, with all studies providing sample descriptions and sampling methods. Findings of all studies were consistent with the data as they were presented, and major themes were easily identified.
The studies reflected the views of 313 decision-making stakeholders, including patients (n = 173), caregivers (n = 84), and clinicians (n = 56) (see Table, Supplemental Digital Content 2, http://links.lww.com/JCN/A47). Patients and their caregivers participated in the following decisions: post-ICD refusal (n = 18), post-ICD implantation (n = 45), pre-VAD decision (n = 15), post-VAD refusal (n = 29), including patients who eventually agreed to VAD implantation (n = 10), post-VAD implantation (n = 68), including VAD as destination therapy (n = 53), and bridge to transplantation (n = 18).
Three themes emerged from the synthesis of the studies: processing the decision, timing and prognostication, and considering the future. Subthemes within “processing the decision” were transmission of information and changing decision. Timing of the decisions and judging health status were factors that emerged within the “timing and prognostication” theme. Under the theme “considering the future” were subthemes life or death and looking forward. Each study within a theme and subtheme was enumerated, and representative quotes were selected (Table).
Processing the Decision
The theme processing the decision encompasses the time of initial presentation of the device therapy. Participants recognized this as a discrete period,27 described as a “complicated decision context.”30 Whereas most study participants did not change their treatment decisions, some did describe doing so during this time. This was a time wherein clinicians discussed concern that they would overly influence patient decisions or complicate the process by introducing difficult discussions.
Transmission of information. When beginning a discussion about ICD, VAD, or cardiac transplantation clinicians must impart information to patients and their family. Some participants felt this time was overwhelming and they could not process what they were being told. Information was lost in attempting to exchange it between people during multiple encounters. “The doctor would say stuff and I would hear what I thought the doctor said. But me hearing it and then trying to tell her [my wife]—I’m telling her what I thought I heard. So, by the time it gets back around to the doctor, he’s confused and we’re all confused.”32
Others discussed avoiding information that was fearful or they felt would sway their decision. For their part, clinicians tried to find a balance between imparting key information without adding to the difficulties for patients and caregivers. Although understanding that education is a key element to shared decision-making and informed consent, clinicians were cautious about overemphasizing the risks and further complicating the decision “when you are putting them in you are not having an end of life conversation…. You are having a prolongation of life conversation. I don’t think there is any reason I can see to go there….”9
Changing decisions. The subtheme “changing decisions” illustrates the dynamism that factors in complex decision-making. Some patients and caregivers described making an immediate decision that changed as they learned more or grew to understand the severity of their illness. There were also instances in which patients experienced stability in their progression of their HF such that their treatment of choice could be delayed. For others, illness worsened such that the initial decision could not be carried out, “…when we first started out…we had hopes of a transplant…but once the lung function was done, and the kidneys…there was pretty much nothing. There was no hope other than the LVAD.”30
Timing and Prognostication
The theme “timing and prognostication” described the influence of time and how attempts to make predictions factored into the decisional process.
Timing encompassed judgments about when to carry out a decision and the pace of the process. It also included the influence of time on participant feelings about the treatment decision. Ideally, the decisions move at a slow pace, allowing careful consideration of the treatment options.11 However, in practice the process may need to be sped up or truncated because of disease progression. “He had gotten really sick…and they were like ‘This needs to be done like this week.’ Like ‘If you are going to choose to do it, he needs to do it like right now.’”30
Prognostication defined patient, caregiver, and clinician attempts to judge the patient’s health status and possible treatment outcomes in terms of processing the decision and framing expectations for the future. One study described patients having difficulty understanding being ill enough to consider VAD but not to proceed with implantation.25 Participants described assessing their health status and realizing that the treatment was needed.9,28,30,32–34 Others judged that they could defer, “No way, I feel good, I’m not going to die. I wasn’t in any pain or anything.”31
Considering the Future
Across therapies and among all decisional stakeholders, the future was frequently considered and discussed. Life or death describes patient, caregiver, and clinician views of the decision as a binary one that did not require deliberation. For some, this made the decision simple and clear. “There is no decision when they give you the alternative. I am not ready to die.”34 Although most made the decision to prolong life, some did accept death as an option over further treatment when considering their future, “…my life is sitting here and watching TV…that’s why I had the DNR in place and that’s why I didn’t have the defibrillator put in…(Later in the interview)…to take a defibrillator would just lengthen the process that I don’t really want lengthened.”9
Looking forward. Within the subtheme “looking forward,” participants discussed the treatment in terms of its impact on their quality of life and outcome expectations. Experiencing life and being there for family were repeatedly discussed as things to look forward to.28,30,32 Participants also considered the life expectancy of the devices, hoped to maintain stability, and anticipated decisions that may come later in the course of treatment.27,30 Others described the effects of one decision on another, “I received the LVAD as a bridge to transplant. I am medically stable and that is good, but now I am not moving on the transplant list, the LVAD is really a double-edge sword because I feel like it is keeping me from getting a heart.”34
Although the body of literature on heart failure decision-making is growing, there is still much to be understood about this population’s decisional process. Patients often undergo multiple treatments as their disease advances. Patients who receive an ICD may later be implanted with a VAD and may in turn receive a donor heart. The decisional process across multiple therapies is currently underrepresented in the literature. The study authors sought to uncover commonalities in the decisional process across therapies through synthesis of findings from studies that were focused on specific treatments.
Common concerns and factors were present across therapies. Patients, caregivers, and clinicians considered the possible outcomes of decisions. They evaluated present health status to make prognostications about what the treatment may mean for them in the future. Time was a factor in determining who made the decision and how the decision was made, as well as when and whether decisions changed.31,33 In addition, participants in several of the studies described a dichotomy between quick and reflective decisional processes.29,31,34 These commonalities could represent key moments in which to engage patients in discussions about possible treatment options, as well as points at which patients and their family members need additional support.
Across the therapies, participants described the initial decisional period as stressful and overwhelming, impacting patient and caregiver understanding of the treatments. This was further influenced by the health of the patient at the time of presentation. This suggests that improvements are needed to the support we are currently providing patients when first introducing a therapy.
We found no qualitative research specific to cardiac transplant decision-making. Although the studies included in the review presented the views of patients planning to move from VAD to transplant, the views of HTx patients who had made other decisions were absent. This presents both an ethical dilemma and a significant gap in the literature. Just as some defibrillator and VAD patients acknowledged changing their decisions, likely those waiting for a donor heart reconsider their choice as well. Some patients felt that their decision, whether they accepted or rejected VAD therapy, hindered their likelihood to receive a donor heart.31,34 Further research is needed to understand the decisional process between bridge to transplant and receiving a donor heart. For example, there may be times such as hospitalization, or prolonged waitlist time, when supporting and reviewing decisions in a systematic manner would be beneficial to patients.
There are a number of areas of weakness in this study. A common critique of qualitative synthesis is that the data are not in their raw state but rather come from data selected and interpreted in support of other researchers’ aims.19 This review used established steps to offset this concern19,22; however, currently, there are a limited number of research in this area. This resulted in a number of authors represented multiple times in the data set, which likely led to repetitive findings and reduced the robustness of the data. In addition, the data collection, analysis, and synthesis were conducted solely by the first author. A team approach would have offset the risk of bias and possibly led to a more robust interpretation of the data.
Beyond treatments, patients also make decisions about self-care, end-of-life choices, and care planning. In addition, patients with devices, or their caregivers, may also have to decide whether to replace them or turn them off. Synthesizing findings requires studies included to be similar enough to allow for integration.19,22 For this reason, the focus of this study was narrowed to the decision to start advanced therapies. However, it must be acknowledged that, through doing this, a large part of the trajectory remains unexplored.
This synthesis revealed themes common across heart failure treatments that represent complex decisions. There are patients who deliberate and those who do not, others who remain with their initial decision, and those who change their minds. The initial decisional phase is one in which patients are considering the immediate information being given, while attempting to judge their health status and future goals. As patients move from the treatment initiation, they still reflect on their decision and consider the future. One suggestion for improvement of the decisional process is that clinicians begin to consider a more longitudinal, broader process. Future research should include the perspectives of patients who have made multiple HF treatment decisions or declined treatments. This review illustrates the need for prospective, longitudinal studies of decision-makers to optimize shared decision-making and patient-centered care.
What’s New and Important
- This synthesis of the literature revealed commonalities across HF treatments. Recognizing commonalities and key points could help nurses and other HF clinicians optimize shared decision-making and patient-centered care.
- Time was a factor in the presentation of the treatment, decisional timing, and attempts at prognostication. Patient made their decisions based on hopes for the future and described choosing between life and death.
- This study is an early step in exploring longitudinal decisional changes and influences.
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