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User-centered Development of a Decision Aid for Patients Facing Implantable Cardioverter-Defibrillator Replacement: A Mixed-Methods Study

Lewis, Krystina B., MN, RN; Birnie, David, MD; Carroll, Sandra L., PhD, RN; Clark, Lorraine, MHS, RN; Kelly, Freya, MN, RN; Gibson, Paul; Rockburn, Lloyd; Rockburn, Louise; Stacey, Dawn, PhD, RN

doi: 10.1097/JCN.0000000000000477
ARTICLES: Arrhythmia

Background: Because of battery depletion, an implantable cardioverter-defibrillator (ICD) generator requires surgical replacement every 5 to 7 years. Routine replacement is the norm without discussion with patients about whether or not to proceed.

Objective: The aim of this study was to develop a patient decision aid (PDA) for patients facing ICD replacement and plan for its implementation.

Methods: An embedded mixed-methods study was conducted using questionnaires and semistructured interviews focused on current ICD replacement practices; PDA acceptability, usability, and content; and PDA implementation. Transcripts were analyzed using constant comparative analysis.

Results: Eighteen PDA end users in 16 interviews characterized the current ICD replacement approach as automatic without consideration for patient preferences. The PDA was positively received, and the content was iteratively revised 4 times during the interviews. Changes were related to missing and excess information, language, and wording. The PDA was identified as a means to support a shared decision-making (SDM) process, not to be used as a standalone instrument. To shift current practices to an SDM process, participants identified that an invitation to discuss the option of ICD replacement is required—whether initiated by the patient or the clinician.

Conclusion: Currently, the option of ICD replacement is rarely offered, and patient preferences are seldom elicited. Participants believed the PDA to be a useful intervention that could help facilitate an SDM process for patients facing ICD replacement. Preparing for implementation during the development phase will allow us to strategize effectively to overcome perceived barriers and capitalize on perceived facilitators during actual implementation.

Krystina B. Lewis, MN, RN PhD candidate, School of Nursing, University of Ottawa, and Registered Nurse, University of Ottawa Health Institute, Ontario, Canada.

David Birnie, MD Director of Arrhythmia Service, University of Ottawa Heart Institute, Ontario, Canada.

Sandra L. Carroll, PhD, RN Associate Professor, School of Nursing, McMaster University, Hamilton, Ontario, Canada.

Lorraine Clark, MHS, RN Clinical Manager, Clinical Services, University of Ottawa Heart Institute, Ontario, Canada.

Freya Kelly, MN, RN Registered Nurse, University of Ottawa Heart Institute, Ontario, Canada.

Paul Gibson Patient Partner, Health Consumer, Ottawa, Canada.

Lloyd Rockburn Patient Partner, Health Consumer, Ottawa, Canada.

Louise Rockburn Patient Partner, Health Consumer, Ottawa, Canada.

Dawn Stacey, PhD, RN Professor, School of Nursing, University of Ottawa, and Senior Scientist, Ottawa Hospital Research Institute, Ontario, Canada.

This study was supported by the Canadian Council of Cardiovascular Nurses. K.B.L. is supported by a Canadian Institutes of Health Research fellowship.

The authors have no conflicts of interest to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.jcnjournal.com).

Correspondence Krystina B. Lewis, MN, RN, School of Nursing, University of Ottawa, 451 Smyth Rd, RGN 1118, Ottawa, ON, Canada K1H 8 M5 (klewi091@uottawa.ca).

Implantable cardioverter-defibrillators (ICD) are lifesaving in appropriately selected patients at a high risk of sudden cardiac death from ventricular dysrhythmias. Routine replacement of the ICD generator is the norm without a discussion about whether or not a patient should proceed.1,2 More than 50% who had previously undergone replacement did not know it was optional.2 In the context of older age or serious illness, 5% to 14% of patients would not replace the ICD, and 16% were undecided.2,3 For a more patient-centered approach, each patient should be restratified according to risks and survival benefit in the context of advancing age, worsening (or improving) heart function, and/or noncardiac comorbidities.4 This should be paired with the patient's informed preferences and values for ICD therapy.5 Most patients want to be offered a choice, want information about the risks and benefits of each option, and want to be asked about their preferences.6,7 This is known as shared decision-making (SDM) and can be facilitated by a patient decision aid (PDA)—an evidence-based intervention that makes explicit the decision, the options, the chances of risks and benefits occurring, and the clarification of personal preferences and values.8 Patient decision aids improve knowledge and realistic expectations and result in values-choice agreement. Despite their established effectiveness in research, the uptake of PDAs in routine clinical practice has been slow.9,10

The overall aim of this study was to develop a PDA for patients facing ICD replacement and plan for its implementation by involving the interprofessional team, patients, and family in the development process. Specific aims included (1) to understand the current approach toward ICD replacement; (2) to seek feedback on PDA content, acceptability, and usability; and (3) to elicit feedback on how best to implement it in clinical practice.

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Methods

Study Design

An embedded mixed-methods study was conducted using acceptability and usability questionnaires and semistructured interviews. An interpretive description design guided the qualitative methods to generate clinically relevant knowledge and inform clinically relevant solutions.11 The Normalization Process Theory, a middle-range theory of implementation, guided implementation planning.12 Ethical approval was received from the Ottawa Health Science Network Research Ethics Board (20150308-01H) and the University of Ottawa Research Ethics Board (A09-15-05). All participants provided written consent.

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Setting and Participants

This study was conducted in an ambulatory cardiac device clinic in a Canadian tertiary care hospital. In this hospital, 180 ICDs were replaced by cardiac electrophysiologists between April 1, 2016, and March 31, 2017 (Cardiac Care Network, Wait Times Information System). Patients and their ICDs are assessed semiannually in this device clinic by 1 of 8 nurses and 1 of 8 rotating cardiac electrophysiologists.

Purposeful sampling was used to recruit members of the interprofessional team with 1 or more years of clinical experience with ICDs and patients and family members who have previously accepted or declined ICD replacement. Interdisciplinary members external to the device clinic but involved in the care of these patients were also invited. Patients with pacemaker dependency or cardiac resynchronization therapy were excluded.

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Systematic Patient Decision Aid Intervention Development

Patient decision aid content and development were guided by the International Patient Decision Aids Standards' systematic process13,14 (Figure). First, we conducted formal and informal needs assessments with patients and clinicians.2 Second, we conducted a systematic review to synthesize the risks and benefits of ICD replacement.16 The risks derived from this review were included in the PDA (Table 1). Given the paucity of survival benefit data after ICD replacement, pooled data from 5 randomized controlled trials, a meta-analysis, and a registry were used to communicate the survival benefit by age and ICD indication.17–20 The probabilities were peer reviewed by expert cardiac electrophysiologists external to our institution.

FIGURE

FIGURE

Third, using an integrated knowledge translation approach, a steering committee composed of 2 cardiac nurses, a cardiac electrophysiologist, a nurse administrator, expert researchers in PDA development, 2 patients with an ICD, and a family member was established. Committee members contributed to the initial development and iterative revisions of the paper-based PDA prototype and the interpretation and approval of study results. Prototype design was based on the Ottawa Decision Support Framework.15 Once the initial prototype was developed by the steering committee, broad feedback was sought from anticipated end users external from the steering committee via semistructured interviews.

TABLE 1

TABLE 1

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Data Collection

Semistructured Interviews

Two semistructured interview guides—one tailored for patients and families and the other tailored for clinicians—were developed by the researchers and pilot tested before study commencement with individuals representative of our target sample but otherwise not involved in the study. The guides were focused on current ICD replacement practices; PDA acceptability, usability, and content; and PDA implementability into the clinical workflow, asking participants to reflect on their past experiences with ICD replacement and drawing on their knowledge of current clinic workflows. Demographics were collected. According to the Normalization Process Theory, understanding the current approach is crucial before exploring how a novel complex intervention can be adopted in practice. Participants were asked to review the PDA before the interview for feedback and rating its acceptability, usability, and implementability.

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Acceptability and Usability

Selected questions have been extensively used for PDA acceptability22 and usability evaluations.23,24 Quantitative data on the comprehensibility of PDA components, length, amount of information, and overall balance of the PDA's presentation of treatment options were collected.24

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Data Analysis

Taped interviews were transcribed verbatim. Inductive analytical methods with constant comparative methods were used.25 The qualitative analysis process occurred in 6 phases: (1) broad open coding: data describing the current ICD replacement approach were analyzed separately from data describing PDA implementation; (2) codebook development: initial categories arose from the data but were framed around study aims; (3) interpretation of initial categories to generate overarching and subthemes; (4) coding conducted by a second independent reviewer; (5) codebook refinement based on discussion between reviewers and consensus; and (6) independent coding repeated by reviewers using the refined codebook. NVivo 11 software (QSR International, London, England) was used for data management and analysis. Demographic and PDA acceptability and usability data were analyzed descriptively.

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Results

Participant Characteristics

There were 18 end users in 16 interviews, including 12 clinicians (nurses, cardiac electrophysiologists, palliative care specialist, psychologist), 4 patients, and 2 spouses (Table 2). All patients had accepted ICD replacement at least once.

TABLE 2

TABLE 2

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Current Approach: Automatic Implantable Cardioverter-Defibrillator Replacement

The current ICD replacement approach was viewed by participants as automatic. Once battery depletion was detected on ICD interrogation, patients were informed that it was time for a device replacement with the procedure performed within weeks. Three subthemes were identified (Table 3).

TABLE 3

TABLE 3

The theme “implicit persuasion” refers to a clinician's manner of implicitly steering patients toward a particular choice because that is what they perceive to be the best for patients.26 Guided by strong clinical trial evidence, clinicians believed that the mortality benefit of ICDs outweighed potential burdens. This was evidenced in the way ICD therapy was presented to patients: as a lifelong treatment where ICD replacement is a necessary course of action. Consequentially, patients unequivocally anticipated replacement once their next battery ran low, some erroneously believing that it was the only choice. The omission of the option of ICD nonreplacement was not considered inappropriate but rather justified by the perception of acting in the best interest of the patient.

“Influence of previous encounters” referred to how the earliest consultations and conversations about ICD therapy shaped patients' understanding about how the ICD functions and how the therapy is understood. Relying heavily on the information received (or not received) upon initial ICD implant, participants reported mixed messaging, inaccuracies, and omitted information. At the time of replacement, clinicians reported not raising the option to decline ICD replacement in fear of surprising or upsetting patients. Mixed messaging was attributed in part to the device clinic's shared care model, where patients may be seen by any one of the rotating nurses or cardiac electrophysiologists on any given visit. Device clinic staff suggested that the source of patients' misunderstandings about how the ICD functions, overestimation of benefits, and underestimation of risk stemmed from inaccurate information obtained from noncardiovascular clinicians within their circle of care and/or other sources of information such as family, friends, or the Internet.

“Not knowing the patient” was frequently cited as a barrier to initiating discussions about ICD replacement. Clinicians expressed wanting to know more about the patients' overall clinical status, personal circumstances, and preferences and values related to the ICD to best prepare for the sensitive nuances inherent to ICD replacement discussions. Building meaningful rapport was considered difficult due to environmental barriers of time pressures, the shared care model, and the inability to obtain documentation from external (noncardiac) encounters. This was particularly true for patients followed by clinicians in independent practice, patients living far away, or those with unscheduled admissions to community hospitals because, frequently, documentation related to these encounters is not available on our institution's documentation system and not available to the device clinic staff unless brought by the patients themselves. This impacted clinicians' ability to be informed of recent changes to a patient's noncardiac clinical status and whether advanced care planning discussions occurred with others.

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PDA Content, Acceptability, and Usability

The PDA was positively received and iteratively revised 4 times over the course of the interviews. All participants were willing to use the PDA or recommend its use. Acceptability and usability results are in Table 4. Patient decision aid content was revised based on missing information (eg, how the ICD affects the way a person passes away, influence of comorbidities), excess information (eg, presentation of probabilities tailored to patients' risk profile), and wording. Revision details are available as a supplementary table (Supplemental Digital Content 1, http://links.lww.com/JCN/A51). After revisions, the PDA's readability level was Flesh-Kincaid level 7.1. The PDA is available upon request.

TABLE 4

TABLE 4

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Patient Decision Aid Implementation to Support a Shared Decision-making Process

All participants agreed that the PDA is valuable for use in clinical practice, but not to be used as a standalone instrument. Participants believe that the PDA needs to be integrated within a standardized and evidence-based SDM process where information about ICD replacement is provided over time and is consistent for all patients but tailored to the individual. This is to minimize variations in care from 1 patient to the other. Four subthemes were identified (Table 3).

“Need for individualization” was a theme described as requiring a discussion of survival benefits tailored to individuals based on their age, clinical status, comorbidities, and ICD indication. In addition, patient-reported outcomes such as quality of life and their values and preferences for continued ICD therapy were recognized as contextual with the potential to change over time, hence necessary to review throughout the ICD pathway. Cognitive function, health literacy, and preference for role in decision-making (active vs passive) were also noted.

Another theme was “timing: describing the options and then later discussing the options.” Presenting the option of ICD replacement needed to occur at 2 distinct time points: first, described before the initial implant or at the first device clinic appointment after insertion and, second, discussed upon intensified follow-up usually 6 months to 1 year before battery depletion—a discussion supported by the PDA. Participants favored this 2-step approach for 2 reasons. First, the presentation of options would be expected. Second, it would allow for unhurried deliberation with family members and other members of the patient's healthcare team.

A palliative care physician noted the value of the PDA for informing about advanced care planning. Raising awareness about ICD concepts and trade-offs at the time of replacement can be useful for the future. It is a way of adjusting the way in which ICD therapy is framed: not as an irrevocable treatment but one of appropriate use based on a patient's health status and his/her evolving values and preferences for it.

“Team approach including patient and family” was described as essential to PDA implementation with the commitment, collaboration, and communication between all those involved in the care of ICD patients. Because battery depletion is detected and monitored in the device clinic, most agreed that device clinic staff should initiate, control, and lead this process. Device clinic nurses and physicians agreed with shared responsibility in describing and discussing ICD replacement options. General practitioners, heart function specialists, and palliative care specialists were also considered to have roles in supporting PDA use and related discussions. One participant suggested that a palliative cardiovascular service should be established to support these conversations. However, before pursuing any decision, the most responsible physician—often from the device clinic—needed to be assured from their conversation that the patient was making an informed decision.

“Education about ICDs and SDM” was suggested as a proposed solution to best prepare all team members to meaningfully participate in this decision. Education was considered the remedy for patients' misunderstanding of ICD function, benefit, and potential burdens and, most importantly, necessary for patients to understand the sudden versus prolonged trade-offs of ICD therapy. It was hypothesized that clinicians external to the device clinic may be fueling patient misunderstandings given their lower levels of device-related knowledge. Although device clinic staff are experts in cardiac devices, they admitted to not being skillfully prepared to engage patients in discussions about ICD replacement citing that doing so was difficult and uncomfortable. Education about ICDs and SDM was proposed as the solution for all those involved.

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Shifting From an Automated Approach to a Shared Decision-making Process

To shift the current automated approach to an SDM process, an invitation to discuss ICD replacement is required. Clinicians, particularly nurses, referred to the need for a “hint” from their patients to ensure that raising the option of ICD replacement would be well received. The hint could be in the form of a declaration of a recent diagnosis, of a worsening prognosis, or of not coping well with the ICD, for example. Conversely, other participants believed that the invitation should be provided by the clinician—considered the gatekeeper of the information—because some patients may otherwise be unaware or unsure of whether the topic can or should be discussed.

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Discussion

Our study was designed to engage end users in the development process for a new PDA for ICD replacement to ensure that it is implementable in existing workflows. Overall, the PDA for ICD replacement was considered a useful intervention to guide eventual end users through this increasingly common yet complex decision.

There was unanimous agreement among participants that an SDM process is needed for patients approaching ICD replacement. The PDA—if paired with a discussion with an interprofessional team member—was considered “the invitation” that could facilitate SDM by offering an opportunity for revising ICD function, risks, and benefits and clarifying patients' evolving preferences for ICD therapy, which are often overlooked.27 It was also considered useful to minimize variations in information provision, a current consequence of the setting's shared care model, and to inform patients of the option of ICD deactivation when nearing end of life. Nurses are well suited for decision support delivery because supporting patients in decision-making deliberation fits within the discipline's scope of practice, requires evidence-based information to communicate the details of each option, and requires a relational process to build partnerships with patients.28 Our intervention may be a potential answer to the field's call for better instruments and strategies to help clinicians integrate SDM throughout the ICD pathway.4,29

By collaborating with PDA end users on our steering committee and by listening to participants in the interviews, we developed an intervention ready for implementation in clinical practice. The participatory nature of this study allowed us to adapt the intervention to the local context and generate buy-in. As well, we were able to uncover the priorities and needs of clinicians, patients, and administrators for ICD replacement decision-making, which is necessary for proposed best practices in user-centered design of PDAs.30 The engagement of patient and family members in this process has been proposed as 1 pathway to greater success of SDM implementation.31 Finally, our experiences of involving patients and family members on the steering committee are consistent with other studies indicating that it is feasible and helpful and ensured true rather than tokenistic engagement.32

Planning for PDA implementation during the development phase will allow for preparation to address and overcome features anticipated to facilitate or hinder its uptake in clinical practice. Reasons for limited uptake in the traditional PDA “referral model” include lack of confidence in PDA content, fears of disruption in established workflows, and indifference among clinicians.10 We attempted to mitigate these attitudinal barriers by seeking feedback from clinical leaders, frontline device clinic staff, and patients with ICD replacement experience. The involvement of an administrator on our steering committee attempted to obtain support at the organizational level. Involvement of hospital administrators throughout the research process may help in addressing barriers, creating policies and practices, allocating resources, and establishing a process to monitor and assess SDM and PDA use.33

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Strengths and Limitations

To enhance the credibility of our results, we sought the perspective of multiple members of the interprofessional and interdisciplinary teams, including patients and family. Only 4 patients and 2 spouses were interviewed, and we were unable to recruit a patient who had declined ICD replacement. However, 2 patient and 1 spouse representatives contributed through their role on the steering committee, and additional acceptability/usability data will be collected from patients facing ICD replacement in the field testing phase. Data analysis was conducted by 2 team members independently. Although our findings may be limited to the local context in which the study was conducted, or other centers with similar device clinic structures and/or workflows, we enhanced transferability by providing a detailed description of the setting.

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Conclusion and Future Directions

Currently, the option of ICD replacement is rarely offered, and patient preferences for continued ICD therapy are seldom elicited. The PDA was considered a useful intervention that could support an SDM process at this decision point within the ICD pathway. Engaging patients and the interprofessional team in the PDA development process may have increased confidence in its content and willingness to integrate it into existing workflows. Preliminary effectiveness data for this PDA are currently being collected in a feasibility trial (ClinicalTrials.gov #NCT02668900). Only when implemented will we be able to determine whether our integrated knowledge translation approach was effective in overcoming barriers to PDA implementation.

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What's New and Important

  • Currently, ICD replacement is automatic without risk restratification based on clinical characteristics or patients' preferences for continued therapy.
  • An evidence-based PDA can support an SDM process by offering a formalized opportunity for clarifying patients' evolving preferences for continued ICD therapy and revising the benefits and risks of ICD therapy according to the patient's clinical risk profile.
  • An integrated knowledge translation approach was valuable to develop a PDA created by and for patients and the interprofessional/interdisciplinary team and plan for its implementation. This approach increased confidence in PDA content and willingness to integrate it into existing workflows.
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    Keywords:

    decision-making; decision support techniques; defibrillators; implantable; patient preference

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