This was a qualitative study, using semistructured interviews to explore individual perspectives on barriers and facilitators to RM of CIEDs and patient engagement. This study adhered to the COREQ (Consolidated Criteria for Reporting Qualitative Research) [11] checklist for study execution and subsequent reporting.

We used the theoretical domains framework (TDF) to understand barriers and enablers through an implementation science lens. The TDF is comprised of 14 domains and 84 constructs to bring together many behavior-change theories. It was designed to bridge the gap between behavior-change theory and various medical disciplines, making it both accessible and applicable to a wide range of health care professionals [12].

We adopted a hybrid approach, combining postpositivist principles and codebook thematic analysis [13]. This approach recognizes that knowledge is never fully objective but integrates procedures to ensure rigor. Consistent with this perspective, we acknowledge that all observations are shaped by the researcher’s perspectives, assumptions, and contexts, which are tentative and subject to revision. The research team was composed of cardiologists (CC, AL, SL, AS, and KC), a doctor-in-training and PhD student (BS), clinical researchers (ETO, CC, AL, SL, AS, and KC), and a digital health expert (TS). Researchers (BS, EO, CC, and TS) have experience conducting qualitative research, while clinician-researchers (CC, AL, SL, AS, and KC) have clinical cardiology experience. Interviews were conducted by the lead researcher (BS). Participants were aware that the interviewer was a PhD student and doctor-in-training; however, they had not met him prior to their interview.

Between July 2022 and April 2023, we identified stakeholders (cardiologists, cardiac physiologists, nurses, and patients) who either used RM or were involved in analyzing and deciding on appropriate action for the data or alerts received via CIED RM. All stakeholders were based in Australia. Australia’s health care system combines Medicare, which provides universal public coverage, in parallel with private insurance for additional services. Stakeholders were recruited from 5 hospitals providing CIED and at least some RM services to urban and regional areas of New South Wales, Australia: Westmead, Wollongong, Royal Prince Alfred, Concord, and John Hunter. Stakeholder eligibility criteria included being 18 years or older and English speaking. Patient-specific criteria included currently having a CIED in-situ, which is undergoing RM. Cardiologist-specific criteria included being a consultant, public hospital or private practice-based, and managing at least one patient currently receiving RM. Cardiac physiologist and nurse-specific criteria included managing at least one patient currently receiving RM and public hospital or private practice-based.

Specific interview guides (Multimedia Appendix 1) were developed based on the stakeholders being interviewed (cardiologists, cardiac physiologists, nurses or allied health clinicians, and patients). The interview guides explored (1) stakeholder perspectives on the barriers and facilitators of CIED RM and (2) patient engagement with CIED and overall cardiovascular disease (CVD) management. Additionally, participant demographic data were collected verbally at the beginning of each interview. To develop the interview guides, we conducted a comprehensive literature review, identifying relevant studies on patient perspectives and existing interview guides used in similar studies. Interview guides were further refined after consulting with a cardiologist and conducting pilot interviews to ensure that questions were clear, comprehensive, and appropriate for the target audience. Potential clinical participants (cardiologists, cardiac physiologists, and nurses) were identified through snowball sampling conducted by the principal investigators and clinical staff from each site, then invited to participate either via email or in person. Patients were identified through convenience sampling by site clinicians and were invited to participate via phone call or in person. There were no dropouts, and all participants who were approached agreed to partake in the study. Participants consented either electronically or verbally prior to study commencement. All interviews were conducted either over telephone calls or in person at a CIED clinic with only the researcher present. The interview duration ranged from 15 to 45 minutes. We continued to conduct interviews until the researcher judged that the dataset was sufficiently rich to meaningfully address the research question, conducting 35 interviews in total. This number exceeds the sample adequacy range suggested by Hennick and Kaiser, supporting the sufficiency of our sample. Interviews were audio recorded and transcribed verbatim, without field notes being taken. Participants did not receive a copy of the transcript to review or provide feedback on study findings.

Interview transcripts were uploaded to NVivo (version 14; QRS International Pty Ltd) software. Two investigators (BS and EO) analyzed using a hybrid approach, combining the benefits of an inductive thematic analysis with a deductive approach [14] to represent the data in a generalizable way using the TDF (Figure 1).

Data were analyzed in an iterative process. Initially 2 researchers (BS and EO) read and reread the first 5 transcripts and coding fragments relevant to the research question. The codes were reviewed, discussed, and deliberated between investigators (BS and EO) to compare the data interpretation. The deliberation aimed to ensure we had comprehensively covered all aspects of the research question, to explore any potential nuances in the interpretation, and resulted in the initial codebook development. One investigator (BS) continued the analysis of the remaining transcripts. This process was continually reviewed with refined versions of the codebook reviewed by the investigator (EO). This process enabled a transparent and rigorous approach to coding while remaining sensitive to the inductive and interpretive nature of the analysis.

Using a deductive analysis approach, codes were then matched to the appropriate TDF domains. This process was reviewed, discussed, and deliberated between investigators (BS and EO) until consensus was reached and consistent.

One investigator (BS) used an inductive analysis approach to develop subthemes from the codes before developing overarching themes [15]. Themes and subthemes were generated from codes across all participants, rather than stratifying by stakeholder title (cardiologists, cardiac physiologists, nurses, and patients). This process was reviewed and discussed between investigators (BS and EO) until a consensus was reached, resulting in the final data output.

In the inductive phase, we ensured rigor by using structured codebooks and multiple coders to independently code the same data. The coders discussed their interpretations to refine and align them, ensuring consistency in the analysis while preserving the interpretive flexibility of the approach. In contrast, in the deductive phase, we applied the TDF to categorize themes. To ensure consistency and coherence in this process, we compared interpretations and reached a consensus on domain alignment. This collaborative approach helped enhance the reliability of our deductive analysis while respecting the interpretive nature of qualitative research.

Ethics approval was granted by the Western Sydney Local Health District (2022/ETH00271). All participants provided informed consent to partake in the study prior to data collection and were informed that they could withdraw from the study at any time. Participants were assigned a study ID and had all data deidentified. No form of compensation was provided to any participant for their involvement in the study.

A total of 35 interviews were conducted between July 2022 and April 2023. In total, 16 of the interviews were conducted with patients, 10 with cardiologists, and 9 with cardiac physiologists and cardiac nurses. The mean patient age was 73.1 (SD 10.7) years, and the majority were male (n=12, 75%) and born in Australia (n=12, 75%). Pacemakers (n=8, 50%) were the most common CIED type, and the mean duration of RM was 4.3 (SD 2.6) years. The mean cardiologist age was 46.2 (SD 6.3) years, and the majority were male (n=9, 90%), subspecialized in electrophysiology (n=7, 70%), had a mean duration of 12.3 (SD 6.6) years as a cardiologist, and a mean duration of 7.7 (3.6) years managing patients with RM. The mean physiologist or nurse age was 36.6 (SD 9.4), and the majority were female (n=5, 56%), and had a mean duration of 4.3 (SD 2.6) years managing patients with RM. Participant demographic and clinical experience results are presented in Table 1.

We organized our results into themes and subthemes. Themes and subthemes are summarized in Figure 2, with subthemes and codes described below. One theme was deemed an enabler, and 4 barriers to RM. Illustrative quotes for each subtheme and code are presented in Tables S1-S13 in Multimedia Appendix 2.

Subthemes were categorized into 6 TDF domains. The subthemes “RM improves CIED and CVD management,” “RM enhances the emphasis on patient-centered care,” and “CIED data sharing with patients” were developed within the Beliefs About Capabilities domain. Subthemes “Insufficient funding for management of RM service” “Insufficient staffing for management of remote monitored,” and “Remote monitoring access inequity” were developed within the Environmental Context and Resources domain. The subtheme “Remote monitoring alert burden” was developed within the Beliefs About Consequences domain. Subthemes “Inconsistencies in interpreting and managing RM alerts” and “Inadequate patient postimplant knowledge” were developed within the Knowledge domain. The subtheme “Patient anxiety associated with remote monitoring” was developed within the Emotions domain. Finally, the subthemes “Need for alert management guidance” and “Need to improve patient engagement with alerts” were developed within the Goals domain.

RM of CIEDs offers significant advantages for individuals with CVD; however, there is still a large scope for improved implementation. This study provides a current multidisciplinary perspective on RM implementation and a framework of barriers and enablers to address for improving future implementation and scale-up. We identified 5 main themes representing the barriers and facilitators to CIED with RM use. These themes are mapped to 6 domains of the TDF, which can inform targeted interventions to enhance implementation and maximize the potential benefits of CIED RM.

Across the themes, there was a reinforcement of the benefits of CIED RM directly to the patient in both improved efficiencies in health care delivery and improved health outcomes through early detection of issues, prevention of hospital admissions, and better provision of care to rural or remote patients. These perspectives are corroborated by several recent studies which have demonstrated that RM enables earlier detection of actionable alerts [16], improves outcomes including reduced inappropriate shocks [17], decreases rates of strokes [16], and reduces mortality rates demonstrated in the pooled analysis of 3 RCTs using continuous RM [18]. Furthermore, improvements in health care service utilization have been demonstrated with reduced emergency department presentations [19], hospital admissions [20,21], and hospitalization length-of-stay times [21]. However, in patients with heart failure, RM has not consistently demonstrated benefits in mortality and heart failure hospital readmissions [22].

In total, 3 of the 5 themes identified centered on patient engagement, understanding, and perceived utility. Across subthemes, it was identified that RM enhances the focus on patient-centered care (offering a user-friendly service, minimizing in-person reviews, correlating concerns with CIED data, and extending the service to patients who would otherwise lack such care) and enhances the patient’s sense of care. This is underscored by expressions of patient satisfaction, appreciation, reassurance, and an improved sense of safety in managing their CIED and CVD. These observations align with prior studies that have consistently shown positive outcomes in terms of patient satisfaction [23,24], acceptance [25], and an enhanced feeling of safety [23,24,26].

However, resourcing and an inadequate recognition of the tasks arising from RM, as well as the skills and training needed to manage alerts, were consistently identified as barriers to CIED RM. Lack of funding and appropriate reimbursement schemes have also been seen as a prominent barrier in European and North American countries [6,27]. While a recent meta-analysis has demonstrated that CIED RM is a cost-effective intervention for health care systems [28], current models of care do not yet account for the additional tasks that arise from RM implementation, particularly those associated with alert management. Staff described alert management as comprising multiple additional phone calls, troubleshooting connectivity issues, alert triage, and scheduling in-person reviews [29]. Many staff and health services are not recognized for the increased workload associated with RM [27], which may be expected to rise with the increasing complexity of CVD, the complexity of technology, and the number of CIED implants.

RM data management was also consistently identified as a challenge to RM implementation. The “alert burden” associated with nonclinically significant alerts was particularly called out as a process management challenge. Contributing to this was the generalized nature of alert parameters, the discrepancies between alert interpretation, and the lack of clinical appropriateness guidance. Potential risks could also arise if the “alert burden” arising from “nonactionable” alerts jeopardizes patient care through the missing of time-critical alerts, a phenomenon described as “alert fatigue” [30]. Consequently, clinicians have expressed the need for the standardization of RM data management from the guidance of a national expert consensus panel. This call for RM standardization processes is not novel to this study, with multiple recent studies identifying the growing alert burden and need for guidance on standardized improved management approaches [6,31,32]. Recently, an international expert consensus statement was created by the Heart Rhythm Society and other large cardiac organizations to provide guidance for device clinics and clinicians on managing CIED follow-up, with some recommendations on operationalizing RM follow-up; however, this guidance lacks specificity on how to react to clinical issues detected via CIED RM [1]. In this study, some clinicians reported that their respective hospitals had instituted internal protocols for managing RM data, yielding positive outcomes in workload management without compromising patient care. Given the clinician’s desire and potential benefits of a standardized approach to RM data management, improved clinical guidance on RM data management is required.

Insufficient post-CIED implant education was a key barrier identified across stakeholders. This study identified that many patients believe they do not receive adequate information, both peri-implant and upon discharge. This is in line with previous studies that have identified that patients have a substantial deficit in their CIED knowledge, despite having a strong desire to receive more information, specifically around restrictions on daily living and how to deal with device-related issues [8,9,33]. Clinicians noted that limited understanding of the technology by the patients can prevent the uptake of the RM service and increase patient anxiety living with a CIED. Despite this concern, clinicians noted that patient education is not enforced nor standardized, with variation seen in the provision of information due to factors such as CIED type, insurance status, CIED manufacturer, and clinic staff availability. Large language models show potential in addressing gaps in patient education for general cardiac risk factors [34]; however, further training is needed before clinicians can trust their ability to enhance understanding and engagement for patients with CIED [35]. Future co-design studies with key stakeholders are required to develop an effective and efficient program to allow adequate and standardized patient education, without significantly increasing clinician workload.

Finally, patient engagement with CIED management emerged as a prominent theme across stakeholders. CIED RM has the unique opportunity to better engage patients with their CVD management through the frequent transmission of cardiac data. Clinicians outlined that a future goal for RM is to better engage patients with the alerts received, through early contact on “actionable alerts.” A potential modality proposed by stakeholders for this engagement is through a digital tool such as an SMS text messaging platform or app, where patients could access their data or alerts and communicate with their health care team. Clinicians had mixed beliefs on the utility of data sharing with patients, with some believing that it would positively increase engagement, while others are concerned it would increase patient anxiety and clinic workload. Patients believe that if data or alerts were to be provided to them, it would need to be presented in a user-friendly format. Previous studies focusing on CIED RM data interoperability with patients found that the data shared should be simplified, yet informative [36], be personalized and accompanied with informational support [37], and can ultimately enhance shared decision-making without increasing clinical workload [38]. Whilst CIED data sharing with patients may improve patient management, the feasibility of this technology is yet to be thoroughly explored.

The strength of this study is the involvement of both patients and multidisciplinary clinicians, thus providing a comprehensive perspective of CIED RM barriers and enablers. The study also mapped the elicited themes and subthemes to behavior change techniques, which can be used to target actionable strategies for future adaptations to improve the RM service. However, this study has some limitations that need to be considered. First, participants were only recruited from New South Wales, Australia, with most included patients located in metropolitan and regional areas. However, the included multidisciplinary clinicians also serve patients from rural and remote regions and thus have a strong understanding of the barriers and enablers of the RM service in these areas. Second, the approach to participant recruitment used convenience sampling, which may limit the generalizability of our results. Despite this, the participant population sampled is varied in their backgrounds, with patients having a wide spread of CIED types and indications for CIED implants, and clinicians having an appropriate mix of genders, occupations, and subspecializations for cardiologists. Thereby, the collected information is insightful and likely applicable to the wider population when informing future research and clinical directions of RM.

This study highlights the benefits and challenges of CIED RM from the perspectives of patients and multidisciplinary clinicians. It emphasizes both the role of the patient with themes centering on patient engagement, education, and benefits, as well as that of multidisciplinary clinicians challenged by the wealth of data, alert burden, and complexity of tasks arising from RM. The findings can serve as a roadmap to action to guide the continued development and implementation of RM services into the future. It seems clear that there is great potential for patient and health system benefits from the implementation of good systems for RM, but we are not there yet.