This theme reveals the increased demands placed on CRS due to the nature of DCTs. It highlights an increased need for organization and workload management. When discussing their roles, participants highlighted the expanding scope of responsibilities, requiring them to assume diverse roles and implement improvisations, adaptations, and flexible measures to effectively support patients.

CRS noted that remote trials create new tasks and require additional effort compared to face-to-face trials. Impacts include the need to work overtime and deal with late-night calls to address patient-facing technology issues, at times disrupting staff work-life balance:

Participants highlighted the need for heightened organization for successful DCT implementation. Increased efforts are needed during initial visits, involving addressing scheduling issues, aligning site visit resources, coordinating patient contact, and managing appointments. Sustaining communication with remote patients necessitates extensive follow-up and relies on CRS organizing frequent communication via telephone, SMS text message, and email. During a DCT, providing general patient support requires CRS to make a more conscious effort, with challenges particularly evident when supporting older participants who require additional assistance adapting to the technology. Furthermore, there is a need for the trial staff to supplement the technology experience with human interaction to bridge the technology and remote gap:

A notable shift has occurred in the trial staff’s role, which now includes training patients on technology and providing comprehensive device instructions. The evolved role involves offering technology support as well as follow-up support for seamless technology use. CRS also serve as the primary point of contact for addressing patient issues within the trial setting. Patients directly contact CRS rather than relying on trial support services, and CRS act as an intermediary between patients, sponsors, and trial technology vendors. This expanded responsibility includes addressing technology support, device-related issues, software challenges, and telephone and password problems:

Participants emphasized the need for additional technical skills to support patients when conducting a DCT. CRS point to an increased workload, exacerbated by the trial technology’s manual and laborious nature; the lack of standardization; and the need to engage with diverse, complex technologies used across the trial portfolios:

CRS highlighted the difficulties of misalignment between technology vendors, sponsors, and the practical needs of the trial site. They stressed the importance of vendors being aware of site-specific challenges and integrating site feedback to effectively address technological issues. Furthermore, some CRS felt that technology solutions emphasized administrative processes that overlook the perspectives and needs of both sites and patients, hindering trial efficacy.

CRS discussed the importance of an adaptive and improvised problem-solving approach to ensure the smooth operation of DCTs. Their approach included proactive engagement with patients beyond established trial protocols, such as unscheduled calls, check-ins, tailored email support, and providing handwritten instructions on device use. In addition, CRS described using patient diary entries and data proactively to initiate meaningful conversations in remote interactions. They highlighted flexibility and adaptability as crucial, noting the need to adjust protocol expectations, provide additional telephone support, and schedule remote visits based on patient availability. CRS indicated that they had to rely on instinct and intuition, drawing upon their professional background and experience in their approach to patients. They felt that the limitations of technology meant that they had to develop an awareness of patient patterns and trial-related behaviors:

CRS indicated that, at times, they needed to use workarounds to overcome the challenges of the provided technologies, remote interactions, and DCT limitations, including patient literacy and connectivity complications. They would circumvent the help desk by directly addressing patient needs, acting as intermediaries, and assuming help desk responsibilities, all to ensure continued patient trial participation:

Remote tools and methods can improve trial efficiency and reduce burdens [44]. However, our findings echo those of Coyle et al [15], highlighting the extra burden on trial staff when using DCT technologies. Our study underscores how the introduction of DCTs has heightened demands on CRS, necessitating additional responsibilities, burdens, and organizational efforts. Our research further underscores how CRS grapple with burdens throughout trials, similar to findings from Rogers et al [35], who identified the challenges that CRS face in providing technical support to patients during DCTs. Our study outlines how CRS roles are evolving in response to DCTs, necessitating the acquisition of additional skills to ensure trial success and effectively support patients. CRS face new challenges and must adapt to the technology focus and remote nature of these trials, at times assuming roles for which they may not be formally qualified. Rogers et al [35], who reviewed how CRS face challenges in learning to manage trials using new technologies [4], suggest that trial site teams may not have the skills to support digital clinical trials. Our findings suggest that CRS are adjusting to the demands of DCTs, a process that requires additional time and effort to ensure trial success. CRS demonstrate adaptability and resourcefulness in response to inadequate existing structures, using workarounds and instinctive strategies. Our findings indicate that DCTs do not fully cater to CRS needs during the trial and may restrict their ability to perform their roles as they envision them. However, these necessary adaptations may bring about negative consequences and disrupt workflows, have unintended side effects, change trial approaches, and lead to potential adverse impacts.

CRS discussed the growing expectation that patients will assume more responsibilities in DCTs compared to traditional trials. Participants discussed how patients are expected to undertake tasks such as frequent diary entries, which can become overwhelming. Patients are expected to manage trial-related technology tools, with technology vendors assuming that patients have a comprehensive understanding of the technical hardware and software:

CRS noted challenges in supporting patients from specific demographic groups, particularly regarding their varying comfort levels with technology. They observed a lack of familiarity and technological literacy challenges, especially among older participants, which posed barriers during a DCT. The disparity between technology solutions and patients’ technical proficiency impacted their ability to operate devices and participate effectively in DCTs:

Participants described the emotional impacts on patients due to the decentralized and technology-mediated nature of DCTs. Frustration with these trials influences the overall patient trial experience and can even lead to withdrawal of consent. CRS observed that patients, particularly older adults who face heightened demands due to the nature of DCTs, experience emotional strain, leading to feelings of being overwhelmed, diminished confidence, anxiety, and increased stress:

CRS noted that the nature of DCTs could undermine the development of trust with patients. The limitations of, and the absence of interpersonal interactions in, technology-mediated communication can hinder the trust-building process between CRS and patients, contrasting with on-site trial experiences. Consequently, patients may feel more like trial subjects than individuals receiving personalized care. CRS highlighted how some patients had indicated that they preferred conventional trial methods, which exacerbates the challenges faced by trial sites:

Conversely, some CRS highlighted how DCT experiences with more comprehensive remote monitoring technologies can reassure patients, positively impacting their well-being during the trial. Patient perception and awareness of efficient trial staff monitoring provide reassurance. Regular informed data reviews with CRS can also reassure patients, boosting their confidence and trust in the CRS and technology used as part of a DCT:

CRS discussed the challenges that patients face with trial technology, which make the DCT process harder. These include difficulties with device use, connectivity problems, malfunctions, usability concerns, and Wi-Fi–related issues, leading to increased burdens and hindrances for patients and CRS during the trial experience:

Advocates for DCT tools and techniques emphasize their potential to alleviate patient burden in trials [44]; for example, Dorsey et al [45] suggest that data collection becomes passive for patients using DCT technologies. These technologies can also allow CRS to monitor patients’ symptoms and provide informed feedback, which can reassure patients. However, similar to Cummins et al [46], our study suggests that DCTs impose additional expectations and responsibilities on participants. Previously, Moser et al [47] suggested that personal, emotional, and psychosocial factors significantly influence patient attrition in clinical trials. Trust is a pivotal component of both person-centered care [48] and patient-centered care [31]. It facilitates patient participation in research [49] and enhances retention [15,50,51]. Our findings highlight several adverse emotional impacts observed in patients during DCTs, including feeling overwhelmed and frustrated, with a notable impact on patient trust. Our findings challenge the suggestions that DCTs reduce patient burden and promote a patient-centered experience and indicate the potential for negatively impacting patient retention.

We identified an overarching superordinate theme (Figure 1) based on consistent observations made by CRS. The limited quality and frequency of interactions between patients and CRS, stemming from the remote, technology-mediated nature of DCTs, emerged as a central organizing concept in our analysis. This limitation impacts several important components of patient-CRS interactions, serving as a primary obstacle to effective patient management, support, understanding, and care. Three main themes were identified within this superordinate theme, and these are outlined in the following subsections.

Theme 3 discusses how carrying out a trial in a remote or decentralized manner has implications for how CRS understand patients and their experiences. Our data highlight the efforts needed to overcome barriers to comprehending patient experiences, accessing relevant data, enabling effective monitoring, and the instrumentalizing of communication.

CRS noted that the lack of direct patient oversight in DCTs limits their ability to monitor and understand patients and their experiences throughout the trial. The constraints imposed by DCTs contribute to challenges in understanding the patient’s experiences beyond protocol adherence as well as hinder timely assistance and support. Unlike on-site interactions, DCTs provide fewer insights into patient experiences, and CRS face challenges in monitoring medication adherence, which they perceive may be carried out more effectively during traditional, in-person visits:

Remote interactions in DCTs present challenges in obtaining important patient information and understanding. Prompts from the patient are needed to understand when they are having issues. The absence of informal dialogues and in-person interactions hinders CRS awareness of pertinent patient details, affecting the evaluation of patient conditions and the timely recognition of changes in patient conditions:

CRS depend on patient questionnaires to identify issues and comprehend patient needs. However, the types of data collected compromise CRS awareness of patient conditions and hinder informed discussions, evaluations, and individualized feedback, posing challenges in tailoring support. The limitations in technology-driven reports diverge from traditional trial site insights, impacting the depth of support provided. The remote and technological nature of DCTs delays CRS recognition of patient needs and hinders the delivery of comprehensive support. CRS also encounter challenges determining when to initiate patient contact and providing timely support beyond trial protocol expectations and data collection requirements. Establishing communication with remote patients is challenging and complicates the trial staff’s role, leading to additional stress. It requires concerted efforts to connect and coordinate schedules between CRS and patients, and it is common for patients to be unresponsive to calls or messages.

The participants highlighted the complexity involved in analyzing, identifying, and understanding the collected trial data, which made related tasks laborious. Limitations in technologies for data observation and analysis in DCTs can lead to delayed issue detection, burdensome data processes, and insufficient reports or insights to support patients. Some CRS reported relying on informal methods, such as using Microsoft Excel, to analyze patient data and identify changes or symptom patterns. They also noted a time lag in patient compliance awareness and challenges in acquiring real-time data:

CRS praised the advancements in DCT technology for enabling remote patient monitoring, including tracking patient progress, medication adherence, and symptoms. This capability empowers CRS to identify concerns and manage patients. In addition, technology centralizes data and documentation, streamlining access and facilitating longitudinal comparisons of patient information. Furthermore, some technologies enhance staff-patient interaction by providing insights into patient patterns, thereby informing and enabling more effective communication. Notifications enable timely interventions, and data readings enable analysis, both ensuring patient safety and well-being through remote monitoring:

CRS highlighted that patient contact in a DCT is primarily prompted by formal problems, such as compliance concerns, irregular diary entries, and compliance or data discrepancies, which then necessitate site follow-up. Our data highlighted how remote visits focus solely on a business-only and data collection approach. Structured assessments during remote visits, centered around specific questions, reinforce this formal, data-centric dynamic, resulting in a lack of casual conversation and personal connection opportunities and restricting the interpersonal relationship between CRS and patients:

Research has shown that effective patient care depends on the trial staffs’ ability to understand and respond to individual experiences [52]. Fogel [53] outlined the significance of the trial staff’s ability to maintain awareness of participants’ feelings throughout the trial process. Our research suggests that DCTs pose barriers for CRS in understanding patients and their trial experiences, stemming from the absence of direct patient oversight and the constraints of technology-based interactions. These limitations hamper the trial staff’s ability to fully understand the patient’s needs. The crucial role of CRS in supporting patients’ experiences and the gap in understanding patients’ experiences in DCTs leads to a disparity in effectively supporting patients throughout such trials. CRS discussed how DCTs necessitate a business-oriented, data collection approach during remote patient interactions, particularly during communication driven by trial protocols. They noted how a lack of patient compliance is the primary trigger for reaching out to patients outside of established protocols. These instrumentalized communication approaches may diminish their sense of autonomy, and this depersonalization can adversely affect patient satisfaction, motivation, trust, patient outcomes, and participation. It is important to note that our study emphasized how some DCT technologies can facilitate enhanced patient monitoring. These findings resonate with those of Coravos et al [54], showcasing how DCT technologies enable real-time symptom alerts [55,56] and provide pertinent patient data and information on study activities.

Theme 4 discusses the impacts of DCTs on forming and maintaining CRS-patient relationships. It examines the dynamics surrounding these relationships during DCTs, addressing challenges in connection building, developing interpersonal bonds, and the various ways in which these relationships are cultivated.

Several challenges were identified in building and maintaining relationships, including limitations in developing connections with patients due to the remote nature of DCTs. CRS highlighted that the absence of face-to-face interactions at trial sites poses hurdles in establishing meaningful connections. Unlike traditional on-site trials, DCTs present more significant challenges due to limited interactions, removing opportunities for creating positive rapport and impeding the formation of the typical bonds developed during on-site trials. Participants also discussed issues with DCT technology functionality, pointing to a lack of dedicated mechanisms to support the interpersonal dynamic between the trial staff and the patient:

CRS noted that jointly navigating technology challenges with patients fostered camaraderie through increased interaction during remote technological issues. Increased interaction with patients during their health challenges allows CRS to provide assistance, strengthening the CRS-patient relationship. Furthermore, trial data and readings collected using patient-facing technology provide CRS with patient insights and serve as a focal component, contributing to personalized insights and calls and, in turn, supporting relationship development. Relationships are further enhanced by personalizing patient information, proactively providing tailored support notes, engaging in conversations about personal matters, staggering interactions, and showing genuine interest:

CRS discussed how patient interactions and technology limited personalization and hindered interpersonal connection, resulting in an impersonal and generic patient experience. They discussed various issues affecting the connection and bond with their patients, which could potentially lead to patient attrition. They highlighted the limited opportunities to build rapport, develop lasting connections, and enhance interactions, particularly due to the challenges of maintaining a connection remotely without past interactions or shared experiences with patients. By removing in-person engagement, DCTs and technology-driven experiences may leave patients feeling a lack of human care, fostering a perception of trials as cold and impersonal. Simultaneously, SMS text message and telephone interactions, prioritized for efficiency, may further diminish emotional understanding due to their brevity:

CRS noted that DCTs can contribute to a sense of estrangement for both CRS and patients. Remote patients risk being reduced to numbers in the system, and CRS may overlook them due to on-site priorities, potentially leaving them feeling neglected. CRS also expressed concern about the absence of individualized attention for patients and the challenge of providing personalized care in remote trials:

CRS discussed how questions arise regarding patient concerns for their data, utility, and overall contribution to the trial. Patients’ perception of their data disappearing into a void and their limited understanding of where the data they provide go and how these data are used raises questions about the value and meaning of their participation, as does the limited positive feedback to patients through technology. CRS acknowledged the importance of on-site face-to-face interactions, which allow for direct communication, enabling them to assess patients’ comfort levels, provide tailored support, build connections, and focus on their needs, fostering a humanized approach to care. Some technologies support CRS, and for those with access, video platforms help replicate the in-person experience, enabling the delivery of person-centered care remotely.

The relationship between CRS and participants is crucial for fostering positive trial experiences [57]. Similarly, the relationship between patients and their health care professionals is fundamental to the concept of patient-centered or person-centered care [27]. Relationships are not merely psychological concepts; they are integral to human motivation and self-determined behavior [58] and serve as a cornerstone for retaining participants and sustaining their motivation throughout a trial [59]. Mohr et al [60] highlight the correlation between CRS fostering personalized relationships with patients and increased treatment adherence. Personalization can enhance relatedness [58]. Fogel [53] highlights the significance of personalizing clinical trial interactions to support a successful trial’s execution. Similarly, de Silva [61] underscores the importance of personalization as a critical component of the person-centered care concept. Our findings highlight how DCTs can negatively impact the formation of relationships and interpersonal connection between CRS and patients and restrict opportunities for personalization and connection. DCTs face considerable hurdles in both motivating [59] and maintaining a patient-centered experience due to the indispensable role of human connection in care [62] and staff traditionally enabling the patient experience [40]. The challenges in relationships, interpersonal connections, and personalization stem from technological limitations, remote constraints, and limited human connection. DCTs struggle to replicate the vital human element necessary for delivering patient-centered trial experiences. As a result, DCTs will face challenges in adherence as well as in effectively motivating, engaging, and retaining patients.

Theme 5 explores the challenges for CRS in delivering the desired support and care to their patients. This theme underscores the difficulties that CRS face in achieving their intended level of support, highlighting intricate and multifaceted challenges in addressing diverse and individualized patient needs.

CRS voiced concerns about the patient centricity of DCTs, noting a misalignment with patient-centered principles. Some believed that these trials prioritize data and project management over patient needs, hindering a patient-centered experience. The limitations of DCTs restrict the trial site’s ability to support a patient-centered experience compared to traditional on-site approaches:

CRS noted challenges in maintaining patient care in the DCT setting, which impacted clinical support and posed potential barriers to fulfilling care roles. Some CRS did not view DCTs and remote approaches as synonymous with patient care. Delivering care through short, remote calls using technology was considered challenging. CRS expressed uneasiness about perceived care levels, with concerns that patients might question the care provided in a DCT. On-site interactions were deemed more impactful for personalized, in-person engagements, contrasting with remote DCTs, which raised concerns about patient safety and the appropriate use of investigational products, requiring a delicate balance in maintaining patient interactions:

DCTs and remote settings hinder CRS from fully understanding and addressing patients’ emotional and psychological well-being. Participants revealed challenges in offering emotional support to patients and perceived that patients may interpret this as a lack of empathy, validation, and acknowledgment from the site, potentially straining empathetic connections:

CRS face various challenges in providing technical and troubleshooting support. Among these are inadequate site support capabilities for executing remote technical assistance, which make it difficult for CRS to guide patients remotely and lead to delays in resolving support issues:

Inadequate help desk support presents challenges for patients, who experience poor response times to their issues, leading to frustration for both patients and CRS. As a result, CRS are often forced to take on help desk roles or refrain from using the help desk altogether. This results in a misalignment between the support provided and patient requirements. Some CRS also expressed frustration at being expected to perform technical support tasks for which they are not qualified. These inherent challenges contribute to trial staff frustration amid the myriad of issues they encounter:

Our study highlights the challenges of a reactive trial staff support model in DCTs, in which patients typically initiate contact during challenging personal and technical situations. Some CRS described this model as reactive in nature, resulting in crisis management rather than proactive intervention. CRS identified challenges in comprehending and addressing patient support needs, often experiencing delays in recognizing the intricacies of patient needs. Participants discussed challenges with timely communication and follow-up support mechanisms, compounded by limited patient availability and unresponsiveness. These factors delay patient communication and hinder the trial site’s ability to provide timely support:

Furthermore, CRS encounter challenges during onboarding and initially educating patients regarding trial requirements, particularly in ensuring their competence with technology, processes, and tools. Participants noted that the onboarding process can be challenging and time consuming, remote education further complicates support, and real-time assistance is lacking. Overall, CRS emphasized the effectiveness of on-site support, highlighting its advantages in providing comprehensive and interactive assistance to patients compared to remote methods.

At the core of the patient-centered trial concept is the need to address each patient’s individual needs [12]. Research by Moser et al [47] highlights the importance of addressing patients’ personal, emotional, and psychosocial aspects to enhance retention in clinical trials. Similarly, Ferrell et al [63] emphasize the critical role of compassion and nonphysical support for trial patients. Furthermore, Keshtkar et al [64] demonstrate that empathy enhances patient satisfaction with their care and contributes to favorable patient outcomes. Interconnected support components are crucial in DCTs to ensure successful troubleshooting, uphold data integrity [65], and maintain clinical support aligned with good clinical practice [66]. In addition, fostering patient competence is essential for retention [59] and continued motivation [58]. Johnson and Marsh [67] highlight the challenges involved in supporting the practical trial needs of patients, and Polhemus et al [68] support patients’ technology needs. Our study supports these insights and outlines the challenges that CRS face in supporting patient needs within a DCT context, emphasizing the limitations imposed by site capabilities and technology in offering adequate support in their absence.

Some CRS outlined several ways in which DCTs benefit patients, enhancing their overall experience. These included ease of participation and increased eligibility due to reduced barriers. By minimizing logistical burdens, such as travel to clinic visits, DCTs help patients alleviate stress and avoid exposure to potential hospital-acquired infections. CRS perceived that patients appreciated being in the familiar environment of their homes, which is especially beneficial for those considered vulnerable, with family members and caregivers also experiencing reduced travel demands. In addition, some CRS viewed DCTs as enabling greater participation and convenience, especially among younger patients who welcome the reduced need for on-site visits and tend to prefer digital diaries over paper diaries:

Moreover, some CRS perceived DCT technologies as empowering for patients, involving them directly in health monitoring and fostering control and understanding of their health through measurements and insights, instilling a sense of ownership in patients. Remote health monitoring enabled by certain DCT technologies allows CRS to collect factual and relevant patient data, which are then used to enhance the support they provide patients. Regular data reviews reassure patients and improve monitoring and support effectiveness. Some CRS felt that DCTs were seen to enable flexible and efficient trials, saving time through quick assessments, remote communication, and information sharing, while telehealth was viewed as effective for assessing patient concerns and reducing paper-based processes, thereby improving trial efficiency:

CRS outlined the multifaceted impacts and challenges affecting patient trial participation. These include reduced patient comfort in opening up during conversations and a reluctance to share important health updates or concerns. Compliance with the trial protocol is impacted, with missed diary entries, for example, necessitating significant site efforts to re-engage patients. CRS also noted compliance being affected by technology issues and slow site responsiveness. Furthermore, delays in accessing patient data affect CRS ability to identify noncompliance. Conversely, on-site care and monitoring can aid patient adherence to protocols. CRS perceived lower patient engagement, responsiveness, and commitment levels in DCT settings. The DCT approach may impact patients’ understanding of study details and their willingness to participate in future trials because some patients decline trial involvement due to technological reluctance and their unfamiliarity with site staff. DCTs also impact accountability, responsibility, and patients’ understanding of their roles, with obstacles such as forgetfulness and non-responsiveness further impacting participation. In addition, ongoing consent and retention may be affected, and challenges faced during DCTs could lead to higher dropout rates:

Minimizing patient burden is crucial for retaining patients in trials [50], and DCTs promise to reduce patient burden [7]. Logistical hurdles such as travel time and distance to trial sites pose significant barriers to patient participation [69]. DCTs address these challenges by offering convenience and flexibility [65,70]. Our research suggests that CRS perceive DCTs as providing enhanced ease of participation, reduced logistical burdens, time savings, and, in some cases, increased patient control over their health—findings that align with previous research. The benefits inherent in these measures give patients autonomy, allowing them flexibility, convenience, and empowerment—enabling them to exercise volition over their health and ownership of their trial experience. The importance of supporting autonomy cannot be understated because patient autonomy is regarded as an ethical mandate in medical research [71] and a vital factor in sustaining motivation [58]. However, our study also suggests that CRS perceive DCTs as having detrimental effects on the conduct of trials, affecting retention [72], accountability [71], and understanding of patients [73], all of which are crucial to successful clinical trial outcomes.