The Burden of a Remote Trial in a Nursing Home Setting; A Qualitative Study

Abstract

Background: Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. Objective: The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. Methods: Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities coordinator , and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. Results: Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. Conclusions: A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.

A systematic review of methods used to conduct decentralised clinical trials

“…While several sources suggested how DCTs may impact or be perceived by other stakeholders, such as usual healthcare providers, payers, regulators and ethical review boards, only 2 contained specific quotations from stakeholders other than participants and researchers (including pharmaceutical industry representatives). A qualitative study of a remote trial in a nursing home described in detail the specific burdens of the trial on nursing home staff in terms of comprehension, time, communication, emotional load, logistical burden and product accountability 77 . In a public‐facing online magazine article, a Food and Drug Administration (FDA) representative was quoted as having written, “ The FDA is open to innovative trial designs that create efficiencies, serve the needs of patients while protecting their interests and safety, and create data that will be fit for use for regulatory decisions ” 82…”

“…Value Suitability for research question Not suitable for all research questions 86,94,100,104,110 Risk to research quality Difficulty ensuring eligibility 60,105,111 Lack of suitable devices to collect data remotely 74 Lack of researcher control over data collection 94,112,113 Risk of poor comprehension of study purpose by participants and resulting in reduced adherence 49,72,77,80,94,105 Commercial value of research Lack of involvement of prescribing physicians in research may reduce familiarity of product and post-approval sales 106 Burden Increasing the burden of trial participation Reduced participant choice 72,94 Limited communication opportunities 72 Financial cost of technology use 51 Volume of trial activities 66,77,93 Complexity of trial activities 47,60,81 Burden of wearing and charging devices 65,77,81 Emotional burden of responsibility for trial conduct 77 Lack of in-person support 107 a few acknowledged a potential to simply transfer the burden of trial activities from site-based study staff onto individual participants; for example, "Burden factors unique to remote study protocols include, for example, the imposition of recurrent performance of home-based tasks or requirement for consistent reporting on symptoms and drug intake times" 66 and "Participants having to activate, charge and wear the digital sensors for long hours may be a significant obstacle to success of the virtual trials". 65…”

“…A qualitative study of a remote trial in a nursing home described in detail the specific burdens of the trial on nursing home staff in terms of comprehension, time, communication, emotional load, logistical burden and product accountability. 77 In a public-facing online magazine article, a Food and Drug Administration (FDA) representative was quoted as having written, "The FDA is open to innovative trial designs that create efficiencies, serve the needs of patients while protecting their interests and safety, and create data that will be fit for use for regulatory decisions". 82…”

“…Thirteen sources contained qualitative data on participant experiences or opinions of DCT methods gained from participant satisfaction questionnaires. 25,34,47,65,[67][68][69][70][71][72][73][74][75] Fourteen had subjective assessments of participant experience, 30,34,47,51,[72][73][74][75][76][77][78][79][80][81] e.g., "The teleconsultation visits were well received by the patients in both the decentralised and conventional settings, especially when an effort was made to arrange calls outside the participant's working hours." 81 Only 3 sources contained verbatim quotations from patients or participants including experiences or opinions of DCTs 33,69,72 ; these are summarised in Table 7.…”

“…Increased burden on trial staff Challenges in providing technical support to participants 60,77,80,81,95 Learning to manage trials using new technologies 104,106,114 Higher cost of trial conduct Initial investments in equipment and training 77,94,106 Unforeseen costs 80,81,106 Safety Risk of physical harm to participants Potential for inappropriate/unsafe administration of trial medicines 111 Risk of harm to autonomy Lack of face-to-face interaction to check understanding 60,94,111 Loss of protective doctor-patient relationship 111 Potential for breach of confidentiality Home delivery of trial materials may be identifiable 73 Vulnerability of electronic data transmission 60,72,96,105,107,114 Risk of harm to patients Implementation of healthcare interventions based on potentially inaccurate research findings 111 Equity Excluding groups of potential participants Differential technological barriers 80,91,115 T A B L E 6 Summary of decentralised clinical trial (DCT) facilitators and barriers…”