COVID-19 and System Access Hamper Clinical Trial Recruitment, Study Shows

The FEMuR III randomised controlled trial faced significant recruitment challenges, compounded by the COVID-19 pandemic and systemic issues within healthcare settings. A qualitative study published in Trials journal, highlighted that the pandemic forced trial recruitment to halt on March 19, 2020, with only 21.5% of the target sample (96 participants) recruited. Recruitment remained inconsistent until the second quarter of 2022 due to regional lockdowns and resource reallocation to COVID-19-related research.

Impact of COVID-19 on Recruitment

Beyond complete halts, restrictions on non-essential staff entering wards limited recruiters' opportunities. Carer and family member access was also restricted, making it difficult for patients to discuss participation with their families. Some patients were hesitant to engage in extra therapy sessions or allow healthcare professionals into their homes, primarily due to fear of contracting COVID-19.

‘COVID was already something extra to deal with. They were already really stressed. The idea of having someone else come in or something else to deal with, people just said, “No. I’m not doing that.”’ (Participant 3).

Interestingly, some recruiters noted that the trial's offer of increased social contact, regardless of the assigned arm, motivated patients during the isolation of the pandemic.

Access and Integration Barriers

Recruiters faced practical difficulties in accessing clinical notes and systems to determine patient eligibility. Variable access to clinical systems and challenges in approaching patients within busy ward environments further complicated the process. Patient turnover and movement between wards also hindered follow-up efforts due to limited system access for researchers.

The recruitment process was labor-intensive, involving multiple ward visits and duplicate paperwork. Competing priorities among clinical staff, who were often unable to assist due to ward pressures, also posed a challenge. Some recruiters felt isolated from the main trial site, with communication difficulties between acute and community sites hindering intervention delivery.

Rapport, Relationships, and Communication

Communication style, rapport, and communication skills were crucial in explaining the trial to patients. Introducing patients to research team members with whom they were already familiar facilitated relaxed conversations and trust. Reducing stress for patients by minimizing initial information or recruiting in the home setting also proved beneficial.

Relationships with clinical and clerical ward staff were key to successful recruitment. Family involvement could either encourage or discourage participation, depending on their perceptions of the trial.

Information and Knowledge Gaps

Inadequate guidance around the recruitment process led to inconsistent trial implementation across different sites. Recruiters reported that the patient information sheet was initially overwhelming, with too much information. Some felt that questionnaires covered overlapping concepts, increasing patient burden.

‘Why don't you have a little read through that, and we'll come back to you in 2 days?’ and they’re like, “I really feel rough. I'm on all kinds of medication for pain. I've just had an operation. What the hell are you asking me to read 18 pages for?”’ (Participant 7).

Addressing Perceptions of Research

Negative perceptions of research, such as patients feeling like "lab rats," and misunderstandings about randomization, also hindered recruitment. Patients with prior research experience or connections to healthcare were more likely to participate.

Explaining equipoise—the genuine uncertainty about which treatment is more effective—was crucial in reassuring patients that they would not lose out by participating. Carer reluctance, stemming from a lack of perceived personal benefit or discomfort with questionnaires, also posed a challenge.

Ethical Dilemmas and Eligibility Ambiguity

Recruiters faced ethical and moral dilemmas when deciding whether to approach patients with limited capacity, significant life stresses, or reduced life expectancy. Some erred on the side of caution, while others felt it was essential to offer all eligible patients the opportunity to participate.

Difficulty in separating clinical and research roles, coupled with patients seeking clinical input from recruiters, further complicated the process.