Trials and Tribulations: Palliative Care Trial Recruitment Approaches and Challenges

In 2017, we received funding form the Patient-Centered Outcomes Research Institute to conduct a large, state-wide, randomized controlled trial to test the effectiveness of a home-based palliative care (HBPC) program within accountable care organizations. Participants were randomized to either HBPC or enhanced usual care, where physicians were provided added training and support in core palliative care practices. Originally, we planned to obtain patient referrals to the trial from primary care physicians, however we were unable to engage primary care physicians in patient identification processes. In this session we will describe the numerous trial modifications made to our trial recruitment methods and the success of each approach. Ultimately, after 20 months of trial recruitment, we had recruited just 28 patients and 10 of their caregivers. Findings from this terminated trial may inform other researchers in development of participant recruitment methods.

Grassroots Approaches To Community-Based Representative Recruitment In Multidomain Trials

U.S. POINTER is a randomized, controlled, multi-domain clinical trial to slow the progression of cognitive decline within the American population via tailored and culturally-appropriate healthy lifestyle interventions. For findings to be broadly relevant across the American population, incorporating an inclusive and robust recruitment effort has been essential to form a diverse and properly representative participant cohort. As such, the trial’s inclusive enrollment goal is 30% from traditionally underrepresented communities that include those at elevated risk for Alzheimer’s disease and related disorders. To accomplish this goal, U.S. POINTER developed and deployed a grassroots recruitment strategy in partnership with outreach specialists at each site that includes a mix of evidence-based and innovative community engagement approaches. While the COVID-19 pandemic continues to present unique challenges for recruitment, our team has been able to strategize ways to continue working within the community to support trial recruitment. An overview of these methods will be presented.

Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan

Background Addressing the global burden of multidrug-resistant tuberculosis (MDR-TB) requires identification of shorter, less toxic treatment regimens. Médecins Sans Frontières (MSF) is currently conducting a phase II/III randomised controlled clinical trial, to find more effective, shorter and tolerable treatments for people with MDR-TB. Recruitment to the trial in Uzbekistan has been slower than expected; we aimed to study patient and health worker experiences of the trial, examining potential factors perceived to impede and facilitate trial recruitment, as well as general perceptions of clinical research in this context. Methods We conducted a qualitative study using maximum variation, purposive sampling of participants. We carried out in-depth interviews (IDIs) and focus group discussions (FGDs) guided by semi-structured topic guides. In December 2019 and January 2020, 26 interviews were conducted with patients, Ministry of Health (MoH) and MSF staff and trial health workers, to explore challenges and barriers to patient recruitment as well as perceptions of the trial and research in general. Preliminary findings from the interviews informed three subsequent focus group discussions held with patients, nurses and counsellors. Focus groups adopted a person-centred design, brainstorming potential solutions to problems and barriers. Interviews and FGDs were audio recorded, translated and transcribed verbatim. Thematic analysis, drawing on constant comparison, was used to analyse the data. Results Health system contexts may compete with new approaches especially when legislative health regulations or policy around treatment is ingrained in staff beliefs, perceptions and practice, which can undermine clinical trial recruitment. Trust plays a significant role in how patients engage with the trial. Decision-making processes are dynamic and associated with relationship to diagnosis, assimilation of information, previous knowledge or experience and influence of peers and close relations. Conclusions This qualitative analysis highlights ways in which insights developed together with patients and healthcare workers might inform approaches towards improved recruitment into trials, with the overall objective of delivering evidence for better treatments.

A Scoping Review of Social Media Sites as a Tool for Clinical Trial Recruitment and Retention (Preprint)

BACKGROUND Clinical trials are an essential process in discovering new biomedical or behavioral outcomes in disease processes. There are several steps involved in creating a clinical trial. One step, patient recruitment, is often touted as the largest contributor to trial delays, which has financial, scientific, and ethical ramifications. Approximately 1.2 billion dollars in the United States is spent each year on this process and as many as 86% of clinical trials do not meet recruitment targets within their perspective timeframes, and 19% of trials had to be terminated early due to insufficient recruitment and/or patient retention1. Social media is a viable, inexpensive tool that can be utilized to improve both recruitment and retention rates2. To date, platforms such as Facebook, Twitter and others have been widely utilized in recruitment for clinical trials, communication among stakeholders, and educational tools. Social media also has the advantage of reaching populations that otherwise would be more difficult to reach3. A list of these platforms and each of their distinct advantages for clinical trial recruitment can be found in Table 1. This review aims to highlight the unique characteristics of several social media platforms and their advantageous properties in increasing recruitment and retention during clinical trials. OBJECTIVE This narrative review analyzes the current use of several social media sites in clinical trial recruitment and retention. It also offers insight concerning potential uses of these sites that are not currently utilized. METHODS A literature search was performed using PubMed, Google Scholar, and ResearchGate to access and review relevant articles published in peer-reviewed journals concerning social media and its use in clinical trials. Two independent researchers with education and experience in dermatology screened publications to select studies featuring quantitative results concerning social media and clinical trial recruitment. RESULTS 13 social media applications were studied and reviewed. 7 of these social media sites or applications have currently been studied, and their use in complementing traditional recruiting methods such as advertisements in newspapers, health fairs, and direct mailing, has been analyzed and reported. 6 additional social media applications have further been studied, and their potential use within clinical trial research has been additionally analyzed. CONCLUSIONS A large number and variety of social media platforms exist to aid in the recruitment and retention process for clinical trials, many of which can utilize niche features and reach a targeted demographic. Although recruitment remains a barrier for researchers involved in clinical trials, the potential to recruit through social media may be underutilized. Many avenues that exist to improve recruitment have not been leveraged. For example, partnering to create collaborative videos with social media influencers on platforms such as Instagram and Youtube may help to broaden the audience and increase clinical trial enrollments. Creating biomedical educational profiles or channels that discuss details of clinical trials with descriptions of these trials could also be employed to increase the scope of the audience. Reddit, Smart Patients, and Patients Like Me can target difficult-to-reach patient populations due to their use of subgroups, allowing researchers to reach their target audience. Additionally, many of these platforms provide user engagement features that allow users to respond directly to videos or posts and could be used to encourage enrollment by allowing users to react directly to clinical trial advertisements.