Recruitment Challenges and Strategies for Multimodal Intervention Trials

Determining ways to improve hip fracture recovery in older adults is important, however recruitment of this target population into clinical trials is challenging. Multimodal interventions that target multiple mechanisms of recovery may improve outcomes, but each component presents unique recruitment barriers. While exercise interventions have been shown to be beneficial for hip fracture recovery, offering exercise following completion of conventional physical therapy can be viewed as a burdensome time commitment. Hormone replacement therapy may hold promise for overcoming anabolic resistance, but concern about adverse side effects can also deter participation. STEP-HI is a multisite trial testing whether exercise and testosterone can improve hip fracture recovery in older women. In this talk, recruitment barriers experienced in STEP-HI and strategies employed to overcome these barriers will be discussed. Strategies include: partnering with hospitals, skilled nursing facilities and orthopedic surgeons. providing talks and education materials; and featuring past participant testimonials in recruitment materials.

VA Problem-Solving Training During COVID-19 for Clinicians of Patients With Complex Comorbidities

To address the shortage of mental health providers in geriatrics, VA has implemented clinician training in a VA Problem Solving Training (PST) protocol adapted to the needs of mostly older patients with complex comorbidities. This presentation will summarize PST implementation adaptations during COVID-19, and compare Veteran treatment outcomes before (2019) and during COVID-19 (2020). Sixty-one clinicians attended a workshop and small-group consultation for two training cases. Consultants provided ongoing feedback to program leadership about pandemic-related implementation challenges. Program adaptations during COVID-19 addressed challenges related to delivering treatment by telephone, video, or in-person and recruitment barriers. Veterans in both cohorts (N = 122) had significant reductions in mental health symptoms from baseline to posttreatment in paired t-test comparisons (ps < .01). Flexibilities afforded to clinicians in the training during the pandemic did not diminish the effectiveness of the intervention, thus supporting continued implementation of the training program with added flexibility.

Implementing Physical Activity Studies During COVID-19 and Winter Storms: Lessons Learned

Patient recruitment and retention are challenging for longitudinal studies. Stay-at-home restrictions for the Galveston and Houston regions in 2020 for COVID-19 and in 2021 for the Winter Storms shut down elective healthcare activities and created additional recruitment barriers during the implementation of a 12-month study examining the physical function of older adults receiving a total knee arthroplasty. This presentation describes recruitment and retention strategies during natural disasters. Ten participants started the study during the pandemic and 6 remained through the winter storms (3 withdrew, 1 no showed). Physical activity monitors were distributed and collected through mail, patient reported outcomes were completed online or over the phone, clinician-initiated measures were only collected when clinics were open, and efforts were made to minimize staff burden and follow evolving hospital guidelines. Most importantly, regular communication and follow-up with participants, research team, and department personnel created a sense of community.

Feasibility Study for a Randomised Controlled Trial for the Topical Treatment of Impetigo in Australian General Practice

Impetigo affects millions of children worldwide. Most guidelines recommend antibiotics as first-line treatment; however, topical antiseptics present a potentially valuable, understudied, antibiotic-sparing treatment for mild impetigo. We aimed to determine the feasibility of a randomised controlled trial (RCT) comparing efficacy of soft white paraffin (SWP), hydrogen peroxide (H2O2) and mupirocin for mild impetigo. Participants were recruited from general practices and randomly assigned one of three treatments. Size and number of lesions were measured at the initial consultation and day six. Post-recruitment, interviews with general practitioners were transcribed and themes identified to determine protocol acceptability, recruitment barriers and avenues to improve delivery. Two participants received SWP (n = 1) and mupirocin (n = 1). Both commenced oral antibiotics following failure of assigned topical treatment in which lesions increased in size or number. Recruitment barriers included reduced presentation of impetigo due to COVID-19, pre-treatment with existing at-home medications and moderate/severe infection. Childcare centers and pharmacies were identified as alternative venues to improve the recruitment rate. Valuable insight was gained into the practicality of conducting a RCT of impetigo treatments in general practice. Future trials should consider recruiting outside of general practice clinics to capture patients at earlier, more mild stages of infection. Further investigation into the prevalence and impact of use of at-home expired antibiotics may be beneficial.

Recruiting ‘hard to reach’ parents for health promotion research: experiences from a qualitative study

Objective Marginalised populations are less likely to take part in health research, and are sometimes considered ‘easy to ignore’. We aimed to describe our approach and results of recruiting parents who experience disadvantage, for focus groups exploring infant feeding on the island of Ireland. Upon receiving ethical approval, we implemented recruitment strategies that included building rapport with community organisations through existing networks, targeting specific organisations with information about our aims, and utilising social media groups for parents. Results We approached 74 organisations of which 17 helped with recruitment. We recruited 86 parents/carers (one male) for 19 focus groups (15 urban/4 rural). Seventy two percent met at the eligibility criteria. Most participants were recruited through organisations (91%), and the remainder on social media (9%). Recruitment barriers included multiple steps, research fatigue, or uncertainty around expectations. Factors such as building rapport, simplifying the recruitment process and being flexible with procedures were facilitators. Despite comprehensive, multi-pronged approaches, the most marginalised parents may not have been reached. Further alternative recruitment strategies are required for recruiting fathers, rural populations, or those without the capacity or opportunity to engage with local services.

Stakeholder perspectives on barriers and enablers to recruiting anxious children undergoing day surgery under general anaesthetic: a qualitative internal pilot study of the MAGIC randomised controlled trial

Background The ‘Melatonin for Anxiety prior to General anaesthesia In Children’ (MAGIC) trial was designed to compare midazolam and melatonin as pre-medications for anxious children (aged five to fourteen), undergoing day-case surgical procedures under general anaesthesia. Low recruitment is a challenge for many trials, particularly paediatric trials and those in ‘emergency’ settings. A qualitative study as part of MAGIC aimed to gather stakeholder perspectives on barriers and enablers to recruitment. Methods Sixteen stakeholders from six sites participated in semi-structured interviews about their experiences of setting up the MAGIC trial and recruiting patients as part of the internal pilot. Data was analysed using framework analysis. Results Participants identified barriers and enablers to recruitment. Barriers and enablers related to the study, participants, the population of anxious children, practitioners, collaboration with other health professionals, ethics, specific settings and the context of surgical day units and the wider health system. Attempting to recruit anxious children from a surgical day unit is particularly challenging for several reasons. Issues include the practicalities of dealing with a child experiencing anxiety for parents/guardians; professional unwillingness to make things more difficult for families and clinicians and nurses valuing predictability within a busy and time-sensitive setting. Conclusions Multi-site RCTs face recruitment barriers relating to study-wide and site-specific factors. There are multiple barriers to recruiting anxious children due to undergo day-case surgery. Barriers across domains can interrelate and reinforce each other, reflecting challenges relating to populations and settings. For example, in the case of anxious children, parents and other health professionals are concerned about exacerbating children’s anxiety prior to surgery. They may look for ways to keep things predictable and avoid the uncertainty of an RCT. Pre-trial engagement work could help address concerns among collaborating health professionals. Using rapid ethnography during set-up or an internal pilot to focus on how the protocol will be or has been operationalised in practice may help identify issues. Allowing time to reflect on the findings of internal pilots and implement necessary changes could facilitate higher recruitment during the main phase of a trial. Trial registration NIHR Trial Registration Number: ISRCTN18296119. Registered on October 01, 2019.

P100 Recruitment barriers in multicentre collaborative studies as demonstrated by a single unit experience of the Management of Acutely Symptomatic Hernias (MASH) study

Introduction MASH is a multi-centre prospective cohort study assessing the management of patients presenting with symptomatic abdominal wall hernia. Consenting patients are recruited during acute admission, with telephone follow up at day 30 and 90. We performed a retrospective review of all patients referred to a single general surgical unit with a symptomatic hernia to quantify recruitment rate and identify barriers to recruitment. Methods Patients meeting the inclusion criteria 1st August to 18th September were identified from prospective handover lists and electronic records and compared to the prospectively compiled screening log. Reason for not enrolment was coded according to protocol with an additional code added for patients not identified at time of admission. Results 8/23 (35%) eligible patients were enrolled. 15/23 (65%) were not enrolled due to; Patient not identified at time of admission n = 9 (60%), declined n = 2 (13.3%), too unwell to consent n = 2 (13.3%), translational barrier n = 1 (6.6%) and lacking capacity n = 1 (6.6%). Patients not identified at time of admission included those seen by clinicians not involved in study (new starters and locums) and those discharged directly from A&E with insufficient time and resources to gain consent. Conclusion In our unit 65% of eligible patients were not recruited, the majority of whom were missed at time of presentation. This study will generate important information on management and outcomes of acute hernias however strategies are required to recognise and mitigate recruitment bias. Staff turnover may be a significant factor in prospective studies, particularly those prolonged during the COVID-19 pandemic.

Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial

Background Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation. Objective The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. Methods We applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app–based intervention for people diagnosed with schizophrenia. Results Recruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. Conclusions Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

Modifiable Barriers for Recruitment and Retention of Oldeult Participants from Underrepresented Minorities in Alzheimer’s Disease Research

Clinical Alzheimer’s disease (AD) trials currently face a critical shortfall of thousands of eligible participants, which inflates the duration and cost of the clinical study as well as threatens the scientific merit of promising clinical interventions. This recruitment crisis is further compounded by the fact that underrepresented and marginalized populations—particularly those identifying as a racial or ethnic minority, those with low socioeconomic status, or living in rural areas—have been historically underrepresented in ongoing AD clinical trials despite overwhelming evidence that such populations are at increased risk for developing dementia. As a result of various recruitment barriers, current AD clinical studies frequently reflect a decreasingly representative segment of the US population, which threatens the overall generalizability of these findings. The current narrative review provides an updated examination and critique of common recruitment barriers and potential solutions, as well as a discussion of theoretical approaches that may address barriers disproportionately experienced by underrepresented communities. AD clinical researchers are encouraged to take purposive action aimed at increasing diversity of enrolled AD clinical trial cohorts by actively identifying and quantifying barriers to research participation—especially recruitment barriers and health disparities that disproportionately prevent underrepresented and marginalized populations from participating in research. Furthermore, researchers are encouraged to closely track which individuals who express interest in AD research ultimately enroll in research studies to examine whether AD research participation is appropriately representative of the intended population for whom these new and novel AD interventions are being designed.

Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial (Preprint)

BACKGROUND Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation. OBJECTIVE The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. METHODS We applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app–based intervention for people diagnosed with schizophrenia. RESULTS Recruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. CONCLUSIONS Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.