Factors influencing recruitment to a randomised placebo-controlled trial of oral naltrexone and extended release implant naltrexone: Qualitative study

Tompkins, Charlotte N. E.; Neale, Joanne; Marsden, John; Strang, John

doi:10.1016/j.jsat.2019.01.012

Cited by 8 publications

(9 citation statements)

References 47 publications

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“…Participants with greater stability and private housing did not perceive or express environmental barriers to participation, though they expressed other concerns, such as how to navigate social drinking culture. However, for many people, substance use disorders and socioeconomic marginalization are intertwined (Galea & Vlahov, 2002; Henkel, 2011), and the opportunity to participate in an RCT occurs amid challenging socioeconomic conditions, such as income insufficiency, housing instability, or lack of control over environmental stressors (Tompkins et al, 2019).…”

Section: Resultsmentioning

confidence: 99%

Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants

2021

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Amid the growth of addiction medicine randomized controlled trials (RCTs), scholars have begun examining participants’ study experiences, highlighting facilitators and barriers to enrollment. However, this work can overlook the interplay between trial participation and social-structural dimensions among people with substance use disorders linked to the social nature of use, socioeconomic marginalization, and time demands of substance procurement and use. To effectively conduct RCTs with this unique population, it is necessary to examine the broader social context of study participation. We conducted nested qualitative interviews with 22 participants involved in an RCT testing a treatment for alcohol and opioid use disorders in HIV clinics. Thematic analyses revealed social-structural circumstances shaping RCT participation as well as how participation constitutes a turning point, prompting individuals to reconfigure social networks, reorient to spatial environments, and reorganize day-to-day life—with implications for how substance use disorder RCTs should be approached by researchers.

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Section: Resultsmentioning

confidence: 99%

Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants

2021

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“…While the findings can be mapped to the TDF domains, and compliment and align with existing literature on factors that influence RCT recruitment, knowledge is also extended by identifying the importance of the overall trial context, that is the specific population, condition and/or treatment being offered [ 23 ]. To optimise recruitment, trial teams must consider their context, and understand and respond to their patient population and condition, accounting for specific vulnerabilities that the patient group may have.…”

Section: Discussionmentioning

confidence: 99%

Using a theory-informed approach to explore patient and staff perspectives on factors that influence clinical trial recruitment for patients with cirrhosis and small oesophageal varices

et al. 2022

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Objective The success of pharmacological randomised controlled trials (RCTs) depends on the recruitment of the required number of participants. Recruitment to RCTs for patients with cirrhosis and small oesophageal varices raises specific additional challenges. The objectives of the study were 1) to explore patient perspectives on factors that influence RCT recruitment, 2) to understand factors that influence the success of recruitment from a staff perspective, and 3) to identify opportunities for tailored interventions to improve trial recruitment in this context. Methods The qualitative study was embedded in a multi-centre blinded RCT (BOPPP trial) and was conducted alongside site opening. Semi-structured interviews were conducted with patients who enrolled to participate in the trial (n = 13), patients who declined to take part (n = 5), and staff who were responsible for recruiting participants to the trial (n = 18). An open approach to data collection and analysis was adopted and the Theoretical Domains Framework (TDF) was used to provide a theoretical lens through which to view influences on behaviour. Data was analysed using thematic analysis. Results The findings consist of 5 overarching themes that outline trial recruitment influences at the patient, staff, team, organisational and trial levels: i) patient risks and benefits ii) staff attitudes, knowledge and capacity, iii) team-based approach, iv) organisational context and v) Trial collective. Patient-generated themes map onto thirteen of the fourteen TDF domains and staff-generated themes map onto all TDF domains. The overarching themes are not mutually exclusive; with evidence of direct interactions between patient and staff-level themes that influence recruitment behaviours. Conclusions This study uses a theory-informed approach to gain new insights into improving clinical trial recruitment for patients with cirrhosis and small oesophageal varices. Although people with cirrhosis often display decreased healthcare-seeking behaviours, we found that patients used research to empower themselves to improve their health. Pragmatic trials involving unpredictable populations require staff expertise in building trust, and a deep knowledge of the patient group and their vulnerabilities. RCT recruitment is also more successful when research visits align with what staff identified as the natural rhythm of care. Trial registration ISRCTN10324656; https://clinicaltrials.gov/.

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“…Meanwhile, Tompkins et al . demonstrated how post‐trial qualitative research can help to account for poor recruitment. We were surprised that we did not identify any studies that focused on how prevention and treatment interventions for illicit drug use are implemented post‐RCT in new settings and routine practice and this, again, suggests a missed opportunity to capitalize on qualitative work.…”

Section: Discussionmentioning

confidence: 99%

“…Finally, a UK study was conducted to understand more clearly poor recruitment to the Naltrexone Enhanced Addiction Treatment (NEAT) trial . The NEAT trial was designed to explore the effectiveness of active extended release naltrexone implants and oral naltrexone in contrast to placebo medication in people with opioid use disorder seeking treatment.…”

Section: Qualitative Research and Rcts In Addiction Sciencementioning

confidence: 99%

Adding quality to quantity in randomized controlled trials of addiction prevention and treatment: a new framework to facilitate the integration of qualitative research

Maher

Neale

2019

Addiction

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Background and aims Randomized controlled trials (RCTs) are important for evaluating interventions, and qualitative research is increasingly recognized as being crucial to the success of this enterprise. We aimed to describe and demonstrate a temporal parallel purpose framework to help researchers understand how to make optimum use of qualitative research before, during and after RCTs. This framework sets out specific rationales for conducting qualitative research at each stage of a trial, where the rationales presented relate to both the intervention and evaluation methodology. Method and results We conducted a scoping review of published qualitative studies undertaken alongside RCTs focusing on illicit drug use. We then used the temporal parallel purpose framework to present key findings to demonstrate how qualitative studies can add value to addiction RCTs by enhancing understanding of the intervention being trialled and/or the RCT itself. In so doing, we highlight the missed opportunities for addiction science when qualitative research is overlooked. We also explain why barriers to combining qualitative research and RCTs are neither inevitable nor insurmountable. Conclusions The temporal parallel purpose framework provides a tool for assessing when and why to combine qualitative research with addiction treatment and prevention RCTs. Our paper and framework can help researchers formulate key questions that qualitative research can address. This can potentially save resources by reducing the number of poorly designed interventions and trials and prevent morbidity, mortality, and other addiction‐related harms by facilitating the identification and implementation of interventions that are most likely to be effective.

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Factors influencing recruitment to a randomised placebo-controlled trial of oral naltrexone and extended release implant naltrexone: Qualitative study

Cited by 8 publications

References 47 publications

Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants

Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants

Using a theory-informed approach to explore patient and staff perspectives on factors that influence clinical trial recruitment for patients with cirrhosis and small oesophageal varices

Adding quality to quantity in randomized controlled trials of addiction prevention and treatment: a new framework to facilitate the integration of qualitative research

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