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Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis.

ABSTRACT: BACKGROUND:Although recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists. METHODS:Using qualitative descriptive methods, we collected data from pharmacists and study participants. Pharmacists were asked about their impressions of the study, as well as challenges they faced and methods they used to recruit potential participants. Focus groups with trial participants centered on the patient recruitment materials. Interviews and focus groups were recorded, transcribed and analyzed using thematic analysis. RESULTS:Pharmacists noted that their first impressions of the study were positive as they described being enticed to help the study team by the potential benefit of copayment elimination for their patients and the low time commitment. Pharmacists noted they were more likely to recruit if they were well informed on the study, as they could answer their patients' questions. Participants noted that their primary motivations for participating were the tangible benefits of free medications and the intrinsic value of participating in research. CONCLUSIONS:We noted that recruitment through pharmacies was an effective method as most patients have trusting relationships with their pharmacist. To optimize recruitment through pharmacies, study procedures should be straightforward, and pharmacists need to be equipped with good knowledge of the study. When promoting a study to potential participants, messaging should ensure the individuals are aware of the tangible benefits of participation while still presenting a full overview of the trial. TRIAL REGISTRATION:Trial Registration Number: NCT02579655 - initially registered Oct 19, 2015.

SUBMITTER: Fletcher JM

PROVIDER: S-EPMC7603682 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis.

Fletcher Jane M JM Saunders-Smith Terry T Manns Braden J BJ Tsuyuki Ross R Hemmelgarn Brenda R BR Tonelli Marcello M Campbell David J T DJT

BMC medical research methodology 20201031 1

<h4>Background</h4>Although recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists.<h4> ...[more]

PMID: 33129278

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Project description:BackgroundRecruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs.Methods and findingsA systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00-2.18], attendance at an education session [RR 1.14, 95% CI 1.01-1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14-1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11-2.74), and also monetary incentives (RR1.39, 95% CI 1.13-1.64 to RR 1.53, 95% CI 1.28-1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007.ConclusionRecruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis. Please see later in the article for the Editors' Summary.

Project description:BackgroundRacial and ethnic minority groups are underrepresented in health research, contributing to persistent health disparities in the United States. Identifying effective recruitment and retention strategies among minority groups and their subpopulations is an important research agenda. Web-based intervention approaches are becoming increasingly popular with the ubiquitous use of the internet. However, it is not completely clear which recruitment and retention strategies have been successful in web-based intervention trials targeting racial and ethnic minorities.ObjectiveThis study aims to describe lessons learned in recruiting and retaining one of the understudied ethnic minority women-Korean Americans-enrolled in a web-based intervention trial and to compare our findings with the strategies reported in relevant published web-based intervention trials.MethodsMultiple sources of data were used to address the objectives of this study, including the study team's meeting minutes, participant tracking and contact logs, survey reports, and postintervention interviews. In addition, an electronic search involving 2 databases (PubMed and CINAHL) was performed to identify published studies using web-based interventions. Qualitative analysis was then performed to identify common themes addressing recruitment and retention strategies across the trials using web-based intervention modalities.ResultsA total of 9 categories of recruitment and retention strategies emerged: authentic care; accommodation of time, place, and transportation; financial incentives; diversity among the study team; multiple, yet standardized modes of communication; mobilizing existing community relationships with efforts to build trust; prioritizing features of web-based intervention; combined use of web-based and direct recruitment; and self-directed web-based intervention with human support. Although all the studies included in the analysis combined multiple strategies, prioritizing features of web-based intervention or use of human support were particularly relevant for promoting recruitment and retention of racial and ethnic minorities in web-based intervention trials.ConclusionsThe growing prevalence of internet use among racial and ethnic minority populations represents an excellent opportunity to design and deliver intervention programs via the internet. Future research should explore and compare successful recruitment and retention methods among race and ethnic groups for web-based interventions.Trial registrationClinicalTrials.gov NCT03726619; https://clinicaltrials.gov/ct2/show/NCT03726619.

Project description:BackgroundThe Assessing outcomes of enhanced Chronic disease Care through patient Education and a value-baSed formulary Study (ACCESS) is a randomized controlled trial evaluating two interventions targeting barriers to care among those at high risk of cardiovascular disease: copayment elimination for cardioprotective medications, and a tailored self-management support programme. We designed a process evaluation to better understand participant perspectives on the interventions.DesignWe used a qualitative descriptive study design, collecting patient and pharmacist feedback via individual semi-structured telephone interviews and in-person focus groups. Data were analysed inductively using thematic analysis.ResultsFifty-three patients (39 interviews and 14 in two focus groups) and 20 pharmacists participated. Copayment elimination provided quality of life benefits: minimizing the need to 'cut-back', allowing 'peace of mind' and providing emotional support. Health-related benefits included: improving adherence to covered medications, and helping to afford non-covered goods. The only criticism was that not all medications and testing supplies were covered. Patients reported that the educational materials provided helpful information, acted as a reminder, improved confidence, improved adherence to medication, and helped initiate conversations with providers about indicated medication. Some participants felt that the educational materials were repetitive, overly medication-focused and not tailored enough. Pharmacists felt that their patients benefitted from both interventions, which improved patient adherence and communication with their patients.ConclusionThe success of interventions intended to change behaviour is largely dependent upon participant's feelings that the intervention is helpful. This process evaluation provided insights into participants' perceptions on these interventions. Reception of both was largely positive with a few criticisms noted.

Project description:IntroductionPharmacist-patient communication during medication counselling has been successfully investigated using Communication Accommodation Theory (CAT). Communication researchers in other healthcare professions have utilised Discursis software as an adjunct to their manual qualitative analysis processes. Discursis provides a visual, chronological representation of communication exchanges and identifies patterns of interactant engagement.AimThe aim of this study was to describe how Discursis software was used to enhance previously conducted qualitative analysis of pharmacist-patient interactions (by visualising pharmacist-patient speech patterns, episodes of engagement, and identifying CAT strategies employed by pharmacists within these episodes).MethodsVisual plots from 48 transcribed audio recordings of pharmacist-patient exchanges were generated by Discursis. Representative plots were selected to show moderate-high and low- level speaker engagement. Details of engagement were investigated for pharmacist application of CAT strategies (approximation, interpretability, discourse management, emotional expression, and interpersonal control).ResultsDiscursis plots allowed for identification of distinct patterns occurring within pharmacist-patient exchanges. Moderate-high pharmacist-patient engagement was characterised by multiple off-diagonal squares while alternating single coloured squares depicted low engagement. Engagement episodes were associated with multiple CAT strategies such as discourse management (open-ended questions). Patterns reflecting pharmacist or patient speaker dominance were dependant on clinical setting.Discussion and conclusionsDiscursis analysis of pharmacist-patient interactions, a novel application of the technology in health communication, was found to be an effective visualisation tool to pin-point episodes for CAT analysis. Discursis has numerous practical and theoretical applications for future health communication research and training. Researchers can use the software to support qualitative analysis where large data sets can be quickly reviewed to identify key areas for concentrated analysis. Because Discursis plots are easily generated from audio recorded transcripts, they are conducive as teaching tools for both students and practitioners to assess and develop their communication skills.

Project description:BackgroundRecruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research.DesignTwo qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically.SettingNHS secondary care organisations throughout the UK. Interviews were undertaken via telephone.ParticipantsThirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed.ResultsWe used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient's circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients' treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated.ConclusionsA wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials.Trial registrationACTIVE: ( ISRCTN98152560 ). Registered on 06/03/2018. PRESTO: ( ISRCTN12094890 ). Registered on 22/02/2018.

Project description:BACKGROUND:More than a quarter of randomized controlled trials (RCTs) are prematurely discontinued, mostly due to poor recruitment of patients. In this study, we systematically compared RCTs discontinued or revised for poor recruitment and completed RCTs with the same underlying research question to better understand the causes of poor recruitment, particularly related to methodological aspects and context-specific study settings. METHODS:We compared RCTs that were discontinued or revised for poor recruitment to RCTs that were completed as planned, matching in terms of population and intervention. Based on an existing sample of RCTs discontinued or revised due to poor recruitment, we identified matching RCTs through a literature search for systematic reviews that cited the discontinued or revised RCT and matching completed RCTs without poor recruitment. Based on extracted data, we explored differences in the design, conduct, and study settings between RCTs with and without poor recruitment, separately for each research question using semi-structured discussions. RESULTS:We identified 15 separate research questions with a total of 29 RCTs discontinued or revised for poor recruitment and 48 RCTs completed as planned. Prominent research areas in the sample were cancer and acute care. The mean number of RCTs with poor recruitment per research question was 1.9 ranging from 1 to 4 suggesting clusters of research questions or settings prone to recruitment problems. The reporting quality of the recruitment process in RCT publications was generally low. We found that RCTs with poor recruitment often had narrower eligibility criteria, were investigator- rather than industry-sponsored, were associated with a higher burden for patients and recruiters, sometimes used outdated control interventions, and were often launched later in time than RCTs without poor recruitment compromising uncertainty about tested interventions through emerging evidence. Whether a multi- or single-center setting was advantageous for patient recruitment seemed to depend on the research context. CONCLUSIONS:Our study confirmed previously identified causes for poor recruitment, i.e., narrow eligibility criteria, investigator sponsorship, and a reduced motivation of patients and recruiters. Newly identified aspects were that researchers need to be aware of all other RCTs on a research question so that compromising effects on the recruitment can be minimized and that a larger number of centers is not always advantageous.

Dataset Information

Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis.

Publications

Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis.

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