Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Objectives : The aim of this article is to provide recommendations on the structure, materials, and outcomes that should be adopted for communication training programs designed to improve clinical trial education for patients. Methods: A systematic review of peer‐reviewed articles was conducted. A total of 22 studies were included. Several dimensions were analyzed, such as program design, con‐ tent development, pedagogical tools, content of the program, and the outcomes affected. Results: The trainings described in the articles analyzed generally took the form of work‐ shops and were developed by groups of heterogeneous experts. Trainings used a variety of educational materials and activities often developed by the research team hosting the training. The outcome measures and assessment methods were not consistent among the trainings, which hinders the ability to statistically synthetize findings. Conclusions : Findings from the review point to a number of recommendations for the development of future clinical research communication training programs. Training pro‐ grams should be developed by a team of experts with a range of expertise and should be organized in the form of workshops. Participants should be able to role‐play newly acquired communication skills using standardized patients.


Introduction
Clinical trials represent the first essential step toward the development of treatments targeting cancer and various diseases [1,2], and allow researchers to Test the effectiveness of preventive measures, treatments, screenings, and diagnostic techniques [3]. However, despite the evidence for the positive benefits of conducting clinical trials, and despite the overall agreement on the importance of clinical research (as evidenced by the Cancer Moonshot initiative and recent, highly funded efforts directed toward advancing precision medicine), researchers are limited by the low number of patients consenting to join clinical research studies [4,5]. The most critical consequence of low accrual rates is that treatment effectiveness cannot be adequately assessed, even if a new regimen appears to be promising [6]. Research on the reasons for clinical trials' low accrual rates has identified several key barriers, which include a low rate of physicians' referral [7,8]. Many physicians characterize discussions about research and clinical trials with patients as particularly challenging, a problem, which is rarely addressed, even by academic medical centers committed to the research enterprise [9].
Physicians are not the only professionals who face challenges when trying to communicate about clinical trials. In fact, clinical and medical research teams are typically composed of a heterogeneous group of professionals with specific skills and roles; these include study nurses, clinical research coordinators, research associates, nonstudy personnel, and professional recruiters [9]. Regardless of the role, however, good communication skills are necessary to meet the needs of both patients and PIs to ensure both information comprehension and accrual [10,11]. Conversations with patients and their families intended to educate them about participation in clinical trials and research studies present unique challenges that differ significantly from typical exchanges in the provider-patient encounter. Discussions about clinical trial participation are quite challenging due to the uncertainty regarding the outcomes of clinical trials, and the complex nature of consent documents [12]. For example, a treatment recommendation that involves the possibility of enrolling in a clinical trial is fraught with uncertainty because patients are generally randomized into one of multiple treatment arms, and because the treatment itself is under study [13]. Thus, both the treatment outcomes and any possible side effects have yet to be defined. Additionally, recruiters (whether clinical research professionals, physicians, or study nurses) need to provide information through documents that are strictly governed by legal and ethical policies. The content and the structure of the consenting documents are complex and often difficult to understand for patients [14]. Many patients express concerns about the trustworthiness of the clinical research process and the experts involved [14,15].
Because of the uncertainty associated with the treatment, the complexity of procedures and documents, the vulnerability of patients, and the often-negative attitudes of patients toward medical research, discussions about clinical trial participation can be difficult for both patients as well as clinical personnel. Because patients' intentions to enroll into a clinical trial are strongly related to the competency of communication by recruiters [16,17], and because communication is a mediating variable in the decision process on whether or not enroll [14,15,18], it is essential for medical and clinical research professionals receive training on how to better communicate with patients about participating in clinical trials and research studies. Trainings specifically aimed at improving communication skills may help to increase the rate of patient accrual to clinical trials [10,19].
Although there have been successful training programs focused on doctor-patient communication [20][21][22][23][24][25], there is little theoretical and empirical research on the best way to develop trainings for improving clinical trial communication. Previous studies of other types of communication training programs in health care environments have provided evidence that the structure of the training as well as the type of educational materials employed have dramatic consequences on the effectiveness of the trainings and the learning outcomes of participants [24,[26][27][28] . In the  case of trainings to improve communication about clinical trials and research studies, there is  no clear evidence about the best structure for trainings or the materials to be used. Therefore,  this study aims to fill a gap in the literature by addressing the following research questions:   RQ1: How are clinical trials communication training programs structured? RQ2: What type of content is included in communication skills training programs for those who recruit for clinical trials study? RQ3: How are the outcomes of these trainings assessed?

Key terms and databases
A literature review was performed by using several databases, namely scholar.google.com, university library's database, MEDLINE, PsycINFO. The search terms used were "clinical trials training," "clinical trials recruiters training," "cancer trials training," "clinical trials recruiters' communication," and "clinical trials patients' recruitment." Second, an additional search was conducted by checking the references employed by the articles considered relevant for the purposes of the present study. This process yielded 22 articles on communication training programs designed to increase medical and nonmedical professionals' efficacy in recruiting potential participants for research studies and clinical trials.

Inclusion and exclusion criteria
In order to be included in this systematic review, the studies had to meet several criteria. First, they had to deliver and test educational trainings; second, participants in the trainings had to be health care professionals; third, the trainings had to provide instructions and educational materials or activities to improve clinical trial communication skills. After a careful review of the literature, 22 studies were found to be appropriate for the present systematic review. Further, in order to be considered in this systematic review, the studies had to meet the following inclusionary criteria: report on physicians' and medical personnel communication strategies to recruit patients; provide empirical evidence rather than theoretical assertions or recommendations (that is, qualitative or quantitative data had to be reported), and results had to be published in a peer-review journal.

Data extraction and analysis
Information from the studies selected for this project was summarized into tables and compared across studies. Key information that was retrieved included authors' names, year of publication, country where the trainings were conducted, journal in which the findings were published, theoretical background, methods adopted for the study, type of training, demographics, content development methodology, format of educational material, timing of the program, and learning assessment.

Results
From the search for relevant studies, the authors included a total of 22 studies conducted between 1998 and 2016. All of the articles included in the present study were published in peerreviewed journals. The majority of the studies did not report using a theoretical framework as basis for the communication training program. Also, the majority of the studies did not provide exhaustive information about participants' demographics. When these data were available (7 studies out of 22), more participants were reported to be female, for a total of 275 females participating versus 212 total males participating. When data were available about the profession of participants (12 studies out of 22), Participants included 658 physicians, 373 nurses, 29 research coordinators, and only 1 person described as a professional recruiter, although all participants in these training programs were responsible for recruiting patients for clinical trials.
Half of the studies assessed the effectiveness of training by using quasi-experimental designs; two of the remaining studies used survey as data collection methodology, and the other two studies used qualitative methodologies. Only 8 studies out of 22 reported whether the intervention was the first communication raining experience for participants, or not.

Design of training programs
With regard to the type of training developed and implemented, 18 studies out of the 22 analyzed employed a workshop format, while 1 training utilized coaching sections and peerreviews [10]. Duration of the trainings varied across studies, ranging from a minimum of 3 hours, to a maximum of three days. Some trainings were spread over 2 days [29][30][31] or 3 days [46]. In the majority of the studies, participants selfselected into the training programs. Consistent with what has been observed in the literature on communication training in health care environments [32], the duration of the training programs seems to be an indicator of their effectiveness, with the longest trainings having the most positive outcomes. Information about the design of the trainings for each study is presented in Table 1.

Content development and pedagogic tools
The educational content of the trainings reviewed was varied, as was the source material used. Seventeen studies reported creating original content for their training, using source material that included the team's own original research, and collaborations with experts, such as oncologists, nurses, and clinical trials managers. One study explicitly reported the contributions of patients [30]. Another publication did not describe the process of developing the material, but reported that the training was done by instructors with previous experience in teaching communication skills to physicians. Similarly, the pedagogical tools adopted were varied. There was a general preference for the use of video materials, such as DVDs or videotaped scenarios, which were used in 10 training programs [29,30,[33][34][35][36][37][38][39][40]. Other formats used included case studies, vignettes, instructional manuals, dummy referral letters, protocols, and didactic presentations. The majority of the trainings included role-playing activities, and/or review of real-world discussions among recruiters and patients (whether actual or standardized patients). In many cases, checklists were used to standardize the observation and analysis of such discussions. Table 1 reports the role and profession of the people who developed the content and materials used in the trainings, as well as the formats used in each training.

Information conveyed
Several areas of focus for the trainings were reported. Six studies [10,13,29,38,42,46], reported training participants on the importance of assessing the eligibility of patients for the clinical trials. Authors reported assessing participants' performance on how to offer the opportunity to participate in clinical trials (with the exception of [40], which does not explicitly mention it). Only six studies instructed participants how to address possible benefits and side effects associated with clinical trials participation [11,29,35,37,45,46]. Generally, authors did not recommend different communication strategies for different phases of clinical trials. Seven trainings out of the 22 analyzed in this review instructed participants on how to check for patients' understanding of the information provided [10,13,29,30,34,37,42]. In this regard, Mann et al. [10] and Brown et al. [37] reported "summarizing" as a useful technique to check for patients' understanding. Other topics specifically addressed by the training programs included how to explain the aims of clinical trials [10,13,29,30,39,41], the importance of informing patients about the voluntariness of their potential enrollment [10,11,29,30,33], or the importance of avoiding coercive behaviors and/or the importance of adopting a shared decision making process [34,35,37]. In some training, participants were instructed on strategies for clarifying key terms such as "randomization" and "placebo," which tend to be difficult for a large proportion of patients to understand or accept [10,13,30,36,39,41,42,45,46,48]. Few studies explicitly addressed concerns and strategies to successfully deal with potential participants' struggle to manage uncertainty [29,30,36,37,42]. Ultimately, only 3 studies out of 22 specifically discussed the role that family members play in influencing patients' decisions on whether to enroll or not in clinical trials or provided training on how to better address family members' concerns [29,30,36,40,47]. A summary of the main information conveyed is shown in Table 2.

Assessments
Whether training programs had a concrete impact on the communication skills of the participants was assessed through several means. Consistent with the literature on trainings to improve physician-patient communication [27,49,50], one of the most widely adopted strategies (13 studies out of 22) consisted of an evaluation of audio recorded interactions of participants in the training programs with either real-world patients or standardized patients. Similarly, 16 studies reported having used self-assessments, although specific measures differed across studies. In one study [41], the self-assessment consisted in a qualitative description of the experience participants in the training program had when interacting with patients. Only three studies did not explicitly report any assessment of the outcomes [11,38,43]. Although similar methodologies were used, the outcomes of the trainings tended to differ significantly across studies. The strategies used to assess the communication trainings are shown in Table 3.

Improved outcomes
Clinical trial communication training programs influenced several outcomes. In seven studies, participants reported increased confidence in their ability to better interact with and educate patients. However, in terms of better communication of clinical trials, only a few studies reported strong effects [29,30,33,36,41], with only one article reporting modest but significant changes [39]. A study by Brown et al. [37] reported no significant improvement in participants' ability to provide clinical information, nor did they report differences in the way participants structured their consultations. However, the authors reported improvements in shared-decision making behaviors, and in refraining from using coercive behaviors [37]. Fallowfield et al. [40] demonstrated improvements in participants' communication and information provision skills as a result of the training, even if communication about clinical trials specifically was not significantly affected by training. In one study [10], participants reported increased knowledge of trial design, and an improved ability to adhere to the study protocol after receiving the training. Mills et al. [13] observed that after the training participants improved in their ability to address patients' preferences. Only three studies assessed and obtained improvements in accrual rates [38,43,47]. The positive changes associated with training participation are shown in Table 3.

Discussion
This study presents a systematic review of published articles on trainings to improve communication about clinical trials with patients. From the review, it appeared that the majority of the trainings followed the format of a workshop, as also observed in a previous review [51]. The duration of the trainings ranged from 3 hours to 3 days. According to literature on communication training programs for physicians (not specifically aimed at improving clinical trial communication), the optimal length for a training workshop seems to be 3 days [32]. However, currently there are not enough data to confirm these results in a clinical trial communication context.
In the majority of the articles reviewed, the educational materials used in the trainings were developed through the collaborative efforts of several experts with diverse backgrounds, including oncologists, clinical trial coordinators, researchers, and nurses. Having an interdisciplinary team seems to be a common strategy for successfully developing trainings to improve clinical trial communication. In order to further enhance educational materials and messages' effectiveness, appeal, and clarity, it may be beneficial to include communication researchers in the team.
The pedagogical materials were quite varied across trainings; despite this, there seemed to be a preference for visual forms of communication such as videos and vignettes, and role-playing [52,53]. Many training programs used checklists in order to help both participants and educators to assess the outcomes of recruiters-patient interactions (both when the conversation was reproduced in videos, as well as during role-playing). These checklists were described as useful educational tools by all the studies and should be included in future training protocols, even if specific details on the content of these checklists are only approximately reported in the articles. Trainings themselves focused on several topics. A portion of this information is consistent with the recommendations provided by the literature on clinical trials accrual [5,9,54]. However, the choice of topics differed across the trainings, and not all key areas were reported as having been covered. Research teams generally collected preliminary data to provide better targeted information; this strategy is consistent with recommendations from previous studies focusing on communication trainings for physicians [55,56], which encouraged trainers to consider contextual factors and characteristics of the organizations in which participants operate. However, future programs should provide content that is consistent with research on the barriers faced by potential participants in order to develop well-design trainings that are geared toward effective patient education. A first step toward this goal would be establishing an agreement on the outcomes that should be obtained through communication trainings to improve clinical trial accrual. In addition, only few studies reported positive, significant changes in participants' recruiting skills, although all participants reported increased confidence and satisfaction with the training. This is in line with findings from Townsend et al. [51]. Unfortunately, the fact that outcomes differed by study hindered our ability to statistically analyze results from the entire body of literature.
The articles synthetized in this paper represent an important effort toward the improvement of patient education about participation in clinical trials and research studies, and potentially, an increase in accrual rates. However, despite having conducted an extensive literature search, only 22 studies were found as adequate to be included in this systematic review. In our opinion, this finding alone is sufficient to call for additional studies aimed at evaluating the efficacy of trainings for improving clinical trial communication and subsequently, patient satisfaction with the enrollment/consent process as well as improved accrual rates for clinical trials.
This study contributes to the emerging literature on clinical trial communication, and to the literature addressing clinical trials planning processes. Despite its contributions, this systematic review presents certain limitations. Only peer-reviewed studies were included; there is the possibility that other teams have conducted training programs to improve clinical trial communication and have disseminated findings in formats other than peer-reviewed journals. Future reviews should search for such materials and include them in their analysis. In addition, only materials in English were included, but it is possible that studies have been published in other languages.

Conclusion
Despite the wide diffusion of communication trainings for physician and medical personnel, only a few studies were retrieved with regard to specific trainings on communication about clinical trials. These studies demonstrated significant impact on outcomes such as participants' satisfaction, self-confidence, and understanding of the design of clinical trials. However, few training demonstrated any significant improvement in participants' recruiting skills. In light of the urgency of the need to increase clinical trial accrual, improved communication training may be an effective way to support recruitment goals. Researchers should further define the most effective strategies to meet the educational needs of professional recruiters, research coordinators, and study personnel, with the ultimate goal of improving accrual rates and the quality of patients' experience while enrolled in clinical trials and research studies.

Practice implications
Training programs for improving communication with patients about participation in clinical trials and research studies should be developed based on the insights from several experts, including social scientists focused on communication. These trainings should be organized in the form of workshops, where participants can receive both didactic education and the opportunity to role-play new communication skills. Role-playing exercises may prove to be particularly effective with standardized patients, if such a resource is available. The use of checklists during observations of role-plays is recommended as an objective test of behavioral outcomes. The long-term outcomes of the training on patient satisfaction with the enrollment and consenting process as well as study accrual rates should be carefully defined and assessed.

Author details
Aurora Occa* and Susan E. Morgan *Address all correspondence to: aurora.occa@gmail.com