**Assessing Communication Practice during Clinical Trial Recruitment and Consent: The Clinical Trial Communication Inventory (CTCI) Trial Recruitment and Consent: The Clinical Trial Communication Inventory (CTCI)**

**Assessing Communication Practice during Clinical** 

DOI: 10.5772/intechopen.70192

Susan E. Morgan, Amber Finn, Jessica Raley, Wei Peng, Aurora Occa, Soroya Julian McFarlane, Janice Krieger and JoNell E. Potter Jessica Raley, Wei Peng, Aurora Occa, Soroya Julian McFarlane, Janice Krieger and JoNell E. Potter

Additional information is available at the end of the chapter Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.70192

Susan E. Morgan, Amber Finn,

#### **Abstract**

The development and evaluation of training programs with the potential to improve informed consent and accrual to clinical trials depend heavily on the ability to measure outcomes of these trainings. In this chapter, we present the development of an instrument, the clinical trial communication inventory (CTCI). Data were collected from 87 clinical research professionals at three academic medical centers, which were analyzed using factor analytic methods and reliability testing procedures. This testing resulted in eight subscales representing verbal, nonverbal, and privacy protection behaviors. While the final CTCI instrument would benefit from further validity testing, it represents a resource that can be used to evaluate future trainings of research professionals.

**Keywords:** clinical trial communication, accrual, verbal & nonverbal communication, informed consent, measures

### **1. Introduction**

The abysmal rate of accrual to clinical trials, particularly among members of minority and underserved populations, has impeded medical and scientific progress [1]. Ironically, when members of marginalized populations do not participate in numbers that allow the medical community to draw conclusions about the efficacy of new treatments for members of

Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons

these communities, health disparities are deepened further [2]. This makes the participation of members of marginalized communities in clinical trials and research studies increasingly urgent.

patients in a clinical trial recruitment context can be taught [17]. The content of clinical trial communication training programs varies considerably (as do outcomes), but most programs appear to be successful in improving the confidence of those who recruit for

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While clinical trial communication training programs are not yet widely available, there are some laudable examples that warrant discussion. Fallowfield and colleagues [19–21] have been among the first to develop communication training programs specifically focused on clinical trial recruitment and consent issues. Their training programs provided information on common communication issues and ethical concerns and were primarily directed toward physicians and nurses with clinical trial management roles. The main outcomes from these trainings were improved knowledge of clinical trials and increased confidence in their ability to recruit and consent patients. Similarly, Wells and colleagues [22] developed a training program to improve professionals' communication abilities but focused largely on developing increased cultural competency by focusing on barriers and beliefs of African Americans and Latinos. The program focused on outcomes related to knowledge and attitudes of minority patients' cultural needs. Another communication training program, developed and piloted at the University of Miami, focused on educating research coordinators on specific verbal and nonverbal communication skills to improve clinical trial recruitment and informed consent discussions. This communication training program consisted of five modules and adopted several educational strategies including a didactic presentation, in-group discussions, live

One issue that has troubled virtually all existing clinical trial communication programs is the actual assessment of training outcomes. This may be a symptom of a larger problem in that there seems to be little consensus about what the goal should be for communication trainings. We assert that there should be two central goals: (1) increasing the willingness and ability of recruiters to use "best practices" in communication about clinical trial participation, with the ultimate goal of (2) increasing informed decision making among potential participants. Whether patients and other potential participants provide informed consent to enroll in a study or make an informed decision to decline the opportunity to participate, we believe that all patients should be presented with the choice to advance knowledge relevant to their health conditions wherever such opportunities exist. The burden is on us to communicate well in order to maximize the patients' comprehension of all factors that are relevant to their

Current assessments of the quality of communication practice as an outcome of clinical trial communication training has focused on several tools: (1) surveys of training participants' knowledge, attitudes, and perceived self-efficacy; (2) role-plays to practice skills; (3) videotaping participants to provide individualized feedback, and (4) the use of check lists to assess recruiters' behaviors when interacting with potential participants [18]. While all of these assessment strategies are valuable, none of these approaches has been validated, including the self-report survey, which is the most commonly used tool [18]. The development and evaluation of more effective training programs depend heavily on the use of validated and,

studies [18].

decisions.

demos, and role play activities [17].

preferably, triangulated outcome measures.

There is growing evidence that the communication behaviors exhibited by medical and nonmedical professionals tasked with approaching and consenting patients impacts eventual enrollment [3–6]. Most research on clinical trial communication has focused on general guidelines for communication practice. These guidelines include making sure that the type and amount of information are appropriate for the patient [7], using plain language to explain a trial [5, 8, 9] and being open to answering potential participants' questions [3, 8, 10]. Additionally, recruiters are exhorted to be "warm" and respectful with patients [8, 11].

It is important, however, to examine the specific communication behaviors that lead to more effective recruitment, consent, and retention. A study of 63 medical professionals in two diverse U.S. cities indicates that both verbal and nonverbal communication practices support effective recruitment and consent processes [12–15]. Specific verbal communication behaviors that are associated with effective patient recruitment and consent include translating and simplifying information through the use of lay language and examples; reframing information through the use of metaphors, analogies, and storytelling; balancing discussions of risks with benefits; and encouraging potential participants to ask questions [12].

Nonverbal communication behaviors may be even more important, given the central role of nonverbal communication in the process of meaning generation [16]. However, this topic has received little attention by researchers studying factors that impact clinical trial accrual. In the recruitment and consent process, nonverbal communication behaviors that appear to be particularly important include the ability to "read" patients' state of mind before approaching them to participate in a study; the willingness to adapt to a patients' mood and communication preferences; mirroring patients' body posture, tone, and rate of speech; using eye contact, touch, and smiling in situationally and culturally appropriate ways; and being conscious of the impact of physical appearance [13]. Importantly, both verbal and nonverbal communication function to create a sense of relational connection which, in turn, creates both trust and the motivation required for patients to process often-complicated study information [14].

It should be noted that while these verbal and nonverbal communication behaviors are necessary (but not sufficient) for increasing enrollment in clinical trials, the goal of clinical trial communication interventions should not simply focus on accrual but rather improve informed decision making by potential participants. Thus, whether patients consent or do not consent is beside the point. All patients, we believe, should be (1) offered the opportunity to contribute to medical knowledge through study participation and (2) provided study information in language (and a format) that they understand so they can make an informed decision about whether to participate.

Contrary to popular belief, good communication skills come naturally to very few people. Just as public speaking abilities can be developed through professional training, the specific interpersonal verbal and nonverbal practices that foster positive interactions with patients in a clinical trial recruitment context can be taught [17]. The content of clinical trial communication training programs varies considerably (as do outcomes), but most programs appear to be successful in improving the confidence of those who recruit for studies [18].

these communities, health disparities are deepened further [2]. This makes the participation of members of marginalized communities in clinical trials and research studies increasingly

There is growing evidence that the communication behaviors exhibited by medical and nonmedical professionals tasked with approaching and consenting patients impacts eventual enrollment [3–6]. Most research on clinical trial communication has focused on general guidelines for communication practice. These guidelines include making sure that the type and amount of information are appropriate for the patient [7], using plain language to explain a trial [5, 8, 9] and being open to answering potential participants' questions [3, 8, 10]. Additionally, recruiters are exhorted to be "warm" and respectful with patients [8, 11].

It is important, however, to examine the specific communication behaviors that lead to more effective recruitment, consent, and retention. A study of 63 medical professionals in two diverse U.S. cities indicates that both verbal and nonverbal communication practices support effective recruitment and consent processes [12–15]. Specific verbal communication behaviors that are associated with effective patient recruitment and consent include translating and simplifying information through the use of lay language and examples; reframing information through the use of metaphors, analogies, and storytelling; balancing discussions of risks with

Nonverbal communication behaviors may be even more important, given the central role of nonverbal communication in the process of meaning generation [16]. However, this topic has received little attention by researchers studying factors that impact clinical trial accrual. In the recruitment and consent process, nonverbal communication behaviors that appear to be particularly important include the ability to "read" patients' state of mind before approaching them to participate in a study; the willingness to adapt to a patients' mood and communication preferences; mirroring patients' body posture, tone, and rate of speech; using eye contact, touch, and smiling in situationally and culturally appropriate ways; and being conscious of the impact of physical appearance [13]. Importantly, both verbal and nonverbal communication function to create a sense of relational connection which, in turn, creates both trust and the motivation required for patients to process often-complicated study

It should be noted that while these verbal and nonverbal communication behaviors are necessary (but not sufficient) for increasing enrollment in clinical trials, the goal of clinical trial communication interventions should not simply focus on accrual but rather improve informed decision making by potential participants. Thus, whether patients consent or do not consent is beside the point. All patients, we believe, should be (1) offered the opportunity to contribute to medical knowledge through study participation and (2) provided study information in language (and a format) that they understand so they can make an informed decision about

Contrary to popular belief, good communication skills come naturally to very few people. Just as public speaking abilities can be developed through professional training, the specific interpersonal verbal and nonverbal practices that foster positive interactions with

benefits; and encouraging potential participants to ask questions [12].

urgent.

200 Clinical Trials in Vulnerable Populations

information [14].

whether to participate.

While clinical trial communication training programs are not yet widely available, there are some laudable examples that warrant discussion. Fallowfield and colleagues [19–21] have been among the first to develop communication training programs specifically focused on clinical trial recruitment and consent issues. Their training programs provided information on common communication issues and ethical concerns and were primarily directed toward physicians and nurses with clinical trial management roles. The main outcomes from these trainings were improved knowledge of clinical trials and increased confidence in their ability to recruit and consent patients. Similarly, Wells and colleagues [22] developed a training program to improve professionals' communication abilities but focused largely on developing increased cultural competency by focusing on barriers and beliefs of African Americans and Latinos. The program focused on outcomes related to knowledge and attitudes of minority patients' cultural needs. Another communication training program, developed and piloted at the University of Miami, focused on educating research coordinators on specific verbal and nonverbal communication skills to improve clinical trial recruitment and informed consent discussions. This communication training program consisted of five modules and adopted several educational strategies including a didactic presentation, in-group discussions, live demos, and role play activities [17].

One issue that has troubled virtually all existing clinical trial communication programs is the actual assessment of training outcomes. This may be a symptom of a larger problem in that there seems to be little consensus about what the goal should be for communication trainings. We assert that there should be two central goals: (1) increasing the willingness and ability of recruiters to use "best practices" in communication about clinical trial participation, with the ultimate goal of (2) increasing informed decision making among potential participants. Whether patients and other potential participants provide informed consent to enroll in a study or make an informed decision to decline the opportunity to participate, we believe that all patients should be presented with the choice to advance knowledge relevant to their health conditions wherever such opportunities exist. The burden is on us to communicate well in order to maximize the patients' comprehension of all factors that are relevant to their decisions.

Current assessments of the quality of communication practice as an outcome of clinical trial communication training has focused on several tools: (1) surveys of training participants' knowledge, attitudes, and perceived self-efficacy; (2) role-plays to practice skills; (3) videotaping participants to provide individualized feedback, and (4) the use of check lists to assess recruiters' behaviors when interacting with potential participants [18]. While all of these assessment strategies are valuable, none of these approaches has been validated, including the self-report survey, which is the most commonly used tool [18]. The development and evaluation of more effective training programs depend heavily on the use of validated and, preferably, triangulated outcome measures.

Toward this end, we have developed a self-report questionnaire that focuses on communication behaviors that are critical for effective clinical trial recruitment and consent. The measure is grounded in the empirical literature on clinical trial communication, particularly the work of Morgan and colleagues, who identified verbal and nonverbal communication behaviors that recruiters themselves associate with effective recruitment and consent processes [12–15]. We created an initial pool of 138\* items which corresponded to a wide variety of communication behaviors including eye contact; conversational style; protection of patient privacy; tone of voice; ability to "read" patients; ability to adapt to patient communication preferences; mirroring patient communication behaviors; smiling and friendliness; body positioning; the use of touch; physical appearance; simplifying/"translating" medical and technical information into lay language; reframing or using metaphors and analogies to explain difficult concepts; encouraging question asking; balancing the presentation of risks and benefits of study participation; describing the benefits to self and society of study participation; and other communication behaviors that ensure that potential participants comprehend information that is relevant to the decision to participate in a research study or clinical trial.

**Variable n (%)**

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 Male 14 (19.7) Female 54 (76.1) Not reported 3 (4.2)

 American Indian 0 (0) Asian 4 (5.6) Pacific Islander 0 (0) Black or African American 4 (5.6) Middle Eastern 0 (0) White or Caucasian 60 (84.5) Not reported 3 (4.2)

Hispanic 32 (45.1)

 High school–less than bachelors 8 (11.3) Bachelor 23 (32.4) Master 23 (32.4) PhD 6 (8.5) MD 11 (15.5)

 University of Miami 40 (57.1) University of Florida 28 (40) Both UM and UF 1 (1.4) Other 1 (1.4) Not reported 1 (1.4)

 Drug 44 (62) Device 11 (15.5) Behavioral/social 30 (42.3) Medical intervention/procedure 16 (22.5)

\*Some individuals reported recruiting for more than one type of trial.

**Table 1.** Characteristics of the sample.

Gender

Race

Ethnicity

Education

Institution

Type of trial\*
