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Comparing Communication Training Programs for Cancer Doctors

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Comparing Communication Training Programs for Cancer Doctors - NCBI Bookshelf An official website of the United States government Here's how you know The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Log in Show account info Close Account Logged in as: username Dashboard Publications Account settings Log out Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation Bookshelf Search database Books All Databases Assembly Biocollections BioProject BioSample Books ClinVar Conserved Domains dbVar Gene Genome GEO DataSets GEO Profiles GTR Identical Protein Groups MedGen MeSH NLM Catalog Nucleotide OMIM PMC Protein Protein Clusters Protein Family Models PubChem BioAssay PubChem Compound PubChem Substance PubMed SNP SRA Structure Taxonomy ToolKit ToolKitAll ToolKitBookgh Search term Search Browse Titles Advanced Help Disclaimer NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health. Comparing Communication Training Programs for Cancer Doctors James A. Tulsky , MD, Elise Brannen , Julie Goldman , MPH, Rebecca A. Baranowski , MEd, MS, David Farrell , MPH, Emanuele Mazzola , PhD, and Kathryn I. Pollak , PhD. Author Information and Affiliations Authors James A. Tulsky , MD, 1 Elise Brannen , 1 Julie Goldman , MPH, 1 Rebecca A. Baranowski , MEd, MS, 2 David Farrell , MPH, 3 Emanuele Mazzola , PhD, 1 and Kathryn I. Pollak , PhD 4,5 . Affiliations 1 Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts 2 American Board of Internal Medicine, Philadelphia, Pennsylvania 3 People Designs, Inc, Durham, North Carolina 4 Cancer Control and Population Sciences, Duke Cancer Institute, Durham, North Carolina 5 Department of Population Health Sciences, Duke University, Durham, North Carolina Washington (DC): Patient-Centered Outcomes Research Institute (PCORI) ; 2020 Aug . Copyright and Permissions Copyright © 2020. Dana-Farber Cancer Institute. All Rights Reserved. This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License which permits noncommercial use and distribution provided the original author(s) and source are credited. (See https://creativecommons.org/licenses/by-nc-nd/4.0/ Structured Abstract Background: The emotional state of a cancer patient affects his or her ability to understand medical information and make medical decisions. Communication techniques that recognize patients' emotions are more likely to elicit their concerns, alleviate anxiety, and enhance understanding. In previous work, we observed that oncologists frequently miss patients' emotional cues and do not respond adequately. Intensive face-to-face communication skills training improves these skills, yet such courses are time consuming and costly. We developed Study of Communication in Oncologist Patient Encounters (SCOPE), an online, interactive learning platform that provides oncologists with professionally coded feedback on their own audio-recorded conversations. In a previous randomized controlled trial (RCT), SCOPE increased oncologists' responses to empathic opportunities and led to greater patient trust. To enable greater dissemination, we modified this intervention (Enhanced SCOPE program) to include a smartphone app that allows easy audio recording of clinic visits. To maximize intervention effect, we also added feedback from real patients to oncologists about communication behavior. Objectives: We incorporated the Enhanced SCOPE program into the American Board of Internal Medicine Maintenance of Certification (MOC) program and sought to test its effect on patient satisfaction and oncologist communication behavior. If successful, this would create a platform and incentive for dissemination to oncologists nationwide. Methods: In an RCT, we compared the Enhanced SCOPE program with the standard communication skills practice improvement module (PIM) already embedded in the MOC program. Oncologists completed a baseline questionnaire, distributed satisfaction surveys to a sample of their patients, and audio-recorded 4 clinic visits with 4 unique patients. Oncologists assigned to the control arm received the results of the patient surveys and were asked to conduct a quality improvement activity that responded to these findings. Oncologists assigned to the intervention arm received the survey feedback as well as the Enhanced SCOPE program, including tailored feedback on their own audio-recorded encounters. After completing the online module, intervention arm oncologists audio-recorded 2 more clinic visits and received another round of tailored feedback as a booster. One month after completing the intervention or control arm tasks, oncologists in both study arms audio-recorded another 4 clinic encounters and collected more patient satisfaction surveys. The outcomes were patient satisfaction (Consumer Assessment of Healthcare Providers and Systems [CAHPS] communication subscale score) and oncologist ratio of empathic responses to available empathic opportunities in audio-recorded clinical encounters. Results: A total of 148 physicians across the United States enrolled in the study and were randomly assigned to either the control arm (n = 75) or the intervention arm (n = 73). Unfortunately, despite numerous incentives and assistance from study staff, the overwhelming majority never progressed sufficiently through the study steps (ie, survey and audio-recording collection, and intervention completion). The primary barrier to progression was completing survey collection and audio-recording consent without local research infrastructure. The study requirements were completed by 27 physicians, with 15 (56%) in the intervention arm and 12 (44%) in the control arm, and they collected a total of 455 surveys and 254 audio-recorded encounters. There was no difference between arms on CAHPS survey scores. However, at follow-up, intervention arm oncologists demonstrated nearly 3 times the ratio of empathic responses to opportunities compared with control arm oncologists at baseline ( P = .031). Conclusions: Among the small subset of oncologists who completed all of the project's necessary steps, those receiving the Enhanced SCOPE program demonstrated a better response to empathic opportunities compared with those in the control arm. The effect on patient satisfaction could not be evaluated due to the low uptake of the intervention. Limitations: Failure by many oncologists to progress through this study resulted in insufficient power to determine treatment effect. Background People living with cancer suffer greatly, and the burden is greatest on those with advanced disease. Cancer patients experience extraordinary physical, emotional, and existential challenges, and up to 60% acknowledge difficulty coping with their illness. 1-3 Among patients with advanced disease, 25% describe their suffering as moderate to extreme. 4 Emotional distress can be a significant source of this suffering, as patients experience fear, anger, sadness, isolation, and, particularly, anxiety or depression. 2 , 5-10 Psychological and emotional distress has been correlated with lower quality of life (QOL), 10-13 a desire to hasten death, 14 caregiver distress, 15-17 increased health care use, 18-20 and shorter survival. 21-23 Cancer radically changes the lives of those it affects, and the accompanying psychosocial distress can lead to worse health outcomes. Distress also affects patient decision-making. To make decisions about cancer treatment and future care, patients must understand the nature of the illness, its prognosis, and the available treatment options. A patient's emotional state and ability to comprehend prognostic data, and the ways in which oncologists discuss these data all affect the patient's understanding of medical information. Fearing the loss of hope, patients frequently cope by psychologically denying the information's import. 24 Patients may be incapable of processing the information they hear, 25 , 26 which in turn decreases message-encoding and recall. Emotion affects processing; people who are in negative moods may pay more attention to how messages are given than to the content of the messages. 27 , 28 Thus, when patients are experiencing high levels of negative emotion, and oncologists do not ameliorate this affect, patients may be less likely to understand oncologists' messages. Patients feel better when they express emotional concerns and their physicians respond empathically. Disclosure of emotional concerns helps patients in 2 ways. First, the expression of emotional concerns is therapeutic in itself. The self-disclosure literature demonstrates a variety of positive outcomes associated with expressing personally stressful experiences. 29-34 For women with breast cancer, emotional expression reduced somatic symptoms and medical visits. 35 When oncologists respond empathically to patients' emotions, patients report higher satisfaction and better adherence to treatment. 36 One study used a standardized videotape stimulus to assess the effect of physician compassion on viewers' anxiety. The authors found that women with breast cancer who saw the “enhanced compassion” videotape were significantly less anxious after watching it than women in the other group. 37 Second, cancer patients with unresolved concerns are more distressed than those whose concerns are resolved. 38-41 Oncologists can only respond to patients' concerns that they hear, and 90% of patients say they want to talk to their doctors about these issues. 42 , 43 Oncologists can promote these discussions by asking about patients' emotional concerns. In addition, techniques such as active listening, using open-ended questions and emotional words, and responding appropriately to patients' emotional cues assist in their expression. 44 When oncologists encourage their distressed patients to express their concerns and then respond appropriately, they help relieve patient suffering and create an environment conducive to improved decision-making. Effective patient-centered communication improves multiple patient outcomes. Outside the cancer setting, patient-centered communication has been shown to influence malpractice claims, 45 patient satisfaction, 46 recall of information, 47 and clinical outcomes, such as diabetic glucose control and functional status. 48-50 Among cancer patients, quality of communication affects psychological well-being, with “patient-centered” consultations leading to improved satisfaction and psychological adjustment. 50 Empathic communication reduces patient anxiety and decreases long-term distress. 36 , 37 Finally, communication techniques that focus on patients' emotional states are more likely to elicit patients' concerns about pain or other symptoms, which can then be treated. Patients with advanced cancer worry primarily about their survival and QOL. Whereas survival may be mostly a function of cancer biology and treatment effectiveness, enhancing QOL depends upon a clinician who has elicited the unique concerns of a patient, which may be physical, psychological, social, or spiritual. When physicians communicate empathically, they are more likely to elicit these concerns and more likely to engender the trust required to help patients navigate their cancer journey. All aspects of a patient's care are enhanced by improved communication. Unfortunately, oncologist-patient communication often does not meet experts' standards about response to patients' needs. A large amount of literature documents that physicians generally, and oncologists specifically, often do not meet the accepted quality standards for communication. 43 , 51-57 Physicians rarely talk with seriously ill patients about their goals, values, or even treatment decisions. 58-65 Oncologists commonly do not elicit the full range of concerns that terminally ill cancer patients have or attend to patients' affect. 66 Rather than using facilitative communication techniques, such as open-ended questions or empathic responses, when inquiring about psychosocial issues, oncologists often block discussion by changing the subject or not attending to patients' emotions. 67 As a result, cancer patients tend to disclose fewer than 50% of their concerns to oncologists and other providers. 67 , 68 Our team conducted the SCOPE Trial (Study of Communication in Oncologist Patient Encounters; R01 CA100387, Tulsky, PI) to analyze emotion handling in patient-physician communication and to develop an intervention for physicians. 69 This was a 2-part study. In the first phase, we analyzed audio-recorded oncologist-patient conversations to describe what happens in these encounters. In the second phase, we conducted a randomized controlled trial (RCT) of the SCOPE program in which oncologists received communication skills training. In the initial observational phase, we audio-recorded 398 conversations that occurred in 2 cities between 51 oncologists and 270 patients with advanced cancer. We found that patients disclosed emotional concerns in only 37% of these conversations, fewer than expected given the known high prevalence of distress. 70 When patients did express negative emotions (eg, anxiety, fear), oncologists responded empathically only 27% of the time. Patients likely stop expressing their concerns when they learn they will not receive a helpful response. Several characteristics were associated with the oncologists' communication style. Oncologists who used more empathic statements were younger than those who did not. Also, oncologists who responded empathically were more likely to describe themselves as socioemotional rather than technical in their orientation to medical care (80% vs 45%, respectively, P = .03). Of note, sex was related to the number of empathic opportunities; female patients seen by female oncologists had the most empathic opportunities ( P = .03), suggesting that oncologist behavior (ie, female oncologists tend to use more empathic language than male oncologists) affects the expression of concerns. 70 Oncologists may not address patients' emotional concerns for several reasons. They may be unaware that they are neglecting patients' emotional concerns, lack the skills to address patients' concerns, feel that addressing their concerns will not improve patients' well-being (ie, outcome expectations), lack the confidence to address patients' emotional concerns (ie, self-efficacy), or be unmotivated to improve their communication skills (ie, readiness to change). Also, external barriers, such as lack of time, may deter oncologists from addressing patients' emotional concerns. A significant gap exists between the idealized model of oncologist-patient communication and the reality of practice. Training can improve clinician communication. Although physicians frequently regard the ability to communicate as an inborn talent, these skills can be learned. Rigorous evaluations of communication skills teaching have shown positive results when interventions incorporate adult learning principles, practice, and feedback in settings supervised by trained facilitators. 71-73 Fallowfield conducted an RCT of a 3-day training course involving 160 oncologists from across the United Kingdom. 74 , 75 She found that in addition to favorably altering oncologists' attitudes and beliefs toward psychosocial issues, the course resulted in improved communication behavior in videotaped patient interviews. 75 Intervention oncologists significantly increased their use of open-ended questions, expressions of empathy, and appropriate responses to patient cues or empathic opportunities. These changes persisted for at least 12 months. 76 Members of our team have developed several programs to train physicians to better recognize patients' psychological distress and to respond empathically. An 8-hour communication skills course for medical staff improved their ability to deliver bad news and respond to emotional cues in standardized patient evaluations. 77 We have created the leading communication skills training program, VitalTalk, originally designed as an intensive 4-day communication retreat for oncology fellows. 78 Based on small-group learning using role play and feedback, we demonstrated significant improvement in fellows' empathic communication behaviors. 79 In fact, changes were so profound that the trained fellows were easily identified by blinded raters. Perhaps most importantly, participants found it transformed their practice, and the model has been replicated across the United States and overseas. Communication skills, such as eliciting concerns, handling emotions, and demonstrating empathy, can be taught and lead to increased physician self-confidence and reduced patient distress. Although face-to-face courses are the gold standard for training physicians, they have significant limitations. Well-designed communication skills training workshops are effective in changing physician behavior, yet they are costly and time-intensive. Such interventions require extensive coordination to assemble groups, facilitators, and simulated patients. Although they may be appropriate for physicians in training who can be required to attend, it is unrealistic to expect many practicing oncologists to take the time from their busy practices to undergo such training. Practicing clinicians need a more flexible model to fit communication skills training into their busy lives. The SCOPE program is a widely disseminatable online alternative to the face-to-face course. We recognized this need for alternative evidence-based educational venues that are brief, inexpensive, and easily accessible, and that do not disrupt clinical practice. We developed SCOPE, a computer-based, interactive, tailored program that teaches oncologists basic communication skills, allows them to review their own audio-recorded encounters, and provides suggestions for improving their responses to patients' negative emotions. SCOPE uses the principles found to be effective in face-to-face retreats and incorporates them into an online tool that can be efficiently used in the privacy of an oncologist's home or office. 80 In SCOPE, oncologists learn basic skills and observe them in exemplar videos and then have the opportunity to practice and receive feedback on their own conversations. Furthermore, employing the Social Cognitive Theory model, 81 , 82 SCOPE addresses oncologists' self-efficacy and outcome expectations and provides ongoing coaching and encouragement to overcome barriers to learning and adopting new skills. The original SCOPE program comprised 5 modules: (1) principles of effective communication ; (2) recognizing empathic opportunities; (3) responding to empathic opportunities; (4) conveying prognosis; and (5) answering difficult questions. A final module summarized main points from the intervention. Each module was designed to be viewed in 10 to 15 minutes and followed a similar format. First, barriers to learning the material were addressed. Then, the new communication skill was introduced and demonstrated in 1 or 2 video clips. Important teaching points were summarized and, finally, users were asked to review selected excerpts from their own previously recorded conversations. These excerpts were accompanied by tailored feedback (eg, “Great job, try to use more statements like that!” or “Next time, you may want to try saying….”). Oncologists were then asked to commit to using a new skill with their patients in the future, and they were sent email reminders of this commitment before their next clinic sessions. In an RCT, we tested SCOPE's efficacy with 48 oncologists and 264 patients. 83 The program was well accepted. Of the 24 oncologists in the intervention arm, 21 reported using the CD-ROM, with a median usage time of 64 minutes. More importantly, 91% of the oncologists reported changing their clinical practice as a result of what they learned in SCOPE. 80 Oncologists in the intervention arm used more empathic statements (relative risk, 1.9; 95% CI, 1.1-3.3; P = .02) and were more likely to respond to negative emotions empathically (odds ratio, 2.1; 95% CI, 1.1-4.2; P = .03) compared with oncologists in the control arm. Most importantly, patients seen by the intervention arm oncologists reported higher trust compared with patients seen by the control arm oncologists (estimated mean difference = 0.1; 95% CI, 0.0-0.2; P = .04; a difference from 4.6 to 4.7 on a 5-point scale). 84 After 1 hour of training with the SCOPE program, oncologists improved their skills and increased their patients' trust—results that are almost as strong as those seen in multiday workshops. The SCOPE program, an innovative, computer-based approach to teaching communication skills based on the same principles as face-to-face courses, can achieve similar results to these courses, yet be integrated into the everyday practice of a busy oncologist. SCOPE offers an inexpensive, practical, and disseminatable alternative to communication workshops. Enhanced SCOPE Program: Capturing the Patient's Voice in the Medical Encounter For this project, we created the Enhanced SCOPE program. In addition to coding done only by research assistants , we involved patients in the feedback process. The recorded encounters were reviewed by trained patient advisors who listened to the recordings and directly inserted their own subjective feedback. Physicians rarely are given the opportunity to hear what patients truly think about their communication style. The Enhanced SCOPE program provides oncologists with both objectively coded feedback and a sense of how real patients react to their communication, thus “using the patient's voice” to improve the medical encounter. The only difference between the original SCOPE program (which included objectively coded feedback on the oncologists' conversations) and the Enhanced SCOPE program was the addition of subjective feedback from the patient reviewers. The goal of this project was to incorporate the Enhanced SCOPE program into the American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) program as a practice improvement module (PIM). At the time we initiated the study, MOC and PIMs were required of all board-certified oncologists. If incorporating the Enhanced SCOPE program into the MOC program proved feasible and effective, it could lead to automatic widespread dissemination. We hoped to improve the experience for patients living with cancer by providing oncologists with communication skills training that includes feedback on their own audio-recorded conversations. We also hoped to demonstrate the feasibility of disseminating this intervention to community oncology practices. Our study addressed the following 3 aims: Aim 1: Identify barriers to implementing the Enhanced SCOPE program app and website in participating oncology practices. Barriers include oncologist enrollment, patient enrollment, and transmission of data. Aim 2: Compare the effect of the Enhanced SCOPE program with that of the standard communication PIM on patient satisfaction with oncologist communication as measured by the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) survey. Aim 3: Compare the effect of the Enhanced SCOPE program with that of the standard communication PIM on oncologist communication behaviors, including their use of empathic responses to patients' emotional concerns, as coded from audio-recorded medical encounters. Participation of Patients and Other Stakeholders With the help of the Dana-Farber Patient and Family Advisory Council (PFAC) and the Susan G. Komen organization, we invited many patient advocates to participate in this project. At any time during the project, we had 12 to 16 active patient stakeholders participating in engagement activities, all of whom were patients with metastatic disease. Our patient stakeholders were engaged as research team members throughout the project, consulting on study and intervention design and allowing their voices to be heard directly by participating clinicians. Our patient advisors attended monthly project team meetings to provide feedback on training materials; their feedback helped to ensure HIPAA compliance in a way that minimized disruption to patients and physicians while meeting IRB policies. They were an invaluable resource in the creation and review of the study materials, lending their unique perspectives as patients to comment on and add material to the oncologist training videos. They promoted the opportunity for cancer survivors to participate in analyzing physician-patient conversations and identified potential patient evaluators. They also helped plan the recruitment and training sessions for patient evaluators and attended the training themselves. As we began receiving audio-recorded oncologist-patient encounters, we were able to collaborate with our patient stakeholders in a new way: Stakeholders reviewed these recordings and provided their subsequent feedback, allowing them to contribute directly to the online intervention the oncologists were participating in. After many recordings had been reviewed, a web conference was held with our active patient stakeholders to solicit their feedback on the project and their involvement as well as to provide our own feedback on their reviews. This was very warmly received. As the project came to a close, many of our patient stakeholders shared that they were sad it was ending and that the process had been “very therapeutic” for them. We presented the results of this project to the Dana-Farber PFAC on December 3, 2019. Methods Study Overview The goal of this project was to incorporate the Enhanced SCOPE program into the ABIM MOC program as a PIM. We hoped to improve the experience for patients living with cancer by providing oncologists with communication skills training that included feedback on their own audio-recorded conversations, comparing the effect of the Enhanced SCOPE program with the standard ABIM communication PIM with regard to patient satisfaction and oncologist communication behavior. We also hoped to demonstrate the feasibility of disseminating this intervention to community oncology practices. We conducted an RCT to test the impact of the Enhanced SCOPE program. We selected the ABIM MOC platform because, at the time the original grant was written, this was seen as a powerful incentive to oncologists to participate (as they were all required to complete at least 1 PIM). However, as will be described below, shortly after we received our funding, the ABIM MOC process went through a completely unexpected and radical revision, and these PIMs were no longer required. Therefore, for participating oncologists, this intervention became entirely voluntary, which placed a burden on the investigators to enhance the incentive to participate. Oncologists who chose to enroll in this pilot PIM completed a baseline questionnaire, sent out satisfaction surveys to a sample of their patients, and were then audio-recorded (using a smartphone application) during 4 clinic visits with 4 different patients. Oncologists assigned to the control arm received the results of the patient surveys and were asked to conduct a quality improvement activity that responded to the survey feedback (the current “standard” communication PIM). They were offered several potential resources to use for upgrading their communication skills and were asked to describe their study plan and their success in its completion. Oncologists randomly assigned to the control arm were given the opportunity to conduct the Enhanced SCOPE training after study completion. Oncologists assigned to the intervention arm received the survey feedback as well as the Enhanced SCOPE program, which provided an online interactive didactic learning platform and tailored feedback on their own audio-recorded patient encounters. The feedback came from 2 sources: (1) professional research assistant coders who identified objective learning opportunities based on specific coding criteria (eg, empathic opportunities, use of open-ended questions); and (2) trained patient reviewers who listened to the recordings and offered their own subjective feedback at key moments in the encounters. These patient reviewers were drawn from our stakeholder partners and were active patient advocates. They were treated as members of the research team, were paid for the reviews, and were not patients of the study physicians. They were also trained how to offer feedback that would be motivating and well received. After completing the Enhanced SCOPE online module, intervention arm oncologists audio-recorded 2 more clinic visits and received another round of tailored feedback as a “booster.” One month after completing the intervention or control arm processes, oncologists in both arms audio-recorded another 4 clinic encounters and collected another batch of 25 satisfaction surveys from a new sample of patients. For physicians who struggled to begin or progress through the study, we offered individual site visits by members of our study staff to encourage and support the physicians as they took on this project. We started offering these visits more than halfway through the study timeline in response to low accrual of patient surveys and audio-recorded conversations. We learned that oncologists struggled to adapt the study to their practice settings, and we recognized that a staff visit might enhance their ability to complete the study without biasing study outcomes. During these visits, study staff met with physician office staff to help distribute and collect patient surveys and to set up processes to facilitate participation. Study staff also consulted with the physicians to troubleshoot any barriers to audio-recording conversations. We sent an email to all participating physicians introducing the new offer of assistance and provided the contact information of study staff for those interested in taking advantage of this opportunity. We required permission from the physician before planning a visit. Participating physicians were not required to accept a visit from study staff. Study Setting We administered this study from the Dana-Farber Cancer Institute, conducted in cooperation with ABIM, and enrolled patients in a broad number of oncologist practices across the country. These practices included large academic institutions and small community clinics. Dana-Farber and its affiliates were excluded. Participants We planned to enroll up to 120 oncologists, with a goal of achieving a final total sample size of at least 100 after attrition. All board-certified oncologists practicing in the United States and enrolled in the ABIM MOC program were eligible to participate. Eligible oncologists were invited via email to enroll through the ABIM website. Three rounds of email invitations were sent from ABIM to oncologists before the original accrual goal was met. A randomization key created before oncologist enrollment was used to randomly assign consented oncologists to each study arm, 50 per arm. Each oncologist was to collect 50 patient surveys (25 before and 25 after the intervention) for a total of 5000 surveyed patients. Oncologists introduced the study to patients receiving cancer care from them and then handed patients a copy of the survey to complete at home. In addition, all oncologists were to audio-record 8 conversations with 8 unique patients (4 before and 4 after the intervention) for a total of 800 enrolled patients with audio recordings. Intervention arm oncologists were to record an additional 2 encounters during the booster phase (100 patients) for a total of 900 patients with audio recordings. Eligible patients for the recordings had metastatic cancer, were at least 18 years of age, spoke and read English, and received oncology care from an enrolled physician. Before recording, oncologists identified potential patients and provided them with a flyer prompting them to call study staff at Dana-Farber Cancer Institute. Patients called study staff, who explained the study and provided a website link via text message directing patients to an electronic consent and HIPAA authorization form that they then signed. Figure 1 shows participant flow through the study. Figure 1 Participant Flow. A large proportion of participating patients were accompanied to their oncology visit by at least 1 caregiver. Because caregivers in the room could be heard on the audio recordings, they also were required to provide informed consent. However, they were not the focus of the study and their presence is not relevant to the study aims. Eligible caregivers were those present in the room with the enrolled oncologist and the patient participant receiving oncology care during the audio-recorded clinic visit. All caregivers were introduced to the study by an enrolled oncologist alongside a recruited patient and provided their consent to being recorded via the same electronic consent process used by patients. As the study progressed and encountered overwhelming barriers to participant accrual (see Changes to the Original Study Protocol section), the accrual goal was decreased to 40 physicians, with 20 randomly assigned into each arm. We also decreased the required number of surveys from 25 to 5 before and after intervention (ie, from 50 total surveys to 10 total surveys). The projected number of surveys and recordings were correspondingly decreased to 400 surveys and 360 recordings. Recording Review All recorded encounters were coded by both study staff (“manualized coding”) and by patient reviewers. Professional “Manualized” Coding Study staff coded recorded encounters using the AVA software program developed by our team and used previously in >20 related studies to code >6000 physician-patient encounters. Using AVA, coding was performed directly on the audio recordings, preserving subtleties and context that would be lost through transcript-based coding alone. Coders identified segments within each recording and applied codes to each segment. The coding rules are highly detailed, and our experience from the previous SCOPE studies as well as from numerous other projects is that we can train coders to achieve high interrater reliability with κ scores >0.8 for most codes. After the 2 coders were trained, each coded approximately half of the conversations. In addition, they both coded approximately 15% of the encounters to make sure there was no coder drift. This technique resulted in very rich data that provide a view into specific physician communications at multiple points in each encounter. Trained Patient Review—Patient Reviewers We believe that the most powerful example of engagement in this research is the patient clinic visit audio-recording review with feedback being given to the oncologists. Patient reviewers evaluated recorded encounters using a website developed specifically for the project. Before conducting any reviews, Dr Pollak, a national expert and trainer in motivational interviewing, trained all patient reviewers to help them understand how to frame their comments in behavioral language that was likely to be better understood and internalized by the oncologists (eg, “I liked the way you said, ‘That must be tough’—it showed that you really heard what the patient was saying,” rather than, “You sounded really caring there.”). Reviewers were notified by study staff when an encounter was ready for review. After logging into the platform, the reviewer was presented with a list of assigned encounters. Once an encounter was opened, an audio playback interface allowed reviewers to play, pause, and search through the recording. At any point, the reviewer was able to pause and insert a comment as a voice memo and/or typed message. Upon completion, the reviewer inspected and modified inserted comments and marked the review as complete. Reviewers were trained in use of the site, and study staff provided technical support by email and phone. Each conversation was reviewed by 1 patient reviewer. Coded Data Review and Recorded Example Selection Data from manualized coding were inspected by Dr Pollak who could reject, accept, or modify specific coding. Based on previous experience managing similar review processes, initial encounters would require regular checking and discussion with reviewers and coders. This served as a quality improvement step that led to better review and coding over time, ultimately resulting in very little need for checking these data before their usage in the online training. There were no more than 2 examples given for each skill taught. Similarly, staff examined patient reviewer comments and where necessary clarified these through discussion with the reviewer. Specific comments were edited to better reflect reviewer intentions, and voice memos were occasionally converted to text when a voice memo needed to be adjusted. Up to 3 patient reviewer comments per encounter were selected for presentation to the oncologists, so as to not overwhelm them with feedback. Intervention and Control Intervention After all of an oncologist's recorded encounters had been collected and coded, the data were transferred to an individually tailored web/mobile-based training program, and intervention oncologists were directed to the Enhanced SCOPE training site. The program comprised 5 modules that built sequentially upon one another: (1) principles of effective communication; (2) recognizing empathic opportunities; (3) responding to empathic opportunities; (4) conveying prognosis; and (5) responding to difficult questions. The principles and mnemonics taught in these modules were derived from the OncoTalk communication skills training program. 78 , 79 Although the Enhanced SCOPE program identified oncologists' opportunities for improvement, the overall “tone” of the program was positive and supportive. It used the language of motivational interviewing, stressed how difficult these conversations are for clinicians, stated that shortcomings are ubiquitous among physicians, and praised and encouraged positive behaviors when identified. Each module included an introduction to the topic and taught several concrete skills with video demonstrations created specifically for this application. Each module also included audio clips from the oncologists' own conversations to show examples of when they used the skills and to highlight opportunities where they could have used the skills if they had not done so; the module also offered tailored audio feedback meant to encourage positive behaviors, discourage unhelpful ones, and provide alternative approaches to employ when missed opportunities were detected, as described previously. For example, when an oncologist missed an empathic opportunity, we provided a sample empathic response. Oncologists received patient reviewer comments either verbally or in writing, along with clips from the encounters to which those comments were directed. Feedback rewarded oncologists for demonstrated skills and identified deficiencies with concrete suggestions to improve communication in those areas. In addition to the objectively coded data and examples, oncologists also received examples with feedback selected by the trained patient reviewers. Finally, each module concluded with action steps to which the oncologist would commit, about which they would receive an email reminder. Upon completing the intervention, oncologists were directed by the Enhanced SCOPE website to return to the ABIM PIM and begin follow-up data collection. Study staff also sent emails notifying oncologists when it was time to begin collecting follow-up data and maintained steady contact throughout the follow-up data collection process. The training program was designed for use on multiple platforms, including computers, tablets, and smartphones. The interface was intuitive, with an emphasis on quick digestion of content. Physicians could work through modules in a linear fashion or follow their own preferred trajectory using a menu system. They were encouraged to visit all content areas, and completion was clearly indicated through a progress meter and map showing completed and incomplete sections. The training program tracked usage at the page/screen level, allowing for detailed analysis of each physician's dose and usage trajectory. An administration panel allowed research staff to track physician usage. All technical and design work related to app and website development was performed by People Designs, Inc, a Durham, NC-based firm led by David Farrell, MPH. People Designs developed Enhanced SCOPE, the AVA audio coding software, and several other similar applications used in projects with Drs Tulsky, Pollak, Robert M. Arnold, and Anthony L. Back. Control After all baseline surveys and recorded encounters had been collected and coded, control arm oncologists were directed back to the ABIM PIM website. There, they completed the typical ABIM communication PIM protocol, reviewing the results of their patient surveys, identifying areas in which they could improve, and creating an action plan to achieve that goal. Oncologists then set an impact date by which they felt they could achieve their goal. After implementing their plan and reaching this date, control arm oncologists were directed to collect follow-up surveys. Study staff also sent emails notifying oncologists when it was time to begin collecting follow-up data and maintained steady contact throughout the follow-up data collection process. Control arm oncologists were invited to complete the Enhanced SCOPE training (intervention arm training) after collecting all follow-up data. Study Outcomes CG-CAHPS Survey Patient satisfaction with communication, the primary and patient-reported outcome of this trial, was measured by the CG-CAHPS survey. 84 , 85 This validated 48-item measure created under the aegis of the Agency for Healthcare Research and Quality and endorsed by the National Quality Forum measures patient experience with an outpatient health care provider over the past 12 months. Patient satisfaction as measured by the CG-CAHPS survey provides a tangible assessment of the quality of care patients receive as reported by the patients themselves. Because of the structure of the ABIM PIM, we administered the entire CG-CAHPS survey. It comprises 3 major composites (ie, access to care, physician communication, and courtesy of staff) and 2 global rating items. All composites show acceptable individual-level internal consistency reliabilities (Cronbach α ≥.77), as well as practice-level reliabilities (Cronbach α ≥.75). To answer our study question, we used only data from the communication composite. It is difficult to determine a minimally clinically important difference (MCID) when using this survey tool as an outcome measure. No data really exist to determine how much difference is made by an added unit of patient satisfaction. That said, given the general ceiling effects on these instruments, we selected a 10% difference as being an MCID. Anecdotal conversations with health system leaders suggest that such a difference would be recognized at the system level as a valid response to system change. Audio-Recorded Encounters Our secondary outcome, which was oncologists' empathic responses to patient and caregiver expressions of negative emotions (ie, empathic opportunities), uses the ratio of empathic responses to empathic opportunities. For analytic purposes, at each stage of the study (pre- and postintervention) we combined all of that stage's conversations for each physician (ie, counted all empathic opportunities and responses across 4 conversations as if it was 1 conversation). n u m b e r o f e m p a t h i c r e s p o n s e s b y t h e o n c o l o g i s t n u m b e r o f e m p a t h i c o p p o r t u n i t i e s g i v e n b y t h e p a t i e n t ( o r c a r e g i v e r ) This ratio served as a measure of communication quality with regard to addressing patients' emotional concerns. Sample Size Justification and Power In our original sample size calculation, we determined that 102 physicians with 8 patient audio recordings at baseline and 8 more recordings postintervention and 35 patient responses to the CG-CAHPS surveys at baseline and again at postintervention would meet our study objectives. This was based upon a 2-tailed α equal to .05 with a power of 0.8 and a standardized effect size of 0.2 based upon previous studies. In this calculation, we also assumed an intracluster correlation of 0.1 for the physician conversations nested within oncologists. Midway through the study, due to many setbacks described below in detail, we realized that the full sample of oncologists was not going to complete the study. Furthermore, we had found that the primary barrier to study completion was the survey collection and audio recording. Therefore, we adjusted our sample size considerably and powered for a demonstration project only. This decision was made after considerable discussion with our PCORI program officers. We reduced the number of surveys to 5 per oncologist at baseline and postintervention, and the number of audio recordings to 4 at baseline and again at postintervention. We increased our α to.1 and our effect size to 0.33 to 0.50 SD. With these new assumptions, we calculated a new sample size of 40 oncologists (20 in each arm). Unfortunately, in the end, we did not achieve that sample size either, and only 27 oncologists completed the entire study. Given this final sample, we calculated that we had only 29% power to detect differences in the primary outcome at the α = .05 significance level. For the secondary outcome this new sample size offered a greater power of 60% to detect a difference at the .05 significance level. In summary, had all of our recruited oncologists progressed through the study as planned, we would have been extremely well powered to show a difference between arms on both primary and secondary outcomes. However, given the challenge of low rates of completion of the study by participating oncologists, we ended up with results severely limited by their power to detect differences in both outcomes, and a study at high risk of type II error. Time Frame Data collection lasted approximately 18 months. While the intervention period for the study was flexible, we expected physicians would complete the intervention within approximately 6 months based on previous completion times for the ABIM communication PIM. Physicians who did complete the project spent an average of 275 days from initial release of the project to final data collection. Physicians spent a mean of 195 days in the baseline data collection phase, 46 days in the intervention/action plan, and 36 days in the follow-up data collection phase. Data Collection and Sources All data were organized by oncologist and stored under an oncologist-specific identification number. The CG-CAHPS survey data was managed by ABIM. Oncologists could access the survey through their PIM, printing out hard copies to hand to eligible patients. These patients would then complete the survey either online or by phone as is typical of ABIM PIM survey collection. In certain instances, patients would complete the survey on paper and either mail it to study staff or hand it to visiting staff, who would then enter the data online. Oncologists audio-recorded their patient encounters using a smartphone application specifically developed for this purpose. Upon enrollment, the oncologists received an email message with links to install the smartphone app. The app is compatible with both iOS (iPhone) and Android operating systems. Possession of a compatible smartphone was a requirement for study enrollment. To record an encounter, the physician simply launched the easy-to-use app and tapped “record.” At the end of the recording, physicians tapped a “stop” button and could choose to immediately upload the recording to the “cloud” review platform, or to upload it later to the AVA website (eg, if they did not have a current internet connection). Delivery status of each recording was prominently noted, and the physician was reminded later to upload the recording. Participating oncologists were given detailed instructions for using the app (although it was quite simple and intuitive), and reminded that all data transfer was HIPAA compliant and that study staff members were available by phone and email to provide technical support as needed. Oncologists received regular email reminders as well as occasional phone call and text reminders to complete the various aspects of data collection during both the baseline and follow-up phases. Study staff also offered in-person clinic visits to any oncologist who asked for assistance in the data collection process. Analytical and Statistical Approaches Primary Outcome The primary outcome of this study is addressed by our second aim: We compared the effect of the Enhanced SCOPE program with the standard communication PIM on patient satisfaction by using the validated CG-CAHPS survey. The CG-CAHPS survey is composed of questions that encompass many different composites as well as 2 global rating measures. We analyzed the results for 2 composites—How Well Providers Communicate and Provider-Patient Trust—as well as the global rating of the provider (see Table 1 ). Two other composites—Access to Care and Courtesy of Staff—were deemed not relevant to an intervention on physician communication and were therefore not analyzed. Several single-item questions that were not included in any composite were deemed relevant and thus considered individually. Table 1 Composites Analyzed and Corresponding Questions From the CG-CAHPS Survey. The composite measurements used for our analysis were calculated as the average of the corresponding responses on the questionnaire. Most questions had a 4-response option (1 = yes, definitely; 2 = yes, somewhat; 3 = no; 4 = skip this question). Two of the analyzed questions asked for a rating of the provider with a response option of 0 to 10. Both the responses coded as “4 = skip this question” and the truly missing responses were imputed as the mean value of all the responses to the specific questions, to avoid penalizing oncologists for missing responses. The calculated single measures for each individual for the composites and the individual questions (where needed) were then modeled with an appropriate mixed-effect model: For continuous outcome measurements we used a linear mixed-effect model, whereas for ordered categorical outcome measurements we used a mixed-effect, ordered multinomial logit model (cumulative logistic model). 86 Due to the mean-value imputation mentioned previously, most of the outcome variables were considered continuous with the exception of the provider rating score. For the latter score, the missing responses were excluded from the analysis. All analyses were 2-tailed. Secondary Outcome Our secondary outcome addressed the third aim above and compared the effect of the Enhanced SCOPE program with the standard communication PIM on oncologist communication behaviors. It focused on the ratio of empathic responses to empathic opportunities: n u m b e r o f e m p a t h i c r e s p o n s e s b y t h e o n c o l o g i s t n u m b e r o f e m p a t h i c o p p o r t u n i t i e s g i v e n b y t h e p a t i e n t ( o r c a r e g i v e r ) . The main feature of our modeling strategy was to account for multiple conversations recorded for the same physician, by means of a random effect term on the physician's ID (which was repeated in the data set for each conversation held by the same physician). For all randomly assigned physicians who completed the study (N = 27), we assessed the overall effect of treatment between baseline and follow-up by using a mixed-effect Poisson model. This included an interaction term between the study arm and the study stage (baseline or follow-up), and an offset for the (log) number of empathic opportunities, accounting for the exposure of each physician to different number of possibilities of returning an empathic response. To assess the treatment effect within each arm we then used a second Poisson mixed-effect model with the following predictors: sex, self-reported score describing the socioemotional range vs technical-tactical abilities, and study stage (baseline, midstudy [only for the intervention arm] and follow-up), offset again by the (log) number of opportunities as mentioned previously. We also explored heterogeneity of treatment effect on the secondary outcome for different subgroups by adding an interaction term between treatment status and subgroup to the models. These groups include sex as a biological variable, age, and socioemotional inclination. Missing data, either incomplete responses (items missing) or absent responses (dropouts or missing records), reduce the efficiency of studies and may introduce bias into the analyses. For our purposes, we analyzed 2 different approaches: (1) analyzing the data, excluding the cases containing missing responses; and (2) imputing the missing responses with the means (as described previously). There was no significant difference between the 2 approaches (given how few observations we had) and we made the decision to accept the second approach to allow us to retain as many data points as possible. Changes to the Original Study Protocol Over the course of the project, we made many changes from the funded application due to unforeseen events and delays. First, the approval and activation of the project by our IRB was impeded by the size and complexity of the trial. Our IRB decided that 1600 patients was too many, and in the interest of reducing total patient enrollment, we had to reduce the number of patients being recorded. We determined that we could reduce the number of audio-recorded encounters for those in each arm from 16 per oncologist (8 pre- and 8 postintervention) to 8 per oncologist (4 pre- and 4 postintervention). In addition, the intervention arm oncologists completed 2 additional recorded encounters to serve as “booster feedback” during the intervention. This modification changed our original number from 1600 patient recordings to 900, which was a much more attainable goal given our project timeline. Additionally, we made a change in the number of patients who would anonymously complete the CG-CAHPS survey. We determined that we could reduce the number of patients completing the survey from 35 to 25 per oncologist, pre- and postintervention. With 100 oncologists and pre- and postintervention patient survey collection, that would lead to a total of 5000 surveys. We concluded that these changes left us adequately powered to demonstrate the hypothesized differences between study arms. Both changes were made to achieve approval by the Dana-Farber IRB. Shortly after this study was funded, ABIM made unanticipated significant changes to their MOC program. This was in response to an unexpected and sudden flood of criticism from the internal medicine community about the program. These new changes eliminated PIMs, the platform upon which our intervention was constructed, and created multiple new ways for oncologists to obtain recertification. These changes dramatically reduced the incentive for oncologists to participate in our study. Even after they enrolled (because of interest in the topic), we lost the strongest incentive to complete the project, which had been a requirement to complete a PIM in order to qualify for recertification. In addition, we ran into another unexpected challenge even for those oncologists eager to participate. For many, their local IRB would not cede authority to the Dana-Farber IRB despite its decision that they were considered strictly participants and not investigators. These IRBs required the physicians to undergo a local IRB review. In some cases, we were able to assist and complete the paperwork to make this happen. In others, the oncologists withdrew. Yet an additional challenge lay in the CG-CAHPS survey collection. As stated previously, we required 25 surveys at baseline, and this proved to be an overwhelming barrier for many oncologists. In previous ABIM experience, physicians had always completed these surveys as part of their PIMs; however, it now appeared that without the MOC requirement, many oncologists found the burden to outweigh the benefit. Distributing and collecting the surveys required staff support in their offices which they did not always have, and we heard considerable feedback that the task was simply too difficult. Given all of these barriers, by June 2017, we realized that we had a serious problem motivating the oncologists to complete the study protocol. The study had originally been deliberately designed in a way that would require minimal interaction with the oncologists beyond the contacts they would normally have with ABIM. However, that clearly proved unsuccessful, and we realized more intervention from the study team would be required to complete this project. In consultation with our PCORI program officers, we took the following steps and revised the protocol. We first began a motivational campaign to encourage oncologists to progress through the study. This included a series of personal emails, texts, and phone calls from Dr Pollak (social psychologist and expert in motivational interviewing) in which we sought to establish relationships with the oncologists, help them troubleshoot their barriers to participation, and encourage them to continue in the study and to complete data collection of surveys and recordings. In addition to these coaching calls and messages (which definitely had some level of impact), we also produced 3 motivational video recordings that were sent to all participants. One came from Dr Tulsky (study principal investigator), one from Dr Pollak, and the final one from Dr Richard Baron, the President of ABIM. We sent the physicians small gifts of chocolate when they completed some of the study objectives. And, finally, we created a raffle in which physicians earned “tickets” by completing stages of the study, and the winner would receive an Apple Watch. This last measure was originally approved by the Dana-Farber IRB in July 2017, but in April 2018 that decision was rescinded by the IRB as an undue incentive, and the raffle was removed from the protocol. Unfortunately, despite all of these changes and tremendously hard work by our study team trying to motivate the oncologists, we were still not adequately progressing toward our revised completion goals. Therefore, we made even more adaptations to the protocol. First, after 7 months of attempting to collect 25 CG-CAHPS surveys at baseline, we recognized that the greatest oncologist barrier to progression through the study was survey collection. Therefore, on December 12, 2017, we further reduced the number of surveys required to 5 per oncologist pre- and postintervention. This raised statistical concerns related to validity of so few surveys per oncologist, but we still calculated between 65% and 80% power to detect differences in the CG-CAHPS surveys (and 80% power to detect differences in communication quality, our secondary outcome). While it put us at a higher risk of type II error, it was the only way we could see completing the trial with any level of success. Furthermore, we decided that oncologists who had not collected all 5 baseline surveys after a 2-week period would be automatically “pushed through” to the next stage of the study when they would audio-record visits and complete the online intervention. The surveys had initially been included because they were a component of the original ABIM PIM (which was still important for the control arm of the study), but we became convinced that we would only move forward if we drastically reduced or eliminated the initial survey collection phase. Through conversations with the participating oncologists, it became abundantly clear to us that although the oncologists could readily participate in the online program and the audio-recording of patient encounters in their practices, it was the elements of research overlying these aspects of the intervention (eg, patient surveys, informed consent) that presented the most overwhelming hurdles to their participation. Therefore, at the beginning of 2018, we abandoned the idea that study data would be collected solely through the effort of the oncologists themselves and made the key decision to send our research staff directly to the oncologists' offices to assist them in data collection. We deployed 3 research assistants to clinics from New York to California, and in 1- or 2-day visits, they often completed or made a significant dent in collecting the requisite number of surveys and recordings. In addition, these face-to-face visits created relationships that we leveraged later. We planned to make return visits to as many of these oncologists as possible after they completed the online intervention so that we could assist them in collecting the final recordings and patient surveys. These visits were extremely well received by the participating oncologists and made the greatest impact by far on data collection compared with all preceding changes. In retrospect, this was the primary change that we should have made much earlier in the study. We also made another hugely important modification (that, again, we should have done earlier). We communicated to all oncologists a firm study end date after which they would no longer receive the benefits of study completion (40 MOC points, 40 CME credits, and $75 cash). We communicated these deadlines based on their initial enrollment date: June 30 (n = 44), July 31 (n = 45), and August 20 (n =38). This allowed us to know which oncologists would be unlikely to complete the study data collection. Over time we learned that oncologists who did not engage with the program within the first several months of enrollment were highly unlikely to complete the study. Again, in retrospect, had we done this much earlier we could have continued to enroll new oncologists into the study as we learned which ones would be unlikely to make it to completion. Finally, based on all of the above, we recognized that it was no longer realistic to expect 100 oncologists to complete all elements of the study. Therefore, within a few months of instituting these protocol changes, we also resized the study to a total of 40 oncologists, with the attendant number of audio recordings (n = 360) and patient surveys (n = 400). Results A total of 148 physicians were enrolled in the study and randomly assigned to either the control arm (n = 75) or the intervention arm (n = 73), exceeding our original accrual goal. According to the eligibility criteria, none of these oncologists were affiliated with Dana-Farber Cancer Institute. They practiced in a wide variety of locations from the East and West Coasts, the Midwest, and the South; in rural and urban communities; and in academic and community practices. Due to the changes detailed previously and the lack of enrolled physicians who actually collected surveys and recordings and worked through the PIM, the ultimate accrual goal was decreased to 40 physicians, with 20 in each arm. Over the course of the project, 64% (n = 94) of the original 148 physicians were lost to inactivity, and 18% (n = 27) actively withdrew. For those physicians who withdrew, most cited a lack of time or competing priorities. Other concerns included the burden on patients or staff, privacy concerns from the physician's institution, issues with the recorder application or websites, and other individual concerns. Many physicians who withdrew did not cite a specific reason. A total of 27 physicians completed the project, 15 (56%) in the intervention arm and 12 (44%) in the control arm. These 27 physicians collected 455 surveys and 254 audio-recorded encounters. An additional 260 surveys and 52 recordings were collected by participants who did not complete the protocol for an overall total of 715 surveys and 306 recordings. Table 2 displays the baseline characteristics of the oncologists who completed the project, and Figure 2 shows the flow of physician participants through the study. Table 2 Baseline Characteristics of Oncologists. Figure 2 Study Flow Diagram. Primary Outcome Comparing CG-CAHPS survey scores between oncologists in the intervention and control arms, we did not observe any significant effect of the intervention arm. This was true for all composite scores as well as the single-item questions we analyzed ( Table 3 ). Because of the low sample size and reduced power, there is a high risk of type II error and little can be concluded from these null findings. Table 3 Analysis of Composite Score Results of Survey Responses. Secondary Outcome At baseline, both control and intervention arm oncologists had a low percentage of empathic responses to opportunities (mean, 17% and 15%, respectively; 16% overall). This number is considerably lower than the baseline rate of 28% seen in previous studies. 70 , 83 At follow-up, intervention arm oncologists demonstrated nearly 3 times the ratio of empathic responses to opportunities compared with the control arm at baseline ( P = .031). When considering only the physicians in the control arm of the study, the number of empathic responses decreased from baseline to follow-up (0.48 responses per recorded visit, nearly half), a finding that is consistent with previous studies. 83 On the other hand, conversations recorded at the booster stage for intervention arm physicians had almost twice the number (1.905) of empathic responses with respect to conversations at baseline, before decreasing slightly to 1.362 times for the follow-up stage (with respect to baseline; see Figure 3 ). Figure 3 Percentage of Empathic Responses According to Study Stage . Of the physicians who completed the study, 4 (15%) were female and 23 (85%) were male. As illustrated in Table 4 , when evaluated with a similar mixed Poisson regression, the interaction between sex of patients and sex of physicians showed that when male patients were coupled with male physicians, we observed 0.77 empathic opportunities for every empathic opportunity observed in female patients coupled with female physicians. Overall, male patients seem to offer slightly fewer opportunities than female patients (0.94, P = .775). We also found that oncologists who had a greater self-perceived socioemotional orientation as opposed to a technical-scientific one were significantly more likely to respond appropriately to empathic opportunities. Table 4 Analysis of Composite Score Results of Survey Responses. Discussion We created and disseminated an online communication skills training program for oncologists that, even with a reduced sample size, demonstrated improved communication behavior. However, no significant effect was seen in the primary outcome of patient satisfaction. Due to the small final sample size accrued, as well as the low response variability and ceiling effect in the patient satisfaction ratings on the CG-CAHPS survey, we do not know if this lack of a positive effect was due to lack of power or whether the intervention was simply ineffective with regard to patient-reported outcomes. Referring back to the original 3 aims, we addressed aim 1 (identify barriers to implementing the Enhanced SCOPE program). We learned that the primary barrier is not the technology but rather identifying patients to record and obtaining patient consent in a way that does not require third-party involvement or disrupt clinic flow. Aim 2 (compare the effect of the Enhanced SCOPE program with the standard communication PIM on patient satisfaction as measured by the CG-CAHPS survey) was not addressed. Although no difference was found between arms, the high rate of oncologist dropout and resulting limited sample size did not allow sufficient power to detect a difference had it existed. Furthermore, we do not know whether the high proportion of dropout might have led to differences in the final population of oncologists compared with the general oncology community. Finally, we successfully addressed aim 3 (compare the effect of the Enhanced SCOPE program with the standard communication PIM on oncologist communication behaviors, including the use of empathic responses to patient emotional concerns, as coded from audio-recorded medical encounters). Oncologists in the Enhanced SCOPE program arm were significantly more likely to respond to empathic opportunities after the intervention compared with controls. Despite the sample size limitation, this study makes several important contributions to the field. These include a successful proof of concept for the ability to collect audio-recorded communication data in far-flung practices; a repeat validation of the efficacy of the Enhanced SCOPE program in changing clinician behavior based on the increased responses to empathic opportunities; important lessons learned with regard to conducting research in community oncology practices; and, finally, the creation of a new and highly valuable database of audio-recorded oncology encounters. First, we successfully converted the defining feature of the original SCOPE program, feedback on oncologists' own audio-recorded conversations, into a usable smartphone app that creates clear, discernible audio recordings without the need for special equipment. We demonstrated that it is feasible for highly motivated clinicians to complete this process in the context of a typical community oncology practice. While many physicians required assistance for setup and consenting the patients, the actual creation and uploading of the recordings was completed by the majority of oncologists with little difficulty. The technology we created also allowed us to easily integrate the opinions of real patients in their own voices into the feedback that oncologists received. This novel element of feedback was not only a triumph for patient-centered research, but it also served as a motivating factor for participating oncologists. In the right practice setting, where the constraints of research do not exist and oncologists have effective motivation to audio-record their visits (eg, incentivized by their health system or certifying body), this study demonstrates that the data collection and review could be done feasibly and with little error. That said, a related lesson from this study has to do with the nature of incentives that are likely to work with practicing physicians. ABIM invested a tremendous amount of time and effort in the MOC process, including the PIMs, and that program collapsed under the weight of perceived burden from physicians. One must be exceedingly cautious about the acceptability of even the best designed and intentioned teaching interventions. Second, the study demonstrated that using the Enhanced SCOPE program, which after audio recording only takes about an hour of the physician's time, improves their likelihood of responding to patient distress with empathy. This finding confirms our previous finding from the original SCOPE study 83 and suggests that interventions do indeed work to change clinician behavior. Clearly, there are implementation challenges to be overcome, yet we remain quite excited about the conceptual framework and the technology we have created to address this outcome. Third, we learned important lessons about the challenge of doing research in the community oncology setting. We are confident that the primary barrier to oncologist participation was the difficulty of meeting the requirements for research. These included collecting patient satisfaction surveys in the context of a busy practice, introducing the study and pausing in-clinic for the patient to undergo the informed consent process with our research assistant, and navigating a complex research website (due to study-related issues, oncologists had to navigate to the program via the ABIM and a third party). Almost 75% of oncologists withdrew or disengaged during the baseline data collection phase, with 39% withdrawing before completing baseline survey collection. Concerns that the study was “too much work” or that oncologists didn't have time given competing priorities were commonly cited as reasons for withdrawal or lack of progress. A number of physicians who collected all baseline surveys withdrew, citing the burden of collection on themselves, their staff, and their patients. Similarly, the required remote informed consent process caused innumerable issues leading to invalid recordings and frustration among oncologists. This all begs the question, would conducting this intervention outside the stringent research setting lead to better completion rates and outcomes? If this intervention were to be implemented in a setting where none of this were required (eg, perhaps just a verbal patient consent at the beginning of the visit), we believe the uptake could be very different. In the future, we would recommend that such interventions be tested using more pragmatic trial designs that include no primary patient data collection and fewer barriers to participation. We are confident that in the right setting this intervention can succeed. Physicians were eager to improve their communication skills for their patients and capable of completing the necessary steps; however, they became overwhelmed by the particulars of research and lacked the incentives to push past them due to the changes in the ABIM MOC program. To be successful, adoption of this intervention would need to be without any of the additional requirements of research (eg, surveys and written consent). If hospitals and health care systems were to adopt this program in this way by requiring oncologists to complete it, we believe completion rates would increase greatly and the trends in outcomes seen in this project would become more sharply defined. Finally, this study yielded 306 audio-recorded visits between oncologists and their patients in clinics from New York to California, academic and community settings, and urban and rural environments. We expect that these recorded visits reflect much more closely the general tapestry of care than our (and others') previous studies conducted in primarily academic settings. We hope to continue to use this database to explore a host of other questions about the impact of communication on cancer care. Subpopulation Considerations Due to the small sample size, we conducted no subpopulation analyses, with the exception of the analyses mentioned previously on the sex and socioemotional orientation of the oncologists. Study Limitations This project and the resultant outcome were limited by the small sample size of physicians who completed the full protocol. The changes made to the ABIM MOC program were detrimental to the overall functioning of the project, as they removed the incentives that were key to its potential success. Furthermore, the consent requirements of research severely limited the ease with which oncologists could complete the data collection. In addition, the high dropout rate increases the risk that the randomization itself failed. That said, most physicians dropped out during the survey and audio-recording data collection phases before the intervention, and we ended up with nearly even numbers in both arms. In summary, we developed an intervention that, in the correct environment, still holds great potential for streamlined communication skills training. Conclusions This project demonstrated the ability to disseminate an effective communication training program for physicians using direct feedback from patients that led, among some highly motivated oncologists, to a greater use of empathic responses to empathic opportunities. This confirms, in a different practice setting, findings from our previous research. Unfortunately, we still do not know the effect of such an intervention on patient-level outcomes. 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Related Publication Brannen EN, Pollak KI, Farrell D, et al. When worlds collide: challenges to implementing communication research in community oncology practices. Patient Educ Couns. 2020;103(5):1057-1063. [ PubMed : 31866193 ] Acknowledgments We are extremely grateful to the oncologists, their patients, and family members who allowed us a peek into the room as they shared and responded to the most intimate concerns. We also wish to thank our patient partners, Becky Sail, Anne Willis, Ada Osoy, Cheryl Lou, Erica Bernstein, Gabby Spear, Jennifer Littke, Julie Tympanick, Mariel Nigro, Mathew Steury, Renee Seman, and Teresita Olsen, who served as study team members, consultants, critics, and reviewers of oncology practice. This study would have been far poorer without them. Research reported in this report was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (#CDR-091501-IC). Further information available at: https://www.pcori.org/research-results/2014/comparing-communication-training-programs-cancer-doctors Appendices Appendix A. ABIM Study Landing Page Screenshot (PDF, 368K) Appendix B. AVA Recording Application Screenshots (PDF, 455K) Appendix C. AVA Analyze Website Screenshots (PDF, 400K) Appendix D. Enhanced SCOPE Intervention Website Screenshots (PDF, 2.6M) Original Project Title: Improving Communication Between Cancer Patients and Oncologists Using Patient Feedback on Actual Conversations and the ABIM Maintenance of Certification Program PCORI ID: CDR-091501-IC ClinicalTrials.gov ID: NCT02969031 Suggested citation: Tulsky JA, Brannen E, Goldman J, et al. (2020). Comparing Communication Training Programs for Cancer Doctors . Patient-Centered Outcomes Research Institute (PCORI). https://doi.org/10.25302/08.2020.CDR091501IC Disclaimer The [views, statements, opinions] presented in this report are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors or Methodology Committee. Copyright © 2020. Dana-Farber Cancer Institute. All Rights Reserved. This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License which permits noncommercial use and distribution provided the original author(s) and source are credited. (See https://creativecommons.org/licenses/by-nc-nd/4.0/ Bookshelf ID: NBK621562 PMID: 41945678 DOI: 10.25302/08.2020.CDR091501IC Share Views PubReader Print View Cite this Page Tulsky JA, Brannen E, Goldman J, et al. Comparing Communication Training Programs for Cancer Doctors [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2020 Aug. doi: 10.25302/08.2020.CDR091501IC PDF version of this title (4.5M) In this Page Background Participation of Patients and Other Stakeholders Methods Results Discussion Conclusions References Related Publication Acknowledgments Appendices Other titles in this collection PCORI Final Research Reports Related information NLM Catalog Related NLM Catalog Entries PMC PubMed Central citations PubMed Links to PubMed Recent Activity Clear Turn Off Turn On Comparing Communication Training Programs for Cancer Doctors Comparing Communication Training Programs for Cancer Doctors Your browsing activity is empty. Activity recording is turned off. Turn recording back on See more... 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