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© 2000 American Society for Clinical Oncology Building Bridges Between Physicians and Patients: Results of a Pilot Study Examining New Tools for Collaborative Decision Making in Breast CancerFrom the Department of Engineering-Economic Systems and Operations Research, Stanford University, Stanford; University of California San Francisco; San Francisco Carol Franc Buck Breast Care Center, San Francisco, CA; and Community Breast Health Project, Palo Alto, CA. Address reprint requests to Laura J. Esserman, MD, MBA, Carol Franc Buck Breast Care Center, 2356 Sutter St San Francisco, CA; email essermal{at}medcenter.ucsf.edu
PURPOSE: To present the results of a pilot study testing an intervention designed to improve the quality of medical consultations between breast cancer patients and physicians and, in particular, to report the effects of the intervention on the quality of treatment decisions, the quality of communication, and the satisfaction of patients and physicians. PATIENTS AND METHODS: We enrolled 24 predominantly white, well-educated, early-stage breast cancer patients who were facing local or systemic treatment decisions in a sequential, controlled trial. All patients received a visit preparation session before the consultation in which a trained researcher helped patients organize their questions and concerns. In the control, a researcher observed the consultation. In the intervention, a researcher helped create an agenda, facilitated the discussion, and created a record of the consultation in real time. Valid and reliable surveys measured the quality of treatment decisions and satisfaction with the consultation. RESULTS: Patients in the intervention achieved significantly higher final decision quality scores compared with control patients (median score, 14 v 10, respectively; P = .008) and a significantly higher level of intersubjective agreement with their physicians about decision quality (Cohen’s kappa, 0.49 v 0.285, respectively; P < .0001). Consultation recording methods did not affect the length of time required for the consultation. CONCLUSION: Consultation recording methods provide a promising innovation for medical consultations. Further studies are warranted to broaden the findings, assess impacts on the quality of decisions, cost, and health, and develop practical ways to integrate consultation recording methods into clinics.
TRADITIONALLY, PHYSICIANS have been trained to assess a clinical situation and create a treatment plan for their patients. However, the role of the physician as primary analyst and decision-maker is changing. Many patients want to participate in decisions about their care, and increasingly, physicians are trying to accommodate them. In this new paradigm, physicians’ roles are evolving into that of educator and collaborator. Patients and physicians face many challenges sharing responsibility for decisions. One study of over 1,000 breast cancer patients found that only 42% believed they had achieved their preferred level of participation.1 The lack of patients’ participation may be problematic; studies indicate that breast cancer patients want to participate in their medical decisions, and further, that those who are able to participate in decision making have better psychosocial and health outcomes.2-4 Sharing responsibility for decision making requires good communication during medical consultations. Unfortunately, studies show the majority of patients and physicians do not receive special training in communication or collaborative decision-making skills.5-10 Poor communication has been linked to dissatisfaction, conflict, and worse outcomes for patients. Studies suggest that these patients tend to change physicians,11,12 to initiate complaints and malpractice suits against physicians,13 and not to adhere to medical treatment plans.14,15 Several researchers have designed seminars and programs to improve the communication skills of physicians. Programs teach clinicians how to interview patients to elicit medical history,16 how to establish rapport,17,18 and how to elicit and address patients’ questions.5,19,20 Other researchers have designed interventions to improve the communication skills of patients. These visit preparation interventions seek to increase patients’ comfort and confidence when communicating with their physician.9,21 We created a similar intervention, consultation planning, that prepares breast cancer patients to articulate their questions and concerns during consultations (Belkora et al, manuscript submitted for publication). Visit preparation interventions have been linked to improved health outcomes in chronic disease management, such as diabetes and peptic ulcer disease. However, the main health outcome measure, compliance, does not apply in acute diseases such as breast cancer. The tools and training that help patients and physicians communicate are important, but alone they may not be sufficient to help patients and physicians effectively collaborate. In breast cancer, patients and physicians make treatment decisions soon after the diagnosis, when patients are experiencing a great deal of stress and anxiety.22,23 Studies suggest that patients suffering from stress and anxiety are not able to comprehend a lot of information.24 Moreover, studies have shown that the cancer clinicians, in particular, suffer from burnout, stress, and psychiatric disorders as a result of the constant exposure to death and dying and the lack of training to address emotional issues.25,26 In a few short visits, breast cancer patients and their physicians must overcome emotional barriers, bridge the distance between their views, and agree on a course of action. We wanted to help patients and physicians engage in collaborative decision making and improve the quality of their communication without overloading or overwhelming them. Therefore, we focused on ways to improve the quality of the critical consultations between diagnosis and treatment. We translated standard meeting facilitation processes that have been well validated in the business community to the medical consultation.27 Then, we qualitatively integrated decision analysis to structure the discussion about treatment decisions and action science to promote open communication.28-30 This is not the first attempt to translate techniques commonly used in other industries to the field of medicine. Berwick et al31,32 have successfully brought methods for quality improvement, data management, and other business processes to improve the effectiveness and quality of health care. We developed consultation recording to structure the outpatient consultation for decision making. Using a framework to improve the quality of medical interactions is not new. The subjective objective assessment plan note was introduced to standardize the medical interview examination and assessment.33 The literature does not include standard metrics to measure the quality of decision making and track how it changes over time. Rather, standard metrics measure satisfaction with decisions or decision-making style.34,35 Thus, we also developed and tested new metrics to measure the impact of these methods. Our hypothesis was that consultation recording would increase the quality of treatment decisions, the satisfaction with the consultation, and the amount of agreement between patients and physicians. Higher decision quality and higher agreement should reduce the need for multiple consultations. As a result, we also hypothesize that consultation recording should reduce the number of follow-up visits before treatment begins. In this article, we report the results of a pilot study comparing consultation recording intervention with consultation planning alone.
Setting and Patient Sample We recruited patients from the University of California, San Francisco Carol Franc Buck Breast Care Center (San Francisco, CA) from June 1998 through November 1998. Eligible patients had a diagnosis of breast cancer (or ductal carcinoma-in-situ), could read and speak English, and were consulting one of two physicians, a surgeon or a medical oncologist, about treatment. We identified patients through the scheduling system and through physician referral.
Study Design One investigator trained in consultation recording methods administered both the control and the intervention conditions. Because it was impossible for either the investigator or the physicians to be blind to the intervention, precautions were taken to ensure that the interventions were administered without bias favoring either group. First, the investigator consistently emphasized to patients that different methods for intervening were being tested and that their candid assessment was most important. Second, the investigator encouraged specific patient and physician behaviors (eg, providing examples and asking questions) but did not tell the patients or physicians of the potential impacts on satisfaction or other outcomes. Third, the researcher emphasized that the patients’ evaluations would remain anonymous (in particular, that the physicians would not see the patients’ responses) to help patients feel comfortable answering candidly. The study was performed under the approval of the University of California, San Francisco, Committee on Human Research, and all patients reviewed and signed an informed consent. Patients completed surveys indicating their current desire for participation in decisions and assessment of decision quality. This was followed by a 30-minute consultation planning session for all patients, at which time a researcher created a flow chart of the patients’ specific questions and concerns. Consultation planning methods have been validated as a means to help breast cancer patients prepare for medical visits and have been described in detail elsewhere.7,36,37 Then, patients repeated the surveys indicating their perceptions of decision quality. Before the consultation, the physicians completed a short questionnaire indicating their level of preparedness. After the consultation, the patients and physicians filled out a satisfaction questionnaire and repeated the decision quality survey. The diagram in Fig 1 outlines the sequence of the study. Patients follow the top sequence, and physicians follow the bottom sequence. The squares indicate the interventions and the circles represent the metrics that we administered before and after these activities.
Intervention: Experimental Group Consultation recording is a five-step intervention: contracting, agenda, mapping, commitments, and debriefing. A trained researcher led patients and physicians through the five steps. First, in the contracting phase, patients and physicians discussed how they wished to share decision-making responsibility. Second, the patients and physicians set an agenda. We created a generic structure for the consultation. The physicians shared the agenda (Table 1) with patients at the beginning of the consultation.
Third, the researcher facilitated the progression through the agenda and recorded the main points of the discussion. During this mapping phase, the researcher asked questions designed to prompt physicians and patients to give examples and provide reasoning for their views. The researcher also periodically paraphrased the consultation record that she was creating using Inspiration software (Inspiration Software Inc, Portland, OR). Patients would be encouraged to ask questions during each item, and the physician or researcher would check the patient’s understanding before moving ahead. For example, before listing the treatment alternatives, the researcher would ask the patient to share her understanding of the diagnosis to check that it was accurate. Fourth, the researcher helped the patients and physicians make clear commitments for the next steps that need to be taken. Finally, in the debriefing phase, the researcher, physician, and patient reviewed the printed summary of the consultation. We used the structure in Table 1 to organize the medical consultation and the consultation record. The record pictured in Fig 2 reflects the detailed discussion for one of the patients in the intervention arm of the trial. The text captures statements from the physician and the patient. The arrows connect lines of reasoning and related items. The headings (in bold) are the agenda topics, and the discussion of each agenda item is summarized underneath. The boxes highlight decisions that have been made and the next steps that have been agreed on by both the patient and the physician.
Control Group We designed the control condition to provide a comparison in which a researcher observed the consultation but did not participate unless asked to by the patient or physician.
Measurement of Impact: Baseline and Outcome Measures The MD Decision Scale, a modified version of the Decision Quality Scale, was completed by physicians after the consultation and used to measure the amount of agreement between patients and physicians. This scale asks physicians to agree or disagree to statements such as, "This patient is having difficulty making decisions about her treatment," "I know what is important to this patient for these decisions," and "This patient and I agree on a treatment strategy." The University of California San Francisco Satisfaction with Consultation Scale (SWC), completed after the consultation by both patients (Pt SWC) and physicians (MD SWC), is a seven-item Likert scale. Specifically, the scale focuses on communication and meeting dynamics in statements such as "It was easy for me to voice my questions and concerns" and "I was not able to talk as much as I wanted to during this consultation." We have demonstrated the reliability (Cronbach’s alpha coefficient, 0.9) and validity of this scale for patients. Scores range from -14 to 14, with higher scores indicating higher satisfaction. The researcher timed each consultation and reviewed medical charts to document the number of subsequent consultations with the physician before treatment.
Statistical Analysis
A total of 24 patients were recruited, 12 in the control arm and 12 in the intervention condition. The patients in each group had comparable baseline characteristics. As listed in Table 2, the sample was predominantly white, well-educated, early-stage breast cancer patients. Even though the samples were small, the similarity between the two groups allows for comparisons.
We did not detect a difference in the Patient Decision Scale 1 or the Patient Decision Scale 2 scores for the control group compared with the intervention group. Further, the consultation planning intervention did not significantly affect the Patient Decision Scale scores. The median score on the Patient Decision Scale 1 compared with the Patient Decision Scale 2 for the pooled sample did not differ significantly (4 v 3.3, respectively; P = .42). We did find that breast cancer patients, in general, were confused about decisions. Before the consultation, less than 20% of the patients in the study agreed or strongly agreed to the statements, "I understand what could happen after each medical treatment alternative," "It is clear to me which treatment alternative is best" and "My doctor and I agree on a treatment strategy." However, more than 80% of patients agreed or strongly agreed with the statement, "I understand what could happen without any further medical treatment."
Patients Achieve Higher Decision Quality With Consultation Recording
The data also suggest that the mean increase in decision quality is larger in the intervention group than in the control. The mean change, Patient Decision Scale 3 minus Patient Decision Scale 2, is 9.7 points for the intervention and only 6.6 points for the control, for an estimated difference of 3.1 (P = .057). Figure 4 plots the change in decision quality score for each patient in the intervention and the control conditions.
Patients and Physicians Achieve Higher Agreement With Consultation Recording We also measured the amount of agreement between patients and physicians on aspects of the decisions. We compared the physician’s response with the statement, "This patient is having trouble making decisions" with the patient’s response to the statement "I am having trouble making decisions." The stronger the agreement, the higher the inferred quality of communication during consultations.
For the control group, the strength of agreement was fair, with a
Patients Are More Satisfied With the Consultation
Physicians Like Consultation Recording We had difficulty consistently administering the physician preparation survey because of the busy provider schedules. Further, the physicians remarked that the statements on the SWC survey did not accurately reflect those issues that were important to them. As a result, we stopped administering the physician preparation and MD SWC surveys and plan to revise them for future use. Informally, the physicians reported that they did not feel that the presence of the researcher interfered with establishing a relationship with their patients.
Impact on Costs
Many breast cancer patients are actively seeking involvement in their care.42,43 There has been an explosion of information in the popular press and on the Internet supporting this change. Breast cancer patients find articles covering a broad range of topics from the latest experimental therapies to complementary medicine techniques.44-46 Unfortunately, the information and recommendations from these sources are not always up to date and do not apply to all patients. As a result, many patients become confused and overwhelmed, especially when their physicians contradict what the patients have read or heard. To confuse matters more, many of the benefits of therapy are often expressed as a relative reduction in the odds of recurrence as opposed to absolute reductions. A physician may inform her patients that chemotherapy will reduce her risk of recurrence by 30%. However, this benefit is variable among individuals. In other words, a woman who has a 30% chance of recurrence will experience a 10% reduction in risk, whereas a woman who has a 10% chance of recurrence will experience a 3% reduction. Patients and physicians need to be clear when referring to relative risk reduction, otherwise patients may be making trade-offs on dissimilar quantities. Despite the increase in consumerism, many breast cancer patients come to consultations with little or no prior knowledge of breast cancer and want their physicians to choose on their behalf. In breast cancer, many alternatives do not differ in their impact on survival and recurrence, but do have very different side effects. In adjuvant therapy, some patients must trade-off the long-term effects of chemotherapy (eg, infertility and so on) with a small survival difference. Physicians who assume the responsibility for choosing on behalf of their patients need to be able to understand their patients’ preferences. With limited time and resources, physicians need to synthesize their patient’s detailed medical history along with the relevant evidence from the literature and incorporate their patients’ preferences. This is a challenging task to complete in a short visit, even for the most skilled practitioners. Physicians need to be prepared to handle the diversity of their patients. In particular, physicians need to be able to engage and empower their patients to participate in the consultation in whatever manner is most comfortable for the patient. We developed consultation recording to help physicians function better in this diverse and changing environment. Consultation recording provides a structured process for decision-making consultations. In the control arm, the patients and physicians did not ask the researcher to participate; as a result, the researcher simply observed these sessions. The results of this pilot study support our hypothesis that active facilitation and recording improves the effectiveness of medical consultations. Patients in the intervention group achieved significantly higher decision quality than those in the control group, without spending more time. Intervention patients also achieved a significantly higher level of agreement with physicians on aspects of decision quality and a marginally significant increase in satisfaction with the consultation. Before the study, the physicians were concerned that the presence of a researcher might negatively affect their ability to establish a relationship with their patients. After the study, they reported that they did not feel that the researcher adversely impacted their ability to establish a strong relationship with their patients. In fact, the two physicians felt that the intervention helped them reach a higher level of discussion with their patients and enabled them to get to the heart of issues quicker and more effectively.39 The introduction of a simple structure for the consultation and the creation of a written record of the consultation improved the quality of the consultation. The patients in the intervention group did not worry about writing everything down or remembering everything because a record was being created for them. Instead, they were free to listen and ask questions. Similarly, the physicians were confident that the information the patients in the intervention group took away from the consultation was an accurate reflection of what transpired. The patients and the physicians in the intervention were able to accomplish more in the same amount of time. The introduction of the problem-oriented medical records approximately 30 years ago brought consistency and structure to the medical record.33 Although some physicians object to the specific structure of the subjective objective assessment plan note, none debate the usefulness of a structure for medical records.47-49 In this pilot, we tested a new structure for the medical record that also guides the medical consultation. The steps include explain diagnosis, list treatment alternatives, describe consequences, elicit patient’s preferences, review decisions, and plan the next steps. The structure of the agenda is similar to steps advocated by Grueninger et al20 to facilitate patient education in the medical encounter and provides a decision-making focus for the consultation.28,39 Consultation recording helped patients and physicians bridge the distance between their views and create a shared understanding. This shared understanding is a necessary component for any method of collaborative decision making. Patients have diverse preferences for decision making, and one strategy for consultations will not satisfy all patients. Instead, physicians need to elicit their patients’ preferences and then be flexible to allow patients to participate in whatever way makes them most comfortable. This pilot study did identify some potential limitations of consultation recording. A formal process does not eliminate the need for high-quality, consistent information. Further, although engaging patients in the decision-making process has been shown to have beneficial emotional impacts, consultation recording does not eliminate the need for psychosocial support. Consultation recording is not a complete solution for patients and physicians. Future research could usefully explore the applicability of these methods to a larger population of breast cancer patients and physicians. We need to develop new metrics to measure the physicians’ satisfaction with the consultation. We also need to explore how to further increase the amount of agreement between patients and physicians, so that instead of only moderate agreement, they achieve high agreement. To spread these methods to the community at large, we need to demonstrate that consultation recording methods are realistic to implement in a busy clinic with limited resources and limited time. We are currently exploring several opportunities to use resources that are already in place to implement consultation recording methods. Medical students and residents often observe consultations without participating. Giving them an active role in these consultations may increase their learning and enjoyment with the experience. Some innovative programs across the country use premedical students to create records for emergency room physicians. These programs have found that the premed students cut down on the physician’s workload and decrease the liability of the hospital, while gaining valuable clinical experience.50 Incorporating consultation recording into the medical training of students may enable widespread use of these methods at low cost to hospitals. The health care system is placing increasing demands on physicians to provide better care faster and at a lower cost. Most industries have struggled with similar challenges, and those organizations that were attentive to the needs of their customers survived.31 Breast cancer patients increasingly want to participate in decisions about their care. Physicians and hospitals that enable patients to participate will survive and thrive in this new environment. Physicians, too, need to thrive, and studies demonstrate that those oncologists who have the best communication skills are least likely to experience burnout.25 Consultation recording is an innovative approach to improving the quality of medical consultations. These methods fill a gap in the period between diagnosis and treatment for breast cancer patients and their physicians. Further studies are warranted to broaden the findings, assess impacts on cost and health, and develop practical ways to integrate them in a busy clinical setting.
Supported by grants from the National Science Foundation, the Department of Defense, and the Arthur Vining Davis Foundation. We thank David Spiegel, MD, for his editorial assistance.
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Copyright © 2000 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
) to measure the amount of agreement between patients and physicians on the Decision Scale.
