HELP - Heidelberg decision aid for lung cancer patients: a randomized controlled clinical trial.

BACKGROUND: Shared decision-making (SDM), which increases the patient's well-being, adherence, and success of treatment, is becoming increasingly important in medicine and especially in oncology. To empower patients to participate more actively in consultations with their physicians decision aids have been developed. In non-curative settings, such as the treatment of advanced lung cancer, decisions differ substantially from the curative setting, as uncertain gains in terms of survival outcomes and quality of life have to be weighed against the severe side effects of treatment regimens. There is still a lack of tools developed and implemented for such specific settings in cancer therapy that support shared decision-making. The aim of our study is to evaluate the effectiveness of the HELP decision aid. METHODS: The HELP-study is designed as a randomized, controlled, open monocenter trial with two parallel groups. The intervention consists of the use of the HELP decision aid brochure, accompanied by a decision coaching session. The primary endpoint is clarity of personal attitude as operationalized by the Decisional Conflict Scale (DCS) after the decision coaching. Randomization will be performed as stratified block randomization according to the characteristic of preferred decision-making at baseline with a 1:1 allocation. The participants in the control group get usual care, i.e., the doctor-patient conversation takes place without preliminary coaching and deliberation about their preferences and goals. DISCUSSION: Developing decision aids (DA) for (lung) cancer patients with limited prognosis should empower patients to address these aspects and include information about "Best Supportive Care" as a treatment option. Using and implementing the decision aid HELP can not only give patients the possibility to include their personal wishes and values in the decision-making process, but also raise the awareness of shared decision-making itself among these patients and their physicians. TRIAL REGISTRATION: German Clinical Trial Register DRKS00028023. Registered on 8 February 2022.

Communication with patients with limited prognosis-an integrative mixed-methods evaluation study.

PURPOSE: Oncological societies advocate the continuity of care, specialized communication, and early integration of palliative care. To comply with these recommendations, an interprofessional, longitudinally-structured communication concept, the Milestone Communication Approach (MCA), was previously developed, implemented, and evaluated. Our research question is: what are possible explanations from the patient perspective for prognosis and advance care planning being rarely a topic and for finding no differences between MCA and control groups concerning distress, quality of life, and mood? METHODS: A pragmatic epistemological stance guided the study. A mixed-methods design was chosen including a pragmatic randomized trial (n = 171), qualitative interviews with patients (n = 13) and caregivers (n = 12), and a content analysis (133 milestone conversations, 54 follow-up calls). Data analysis involved the pillar integration process. RESULTS: Two pillar themes emerged: 1 "approaching prognosis and advance care planning"; 2 "living with a life-threatening illness". Information on prognosis seemed to be offered, but patients' reactions were diverse. Some patients have to deal with having advanced lung cancer while nonetheless feeling healthy and seem not to be ready for prognostic information. All patients seemed to struggle to preserve their quality of life and keep distress under control. CONCLUSION: Attending to patients' questions, worries and needs early in a disease trajectory seems key to helping patients adjust to living with lung cancer. If necessary clinicians should name their predicament: having to inform about prognosis versus respecting the patients wish to avoid it. Research should support better understanding of patients not wishing for prognostic information to successfully improve communication strategies. TRIAL REGISTRATION: Registration: German Clinical Trial Register No. DRKS00013649, registration date 12/22/2017, ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013649 ) and No. DRKS00013469, registration date 12/22/2017, ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013469 ).

Factors related to implementation of an interprofessional communication concept in thoracic oncology: a mixed-methods study.

BACKGROUND: An innovative patient-centred interprofessional communication concept with advanced lung cancer patients (Heidelberg Milestone Communication Approach, MCA) has been developed and implemented. Role changes and interprofessional communication are challenging in a busy outpatient oncology service. The aim of the study was to present attitudes to interprofessional collaboration of professions in thoracic oncology during the implementation of MCA and to explore factors and experiences healthcare team members associate with its implementation. METHODS: In a longitudinal study, 3 of the 4 subscales of the validated German translation of the University of the West of England Interprofessional Questionnaire (UWE-IP-D) were collected prior to implementation of MCA (t0) with follow-up data collections at 4 months (t1), 10 months (t2) and 17 months (t3). Descriptive analysis included calculating subscale sum scores and categorizing each subscale into positive, neutral and negative attitudes. Interviews and focus groups on implementation and interprofessional collaboration in the context of MCA were conducted with healthcare staff. The topics were analysed deductively, guided by the Professional Interactions factor of the Tailored Implementation for Chronic Diseases (TICD) framework. RESULTS: The survey with 87 staff (44 nurses, 13 physicians, 12 psycho-social staff, 7 therapists, and 11 others) participating at least once found heterogeneous attitudes. 'Communication and Teamwork' and 'Interprofessional Relationships' were characterized by primarily positive attitudes. Neutral attitudes to 'Interprofessional Interaction' were indicated by the majority of respondents. There were no differences between collection times. Fifteen staff members participated in the interviews and focus groups. The main interprofessional interaction factors associated with implementation concerned the knowledge of the MCA and the impact of the intervention on team roles, on information sharing and on transfer processes between wards. Adaptive processes led to a shift in the perception of responsibilities and interprofessional collaboration. CONCLUSIONS: Positive experiences and potential shortfalls in the implementation were observed. Future introductions of interprofessional communication concepts require further activities which should address the attitudes of healthcare professionals towards interprofessional care. TRIAL REGISTRATION: DRKS00013469 / Date of registration: 22/12/2017.

[Heidelberg Milestones Communication (HeiMeKOM) - Experiences, Best Practice Examples and Recommendations from the Final Symposium on January 30 and 31 in 2020]. / Heidelberger Meilenstein Kommunikation (HeiMeKOM) ­ Erfahrungen, Best Practice Beispiele und Empfehlungen aus dem Abschluss-Symposium am 30./31. Januar 2020.

The National Cancer Plan emphasises the importance of medical communication and calls for its integration into medical education and training. In this context, the Milestone Communication Approach meets the communicative challenges in dealing with lung cancer patients. Interprofessional tandems, consisting of doctors and nurses, conduct structured conversations at defined moments with patients and their relatives. The concept aims at shared decision making, continuity in the care of lung cancer patients and the early integration of palliative care. During the symposium on the Heidelberg Milestone Communication in January 2020, recommendations on the care situation of lung cancer patients in advanced stages were developed. In addition, the further adaptability of HeiMeKOM to other settings and hospitals and to other diseases was discussed as well as the possibility of implementing such a concept in standard care. This article presents the experiences, best practice examples and recommendations discussed during the symposium in order to enable their extrapolation to other similarly oriented projects. The long-term goal is to transfer the milestone concept to other hospital, primarily certified lung cancer centers, and to ensure permanent funding. For further dissemination of the concept and, above all, to have it established in standard care, health policy awareness and support are required in addition to the integration of the concept in competence catalogues of continuing medical and nursing education.

Effects of an Interprofessional Communication Approach on Support Needs, Quality of Life, and Mood of Patients with Advanced Lung Cancer: A Randomized Trial.

BACKGROUND: To address the support needs of newly diagnosed patients with lung cancer with limited prognosis, the Milestone Communication Approach (MCA) was developed and implemented. The main elements of the MCA are situation-specific conversations along the disease trajectory conducted by an interprofessional tandem of physician and nurse. The aim of the study was to evaluate the effects of MCA on addressing support needs, quality of life, and mood as compared with standard oncological care. PATIENTS AND METHODS: A randomized trial was conducted with baseline assessment and follow-up assessments at 3, 6, and 9 months in outpatients with newly diagnosed lung cancer stage IV at a German thoracic oncology hospital. The primary outcome was the Health System and Information Needs subscale of the Short Form Supportive Care Needs Survey (SCNS-SF34-G) at 3-month follow-up. Secondary outcomes included the other subscales of the SCNS-SF34-G, the Schedule for the Evaluation of Individual Quality of Life, the Functional Assessment of Cancer Therapy lung module, the Patient Health Questionnaire for Depression and Anxiety, and the Distress Thermometer. RESULTS: At baseline, 174 patients were randomized, of whom 102 patients (MCA: n = 52; standard care: n = 50) provided data at 3-month follow-up. Patients of the MCA group reported lower information needs at 3-month follow-up (mean ± SD, 33.4 ± 27.5; standard care, 43.1 ± 29.9; p = .033). No effects were found for secondary outcomes. CONCLUSION: MCA lowered patient-reported information needs but did not have other effects. MCA contributed to tailored communication because an adequate level of information and orientation set the basis for patient-centered care. IMPLICATIONS FOR PRACTICE: By addressing relevant issues at predefined times, the Milestone Communication Approach provides individual patient-centered care facilitating the timely integration of palliative care for patients with a limited prognosis. The needs of patients with lung cancer must be assessed and addressed throughout the disease trajectory. Although specific topics may be relevant for all patients, such as information about the disease and associated health care, situations of individual patients and their families must be considered. Additionally, using the short form of the Supportive Care Needs Survey in clinical practice to identify patients' problems might support individually targeted communication and preference-sensitive care.

What patients with lung cancer with comorbidity tell us about interprofessional collaborative care across healthcare sectors: qualitative interview study.

BACKGROUND: Patients with lung cancer with comorbidity often require treatment and care by different health professionals, in different settings and at different points in time during the course of the disease. In order to organise and coordinate healthcare efficiently, effective information exchange and collaboration between all involved care providers are required. The aim of this study was to assess the views of patients with advanced lung cancer with comorbidity regarding coordination of treatment and care across healthcare sectors. METHODS: This qualitative study, as part of the main study, The Heidelberg Milestones Communication Approach, used face-to-face guide-based semistructured interviews with patients with advanced lung cancer and their informal caregivers to explore cross-sectoral information exchange and collaboration in Germany. All generated data were audio-recorded, pseudonymised and transcribed verbatim. Data analysis was performed using qualitative content analysis to structure data into themes and subthemes. All data were managed and organised in MAXQDA. RESULTS: In 15 interviews, participants reported that cross-sectoral collaboration functioned well, if treatments occurred as planned. However, treatment gaps were experienced, especially regarding medication and regimen. As a result, participants felt insecure and obliged to take responsibility for the coordination of healthcare. Patients reported to be in favour of an active patient role but felt that healthcare coordination should still be a responsibility of a care provider. A more intensive information exchange, potentially by using an electronic platform, was expected to strengthen cross-sectoral collaboration. CONCLUSION: Patients with lung cancer are uncertain about their role in the coordination of treatment and care across healthcare sectors. Healthcare providers should be more aware of care recipients' willingness of taking on a more active role in healthcare coordination. TRIAL REGISTRATION NUMBER: DRKS00013469.

Development, implementation, and evaluation of a curriculum for medical students on conflicts of interest and communicating risk.

Background: Insufficient risk competence of physicians, conflicts of interests from interactions with pharmaceutical companies, and the often distorted presentation of benefits and risks of therapies compromise the advising of patients by physicians in the framework of shared decision-making. An important cause of this is that teaching on this subject is mostly lacking, or fragmented when it does take place [1], [2], [3], [4]. Even though the German National Competence-Based Catalog of Learning Goals in Medicine defines learning goals on the topics of conflicts of interest and communication of risk, there are no classes that integrate both topics. Our goal was to develop a model curriculum to teach conflicts of interest and communication of risk that would integrate statistical know-how, communicational competency on the presentation of benefits and risks, and the meaning and management of conflicts of interest. Project Description: The development of the curriculum took place according to the six-step cycle of Kern et al [5]. An integrated curriculum was conceptualized, piloted, and adapted with the support of experts for the topics of shared decision-making, conflicts of interest, and communication of risk. The final version of the curriculum was implemented at the medical schools of Mainz and Heidelberg and evaluated by the students. Results: The final curriculum consists of 19 lesson units. The contents are the fundamentals of statistics, theory of risk communication, practical exercises on communication of risk, and the fundamentals of the mechanisms of effect of conflicts of interest, recognition of distortions in data, and introductions to professional management of conflicts of interest. The course was implemented three times at two different medical schools with a total of 32 students, and it was positively rated by most of the 27 participating students who evaluated it on the 1-6 German school grading scale (mean: 1.4; SD: 0.49; range: 1-2). Discussion: The curriculum we developed fills a gap in the current medical education. The innovative concept, which sensibly connects the transmission of theory and practice, was positively received by the students. The next steps are an evaluation of the curriculum by means of a two-center randomized study and the implementation at German and international medical schools. The process should be accompanied by continuous evaluation and further improvement.

Implementation of the milestones communication approach for patients with limited prognosis: evaluation of intervention fidelity.

BACKGROUND: Despite improvements in diagnostics and therapy, the majority of lung tumours are diagnosed at advanced stage IV with a poor prognosis. Due to the nature of an incurable disease, patients need to engage in shared decision making on advance care planning. To implement this in clinical practice, effective communication between patients, caregivers and healthcare professionals is essential. The Heidelberg Milestones Communication Approach (MCA) is delivered by a specifically trained interprofessional tandem and consists of four milestone conversations (MCs) at pivotal times in the disease trajectory. MC 1 (Diagnosis): i.e. prognosis; MC 2 (Stable disease): i.e. prognostic awareness; MC 3 (Progression): i.e. reassessment; MC 4 (Best supportive care): i.e. end of treatment. In between MCs, follow-up calls are carried out to sustain communication. This study aimed to assess to what extent the MCA was implemented as planned and consolidated in specialized oncology practice. METHODS: A prospective observational process evaluation study was conducted, which focused on the implementation fidelity of the MCA. All MCs during two assessment periods were included. We analysed all written records of the conversations, which are part of the routine documentation during MCs and follow-up calls. Adherence to key aspects of the manual was documented on structured checklists at the beginning of the implementation of the MCA and after 6 months. The analysis was descriptive. Differences between the two assessment periods are analysed with chi-square tests. RESULTS: A total of 133 MCs and 54 follow-up-calls (t1) and of 172 MCs and 92 follow-up calls (t2) were analysed. MC 2 were the most frequently completed conversations (n = 51 and n = 47). Advance care planning was discussed in 26 and 13% of MC 2 in the respective assessment periods; in 31 and 47% of MC 2, prognostic awareness was recorded. The most frequently documented topic in the follow-up calls was the physical condition in patients (82 and 83%). CONCLUSION: The implementation of a trajectory-specific communication concept was largely successful. Additional studies are needed to understand how fidelity could be further improved. TRIAL REGISTRATION: DRKS00013469 / Date of registration: 22.12.2017.

Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial.

BACKGROUND: Risk communication is a core aspect of a physician's work and a fundamental prerequisite for successful shared decision-making. However, many physicians are not able to adequately communicate risks to patients due to a lack of understanding of statistics as well as inadequate management of conflicts of interest (COI). OBJECTIVE: To evaluate the effects of an integrated curriculum encompassing COI and shared decision-making on the participants' risk communication competence, that is, their competence to advise patients on the benefits and harms of diagnostic or therapeutic interventions. DESIGN: A rater-blind randomized controlled trial with a 30 (± 1)-week follow-up conducted from October 2016 to June 2017 at two German academic medical centers. PARTICIPANTS: Sixty-three medical students in their fourth or fifth year. INTERVENTIONS: Participants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual. MAIN MEASURES: Primary outcome: change in risk communication performance in a video-observed structured clinical examination (VOSCE). KEY RESULTS: Participants were 25.7 years old on average (SD 3.6); 73% (46/63) were female. Increase in risk communication performance was significantly higher in the intervention group with post-intervention Cohen's d of 2.35 (95% confidence interval (CI) 1.62 to 3.01, p < 0.01) and of 1.83 (CI 1.13 to 2.47, p < 0.01) 30 (± 1) weeks later. Secondary outcomes with the exception of frequency of interactions with the pharmaceutical industry also showed relevant improvements in the intervention as compared with the control group (d between 0.91 and 2.04 (p < 0.001)). CONCLUSIONS: Our results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance. We interpret the large effect sizes to be a result of the integration of topics that are usually taught separately, leading to a more effective organization of knowledge. TRIAL REGISTRATION: The trial is registered in the International Clinical Trials Registry with the trial number DRKS00010890.

[HeiMeKOM (Heidelberg Milestones Communication): development of an interprofessional intervention for improvement of communication in patients with limited prognosis]. / HeiMeKOM (Heidelberger Meilenstein Kommunikation): Entwicklung einer interprofessionellen Intervention zur Verbesserung der Kommunikation bei Patient*innen mit eingeschränkter Prognose.

BACKGROUND: The care for patients with advanced disease and limited prognosis and their relatives is complex and characterized by insufficient communication and lack of coordination and continuity. AIM: Development of an interprofessional, practice-guided concept of longitudinally structured communication with the goal of fostering communication, improving quality of life and facilitating early integration of palliative care. METHODS: Multi-level process starting from a draft with discussion and approval within the multiprofessional team and correlation with interviews with patients and relatives. Preparation of a comprehensive concept with review of the literature, problem analysis, theoretical foundation, goal setting and intervention components. Discussion of suitability for daily use, adaptation and further development of the concept. RESULTS AND CONCLUSIONS: Concept with the following components: interprofessional communication training, structured conversations at defined moments in a tandem of physician and nurse with patient and relative, follow-up conversations conducted by the nurse, and respective instruments (conversation protocol, question prompt list, memory cards). Only iterative discussion with and the approval of patients, relatives and the multiprofessional team and their approval will put the concept into practice.

Patient handover - the poor relation of medical training?

Objective: The handover of patients to medical colleagues and to members of other professional groups is a central task in the medical care process for patient safety. Nevertheless, little is known about teaching and testing on the subject of handing over. The present article therefore examines the extent to which handover is the subject of teaching and examinations at medical faculties in Germany. Methodology: In 31 medical faculties the teachers were asked about the implementation of the NKLM learning objectives in the area of communication. The survey was conducted within the framework of group interviews with lecturers, in which it was determined whether each learning objective of the NKLM (National Competency-based Catalogue of Learning Objectives in Medicine) on the subject of communication, is explicitly taught in lectures and examinations at the respective faculty. Results: The learning objective "transfer to medical colleagues" is covered by 19 faculties, while the learning objective of interprofessional transfer is covered by 14 faculties. There are examinations for transfer to medical colleagues and interprofessional transfer at two faculties. There is a highly significant relationship between the total number of communicative learning objectives that are put into practice in a faculty and the coverage of the learning objectives for handover. Conclusions: In the field of communications, the subject of handover is less frequently taught at the faculties and, more importantly, it is less frequently examined than other NKLM contents. This is particularly evident in the interprofessional area. The subject is more likely to be taught as a handover between physicians, while the interprofessional interfaces attract less attention. In terms of patient safety, it would be desirable to give a higher priority to the subject of handover. An inter-faculty exchange and the inclusion of the subject of intra- and interprofessional transfer in state examinations could give the implementation process at the faculties a decisive impetus.

The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial.

BACKGROUND: The care needs of patients with a limited prognosis (<12 months median) are complex and dynamic. Patients and caregivers must cope with many challenges, including physical symptoms and disabilities, uncertainty. and compromised self-efficacy. Healthcare is often characterized by disruptions in the transition between healthcare providers. The Milestones Communication Approach (MCA) is a structured, proactive, interprofessional concept that involves physicians and nurses and is aimed at providing coherent care across the disease trajectory. This study aims to evaluate these aspects of MCA: (1) the training of healthcare professionals, (2) implementation context and outcomes, (3) patient outcomes, and (4) effects on interprofessional collaboration. METHODS/DESIGN: A multiphase mixed-methods design will be used for the study. A total of 100 patients and 120 healthcare professionals in a specialized oncology hospital will be involved. The training outcomes will be documented using a questionnaire. Implementation context and outcomes will be explored through semi-structured interviews and written questionnaires with healthcare professionals and with the training participants and through a content analysis of patient files. Patient outcomes will be assessed in a pragmatic non-blinded randomized controlled trial and in qualitative interviews with patients and caregivers. Trial outcomes are supportive care needs (SCNS-SF34-G), quality of life (SeiQol and Fact-L), depression and anxiety symptoms (PHQ-4), and distress (Distress Thermometer). Qualitative semi-structured interviews on patients' views will focus on shared decision-making, communication needs, feeling empathy, and further utilization of healthcare services. Interprofessional collaboration will be explored using the UWE-IP-D before the implementation of MCA (t0) and after 3 (t1), 9 (t2), and 12 (t3) months. DISCUSSION: Using guideline-concordant early palliative care, MCA aims to foster patient-centered communication with shared decision-making and facilitation of advance care planning including end-of-life decisions, thus increasing patient quality of life and decreasing aggressive medical care at the end of life. It is assumed that the communication skills training and interprofessional coaching will improve the communication behavior of healthcare providers and influence team communications and team processes. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013649 and DRKS00013469. Registered on 22 December 2017.

Implementation of "social and communicative competencies" in medical education. The importance of curriculum, organisational and human resource development.

OBJECTIVE: With this article we want to support teachers and curriculum planners to be aware of and apply knowledge and recommendations of organisational (OD), curriculums (CD) and human resource development (HRD) ideas already in the planning phase of a project. Taking these into account can influence the process of change successfully and controlled during the introduction and establishment of curricula in the field of communication and social skills in medical education. APPROACH AND RESULTS: In the context of a multi-stage developmental process, a recommendation on CD for "Communicative and social competencies" was developed. The basis for it was made during two workshops of the GMA-committee "Communicative and social competencies" and supplemented by the available literature and the experience of communication experts. The "Undeloher Recommendation" (see attachment ) includes a compilation of recommendations and guiding questions, which is geared to the various phases of CD. Additionally, general approaches and recommendations of organisational and human resource development were integrated, which turned out to be particularly relevant in the process of CD. Thus, the "Undeloher recommendation" includes an orientation for each phase of the curriculum development process, the organisation and the staff in order to successfully implement a longitudinal curriculum. In addition to theoretical models the long-term discussion process and the personal experiences of a variety of curriculum planners and teachers have been integrated. CONCLUSION: The "Undeloher recommendation" can support the implementation processes of curricula in communication and social skills during development and realisation. Its application was reviewed in the context of workshops based on concrete examples. The participating teachers and curriculum planners assessed it to be very helpful. The recommendation goes beyond of what has been described in terms of content models in the CD so fare. In particular, the organisational and human resource development related aspects such as the formation of a steering committee and recommendations for the phase of sustainability.