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.

Developing a question prompt list for the oncology setting: A scoping review.

OBJECTIVE: The purpose of this study was to provide an overview of existing methods used to develop a Question Prompt List (QPL) for an oncology setting. METHODS: We conducted a search of the literature published between 1999 and 2019 in five online databases followed by a hand search, and extracted data on the methods used to develop a QPL. RESULTS: A total of 21 studies were included. The review shows differences in the development of older QPLs (1999-2009) and current QPLs (2010-2019). However, most QPLs were developed using interviews or focus groups with patients and an expert session to review or adapt the QPL. Health professionals, patients, and researchers were included in nearly all the studies. CONCLUSION: To develop a QPL, it is important to combine several information sources and at least to involve health professionals, patients, and researchers in the development process. Review or evaluation steps can improve the appropriateness and acceptance of a QPL. PRACTICE IMPLICATIONS: Further research is needed to define the type of target population for new QPLs and to develop a framework for their development.

Sustainability of hospital-based midwife-led antenatal care consultation - a qualitative study.

BACKGROUND: All evidence-based knowledge and improvement strategies for quality care must be implemented so patients can benefit from them. In Germany, national expert standards (NES) contribute to quality care in nursing and midwifery. The NES defines for several action levels a dedicated level of quality, which is operationalized by structure, process, and outcome (SPO) criteria. An NES to promote normal childbirth was developed and implemented in 2014. The first action level involves midwife-led antenatal consultation (ML-AC) being conducted in a structured way. Most implementation processes aim to accomplish sustainability, but implementation studies rarely use definitions or a theory of sustainability, even when assessing sustainability. This lack led to the assumption that intervention sustainability after implementation is still a largely unexplored domain. The aim of this study is to investigate the sustainability of midwife-led antenatal consultation (ML-AC) implemented at two hospitals, in Germany. METHODS: In a qualitative approach, 34 qualitative interviews were conducted (between March and October 2017) using semi-structured interview guides. All interviews were transcribed verbatim, anonymized and analyzed thematically using framework method. Four groups of stakeholders in two hospitals offering ML-AC were interviewed: managers (n = 8), midwives conducting ML-AC (n = 10), pregnant women who attended ML-AC (n = 8), and physicians working in obstetrics (n = 8) at the hospitals. RESULTS: The interviewees identified key benefits of ML-AC on a personal and unit level, e.g., reduced obstetric interventions, easier admission processes. Furthermore, the participants defined key requirements that are needed for routinized and institutionalized ML-AC, such as allocating working time for ML-AC, and structural organization of ML-AC. All study participants saw a need to establish secure long-term funding. Additionally, the interviewed staff members stated that ML-AC topics need evaluating and adapting in the future. CONCLUSIONS: Implementing ML-AC in the hospital setting has led to manifold benefits. However, reimbursement through the health care system will be needed to sustain ML-AC. Hospitals implementing ML-AC will need to be aware that adaptations of the NES are necessary to accomplish routinization and institutionalization. After initial implementation, sustaining ML-AC will generally require on-going monitoring and evaluating of benefits, routinization/institutionalization and further development.

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.

Consideration of sense of coherence in a structured communication approach with stage IV lung cancer patients and their informal caregivers: a qualitative interview study.

OBJECTIVE: Salutogenetic aspects are valuable for consideration in patient-centred care of advanced oncological diseases with a limited life expectancy. The Milestone Communication Approach (MCA), involving physician-nurse tandems, addresses specific challenges and needs over the disease trajectory of patients with stage IV lung cancer and their informal caregivers. This study aims to explore patients' and informal caregivers' salutogenetic experiences with the MCA concept. METHODS: This qualitative study used face-to-face semi-structured interviews with patients and informal caregivers. All generated data were audio-recorded, pseudonymised and transcribed verbatim. Data were structured using Qualitative Content Analysis. The material was coded deductively into themes related to the components of sense of coherence (Aaron Antonovsky) and emerging sub-themes. All data was managed and organised in MAXQDA. RESULTS: In 25 interviews, sense of coherence was referred to with all three components: "Comprehensibility" was supported by information conveyed suitably for the patients; "meaningfulness" was addressed as accepting the situation; and "manageability" led to advance care planning the patients were comfortable with. Patients and informal caregivers experienced the interprofessional tandem as an added value for patient care. CONCLUSIONS: Participants appreciate the MCA in its support for coping with a life-limiting disease. Considering salutogenetic aspects facilitates prognostic awareness and advance care planning. Nevertheless, individual needs of patients and informal caregivers require an individualised application of the MCA.

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.

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.

[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.

[Adherence of Antenatal Consultations by Midwives - A Quantitative Content Analysis]. / Adhärenz von Hebammensprechstunden ­ eine quantitative Dokumentenanalyse.

PURPOSE: Worldwide the use of medical interventions in childbirth is increasing, which holds true in Germany as well. In response, different approaches are being developed to enhance normal childbirth. Also, in Germany there is now an expert care standard to promote physiological childbirth, which mandates antenatal consultation conducted by midwives. The extent to which antenatal consultation based on this standard has been implemented and the degree of adherence (as intended by the developers) remain unclear. The aim of this study is to investigate who makes use of antenatal consultations, the topics and content of consultation documents and adherence to the antenatal consultation requirement in 2 hospitals. METHOD: Criteria for analyzing consultation documents were derived based on the content of the care standard and using the Delphi method by 3 experts who had participated in developing the expert care standard. A content analysis of the documents (hospital 1: n=92; hospital 2: n=62) used in antenatal consultation based on criteria identified in the standard was conducted. RESULTS: Six criteria ("worries and anxieties," "agreements," "suggested topics," "all topics," "traceability of birth plan" and "options of birth plan") for analyzing consultation documents were identified. Especially primiparae women (77.2%) avail themselves of antenatal consultation. The variety of topics covered in antenatal consultation is broad. The documents in hospital 2 show high adherence to the standard to promote normal childbirth. The documents of hospital 1 show moderate adherence. CONCLUSIONS: The investigation of adherence helps to determine implementation success and to identify areas needing revision and their modification. Implementation processes require further research to explain the differences in adherence.

Communication along Milestones in Lung Cancer Patients with Advanced Disease.

Patients with advanced lung cancer and their caregivers are confronted with a complex situation as their disease-related burden comprises physical, psychosocial, and spiritual needs. During the illness trajectory with limited prognosis, they are exposed to different multidisciplinary healthcare settings and providers that challenge the continuity and coordination of care. Additionally, decision-making between active cancer treatment and end-of-life care constitutes a continuous balancing act. Several studies have shown that early integration of palliative care and adequate advance care planning improve quality of life and satisfaction with care. For this strategy, the communication skills of healthcare providers and interprofessional collaboration should be strengthened. A longitudinally structured communication approach along pivotal milestones of the disease can empower patients by facilitating coping and prognostic awareness, and achieve early integration of palliative care and advance care planning. Good interprofessional collaboration and communication lead to better coordination and continuity of care.

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.