Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

What do patients expect? Assessing patient-centredness from the patients' perspective: an interview study.

OBJECTIVE: Although there has been much conceptual work on patient-centredness (PC), patients' perspectives on PC were neglected. In a previous study, participating patients rated the relevance of 16 dimensions of an integrative model of PC as high to very high. However, it remained unclear which specific behaviours described in the dimensions were considered most relevant. Thus, the aim of the current study was to further explore which of the specific behaviours described in the model are especially relevant for the high ratings in the previous study. METHODS AND DESIGN: We conducted semistructured interviews with 20 patients with chronic diseases (16 females, 4 males, mean age: 52 years). Patients answered questions regarding their experiences in the German healthcare system and how optimal healthcare would look like from their perspective. Furthermore, patients were asked to reflect on the most important aspects which they had mentioned in the interview before. Data were analysed via content analysis. RESULTS: Participants addressed many different aspects of PC, but mostly focused on three major themes: (1) time appropriate access to care, (2) competence, empathy and being taken seriously by HCPs, (3) HCPs' individual consideration of each patient's situation (eg, wishes and needs). Minor themes were: (1) taking a holistic perspective of the patient, (2) patient-centred communication, (3) integration of multidisciplinary treatment elements, (4) transparency regarding waiting time and (5) reduction of unequal access to care. CONCLUSION: This study enriches the construct of PC by depicting essential aspects of PC from the patients' perspective. The results allow prioritising strategies to implement patient-centred care. Thus, this study helps to pursue the ultimate goal of fostering patient-centred healthcare delivery in Germany.

[PNP Program - Collaborative Mental and Neurological Health Care Program in Baden-Württemberg: Evaluation from the Perspective of Health Care Providers Enrolled in the Program]. / PNP-Vertrag ­ Facharztvertrag Psychotherapie, Neurologie, Psychiatrie in Baden-Württemberg: Evaluation aus der Sicht der teilnehmenden Behandlerinnen und Behandler.

OBJECTIVE: To evaluate structure and process quality from the perspective of health care providers enrolled in the PNP program. This collaborative care program developed by a German statutory health insurance provides specific rules on psychiatric, neurological, psychosomatic, and psychotherapeutic treatment. It aims to improve the quality of health care by strengthening evidence-based outpatient care and collaboration between health care providers. METHODS: Based on qualitative interviews with n = 9 enrolled health care providers a questionnaire was developed and sent to all N = 720 enrolled health care providers. RESULTS: N = 430 health care providers (81 % psychotherapists, 2 % psychiatrists, 2 % neurologists, 15 % ≥ one profession) participated (60 %). 94 % were satisfied with the program. Problems with access, treatment and cooperation were reported. CONCLUSION: The positive evaluation and the potential for improvements of the PNP program can support its advancement (e. g. enrolment, billing).

Spiritual well-being mediates the association between attachment insecurity and psychological distress in advanced cancer patients.

PURPOSE: The diagnosis of a terminal disease bears existential challenges, which activate the attachment system. Attachment insecurity, as well as existential resources, such as spiritual well-being, influences patients' extent of psychological distress. Knowledge about the interrelation of these constructs is limited. Based on current research, we assume spiritual well-being to mediate the association of attachment insecurity and psychological distress. METHODS: We obtained data from the baseline measurement of a randomized controlled trial in advanced cancer patients. Patients were sampled from the University Medical Centers of Hamburg and Leipzig, Germany. Main outcome measures included the Patient Health Questionnaire (PHQ-9), the Death and Dying Distress Scale (DADDS), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), and the Experience in Close Relationships Scale (ECR-M16) for assessing attachment insecurity. We tested the mediation hypothesis with two regression analyses using bootstrapping procedure. RESULTS: A total of 190 patients were included. Spiritual well-being mediated the association of attachment insecurity and depression (R2 = 11%), as well as death anxiety (R2 = 15%), in fearful-avoidant attached patients. Neither dismissingly nor preoccupied attached patients differ in terms of spiritual well-being and psychological distress in comparison with secure attached patients. CONCLUSION: Spiritual well-being plays a relevant role in advanced cancer patient's mental health through mediating the association of attachment and psychological distress. Developing a better understanding of the interdependency of the constructs of spiritual well-being and attachment can help to develop individually tailored advanced cancer care programs and psychotherapeutic interventions. TRIAL REGISTRATION: NCT02051660.

Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care. METHODS: We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary. DISCUSSION: This study is the first large study on routine implementation of SDM conducted in German cancer care. We expect to foster implementation of SDM at the enrolled clinics. Insights gained from this study, using a theoretically and empirically grounded approach, can inform other SDM implementation studies and health policy developments, both nationally and internationally. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 . Registered 8 January 2018.

Measuring the Psychosocial Dimensions of Quality of Life in Patients With Advanced Cancer: Psychometrics of the German Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire.

CONTEXT: Quality of life (QoL) is a central focus of care in advanced cancer. Specialized instruments, such as the Quality of Life at the End of Life-Cancer (QUAL-EC), may be useful to assess psychosocial issues associated with QoL unique to this population. OBJECTIVES: To evaluate the measurement of the psychosocial dimensions of QoL using the German translation of the QUAL-EC-Psychosocial (QUAL-EC-P) questionnaire, including factor structure and psychometrics. METHODS: About 183 patients with advanced cancer from the University Medical Center Hamburg-Eppendorf and University Medical Center Leipzig completed the QUAL-EC-P questionnaire. We conducted exploratory factor analysis as well as item and reliability analysis. We examined convergent validity with correlations between the scale and relevant psychological constructs. RESULTS: The sample was 60% female with mean age of 57.7 (SD = 11.7). We extracted three factors accounting for 44% of the variance aligning with the structure of the instrument. The QUAL-EC-P questionnaire showed good to acceptable internal consistency for the QoL-psychosocial total score (α = 0.77), the Life completion subscale (α = 0.77), and the Relationship with health care provider subscale (α = 0.81). The Preparation for end of life subscale had adequate albeit low internal consistency (α = 0.64) because concerns about family were less associated with financial worry and fear of death than expected. The psychosocial dimensions of QoL correlated negatively with depression (r = -0.27, P ≤ 0.001), anxiety (r = -0.32, P ≤ 0.001), demoralization (r = -0.63, P ≤ 0.001), and attachment insecurity (r = -0.51, P ≤ 0.001) and positively with spiritual well-being (r = 0.63, P ≤ 0.001). CONCLUSION: The QUAL-EC-P questionnaire may be used to assess the psychosocial aspects of QoL and promote their clinical discussion in patients with advanced cancer.

How are decisions made in cancer care? A qualitative study using participant observation of current practice.

OBJECTIVES: Shared decision-making has continuously gained importance over the last years. However, few studies have investigated the current state of shared decision-making implementation in routine cancer care. This study aimed to investigate how treatment decisions are made in routine cancer care and to explore barriers and facilitators to shared decision-making using an observational approach (three independent observers). Furthermore, the study aimed to extend the understanding of current decision-making processes beyond the dyadic physician-patient interaction. DESIGN: Cross-sectional qualitative study using participant observation with semistructured field notes, which were analysed using qualitative content analysis as described by Hsieh and Shannon. SETTING AND PARTICIPANTS: Field notes from participant observations were collected at n=54 outpatient consultations and during two 1-week-long observations at two inpatient wards in different clinics of one comprehensive cancer centre in Germany. RESULTS: Most of the time, either one physician alone or a group of physicians made the treatment decisions. Patients were seldom actively involved. Patients who were 'active' (ie, asked questions, demanded participation, opposed treatment recommendations) facilitated shared decision-making. Time pressure, frequent alternation of responsible physicians and poor coordination of care were the main observed barriers for shared decision-making. We found high variation in decision-making behaviour between different physicians as well as the same physician with different patients. CONCLUSION: Most of the time physicians made the treatment decisions. Shared decision-making was very rarely implemented in current routine cancer care. The entire decision-making process was not observed to follow the principles of shared decision-making. However, some aspects of shared decision-making were occasionally incorporated. Individual as well as organisational factors were found to influence the degree of shared decision-making. If future routine cancer care wishes to follow the principles of shared decision-making, strategies are needed to foster shared decision-making in routine cancer care.

Attachment Insecurity in Advanced Cancer Patients: Psychometric Properties of the German Version of the Brief Experiences in Close Relationships Scale (ECR-M16-G).

CONTEXT: Attachment insecurity refers to difficulty in trusting and relying on others in times of need. Its underlying factors attachment anxiety and attachment avoidance have been empirically associated with impaired coping in advanced cancer and, therefore, should be considered in individually tailored medical and psychosocial treatment. OBJECTIVES: The objective of this study was to evaluate the psychometric properties of the German translation of the Brief Experiences in Close Relationships Scale (ECR-M16-G). METHODS: We recruited 182 advanced cancer patients from outpatient psycho-oncology clinics of the University Medical Center Hamburg-Eppendorf and the University Medical Center Leipzig, local and external cancer care facilities. We performed confirmatory factor analysis to replicate the higher order factor structure reported in previous research. We conducted item and reliability analysis, also correlation analysis, to examine concurrent validity. RESULTS: One hundred fifty-eight patients completed the ECR-M16-G (women 61%, mean age 57.9, SD = 11.1). We replicated the factor structure with the subscales Attachment Anxiety and Attachment Avoidance as second-order factors and Worrying about relationships, Frustration about unavailability, Discomfort with close others, and Turning away from others as first-order factors. An adjusted model that interchanged factor loadings of items 4 and 10 showed good fit (Comparative Fit Index = 0.94, Non-Normed Fit Index = 0.93, root mean square error of approximation = 0.05). Subscales showed acceptable to good internal consistency (anxiety α = .81 and avoidance α = .78). Attachment insecurity (mean = 3.1, SD = 1.0) was positively associated with depression, anxiety, demoralization (P < 0.001), and symptom burden (P = 0.02) and negatively associated with spiritual well-being (P < 0.001). CONCLUSION: The ECR-M16-G is a valid and reliable measure of attachment insecurity in patients with advanced cancer and can be recommended as a tool for clinical care and further research.

Perceived need for psychosocial support depending on emotional distress and mental comorbidity in men and women with cancer.

OBJECTIVE: Although elevated levels of distress are supposed to constitute a need for psychosocial support, the relation between elevated distress and need for support does not appear to be straightforward. We aimed to determine cancer patients' perceived need for psychosocial support, and examine the relation of need to both self-reported emotional distress and the interview-based diagnosis of a mental disorder. METHODS: In a multicenter, cross-sectional study in Germany, 4020 cancer patients (mean age 58 years, 51% women) were evaluated. We obtained self-reports of need for psychosocial support. We measured distress with the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) and depressive symptoms with the Patient Health Questionnaire (PHQ-9). In a subsample, we evaluated the presence of a mental disorder using the Composite International Diagnostic Interview (CIDI). RESULTS: 32.1% (95%-CI 30.6 to 33.6) of patients perceived a need for psychosocial support. Younger age, female sex, and higher education were associated with more needs, being married and living with a partner with fewer needs, respectively. While up to 51.2% of patients with elevated distress levels reported a need for psychosocial support, up to 26.1% of those without elevated distress levels perceived such a need. Results were similar across distress assessment methods. CONCLUSION: Our findings emphasize that the occurrence of mental distress is one important but not an exclusive factor among different motives to report the need for psychosocial support. We should thus consider multifaceted perspectives, facilitators and barriers when planning and implementing patient-centered psychosocial care services.

[psychenet - The Hamburg Network for Mental Health]. / psychenet - das Hamburger Netz psychische Gesundheit.

With the research and development project psychenet: the Hamburg Network for Mental Health (2011 - 2015), the Federal Ministry of Education and Research contributes to strengthening healthcare regions in Germany by establishing new transsectoral cooperations and implementing evaluated innovations. More than 300 partners from research, health care, health industry and government in the Free and Hanseatic City of Hamburg are promoting innovative measures to improve the detection, diagnosis, and treatment for mental disorders. The main objective is to implement integrated healthcare networks based on evidence for effective treatment methods, deriving from high-quality research throughout five indications such as psychosis, depression, somatoform and functional syndromes, anorexia and bulimia and addiction illnesses in adolescence. Those networks are accompanied by additional measures, for example, for improving awareness, information and education for mental health, addressing occupational health or strengthening the participation of patients and their families suffering from mental illness.

[Collaborative and stepped care for depression: Development of a model project within the Hamburg Network for Mental Health (psychenet.de)]. / Collaborative und Stepped Care bei depressiven Erkrankungen : Entwicklung eines Modellprojektes im Hamburger Netz psychische Gesundheit (psychenet.de).

BACKGROUND: Depression is one of the most widespread mental disorders in Germany and causes a great suffering and involves high costs. Guidelines recommend stepped and interdisciplinary collaborative care models for the treatment of depression. OBJECTIVES: Stepped and collaborative care models are described regarding their efficacy and cost-effectiveness. A current model project within the Hamburg Network for Mental Health exemplifies how guideline-based stepped diagnostics and treatment incorporating innovative low-intensity interventions are implemented by a large network of health care professionals and clinics. MATERIALS AND METHODS: An accompanying evaluation using a cluster randomized controlled design assesses depressive symptom reduction and cost-effectiveness for patients treated within "Health Network Depression" ("Gesundheitsnetz Depression", a subproject of psychenet.de) compared with patients treated in routine care. RESULTS: Over 90 partners from inpatient and outpatient treatment have been successfully involved in recruiting over 600 patients within the stepped care model. Communication in the network was greatly facilitated by the use of an innovative online tool for the supply and reservation of treatment capacities. The participating professionals profit from the improved infrastructure and the implementation of advanced training and quality circle work. CONCLUSIONS: New treatment models can greatly improve the treatment of depression owing to their explicit reference to guidelines, the establishment of algorithms for diagnostics and treatment, the integration of practices and clinics, in addition to the implementation of low-intensity treatment alternatives. These models could promote the development of a disease management program for depression.

Socioeconomic status and beliefs about depression, schizophrenia and eating disorders.

PURPOSE: The association between socioeconomic status (SES) and knowledge/belief about depression, schizophrenia and eating disorders will be analysed. METHODS: Data stem from a telephone survey in two large German cities (Hamburg and Munich, n = 2,014, response rate 51 %). Written vignettes with typical signs and symptoms suggestive of a depression, schizophrenia and eating disorders were presented to the respondents. Respondents were then asked about knowledge/belief about causes, symptoms, prevalence and treatment using a standardised questionnaire. Education, occupational position and income were used as SES indicators. RESULTS: Results of mixed hierarchal logistic regression analyses show that individuals with a low SES know less about symptoms and prevalences of depression, schizophrenia and eating disorders. Moreover, people with a high SES are more likely to consider medication as effective in case of depression and schizophrenia, but are less likely to believe that activities such as sports or relaxation are an effective measure to treat the three mental disorders under study. Respondents with a high SES are less likely to believe that a weak will is a possible cause of depression, schizophrenia and eating disorders. We found large similarities in the associations between SES and beliefs across the three mental disorders. Finally, associations of beliefs about mental disorders with education are stronger and more consistent than with income and occupational position. CONCLUSIONS: Results indicate an inequality in mental health literacy and underline that information campaigns on causes, symptoms, prevalence and treatment of mental disorders should consider information needs of people with a low SES.

Rationale and content of psychenet: the Hamburg Network for Mental Health.

With the public-funded research and development project psychenet: the Hamburg Network for Mental Health (2011-2014), the Federal Ministry of Education and Research contributes to strengthening healthcare regions in Germany by establishing new trans-sectoral cooperations and implement and evaluate selected innovations. More than 60 partners from research, health care, health industry and government in the Free and Hanseatic City of Hamburg are promoting innovative measures to improve the treatment for mental disorders. The main objective is to implement integrated healthcare networks based on evidence for effective treatment methods, deriving from high-quality research throughout five indications such as psychosis, depression, somatoform and functional syndromes, anorexia and bulimia and addiction illnesses in adolescence. Those networks are accompanied by additional measures, for example, for improving information and education, addressing occupational health or strengthening the participation of patients and their families suffering from mental illness.

[Development and evaluation of a group therapy for functional memory and attention disorder]. / Konzeption und Erprobung eines gruppentherapeutischen Behandlungskonzepts für die funktionelle Gedächtnis- und Konzentrationsstörung.

OBJECTIVES: Functional Memory and Attention Disorder (FMD) is regularly seen in patients presenting in psychosomatic or memory clinics. The aim of this study was the evaluation of a novel group therapy for FMD in a randomized controlled trial. METHODS: 40 FMD patients were randomly assigned to either the experimental (EG) or the wait-list control group (CG). Out of these 35/31 were analysed (intent to treat vs. observed cases respectively). The intervention consisted of psychoeducation, cognitive restructuring, stress management, relaxation and mindfulness techniques. Data were collected at baseline, three months (post-intervention) and six months (follow-up). Primary outcome was the memory self-efficacy measure of the Metamemory in Adulthood Questionnaire (MSE). Secondary outcomes were the sum scores of the Perceived Stress Questionnaire (PSQ) and the SCL-90-R. RESULTS: The EG showed a significantly higher improvement on MSE at follow-up than the CG. No significant group differences emerged on PSQ or SCL-90-R. The CG showed stable MSE scores during the waiting period without intervention. However, after the CG received their therapy the same pattern on MSE scores as seen in the EG emerged. CONCLUSIONS: This study provides preliminary evidence for an improvement of memory self efficacy in FMD through a newly devised group therapy program consisting of different modules. This result ought to be replicated in larger studies.

Treatment of depressive symptoms and attitudes towards treatment options in a representative German general population sample.

Objective. To estimate treatment rates, self-medication, and preferences for treatment options of depressive symptoms. Methods. A German nationwide representative sample (n=2224) was interviewed. Subjects were asked to fill in a depressive symptom checklist, as well as to answer questions about current treatments and treatment preferences. Results. A total of 16.7% was mildly, 7.5% moderately and 6.5% strongly affected by depressive symptoms; 22.7% of the total affected group were currently or previously being treated by a physician. Self-initiated treatments had been stated as effective in 54.2% of cases. The preference for phytotherapeutic treatment approaches was about 3-6-fold higher than for standard antidepressants and psychotherapies. Treatment preference and wish for treatment increased with increasing severity of symptoms with regard to treatments that had to be professionally initiated. Conclusion. Despite considerable educational efforts, the prevalence of untreated and undiagnosed depressive symptoms seems to be high. There is still little acceptance for the most efficacious therapies for depression. More efforts should be made to increase knowledge about self-administered phytotherapeutic drugs, which might play an important role in a stepped-care approach of future depression management.

[Chronic diseases, psychological distress and coping -- challenges for psychosocial care in medicine]. / Chronische Erkrankungen, psychische Belastungen und Krankheitsbewältigung -- Herausforderungen für eine psychosoziale Versorgung in der Medizin.

Due to the increase of chronic diseases within the last decades the need and demand for psychosocial treatment in medicine has been realized. This review focuses on the psychosocial aspects of chronic diseases and discusses selected topics of medical and rehabilitation psychology. Recent developments in quantitative and qualitative methods have allowed the systematic analysis of psychosocial distress and coping with chronic disease as well as the consequences on social relationships. The need for psychosocial treatment in acute care and rehabilitation can be diagnosed by differential assessment tools for coping and psychiatric morbidity. Specific approaches of psychology and psychotherapy for patients with somatic diseases have been developed and may be regarded as an integrative part of medical treatment in acute care and rehabilitation. In rehabilitation, the traditional individualistic view of psychotherapy has been broadened towards vocational integration and participation in social activities as outcome criteria. Evaluation research as well as the rehabilitation sciences have provided empirical data on psychosocial treatment of chronically ill patients. Under increasing financial restrictions and problems of the health care systems there is a need for quality assurance and the proof of scientific evidence to guarantee psychosocial treatment as an integrated part of medical care in the future.