Evaluating palliative care case conferences in primary care for patients with advanced non-malignant chronic conditions: a cluster-randomised controlled trial (KOPAL).

BACKGROUND: Patients with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are underrepresented in specialist palliative home care (SPHC). However, the complexity of their conditions requires collaboration between general practitioners (GPs) and SPHC teams and timely integration into SPHC to effectively meet their needs. OBJECTIVE: To facilitate joint palliative care planning and the timely transfer of patients with advanced chronic non-malignant conditions to SPHC. METHODS: A two-arm, unblinded, cluster-randomised controlled trial. 49 GP practices in northern Germany were randomised using web-based block randomisation. We included patients with advanced CHF, COPD and/or dementia. The KOPAL intervention consisted of a SPHC nurse-patient consultation followed by an interprofessional telephone case conference between SPHC team and GP. The primary outcome was the number of hospital admissions 48 weeks after baseline. Secondary analyses examined the effects on health-related quality of life and self-rated health status, as measured by the EuroQol 5D scale. RESULTS: A total of 172 patients were included in the analyses. 80.4% of GP practices had worked with SHPC before, most of them exclusively for cancer patients. At baseline, patients reported a mean EQ-VAS of 48.4, a mean quality of life index (EQ-5D-5L) of 0.63 and an average of 0.80 hospital admissions in the previous year. The intervention did not significantly reduce hospital admissions (incidence rate ratio = 0.79, 95%CI: [0.49, 1.26], P = 0.31) or the number of days spent in hospital (incidence rate ratio = 0.65, 95%CI: [0.28, 1.49], P = 0.29). There was also no significant effect on quality of life (∆ = -0.02, 95%CI: [-0.09, 0.05], P = 0.53) or self-rated health (∆ = -2.48, 95%CI: [-9.95, 4.99], P = 0.51). CONCLUSIONS: The study did not show the hypothesised effect on hospitalisations and health-related quality of life. Future research should focus on refining this approach, with particular emphasis on optimising the timing of case conferences and implementing discussed changes to treatment plans, to improve collaboration between GPs and SPHC teams.

The CAREPAL-8: a short screening tool for multidimensional family caregiver burden in palliative care.

BACKGROUND: Family caregivers of terminally ill and dying people do not only experience varying levels but also different dimensions of caregiver-related strain and burden. The aim of the study was to develop a short multidimensional screening tool for the detection of burden in family caregivers in palliative care. METHODS: Family caregivers of cancer patients newly admitted to specialist inpatient palliative care (N = 232) completed questionnaires on psychological burden, quality of life, social support and need fulfillment. A latent class mixture model was used to identify discrete classes of family caregivers related to their multidimensional caregiver burden. Multinomial logistic regression analyses were performed to identify the most predictive items from a set of established questionnaires. RESULTS: Four latent classes of family caregivers were identified: Currently stable caregivers (37%), Caregivers with unmet needs (20%), Psychologically burdened caregivers (30%), and High-risk caregivers (13%). Each of these classes describes a different risk profile of multidimensional family caregiver burden, although family caregivers exhibit high levels of distress across all classes. From a set of 48 items, we identified eight items that predicted the class membership best. These items represent the items of the novel multidimensional screening tool: The 8-item Screening Tool for Family Caregiver Burden in Palliative Care (CAREPAL-8). Except for social support, the items maintained fidelity to the conceptualization of multidimensional caregiver burden used in this study. A preliminary classification system was developed, which has yet to be validated. CONCLUSIONS: This study represents the first step in the establishment of a practical, self-administered screening tool that might help healthcare providers to tailor caregiver care according to their burden in daily practice. Brevity of the 8-item tool might facilitate its use in routine clinical care.

[DNVF Memorandum: Health Services Research in the Last Year of Life]. / DNVF-Memorandum Versorgungsforschung im letzten Lebensjahr.

This memorandum outlines current issues concerning health services research on seriously ill and dying people in the last year of their lives as well as support available for their relatives. Patients in the last phase of life can belong to different disease groups, they may have special characteristics (e. g., people with cognitive and complex impairments, economic disadvantage or migration background) and be in certain phases of life (e. g., parents of minor children, (old) age). The need for a designated memorandum on health services research in the last year of life results from the special situation of those affected and from the special features of health services in this phase of life. With reference to these special features, this memorandum describes methodological and ethical specifics as well as current issues in health services research and how these can be adequately addressed using quantitative, qualitative and mixed methods. It has been developed by the palliative medicine section of the German Network for Health Services Research (DNVF) according to the guidelines for DNVF memoranda.

[Experiences when handling sleep medicines: Group discussions with nursing students about benzodiazepines and Z-drugs]. / Erfahrungen im Umgang mit Schlafmitteln: Gruppendiskussionen mit Auszubildenden in der Pflege über Benzodiazepine und Z-Substanzen.

Experiences when handling sleep medicines: Group discussions with nursing students about benzodiazepines and Z-drugs Abstract. Background and aims: Helping patients who have difficulties falling or staying asleep is one of the challenges of hospital care. The goal of this study was to explore how nursing students experience patients' sleeping problems as well as the usage of sleep-inducing drugs, especially benzodiazepines and Z-drugs in the hospital setting. Methods: In four focus group discussions, we collected data exploring the experiences of nursing students with regards to sleeping problems and sleep-inducing drugs. The transcripts of the discussion were analysed, using documentary method. Results were finally summarized to main categories, using qualitative content analysis. Results: Students experience a generous distribution of sleep-inducing drugs, which are considered as the best possible solution for sleeping problems - in spite of weak evidence. Non-drug alternatives are seldom taught, are often unavailable on the ward and their use is rarely trained. Pharmacological knowledge is too shallow and / or the transfer of theoretical knowledge to practical action is unsuccessful. Sleep and sleeping problems, e. g. in contrast to pain management, are not a topic of priority in the hospital setting. Conclusions: More knowledge and greater sensibility about sleeping problems is needed. For example, nurses' training should incorporate knowledge about medications and non-drug alternatives and how to apply them in critical situations. Doctors and nurses should offer nursing students good role models in these situations.

Supportive care needs and service use during palliative care in family caregivers of patients with advanced cancer: a prospective longitudinal study.

PURPOSE: This study aimed to investigate the supportive care needs of family caregivers (FCs) of advanced cancer patients and their support service use at the beginning of specialist inpatient palliative care (SIPC), near the patient's death, and during bereavement. METHODS: FCs reported their needs using the Family Inventory of Needs (FIN), along with their utilization of psychosocial and bereavement support services at the beginning (N = 232) and 6-9 months after SIPC (N = 160). RESULTS: At the beginning of SIPC, mean of 16.9 of 20 needs were reported to be highly important, and 12.2 were reported to be met. At the time of the patient's death, 16.8 needs were highly important, and 13.8 were met. At both time points, the highest ranked need was related to information about changes in the patient's condition (100% vs. 99%), and the most frequently unmet need was related to feeling hope (73% vs. 71%). Multivariate linear regression analysis revealed a low education level to be consistently related to a greater number of highly important needs. Higher satisfaction with care and better social support was related to a greater number of met needs. Twenty-five percent of FCs had accessed at least one psychosocial support service prior to SIPC, and 30% had done so during bereavement. Among non-users of support services, > 75% indicated sufficient informal support as a barrier to service use. CONCLUSIONS: The findings offer a useful guide for adequately addressing FCs' needs in an effort to optimize FC support. However, only a subgroup of the FCs used support services. Better information and provision of tailored services might improve FCs' situations in the future.

GPs' views on the use of depression screening and GP-targeted feedback: a qualitative study.

PURPOSE: The first aim of this qualitative study was to identify general practitioners' (GPs') views on depression screening combined with GP-targeted feedback in primary care. The second aim was to determine the needs and preferences of GPs with respect to GP-targeted feedback to enhance the efficacy of depression screening. METHODS: A semistructured qualitative interview was conducted with officially registered GPs in Hamburg (Germany). Interviews were audio recorded and transcribed verbatim. An inductive approach was used to code the transcripts. RESULTS: Nine GPs (27 to 70 years; 5 male) from Hamburg, Germany, participated. Regarding depression screening combined with GP-targeted feedback, five thematic groups were identified: application of screening; screening and patient-physician relationships; GPs' attitudes towards screening; benefits and concerns related to screening; and GPs' needs and preferences regarding feedback. While the negative aspects of screening can be described in rather general terms (e.g., screening determines the mental health competence, screening threatens the doctor-patient relationship, revealing questions harm the patients), its advantages were very specific (e.g., promoting the identification of undetected cases, relief of the daily workload, wider communication channel to reach more patients). Standardized GP-targeted feedback of the screening results was perceived as helpful and purposeful. GPs preferred feedback materials that eased their clinical workload (e.g., short text with visuals, pictures, or images). CONCLUSION: Addressing GPs' needs is essential when implementing depression screening tools in clinical practice. To overcome prejudices and enhance the efficacy of screening, further education for GPs on the purpose and application on depression screening may be needed. Standardized GP-targeted feedback in combination with depression screening could be the missing link to improve the detection of depression in primary care.

Patient involvement in developing a patient-targeted feedback intervention after depression screening in primary care within the randomized controlled trial GET.FEEDBACK.GP.

BACKGROUND: Patient and public involvement (PPI) is increasingly required in mental health services research. To empower patients to actively address depression, the GET.FEEDBACK.GP study evaluates a patient-targeted feedback intervention after depression screening using the Patient Health Questionnaire (PHQ-9). OBJECTIVE: To refine the patient-targeted feedback from a previous study within a participatory research team (PRT) by conducting workshops to investigate patients' needs and preferences for feedback. To evaluate the process and outcome of PPI. DESIGN: Patient and public involvement was carried out on the levels of collaboration and consultation. A PRT of patient partners and researchers planned and conducted three workshops with patients. Patients' needs were investigated using a focus group. Participants prioritized needs, discussed feedback drafts and evaluated two drafts using cognitive debriefings. Researchers of the PRT communicated the results at project level. PPI was evaluated using the Public and Patient Engagement Evaluation Tools (PPEET). SETTING AND PARTICIPANTS: A purposeful sampling of N = 12 patients with experiences of depression participated in at least one workshop. RESULTS: Relevant content-related needs about feedback (eg no distinction between severe and moderate symptoms), recommendations for action and patient-relevant information were considered. Needs for comprehensible, valuing, nonstigmatizing language and design elements (eg dimensional bar) were implemented. Workshops and PRT were positively evaluated. DISCUSSION AND CONCLUSIONS: Patient and public involvement influenced the content, wording and design of the feedback. Strengths include two levels of PPI, methodical diversity and purposeful sampling. Limitations include the lack of inclusion of patients who are unaware of their depression. The evaluated PPI concept can be useful for future studies.

Association of depression and anxiety with adherence in primary care patients with heart failure-cross-sectional results of the observational RECODE-HF cohort study.

BACKGROUND: Psychological distress has a negative impact on the prognosis and quality of life for patients with heart failure. We investigated the association between psychological distress and the patients' adherence to medical treatment (medication adherence) and self-care advice (lifestyle adherence) in heart failure. We further examined whether there are different factors associated with low medication compared to low lifestyle adherence. METHOD: This secondary analysis of the RECODE-HF cohort study analyzed baseline data of 3099 primary care heart failure patients aged 74 ± 10 years, 44.5 % female. Using multivariable regression, factors relating to medication and lifestyle adherence were investigated in order to estimate the extent to which these factors confound the association between psychological distress and adherence. RESULTS: Psychological distress was significantly associated with poorer medication adherence but not with lifestyle adherence after controlling for confounders. We identified different factors associated with medication compared to lifestyle adherence. A higher body mass index, a less developed social network, living alone, fewer chronic co-morbidities and unawareness of the heart failure diagnosis were only related to lower lifestyle adherence. Higher education was associated with poorer medication adherence. Male sex, younger age, lower self-efficacy and less familiar relation with the general practitioner were common factors associated with both lower medication and lifestyle adherence. CONCLUSION: Promising factors for increasing medication adherence (reduction of psychological distress) and lifestyle adherence (explaining the patient his/her heart failure diagnosis more than once and increase in the patients' self-efficacy), which were found in this cross-sectional study, must be further investigated in longitudinal studies.

Medical decision making among patients with heart failure - does migration background matter?

BACKGROUND: Some studies, mainly coming from the U.S., indicate disparities in heart failure (HF) treatment according to migration/ethnicity. However, respective results are inconsistent and cannot be transferred to other health care systems. Thus, we will address the following research question: Are there differences in the diagnosis and management of HF between patients with and without a Turkish migration background in Germany? METHODS: A factorial experimental design with video vignettes was applied. In the filmed simulated initial encounters, professional actors played patients, who consulted a primary care physician because of typical HF symptoms. While the dialog was identical in all videos, patients differed in terms of Turkish migration history (no/yes), sex (male/female), and age (55 years/75 years). After viewing the video, primary care physicians (N = 128) were asked standardized and open ended questions concerning their decisions on diagnosis and therapy. RESULTS: Analyses revealed no statistically significant differences (p < 0.05), but a consistent tendency: Primary care doctors more often asked lifestyle and psychosocial questions, they more often diagnosed HF, they gave more advice to rest and how to behave in case of deterioration, they more often auscultated the lung, and more often referred to a specialist when the patient has a Turkish migration history compared to a non-migrant patient. Differences in the medical decisions between the two groups ranged between 1.6 and 15.8%. In 10 out of 12 comparisons, differences were below 10%. CONCLUSIONS: Our results indicate that are no significant inequalities in diagnosis and management of HF according to a Turkish migration background in Germany. Primary care physicians' behaviour and medical decision making do not seem to be influenced by the migration background of the patients. Future studies are needed to verify this result and to address inequalities in HF therapy in an advanced disease stage.

Ethical challenges in family caregivers of patients with advanced cancer - a qualitative study.

BACKGROUND: Caring for patients with advanced or terminal diseases can confront family caregivers (FC) with ethical challenges. The present study aims at tracing paths connected to ethical challenges among FC of advanced cancer patients by exploring morally troubling situations and related burden, as well as strategies to handle the situation and experience of moral distress from the grieving FC's perspective. METHODS: Within a qualitative design, interviews with 12 grieving FC were conducted using a semi-structured interview guide. Data were analysed using grounded theory and abductive reasoning. RESULTS: Core phenomena identified were two paths connected to ethical challenges among FC. Ethical challenges occurred in the context of difficult decision-making (Path 1) and in the context of lacking decision-making options when no decision was to be made by FC (Path 2). We found each path to be triggered by distinct sets of morally troubling situations that occurred during the patient's disease trajectory. In the course of difficult decision-making (Path 1), detrimental external factors could add emotional stress, thus making the decision-making process burdensome. FC used various proactive strategies to overcome those detrimental factors and/or to make the decision. Decisions in conflict with FCs' own moral expectations and values led to moral distress, generating painful emotions. When no decision was to be made by FC (Path 2), FC felt powerless and overrun, which was associated with major emotionality in terms of anxiety and confusion. Either detrimental factors aggravated these feelings to paralyzing shock, or internal resources enabled FC to accept the situation. While acceptance prevented moral distress, paralyzing shock often caused a sense of not meeting their their own moral expectations and values, resulting in moral distress. In both paths, factors were identified that helped FC finding closure and prevented moral residue. Nevertheless, some FC experienced residual moral distress months after the morally troubling situation had occurred. CONCLUSION: Findings provide first information towards understanding paths leading to ethical challenges in FC and can help clinicians to minimize associated emotional burden and moral distress.

Perceptions of time constraints among primary care physicians in Germany.

BACKGROUND: Time constraints during patient visits play a major role for the work stress of primary care physicians. Several studies suggest that there is a critical situation in terms of time constraints in primary care in Germany. Therefore, the following research questions are addressed: (1) What is the time allocated and needed for different types of consultations among primary care physicians in an urban area in Germany? (2) What is the extent of time stress? (3) Are there differences in time stress according to physician characteristics (gender and length of experience) and practice type (single vs. group/shared practice)? METHODS: Data stem from a face-to-face survey of primary care doctors in Hamburg and adjacent regions. A sample of 128 physicians stratified by a combination of physicians' gender and length of experience (≤15 years or > 15 years) was used. Physicians were asked about the time needed (in minutes) to provide high quality of care for patients regarding six types of consultations: (1) new patient appointment, (2) routine consultation, (3) complete physical examination, (4) symptom-oriented examination, (5) check-up, and (6) home visit (without drive). Afterwards, they were asked about the average minutes allocated for the six consultations. Time stress was measured by calculating minutes needed minus minutes available. RESULTS: Average perceived time needed was higher than time allocated for all six types of consultation. However, there were differences in the magnitude of time stress between the consultation types. Time stress was most pronounced and most prevalent in case of a new patient visit. No significant differences in time stress between male and female primary care physicians were found, while less experienced physicians reported more time stress than those with more experience (> 15 years). Physicians working in a single practice had less time stress than those working in a group or shared practice in case of a check-up visit. CONCLUSIONS: Perceived time needed is higher than time allocated for various types of consultation among primary care physicians in Germany. Time stress in primary care is particularly pronounced in case of new patient appointments. Early-career physicians are particularly affected by time stress.

Psychological burden in family caregivers of patients with advanced cancer at initiation of specialist inpatient palliative care.

BACKGROUND: This study prospectively evaluated distress, depressive and anxiety symptoms as well as associated factors in family caregivers (FC) of advanced cancer patients at initiation of specialist inpatient palliative care. METHODS: Within 72 h after the patient's first admission, FCs were asked to complete German versions of the Distress Thermometer, Generalized Anxiety Disorder 7-item scale (GAD-7), Patient Health Questionnaire depression module 9-item scale (PHQ-9) for outcome measure. Multivariate logistic regression analyses were used to identify associated factors. RESULTS: In 232 FCs (62% spouses/partners), mean level of distress was 7.9 (SD 1.8; range, 2-10) with 95% presenting clinically relevant distress levels. Most frequent problems were sadness (91%), sorrows (90%), anxiety (78%), exhaustion (77%) and sleep disturbances (73%). Prevalence rates of moderate to severe anxiety and depressive symptoms were 47 and 39%, respectively. Only 25% of FCs had used at least one source of support previously. In multivariate regression analysis, being female (OR 2.525), spouse/partner (OR 2.714), exhaustion (OR 10.267), and worse palliative care outcome ratings (OR 1.084) increased the likelihood for moderate to severe anxiety symptom levels. Being female (OR 3.302), low socio-economic status (OR 6.772), prior patient care other than home-based care (OR 0.399), exhaustion (OR 3.068), sleep disturbances (OR 4.183), and worse palliative care outcome ratings (OR 1.100) were associated with moderate to severe depressive symptom levels. CONCLUSIONS: FCs of patients presenting with indication for specialist palliative care suffer from high distress and relevant depressive and anxiety symptoms, indicating the high need of psychological support not only for patients, but also their FCs. Several socio-demographic and care-related risk-factors influence mental burden of FCs and should be in professional caregivers' focus in daily clinical practice.

Team members perspectives on conflicts in clinical ethics committees.

BACKGROUND: Clinical ethics committees have been broadly implemented in university hospitals, general hospitals and nursing homes. To ensure the quality of ethics consultations, evaluation should be mandatory. RESEARCH QUESTION/AIM: The aim of this article is to evaluate the perspectives of all people involved and the process of implementation on the wards. RESEARCH DESIGN AND PARTICIPANTS: The data were collected in two steps: by means of non-participating observation of four ethics case consultations and by open-guided interviews with 28 participants. Data analysis was performed according to grounded theory. ETHICAL CONSIDERATIONS: The study received approval from the local Ethics Commission (registration no.: 32/11/10). FINDINGS: 'Communication problems' and 'hierarchical team conflicts' proved to be the main aspects that led to ethics consultation, involving two factors: unresolvable differences arise in the context of team conflicts on the ward and unresolvable differences prevent a solution being found. Hierarchical asymmetries, which are common in the medical field, support this vicious circle. Based on this, minor or major disagreements regarding clinical decisions might be seen as ethical conflicts. The expectation on the clinical ethics committee is to solve this (communication) problem, but the participants experienced that hierarchy is maintained by the clinical ethics committee members. DISCUSSION: The asymmetrical structures of the clinical ethics committee reflect the institutional hierarchical nature. They endure, despite the fact that the clinical ethics committee should be able to detect and overcome them. Disagreements among care givers are described as one of the most difficult ethically relevant situations and should be recognised by the clinical ethics committee. On the contrary, discussion of team conflicts and clinical ethical issues should not be combined, since the first is a mandate for team supervision. CONCLUSION: To avoid dominance by physicians and an excessively factual character of the presentation, the case or conflict could be presented by both physicians and nurses, a strategy that strengthens the interpersonal and emotional aspects and also integrates both professional perspectives.

Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients.

BACKGROUND: This pilot study aimed to investigate quality of life, psychological burden, unmet needs, and care satisfaction in family caregivers of advanced cancer patients (FCs) during specialized inpatient palliative care (SIPC) and to test feasibility and acceptance of the questionnaire survey. METHODS: During a period of 12 weeks, FCs were recruited consecutively within 72 h after the patient's admission. They completed validated scales on several outcomes: quality of life (SF-8), distress (DT), anxiety (GAD-7), depression (PHQ-9), supportive needs (FIN), palliative care outcome (POS), and satisfaction with care (FAMCARE-2). We used non-parametric tests, t-tests and correlation analyses to address our research questions. RESULTS: FCs showed high study commitment: 74 FCs were asked to participate whereof 54 (73%) agreed and 51 (69%) returned the questionnaire. Except for "bodily pain", FCs' quality of life (SF-8) was impaired in all subscales. Most FCs (96%) reported clinically significant own distress (DT), with sadness, sorrows and exhaustion being the most distressing problems (80-83%). Moderate to severe anxiety (GAD-7) and depression (PHQ-9) were prevalent in 43% and 41% of FCs, respectively. FCs scored a mean number of 16.3 of 20 needs (FIN) as very or extremely important (SD 3.3), 20% of needs were unmet in >50% of FCs. The mean POS score assessed by FCs was 16.6 (SD 5.0) and satisfaction (FAMCARE-2) was high (73.4; SD 8.3). CONCLUSIONS: This pilot study demonstrated feasibility of the questionnaire survey and showed relevant psychosocial burden and unmet needs in FCs during SIPC. However, FCs' satisfaction with SIPC seemed to be high. A current multicenter study evaluates these findings longitudinally in a large cohort of FCs.

Timely integration of specialist palliative home care (SPHC) for patients with congestive heart failure, chronic obstructive pulmonary disease and dementia: qualitative evaluation of the experiences of SPHC physicians in the KOPAL trial.

OBJECTIVE: Chronic non-malignant diseases (CNMDs) are under-represented in specialist palliative home care (SPHC). The timely integration of SPHC for patients suffering from these diseases can reduce hospitalisation and alleviate symptom burdens. An intervention of an SPHC nurse-patient consultation followed by an interprofessional telephone case conference with the general practitioner (GP) was tested in the KOPAL trial ('Concept for strengthening interprofessional collaboration for patients with palliative care needs'). As part of the trial, the aim of this study was to gain in-depth insights into SPHC physicians' perspective on care with and without the KOPAL intervention for patients with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia (D). DESIGN: Qualitative evaluation of the KOPAL intervention from the perspective of SPHC physicians as part of the KOPAL trial. Thematic-focused narrative interviews analysed with grounded theory. SETTING: We conducted the KOPAL study and its qualitative evaluation in Lower Saxony and the greater Hamburg area, Germany. PARTICIPANTS: 11 physicians from 14 SPHC teams who participated in the trial were interviewed. RESULTS: A grounded theory of the necessity of collaboration between GPs and SPHC teams for patients with CHF, COPD and dementia was developed. From the perspective of SPHC physicians, patients with CNMD are generally difficult to manage in GP care. The timing of SPHC initiation is patient-specific, underscoring the need for collaboration between SPHC physicians and GPs. However, the primary mandate for healthcare should remain with GPs. SPHC physicians actively seek collaboration with GPs (eg, through the KOPAL intervention), viewing themselves as advisors for GPs and aspiring to collaborate as equal partners. CONCLUSION: Effective communication and the negotiation of future interprofessional collaboration are essential for SPHC teams. TRIAL REGISTRATION NUMBER: DRKS00017795.

Clinical effectiveness of patient-targeted feedback following depression screening in general practice (GET.FEEDBACK.GP): an investigator-initiated, prospective, multicentre, three-arm, observer-blinded, randomised controlled trial in Germany.

BACKGROUND: Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback. METHODS: The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at ClinicalTrials.gov (NCT03988985) and is complete. FINDINGS: Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by -4·15 (95% CI -4·99 to -3·30) in the no feedback group, -4·19 (-5·04 to -3·33) in the GP feedback group, and -4·91 (-5·76 to -4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was -0·77 (-1·60 to 0·07, d=-0·16) and when comparing with the GP-only feedback group was -0·73 (-1·56 to 0·11, d=-0·15). No increase in suicidality was observed as an adverse event in either group. INTERPRETATION: Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups. FUNDING: German Innovation Fund. TRANSLATION: For the German translation of the abstract see Supplementary Materials section.

Physicians' and nurses' expectations and objections toward a clinical ethics committee.

The study aimed to explore the subjective need of healthcare professionals for ethics consultation, their experience with ethical conflicts, and expectations and objections toward a Clinical Ethics Committee. Staff at a university hospital took part in a survey (January to June 2010) using a questionnaire with open and closed questions. Descriptive data for physicians and nurses (response rate = 13.5%, n = 101) are presented. Physicians and nurses reported similar high frequencies of ethical conflicts but rated the relevance of ethical issues differently. Nurses stated ethical issues as less important to physicians than to themselves. Ethical conflicts were mostly discussed with staff from one's own profession. Respondents predominantly expected the Clinical Ethics Committee to provide competent support. Mostly, nurses feared it might have no influence on clinical practice. Findings suggest that experiences of ethical conflicts might reflect interprofessional communication patterns. Expectations and objections against Clinical Ethics Committees were multifaceted, and should be overcome by providing sufficient information. The Clinical Ethics Committee needs to take different perspectives of professions into account.

Cost-effectiveness of a specialist palliative care nurse-patient consultation followed by an interprofessional case conference for patients with non-oncological palliative care needs: results of the KOPAL trial.

BACKGROUND: Worldwide, progressive chronic, non-malignant diseases are highly prevalent. Especially with increasing age, they are characterised by high hospitalisation rates and high healthcare costs. Improved interprofessional collaboration between general practitioners (GPs) and specialist palliative home care (SPHC) teams might reduce hospitalisation while improving symptoms and quality of life, or preventing them from deterioration. The aim of this study was to examine the cost-effectiveness of a newly developed intervention in patients with advanced chronic, non-malignant diseases consisting of a structured palliative care nurse-patient consultation followed by an interprofessional telephone case conference. METHODS: The analysis was based on data from 172 participants of the KOPAL multi-centre, cluster randomised controlled trial. Patients with advanced congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), or dementia were randomised into intervention group (IG) and control group (CG, usual care). Cost-effectiveness was examined over 48 weeks from a societal and healthcare payer's perspective. Effects were quantified as quality-adjusted life years (QALYs, EQ-5D-5L). Incremental cost-effectiveness ratios were calculated and cost-effectiveness acceptability curves were constructed. RESULTS: Baseline imbalances in costs and effects could be observed between IG and CG. After adjusting for these imbalances and compared to the CG, mean costs in the IG were non-significantly higher from a societal and lower from a payer's perspective. On the effect side, the IG had marginally lower mean QALYs. The results were characterized by high statistical uncertainty, indicated by large confidence intervals for the cost and effect differences between groups and probabilities of cost-effectiveness between 18% and 65%, depending on the perspective and willingness-to-pay. CONCLUSIONS: Based on the results of this study, the cost-effectiveness of the KOPAL intervention was uncertain. The results highlighted (methodological) challenges of economic evaluations in patients with chronic, non-malignant diseases related to sample size, heterogeneity of participants, and the way the intervention effectiveness is typically captured in economic evaluations.

Age and gender differences in diagnostic decision-making of early heart failure: results of a mixed-methods interview-study using video vignettes.

OBJECTIVES: Men and women at any age show similar symptoms and signs of heart failure (HF). Since early HF symptoms are ambiguous, doctors may overlook HF as possible cause and misinterpret the signs. The aim was to analyse differences in general practitioners' (GPs) HF diagnosis and diagnostic certainty by patient age and gender and to identify reasons for possible differences. DESIGN: Factorial design with video vignettes presenting patients (played by professional actors) with early HF symptoms was used. Video vignettes differed regarding patients' gender (male/female), age (55 years/75 years) and migration background (no/yes: Turkish), while the dialogue was identical. GPs were asked about possible diagnoses and certainty of diagnoses (quantitative) and to narrate their thoughts on considered diagnoses (qualitative). SETTING: General practices in northern Germany. PARTICIPANTS: 128 GPs stratified by gender and length of clinical experience (≤15 years or >15 years). RESULTS: GPs considered HF more often in women than men (predicted probabilities with 95% CI: 0.83 (0.68 to 0.92) vs 0.63 (0.44 to 0.79), p=0.02), especially in older women compared with younger men (predicted probabilities with 95% CI: 0.89 (0.68 to 0.96) vs 0.52 (0.31 to 0.72), p=0,03). Suspected HF was not reasoned by the patient's gender and only seldom by the patient's age, but by reported symptoms. Diagnostic certainty of HF was higher in women than in men (predicted proportions with 95% CI: 0.48 (0.39 to 0.58) vs 0.36 (0.27 to 0.45), p=0.01), with highest certainty in older women and lowest in younger men (0.57 (0.45 to 0.69) vs 0.27 (0.17 to 0.37), p<0.01). GPs explained their certainty referring to both typical HF symptoms and their gut feeling. CONCLUSION: Despite an identical dialogue, the study showed differences by patients' gender and age in frequency and certainty of HF diagnosis. In order to avoid that GPs overlook or misinterpret early signs of HF, it is important to critically reflect diagnostic decisions and possible social influences.