An integrated mental health video consultations model for patients with somatic symptom disorder in primary care: The randomized VISION pilot trial.

OBJECTIVE: Symptoms of somatic symptom disorder (SSD) are one of the most common reasons for consultations in primary care. However, specialized psychological services are mostly unavailable. This pilot trial aimed to determine the feasibility, acceptability, and safety of the integrated mental health video consultations VISION model for patients with SSD in primary care. METHODS: We conducted a parallel group, randomized controlled pilot trial involving fifty-one patients with SSD from ten primary care practices in Germany, who we randomized to the VISION model or enhanced treatment-as-usual (eTAU). The VISION model comprised five video consultations which featured diagnostic clarification, psychoeducation (acknowledging and legitimizing of symptoms), and brief psychological therapy. eTAU included training primary care practice teams on the DSM-5 concept of SSD and on current guideline recommendations for its treatment in primary care. We assessed feasibility as the primary outcome at 6-months, measuring efficiency of recruitment, intervention acceptability, and safety. RESULTS: Recruitment was efficient reflected in an overall recruitment yield (number randomized per number screened) of 55% (51/92) and a consent rate (number randomized per number eligible) of 94% (51/54). Acceptability of the intervention was high with 98% (123/125) of the video consultations conducted as planned. No serious adverse events were reported in either group. CONCLUSION: An integrated mental health video consultations VISION model for patients with SSD presenting to primary care is feasible, acceptable, and safe. Potential clinical effectiveness of the model should be evaluated in confirmatory trial implementing the multifaceted approach tailored to the individual patient with SSD directly into primary care practice. TRIAL REGISTRATION: The trial protocol was registered at German Clinical Trials Register (number: DRKS00026075, https://www.drks.de).

Outpatient Psychotherapy in Germany­An Evaluation of the Structural Reform.

BACKGROUND: A structural reform of the German psychotherapy guideline in 2017 was intended to facilitate access to outpatient guideline psychotherapy. In the present study, we evaluate the effects of this reform in particular for patients a comorbidity of mental disorders and chronic physical conditions (cMP). METHODS: Pre-post analyses of the two primary endpoints "percentage of mentally ill persons who have made an initial contact with a psychotherapist" and "waiting time for guideline psychotherapy" were carried out employing population-based and weighted routine statutory health insurance data from the German BARMER. The secondary endpoints included evaluations from the patients' perspective, based on a representative survey of patients in psychotherapy, and an overview of the health care situation based on data from the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) (study registration number: DRKS00020344). RESULTS: From 2015 to 2018, the percentage of mentally ill persons who had made an initial contact with a psychotherapist rose moderately, from 3.7% (95% confidence interval, [3.6; 3.7]) to 3.9% [3.8; 3.9] among persons with cMP and from 7.3% [7.2; 7.4] to 7.6% [7.5; 7.7] among those with mental disorders but without any chronic phyisical condition (MnoP). The new structural elements were integrated into patient care. The interval of time between the initial contact and the beginning of guideline psychotherapy became longer in both groups, from a mean of 80.6 [79.4; 81.8] to 114.8 [113.4; 116.2] days among persons with complex disease and from 80.2 [79.2; 81.3] to 109.6 [108.4; 111.0] days among persons with non-complex disease; most patients considered the waiting time. Approximately 8% of the patients who sought psychotherapy reported that they had not obtained access to a psychotherapist. CONCLUSION: Neither in general nor for patients with cMP did the introduction of the structural reform appreciably lower the access barriers to psychotherapy. Further steps are needed so that outpatient care can meet the needs of all patients and particularly those with cMP.

From inpatient to outpatient mental health care: Protocol for a randomised feasibility trial of a care transition intervention for patients with depression and anxiety (the AMBITION-trial).

INTRODUCTION: Despite guideline recommendations, inpatients with mental health disorders often do not receive appropriate treatment after discharge. This leads to high readmission rates, problems with medication adherence, increased risk of chronicity and suicide, and exclusion from the labour market accompanied by high individual and social costs. The causes are both system-related, such as limited treatment availability, and patient-related, such as ambivalent motivation to continue treatment and lack of information about available treatment options. The aim of this trial is to assess the feasibility of a Care Transition Intervention (CTI) which supports patients in the psychosocial follow-up treatment process after discharge from a psychotherapy ward. METHODS AND ANALYSIS: Fifty patients with depression and/or anxiety who are treated as inpatients at a psychotherapy ward will be included and randomised into two groups with a 1:1 ratio. In the intervention group, patients will receive five CTI sessions with a Care Transition Navigator before and after discharge. The sessions will focus on individual patient support including a) identification and tackling of barriers to initiate follow-up treatment, b) reflection on the inpatient stay and individual progress, with focus on the helpful aspects and c) motivation of patients to organise and take up outpatient treatment. Patients in the control group will receive treatment-as-usual during discharge. We will evaluate the following outcomes: effectiveness of recruitment strategies, patient acceptance of randomisation, practicability of implemented workflows, feasibility of data collection, and clinical outcomes.

[The Interdisciplinary Family Consultation in Pediatrics - An Integrative Approach to Complex Burdened Families of Chronically ill Children]. / Die Interdisziplinäre Familienmedizinische Sprechstunde in der Kinderheilkunde ­ Ein integrativer Ansatz für komplex belastete Familien mit einem chronisch kranken Kind.

For families of chronically ill children with a high level of psychosocial stress, it is necessary to involve child and adolescent psychiatric or psychosomatic specialists directly in the pediatric treatment process. For this purpose, a family consultation was set up in the Heidelberg University Pediatrics as part of a model project, which deals with these families in an interdisciplinary and systemic way. It shows that the implementation of the consultation works despite a high organizational effort and is regularly used. The first evaluation results confirm the already described high levels of psychosocial stress in the affected families. They indicate a positive assessment of the consultation and a desire for a permanent offer. First follow-up results indicate a significant decrease in treatment-related concerns, uncertainty and a reduction in treatment-related problems. The lack of a viable funding model poses a challenge for long-term implementation.

Primary care patients' experiences of video consultations for depression and anxiety: a qualitative interview study embedded in a randomized feasibility trial.

BACKGROUND: Integrated mental health care models that provide rapid access to video consultations with mental health specialists for primary care patients are a promising short-term, low-threshold treatment option and may reduce waiting times for specialist care. This qualitative study, nested within a randomized feasibility trial, aimed to explore participants' views on this type of care model, its influence on the lived experience of patients, and barriers and facilitators for its delivery. METHODS: In five primary care practices, 50 adults with depression and/or anxiety were randomly assigned to either an integrated care model (maximum of five video consultations with a mental health specialist) or usual care (primary care or another treatment option). Prior to obtaining the trial results, interviews were held with participants who had received video consultations. Interviews were transcribed and analysed thematically. RESULTS: Twenty of the 23 patients who received video consultations participated in the interviews. Patients engaged well with the care model and reported positive effects on their most pressing needs, while denying safety concerns. Generally, they perceived the usability of video consultations as high, and temporary connectivity failures were not considered a substantial barrier. We identified two key mechanisms of impacts on the patients' lived experience: fast access to specialist mental healthcare and the emerging rapport with the specialist. In particular, patients with no prior mental healthcare experience indicated that familiarity with the primary practice and their physician as a gatekeeper were important facilitators of proactive treatment. CONCLUSIONS: From the patients' perspective, mental health care models integrating video consultations with mental health specialists into primary care are linked to positive lived experiences. Our findings imply that primary care physicians should promote their role as gatekeepers to (1) actively engage patients, (2) apply integrated care models to provide a familiar and safe environment for conducting mental health care video consultations, and (3) be able to regularly assess whether certain patients need in-person services. Scaling up such models may be worthwhile in real-world service settings, where primary care physicians are faced with high workloads and limited specialist services. TRIAL REGISTRATION: DRKS00015812.

Prevalence of adverse childhood experiences and effect on outcomes in bariatric surgery patients: a systematic review and meta-analysis.

Adverse childhood experiences (ACEs) are defined as childhood maltreatment (sexual, physical, and emotional abuse and neglect) and other childhood traumatic experiences. Published prevalence estimates for ACEs in bariatric samples vary greatly and evidence on the association between ACEs and bariatric surgery weight loss and psychosocial outcomes is inconclusive. A systematic literature search on PubMed/Medline, PsycInfo, Web of Science, CINAHL (Cumulative Index of Nursing and Allied Health Literature), and Open Grey for studies published until August 30, 2021, yielded 21 publications for qualitative synthesis: 20 reporting on prevalence of ACEs in bariatric surgery candidates and patients, and 10 on the association of ACEs with outcomes. In meta-analysis, overall moderate to high heterogeneity was observed for prevalence estimates and moderate heterogeneity was observed for associations. Prevalence estimate for at least 1 form of ACEs (6 studies, n = 1368 patients) was 51% (95% confidence interval [CI]: 32%-70%). Effect size (Hedge's g) for the difference between the groups of patients reporting any or a high number of ACEs versus no or a low number of ACEs was calculated from means, standard deviations and group size, or P values. Based on 7 studies (n = 946 patients), the association between ACEs and weight loss was not significant (Hedge's g = -.15 [95% CI: -.38 to .09]; I2 = 53%), regardless of short- or long-term follow-up (P = .413) and the proportion of patients in each study receiving Roux-en-Y gastric bypass (RYGB) (ß = .0005, P = .868). Preliminary findings based on 3 short- and long-term studies (n = 414 patients) showed that ACEs were significantly (P = .001) associated with higher postoperative depressive symptoms (Hedge's g = .50 [95% CI: .22-.78]; I2 = 36%). Associations between ACEs and other psychosocial outcomes such as eating pathology were reported narratively. There is a need for additional long-term studies using validated assessment tools for ACEs to evaluate the effect of ACEs on weight and psychosocial outcomes after bariatric surgery.

The Inventory of Complicated Grief-A Systematic Psychometric Review and Conceptual Replication Study of the Structural Validity.

The Inventory of Complicated Grief (ICG) is a commonly used self-report measure in psycho-oncology, best supportive care, and palliative medicine. However, existing validation studies yielded conflicting results regarding the structural validity. This study provides a psychometric review and conceptual replication of the ICG latent structure to test the hypothesis that existing studies overfit unreliable sources of variance, which overshadow the unidimensionality of the ICG. All proposed latent models identified in the psychometric review were tested in a series of confirmatory and exploratory structural equation models. Specifically, at least five to six latent intercorrelated factors were necessary to reach acceptable model fit. However, a general CG factor accounted for most variance and ICG sum scores showed predictable associations with anxiety and depressive symptoms, which suggests that the ICG is essentially unidimensional. There are indications that other measures of pathological grief show similar inconsistencies. Overall, potentially emerging subfacets of the ICG should not be interpreted as distinct "symptom clusters." If time constraints are an issue as is often the case in clinical research, complicated grief may just be measured by a reduced item set without a significant loss of information or complexity.

[Office-based psychosomatic medicine with a focus on acute care]. / Das Praxismodell der Psychosomatischen Medizin und Psychotherapie mit Akut- beziehungsweise Versorgungsschwerpunkt neben der Richtlinienpsychotherapie.

Objectives: In Germany, the office-based psychosomatic medicine with focus on acute care offers psychosomatic treatment besides primary care by general practitioners and regular psychotherapy. The aim of this study is to determine specific characteristics of these innovative office-based practices. Methods: In a qualitative cross-sectional study, twelve board-certified specialists in psychosomatic medicine, practicing office-based psychosomatic medicine were surveyed by means of semi-structured telephone-interviews. After transcription and coding in MAXQDA 2020, a content analysis was conducted. Results: The innovative practice model was characterized by high numbers of initial contacts in walk-in or pre-planned consultation hours. Besides regular psychotherapy long-term and low-threshold treatment was offered. Physician assistants organised the workflow and administrative tasks. For settlement the EBM-number psychosomatic interview or short-term treatment was used. Focusses were set on somatopsychic and socio-medical treatment and consultant support. Psychotherapy often was realised in form of group sessions by integrating behavioural and psychodynamic psychotherapy. Discussion: The innovative psychosomatic practice model with focus on acute care shows an independent profile. A treatment based on medical understanding of complex somatic disease processes can be provided to somatopsychic patients. Future studies should compare this practice model to psychosomatic practices receiving a treatment by guideline psychotherapy. Conclusions: In Germany, the practices of psychosomatic medicine with a focus on acute care closes an increasing gap in psychosomatic care and augments treatment possibilities, especially for elderly and multimorbid patients.

Negotiating decisions on aggressive cancer care at end-of-life between patients, family members, and physicians - A qualitative interview study.

Background: Patients with advanced cancer do receive increasingly aggressive end-of-life care, despite it does often not prolong survival time but entails decreased quality of life for patients. This qualitative study explores the unfolding of aggressive end-of-life care in clinical practice focusing on the decision-making process and the quality of end-of-life care from family members' perspective. Materials and methods: We conducted semi-structured interviews with 16 family members (six of cancer patients with and ten without aggressive end-of-life care) at the National Center for Tumor Diseases Heidelberg, Germany. We conducted a content analysis applying a theoretical framework to differentiate between 'decision-making' (process of deciding for one choice among many options) and 'decision-taking' (acting upon this choice). Results: While patients of the aggressive care group tended to make and take decisions with their family members and physicians, patients of the other group took the decision against more aggressive treatment alone. Main reason for the decision in favor of aggressive care was the wish to spend more time with loved ones. Patients took decisions against aggressive care given the rapid decline in physical health and to spare relatives difficult decisions and arising feelings of guilt and self-reproach. Conclusion: Treatment decisions at end-of-life are always individual. Nevertheless, treatment courses with aggressive end-of-life care and those without differ markedly. To account for a longitudinal perspective on the interplay between patients, family members, and physicians, cohort studies are needed. Meanwhile, clinicians should validate patients and family members considering refraining from aggressive end-of-life care and explore their motives. Clinical trial registration: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022837, identifier DRKS00022837.

Mental health specialist video consultations for patients with somatic symptom disorder in primary care: protocol for a randomised feasibility trial (the VISION trial).

INTRODUCTION: General practitioners (GP) report increasing difficulties in referring patients with somatic symptom disorder (SSD) in specialised psychosocial care. Barriers are structural conditions of the respective healthcare system and patients' reservations against receiving specialised psychosocial care. As patients with SSD often predominantly assume somatic influencing factors for the development and maintenance of their somatic complaints, close collaboration between the GP and mental health specialist (MHS) seems particularly important. Integrating internet-based video consultations by remotely located MHS and primary care can improve effective treatment of patients with SSD by overcoming structural barriers and provide low-threshold and timely care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing MHS video consultations in primary care practices. METHODS AND ANALYSIS: Fifty primary care patients with SSD will be individually randomised in two groups receiving either enhanced treatment as usual as provided by their GP (control group) or two versus five video consultations conducted by an MHS additionally to enhanced treatment as usual. The video consultations focus on (a) diagnostic clarification, (b) the development of a biopsychosocial disorder model, and (c) development of a treatment plan against the background of a stepped-care algorithm based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters. ETHICS AND DISSEMINATION: This trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-620/2021). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial. TRIAL REGISTRATION NUMBER: DRKS00026075.

The cardiac autonomic response to acute psychological stress in type 2 diabetes.

BACKGROUND: Impaired cardiac autonomic control is common among people with type 2 diabetes. The autonomic nervous system and its regulatory influence on the cardiovascular system also play a key role in the physiological response to psychosocial stressors. It is unclear whether the disease-related impairment of cardiac autonomic control in people with type 2 diabetes affects the stress response. The aim of this study was therefore to examine the cardiac autonomic and the psychological stress response of people with type 2 diabetes compared to healthy control participants. METHODS: We used the trier social stress test to induce stress in n = 51 participants with type 2 diabetes and n = 47 healthy controls. We assessed heart rate (HR) and heart rate variability (HRV) using six ECG samples before, during and after the stress test. We measured participants' psychological stress response using visual analogue scales. RESULTS: Longitudinal multilevel models showed an attenuated HR increase in response to the stress test combined with a slower HR recovery after the stress test, in people with type 2 diabetes. This pattern was accompanied by significantly lower low frequency HRV but no differences in high frequency HRV between the groups. Additionally, people with type 2 diabetes showed an increased level of self-reported psychological tension 45 minutes after the stress test. CONCLUSIONS: The impairment of the autonomic nervous system found in people with type 2 diabetes is reflected in the HR response to stress-but not in the HRV response-and partially mirrored in the psychological stress response. Our results underline the importance of considering the interplay of psychosocial stress and disease-related changes in the physiological stress response system in research and treatment of type 2 diabetes.

Evaluating effects of the structural reform of outpatient psychotherapy for patients with mental disorders in Germany: comparing patients with and without comorbid chronic physical condition - rationale and study protocol of the ES-RiP project.

INTRODUCTION: In 2017, in Germany, a structural reform of the outpatient psychotherapy guideline took place, aiming to reduce waiting times, to facilitate flexible low-threshold access (eg, general reachability by phone) and to lower access barriers for specific patient groups. The reform included new service elements, such as the implementation of additional psychotherapeutic consultations, acute short-term psychotherapeutic interventions and relapse prophylaxis as well as the promotion of group therapies, the facilitation of psychotherapists' availability, and the installation of appointment service centres. The ES-RiP project aims to thoroughly evaluate the effects of the reform with a special focus on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs) compared with patients with a mental disorder but no long-term physical condition (MnoP). The project aims to evaluate (a) the extent to which the reform goals were achieved in the large group of patients with cMPs compared with MnoP, (b) the barriers that might hinder the implementation of the new guideline and (c) the procedures required for further developing and improving outpatient psychotherapy. METHODS AND ANALYSIS: A mixed-methods design (quantitative, qualitative) along with a multilevel approach (patients, service providers, payers) triangulating several data sources (primary and secondary data) will be applied to evaluate the reform from different perspectives. ETHICS AND DISSEMINATION: Ethical approval was obtained from the coordinating committee as well as one local ethics committee, Justus Liebig University Giessen and Marburg - Faculty of Medicine (approval number: AZ 107/20) and Heidelberg (approval number: S-466/2020). The results of this study will be disseminated through expert panels, conference presentations and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00020344.

Evaluating the structural reform of outpatient psychotherapy in Germany (ES-RiP trial) - a qualitative study of provider perspectives.

BACKGROUND: Access to outpatient mental healthcare can be challenging for patients. In Germany, a national structural reform was implemented in 2017 to accelerate and enhance access to outpatient psychotherapy and reduce waiting times. During the first phase of the study 'Evaluation of a structural reform of the outpatient psychotherapy guideline (ES-RiP)' and embedded into a process evaluation, the implementation was to be evaluated through assessing general practitioners' (GPs) and psychotherapists' (PTs) perspectives regarding utilization of provided new measures, and perceived potential for optimization. Particular focus was on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs). METHODS: This exploratory cross-sectional qualitative study used on-site and online focus group discussions and semi-structured telephone interviews with GPs and outpatient PTs. Generated data were analyzed using thematic framework analysis. Descriptive statistics were used to analyze participant characteristics collected via a socio-demographic questionnaire. RESULTS: Perspectives on the structural reform were heterogenous. GPs and PTs considered the component of timely initial psychotherapeutic assessment consultations beneficial. GPs disapproved of their deficits in detailed information about the structural reform and exchange with outpatient PTs. Improvement suggestions included structured short information exchange and joint quality circles. The overall number of available outpatient PTs in rural areas was perceived as insufficient. For patients with cMPs, GPs saw patient barriers for therapy access and continuity in low intrinsic motivation, physical impediments and older age. PTs also saw patient challenges regarding low intrinsic motivation and keeping scheduled appointments. They considered post-reform administrative efforts to be high and reported that the regulations (conformity) lead to planning difficulties and financial losses. Reform elements were tailored to fit in with PTs key therapy areas. Stronger networking and joint lectures were suggested as remedy for the currently still limited exchange with GPs. Unlike the GPs, PTs emphasized that accepting patients into psychotherapeutic treatment was independent of a possibly present chronic physical disease. CONCLUSIONS: The findings contribute to understanding the integration of the delivered structural reform into daily care processes and provide an indication about reached targets and potential improvements. Further phases of the ES-RiP study can build on the findings and broaden insights. TRIAL REGISTRATION: Registration-ID DRKS00020344 (DRKS German Register of Clinical Trials.

Health providers' experiences with mental health specialist video consultations in primary care: a qualitative study nested within a randomised feasibility trial.

OBJECTIVE: Despite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers' experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care. METHODS: A qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data. RESULTS: Considering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients' improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier. CONCLUSIONS: MHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes). TRIAL REGISTRATION NUMBER: DRKS00015812; Results.

Associations of Childhood Neglect With the ACTH and Plasma Cortisol Stress Response in Patients With Type 2 Diabetes.

Background: Cross-sectional as well as longitudinal studies have linked childhood maltreatment to type 2 diabetes in adulthood with childhood neglect showing the strongest effect on type 2 diabetes risk. However, the mechanisms that link childhood maltreatment to type 2 diabetes are still unclear. Alterations in the psychological and physiological stress response system, specifically the hypothalamus-pituitary-adrenal (HPA) axis are a common finding in samples with a background of childhood neglect and are associated with type 2 diabetes. In the present study, we investigated the association between childhood neglect and the physiological and psychological stress response in patients with type 2 diabetes and healthy control participants. Method: We assessed emotional and physical childhood neglect in a sample of n = 74 patients with type 2 diabetes and n = 50 healthy control participants. We used the trier social stress test (TSST) to induce a stress response. Blood ACTH and cortisol levels were measured before (T0), directly after (T1) as well as 30 (T2) and 60 (T3) min after the TSST. Participants' subjective experience was assessed via visual analog scales before, directly after as well as at 45 min after the TSST. We used multiple regression analyses to predict the change in self-reported tension between T0 and T1. Multilevel models were applied to predict cortisol and ACTH levels across all measurement points. Results: We found a significant association between moderate to severe childhood neglect and a stronger psychological stress response in patients with type 2 diabetes, that was not present in healthy controls. In type 2 diabetes patients, but not in healthy controls, higher ACTH levels across all measurement points were significantly associated with higher severity of emotional neglect and higher severity of physical neglect was significantly associated with a stronger increase in plasma cortisol from T0 to T1. Conclusions: This is the first study to investigate whether childhood maltreatment in patients with type 2 diabetes could be associated with a dysregulated stress response. Our results show a link between the psychological and physiological stress response and childhood neglect in type 2 diabetes patients. This pathway is thus a possible mechanism connecting type 2 diabetes and childhood neglect.

Health policy experts' perspectives on implementing mental health specialist video consultations in routine primary care - a qualitative interview study.

BACKGROUND: Many patients with mental disorders are treated by their general practitioner (GP). Innovative technology-based integrated care models (e.g., mental health specialist video consultations) have been proposed to facilitate access to specialist services in primary care settings. While perspectives of patients and providers have been examined, there is little insight into the perspectives of health policy experts on such models. The purpose of this study was to examine the perspectives of health policy experts on (1) current challenges for continuity of care, (2) anticipated benefits and barriers for implementation of mental health specialist video consultations along with (3) practical and regulative preconditions for sustained implementation in primary care. METHODS: In a cross-sectional qualitative study, we conducted 15 semi-structured interviews with health policy experts representing various stakeholders in the German health care system: health insurances, governmental bodies, clinicians' professional associations, and patient representatives. Following a critical realism approach, we applied a qualitative inductive content analysis to derive key themes from the material. RESULTS: Health policy experts saw long waiting times for patients and a lack of collaboration between in- and outpatient mental health services as well as mental health specialists and GPs as main barriers for current continuity of care. Health policy experts also felt that video consultations bear great potential to foster coordinated care between GPs and specialists and ensure timely referral for severely burdened patients. Increased workload for the general practice staff to facilitate video consultations and difficulties in establishing reliable therapeutic alliances between patients and specialists via remote treatment were considered as major barriers. Health policy experts varied significantly in their level of knowledge concerning legal frameworks and regulations pertaining to video consultations. However, the implementation of appropriate reimbursement schemes and sufficient data protection were regarded as the major regulative challenges. CONCLUSIONS: Health policy experts mostly consider mental health specialist video consultations as a promising way to overcome current challenges for the management of patients with mental disorders at the interface between primary and specialist care. To ensure sustained implementation, a multi-stakeholder approach accounting for the perspective of health policy experts, patients, and providers should be followed. TRIAL REGISTRATION: German Clinical Trials Register DRKS00012487.

Predicting anxiety in cancer survivors presenting to primary care - A machine learning approach accounting for physical comorbidity.

BACKGROUND: The purpose of this study was to explore predictors for anxiety as the most common form of psychological distress in cancer survivors while accounting for physical comorbidity. METHODS: We conducted a secondary data analysis of a large study within the German National Cancer Plan which enrolled primary care cancer survivors diagnosed with colon, prostatic, or breast cancer. We selected candidate predictors based on a systematic MEDLINE search. Using supervised machine learning, we developed a prediction model for anxiety by splitting the data into a 70% training set and a 30% test set and further split the training set into 10-folds for cross-validating the hyperparameter tuning step during model selection. We fit six different regression models, selected the model that maximized the root mean square error (RMSE) and fit the selected model to the entire training set. Finally, we evaluated the model performance on the holdout test set. RESULTS: In total, data from 496 cancer survivors were analyzed. The LASSO model (α = 1.0) with weakly penalized model complexity (λ = 0.015) slightly outperformed all other models (RMSE = 0.370). Physical symptoms, namely, fatigue/weakness (ß = 0.18), insomnia (ß = 0.12), and pain (ß = 0.04), were the most important predictors, while the degree of physical comorbidity was negligible. CONCLUSIONS: Prediction of clinically significant anxiety in cancer survivors using readily available predictors is feasible. The findings highlight the need for considering cancer survivors' physical functioning regardless of the degree of comorbidity when assessing their psychological well-being. The generalizability of the model to other populations should be investigated in future external validations.

Aggressiveness of Care at the End-of-Life in Cancer Patients and Its Association With Psychosocial Functioning in Bereaved Caregivers.

STUDY REGISTRATION: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022837,DRKS00022837. BACKGROUND: Intensified oncological treatment for advanced cancer patients at the end-of-life has been specified as aggressiveness of care (AOC) and increased over the past decades. The aims of this study were to 1) determine the frequency of AOC in Central Europe, and 2) investigate differences in mental health outcomes in bereaved caregivers depending on whether the decedent had experienced AOC or not. MATERIALS AND METHODS: We conducted a cross-sectional study in a large tertiary comprehensive cancer care center in Germany. Bereaved caregivers provided information about (a) treatment within the last month of life of the deceased cancer patient and (b) their own mental health status, i.e., decision regret, complicated grief, depression, and anxiety. After multiple imputation of missing data, differences in mental health outcomes between AOC-caregivers and non-AOC-caregivers were analyzed in a multivariate analysis of variances. RESULTS: We enrolled 298 bereaved caregivers of deceased cancer patients. AOC occurred in 30.9% of all patients. In their last month of life, 20.0% of all patients started a new chemotherapy regimen, and 13.8% received ICU-treatment. We found differences in mental health outcomes between bereaved AOC- and non-AOC-caregivers. Bereaved AOC caregivers experienced significantly more decision regret compared to non-AOC caregivers (Cohen's d = 0.49, 95% CI [0.23, 0.76]). CONCLUSION: AOC occurs frequently in European health care and is associated with poorer mental health outcomes in bereaved caregivers. Future cohort studies should substantiate these findings and explore specific trajectories related to AOC. Notwithstanding, shared-decision making at end-of-life should increasingly account for both patients' and caregivers' preferences.

Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial).

BACKGROUND: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. METHODS: In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. DISCUSSION: To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. TRIAL REGISTRATION: ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.