Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease­a Randomized Controlled Trial.

BACKGROUND: Supervised exercise programs are commonly used to treat intermittent claudication (IC). Home-based exercise programs have been developed to lower barriers to participation. We studied the effects of one such program (TeGeCoach) on self-reported walking ability in patients with IC. METHODS: In a pragmatic, multicenter, randomized and controlled trial (registration number NCT03496948), 1982 patients with symptomatic IC, insured by one of three German statutory health-insurance carriers, received either telephone health coaching with remote exercise monitoring (TeGeCoach; n = 994) or routine care (n = 988). The primary outcome was the change in Walking Impairment Questionnaire (WIQ) scores 12 and 24 months after the start of the intervention (intention-to-treat analysis). The secondary outcomes were health-related quality of life, symptoms of depression or anxiety, health competence, patient activation, alcohol use, and nicotine dependence. RESULTS: There was a significant difference between arms in favor of TeGeCoach in the WIQ (p<0.0001). Patients in the TeGeCoach arm had WIQ scores that were 6.30 points higher at 12 months (Bonferroni-corrected 95% CI [4.02; 8.59], Cohen's d = 0.26) and 4.55 points higher at 24 months ([2.20; 6.91], d = 0.19). They also fared better in some of the secondary outcomes at 12 months, including physical health-related quality of life and patient activation, with at least small effect sizes (d > 0.20). The average daily step count was no higher in the TeGeCoach group. CONCLUSION: The observed reductions of symptom burden indicate the benefit of home-based exercise programs in the treatment of intermittent claudication. Such programs expand the opportunities for the guideline-oriented treatment of IC. Future studies should address the effect of home-based exercise programs on clinical variables, e.g., the 6-minute walk test.

The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial.

BACKGROUND: Peripheral artery disease (PAD) is the third most prevalent atherosclerotic cardiovascular disease. In 2016, costs per patient associated with PAD exceeded even the health-economic burden of coronary heart disease. Although affecting over 200 million people worldwide, a clear consensus on the most beneficial components to be included in home-based exercise programs for patients with peripheral artery disease is lacking. The aim of the study was to examine the health care use and costs caused by the 12-month patient-centered 'Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease' (TeGeCoach) program in a randomized controlled trial. METHODS: This is a two-arm, parallel-group, open-label, pragmatic, randomized, controlled clinical trial (TeGeCoach) at three German statutory health insurance funds with follow-up assessments after 12 and 24-months. Study outcomes were medication use (daily defined doses), days in hospital, sick pay days and health care costs, from the health insurers' perspective. Claims data from the participating health insurers were used for analyses. The main analytic approach was an intention-to-treat (ITT) analysis. Other approaches (modified ITT, per protocol, and as treated) were executed additionally as sensitivity analysis. Random-effects regression models were calculated to determine difference-in-difference (DD) estimators for the first- and the second year of follow-up. Additionally, existing differences at baseline between both groups were treated with entropy balancing to check for the stability of the calculated estimators. RESULTS: One thousand six hundred eighty-five patients (Intervention group (IG) = 806; Control group (CG) = 879) were finally included in ITT analyses. The analyses showed non-significant effects of the intervention on savings (first year: - 352€; second year: - 215€). Sensitivity analyses confirmed primary results and showed even larger savings. CONCLUSION: Based on health insurance claims data, a significant reduction due to the home-based TeGeCoach program could not be found for health care use and costs in patients with PAD. Nevertheless, in all sensitivity analysis a tendency became apparent for a non-significant cost reducing effect. TRIAL REGISTRATION: NCT03496948 (www. CLINICALTRIALS: gov), initial release on 23 March 2018.

[Identification of Information Needs for Prevention of the Problematic Use of Benzodiazepines and Z-Drugs - A Focus Group Study]. / Identifikation von Informationsbedürfnissen zur Prävention des problematischen Konsums von Z-Substanzen und Benzodiazepinen ­ eine Fokusgruppenstudie.

OBJECTIVE: In order to develop demand-driven health information about z-drugs and benzodiazepines, we aimed to identify information needs of people at risk of dependency. METHODS: We conducted three focus groups with different target groups: Younger people with sleep disorders (N=7), middle-aged women with occasional/regular intake of z-drugs or benzodiazepines (N=6) and older people with regular drug intake. RESULTS: The information needs primarily refer to the areas "sleep disorders" (esp. alternative treatment options), "z-drugs and benzodiazepines" (esp. risks of intake) and "offers of assistance" (esp. contact points). CONCLUSION: The thematic overlaps indicate that all affected groups can profit from general information about sleep disorders, different treatment options and risks. Additionally, information services should also focus on guidance and referral in the help system.

The psychosocial situation of families caring for children with rare diseases during the COVID-19 pandemic: results of a cross-sectional online survey.

BACKGROUND: The COVID-19 pandemic is affecting many areas of life and has posed additional strains on the highly vulnerable group of caregivers of children with rare diseases (RDs). The psychosocial situation of the family caregivers deserves more attention, both in research and practice. The current study explores the distress level of caregivers of children with RDs, their psychosocial information needs, and caregiver-reported health-related quality of life (HRQoL) of children with RDs in times of the COVID-19 pandemic. METHODS: Data from a cross-sectional online survey conducted within the German CARE-FAM-NET project (children affected by rare diseases and their families-network) between March and August 2020 were examined. The study sample included 149 family caregivers, mostly mothers (83.2%) of 167 children with RDs. The survey assessed demographic and disease-related characteristics, distress and everyday problems of caregivers (Distress Thermometer for Parents; scale 0-10), psychosocial information needs (self-developed items; scale 0-100), and caregiver-reported HRQoL of the children with RDs (DISABKIDS Chronic Generic Measure, short-form; scale 0-100). Using descriptive statistics, we analyzed the psychosocial situation of families during the COVID-19 pandemic. We further conducted correlation analysis to investigate interrelations. RESULTS: The distress level among caregivers was high (M = 6.84, SD = 2.43); 89.6% reported clinical distress (≥ 4). Everyday problems (e.g., sleep problems, fatigue, being out of shape, fears, feeling tense or nervous, and worry) were frequent. Caregivers reported a wide range of psychosocial information needs. In about half of the children (49.5%), caregiver-reported HRQoL was low, while average HRQoL (M = 58.7, SD = 19.5) was comparable to parent-reported norm data of children with severe clinical conditions. Distress correlated positively with psychosocial information needs (r = 0.40), and negatively with the caregiver-reported HRQoL of the children (r = - 0.46). CONCLUSIONS: This study indicates a high psychosocial burden on family caregivers of children with RDs during the early COVID-19 pandemic, characterized by high distress levels and wide-ranging everyday problems, unmet psychosocial information needs, and reduced caregiver-reported HRQoL in children with RDs. The findings highlight the ongoing need for target group-specific, low-threshold support services (e.g., websites) during and after the pandemic.

[Efficiency-Focussed Assessment of Internet-Based Interventions: a Study Protocol]. / Wirksamkeitsfokussierte Bewertung von internetbasierten Interventionen: ein Studienprotokoll.

BACKGROUND: The availability of internet-based interventions for the treatment of mental disorder is steadily growing and is also included in the German health care system. However, there is still room for improvement in terms of the information available to users and practitioners, particularly with regard to the effectiveness of internet-based interventions. OBJECTIVES: To identify and evaluate internet-based interventions for the treatment of mental disorder, listed in the DiGA-Verzeichnis. A user-friendly description of positively evaluated interventions will be made available for interested people at psychenet.de. METHODS: By means of predefined criteria for intervention identification, evaluation and subsequent publication on psychenet.de, a methodological sound and transparent procedure will be established and put into practice. ETHICS AND DISSEMINATION: Ethics approval is not required for this study, as research on secondary data was conducted. Relevant professional, stakeholder and patient associations will be informed about the information offered at psychenet.de.

Effects of walking impairment on mental health burden, health risk behavior and quality of life in patients with intermittent claudication: A cross-sectional path analysis.

INTRODUCTION: Intermittent claudication is the leading symptom of peripheral artery disease (leg pain when walking). The present study investigates the extent to which walking impairment is associated with health-related quality of life, mental health and health risk behavior. METHODS: A theory-based, cross-sectional path model was empirically examined using pre-intervention baseline data from a multicenter, randomized-controlled trial of patients with intermittent claudication (PAD-TeGeCoach). Data were available from 1 696 patients who completed a battery of questionnaires between April 14, 2018 and March 12, 2019, including measures of walking impairment (Walking Impairment Questionnaire), health-related quality of life (SF-12), mental burden (GAD-7, PHQ-9), nicotine- and alcohol-related risk behavior (Fagerström-Test, AUDIT-C). Sociodemographic characteristics and comorbid conditions were included in the postulated model a priori to minimize confounding effects. RESULTS: Walking impairment was associated with an increase in depressive (ß = -.36, p < .001) and anxiety symptoms (ß = -.24, p < .001). The prevalence of depressive and anxiety symptoms was 48.3% and 35.5%, respectively, with female patients and those of younger age being at greater risk. Depressive symptoms were predictive of an increased tobacco use (ß = .21; p < .001). Walking impairment had adverse effects on physical quality of life, both directly (ß = .60, p < .001) and indirectly mediated through depressive symptoms (ß = -.16, p < .001); and indirectly on mental quality of life mediated through depressive (ß = -.43, p < .001) and anxiety symptoms (ß = -.35, p < .001). DISCUSSION: The findings underscore the need for a comprehensive treatment strategy in patients with intermittent claudication. Measures to improve walking impairment (e.g. exercise training) are key to enhance quality of life and should be the primary treatment. As a key mediator of mental quality of life, depressive and anxiety symptoms should be addressed by rigorously including mental health treatment. Risky health behaviors should be approached by promoting behavior change (e.g. smoking cessation) as a secondary prevention of peripheral artery disease.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

[Acceptance and Use of the e-Mental Health Website - www.psychenet.de]. / Akzeptanz und Nutzung einer Website mit Gesundheitsinformationen zu psychischen Erkrankungen ­ www.psychenet.de.

OBJECTIVES: Aim of our study was to investigate acceptance and use of the German e-mental health website - www.psychenet.de offering evidence-based health information, self-tests and patient decision aids concerning mental disorders and issues. METHODS: The website was evaluated by means of an online survey (acceptance) and automatically generated data by web analysis software (use). RESULTS: Overall, the website psychenet.de achieved high acceptance ratings among its users. In addition, the number of visitors to the website has increased steadily. CONCLUSION: Results indicate that psychenet.de offers mental health information that are more likely to be used by certain groups (e. g., highly educated persons). Future research should focus on different presentation modes of health information (e. g. text- vs. video-based) for hard to reach target groups in order to potentially increase reach of health information to a broader audience.

Patient-centeredness in the multimorbid elderly: a focus group study.

BACKGROUND: Patient-centeredness (PC) aims to adapt health care to the individual needs and preferences of patients. An existing integrative model of PC comprises several dimensions of PC which have not yet been investigated from the patients' perspective. Older patients with multimorbidity represent a target group for patient-centered care, as their care needs are particularly complex and should be addressed individually. We aimed to assess the perspective that older patients with multimorbidity have of patient-centered care and to examine the transferability of the integrative model of PC to this specific population. METHOD: We performed 4 guided focus group interviews with a total of 20 older individuals with multimorbidity. The focus group interviews were audio-recorded and transcribed verbatim. Patients' statements were content-analyzed applying an a priori designed system of categories that included the dimensions of PC from the integrative model and the additional category 'prognosis and life expectancy', which had emerged from an initial literature search on aspects of PC specific to the multimorbid elderly. RESULTS: The new category 'prognosis and life expectancy' was confirmed and expanded to 'individual care needs related to aging and chronic disesase'. All dimensions of our integrative PC model were confirmed for older patients with multimorbidity. Among these, we found that eight dimensions (individual care needs related to aging and chronic disease, biopsychosocial perspective, clinician-patient communication, essential characteristics of the clinician, clinician-patient-relationship, involvement of family and friends, coordination and continuity of care, access to care) were complemented by aspects specific to this target population. CONCLUSIONS: The integrative PC model is applicable to the population of older patients with multimorbidity. For a population-specific adaptation, it might be complemented by the dimension 'individual care needs in aging and chronic disease', in conjunction with age-specific aspects within existing dimensions. Together with corresponding results from a Delphi survey, our adapted PC model will serve as the basis for a subsequent systematic review of instruments measuring PC in older patients with multimorbidity. TRIAL REGISTRATION: PROSPERO ( https://www.crd.york.ac.uk/prospero; CRD42018084057; 2018/02/01), German Clinical Trials Register ( www.drks.de ; DRKS00013309; 2018/01/23).

Measuring walking impairment in patients with intermittent claudication: psychometric properties of the Walking Estimated-Limitation Calculated by History (WELCH) questionnaire.

OBJECTIVES: Patient-reported outcome measures can facilitate the assessment of walking impairment in peripheral artery disease patients with intermittent claudication in clinical trials and practice. The aim of this study was to test the psychometric properties of the German version of the 'Walking Estimated-Limitation Calculated by History' (WELCH) questionnaire. METHODS: The assessed properties included feasibility, test-retest reliability, construct validity (i.e., convergent, divergent and known-groups validity) and responsiveness using classic psychometric methods. Psychometric properties were tested as part of a randomized controlled home-based exercise trial for patients with symptomatic peripheral artery disease at Fontaine stage IIA/B. RESULTS: Analyses were conducted in subgroups of 1,696 patients at baseline and 1,233 patients at 12-month follow-up (i.e., post-intervention) who completed the WELCH along with a battery of other self-report measures. The WELCH did not exhibit relevant floor or ceiling effects (< 15% achieved lowest or highest possible scores), showed evidence for good test-retest reliability (ICC = .81, 95% CI [.71-.88]) and was found to be well suited for self-completion by patients (< 5% missing data per item). WELCH scores showed moderate to strong correlations with related measures of walking impairment at both time points (Walking Impairment Questionnaire: r = .56 - .74; VascuQoL-25 activity subscale: r = .61 - .66) and distinguished well among patients with poor and high quality of life when adjusting for confounders (t = 13.67, p < .001, d = .96). Adequate divergent validity was indicated by a weaker correlation between the WELCH and general anxiety at both time points (GAD-7: r =  - .14 to  - .22). The WELCH improved by 6.61 points (SD = 17.04, 95% CI [5.13-8.10], d = 0.39) in response to exercise treatment and was able to identify large clinically important improvements observed on the walking distance (AUC = .78, 95% CI [.71-.84]) and speed subscales (AUC = .77, 95% CI [.68-.86]) of the Walking Impairment Questionnaire. CONCLUSIONS: The WELCH is considered a feasible, reliable and valid patient-reported outcome measure for the measurement of walking impairment in patients with peripheral artery disease. The WELCH showed evidence for responsiveness to changes in walking impairment, yet further studies are warranted to conclusively determine the WELCH's ability to detect intervention effects.

Patient-Centeredness in Older Adults With Multimorbidity: Results of an Online Expert Delphi Study.

BACKGROUND AND OBJECTIVES: Older adults suffering from multimorbidity represent a priority target group for patient-centeredness (PC). We aimed to investigate the transferability of an existing integrated model of PC comprising 15 dimensions on the care of older adults with multimorbidity from an expert perspective. RESEARCH DESIGN AND METHODS: A total of 242 experts were invited to participate in a 2-round online Delphi study. In round 1, they were asked to (a) individually rate relevance and clarity of the dimensions, (b) add missing dimensions, and (c) prioritize the dimensions. In round 2, experts received results of round 1 and were asked to rerate their ratings. RESULTS: Forty-eight experts participated in round 1 and 39 in round 2. Ten dimensions were rated as sufficiently relevant and clear, including one new dimension ("prognosis and life expectancy, burden of treatment"). Four dimensions were rated as relevant but insufficiently clear. One dimension failed to reach our validation threshold on both criteria. The 5 dimensions rated as most important were: "patient as a unique person," "clinician-patient communication," "patient involvement in care," "physical, cognitive, and emotional support," and "involvement of family and friends." DISCUSSION AND IMPLICATIONS: The experts' ratings were higher regarding relevance than regarding clarity, which emphasizes the still existing conceptual uncertainty of PC. Our results give further directions regarding the operationalization of PC in older adults with multimorbidity, which is essential for its implementation in routine care. Further refined using focus groups with geriatric patients, our adapted model serves as a basis for a systematic review of assessment instruments.

Engagement With a Web-Based Intervention to Reduce Harmful Drinking: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Engagement with digital behavior change interventions (DBCIs) is considered a prerequisite for intervention efficacy. However, in many trials on DBCIs, participants use the intervention either only little or not at all. OBJECTIVE: To analyze engagement with a web-based intervention to reduce harmful drinking, we explored (1) whether engagement with a web-based alcohol intervention is related to drinking outcomes, (2) which user characteristics are associated with measures of engagement, and (3) whether reported outcomes are associated with data captured by voluntary intervention questionnaires. METHODS: We analyzed data of the intervention arm of a randomized controlled trial on a DBCI to reduce risky alcohol consumption. Data were collected at baseline (T0), after 90 days (T1), and at the end of the 180-day usage period (T2). Engagement with the intervention was measured via system usage data as well as self-reported usage. Drinking behavior was measured as average daily alcohol consumption as well as the number of binge drinking days. User characteristics included demographics, baseline drinking behavior, readiness to change, alcohol-related outcome expectancies, and alcohol abstinence self-efficacy. Following a bivariate approach, we performed two-tailed Welch's t tests and Wilcoxon signed rank/Mann-Whitney U tests or calculated correlation coefficients. RESULTS: The data of 306 users were analyzed. Time spent engaging with the intervention as measured by system usage did not match self-reported usage. Higher self-reported usage was associated with higher reductions in average daily alcohol consumption (T1: ρ=0.39, P<.001; T2: ρ=0.29, P=.015) and in binge drinking days (T1: ρ=0.62, P<.001; T2: ρ=0.3, P=.006). Higher usage was reported from users who were single (T1: P<.001; T2: P<.001), users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1: P=.001; T2: P=.004). Relationships between self-reported usage and clinical or psychological baseline characteristics were complex. For system usage, the findings were mixed. Reductions in drinking captured by intervention questionnaires were associated with reported outcomes. CONCLUSIONS: Though self-reported usage could be consistently linked to better outcomes and multiple user characteristics, our findings add to the overall inconclusive evidence that can be found throughout the literature. Our findings indicate potential benefits of self-reports as measures of engagement and intervention questionnaires as a basis for tailoring of intervention content. Future studies should adopt a theory-driven approach to engagement research utilizing psychometrically sound self-report questionnaires and include short ecological momentary assessments within the DBCIs. TRIAL REGISTRATION: German Clinical Trials Register DRKS00006104; https://tinyurl.com/y22oc5jo.

Effects of telephone-based health coaching on patient-reported outcomes and health behavior change: A randomized controlled trial.

OBJECTIVE: Telephone based health coaching (TBHC) seems to be a promising approach to foster self-management in patients with chronic conditions. The aim of this study was to evaluate the effectiveness of a TBHC on patient-reported outcomes and health behavior for people living with chronic conditions in Germany. METHODS: Patients insured at a statutory health insurance were randomized to an intervention group (IG; TBHC) and a control group (CG; usual care), using a stratified random allocation before giving informed consent (Zelen's single-consent design). The TBHC was based on motivational interviewing, goal setting, and shared decision-making and carried out by trained nurses. All outcomes were assessed yearly for three years. We used mixed effects models utilizing all available data in a modified intention-to-treat sample for the main analysis. Participants and study centers were included as random effects. All models were adjusted for age, education and campaign affiliation. RESULTS: Of the 10,815 invited patients, 4,283 returned their questionnaires at baseline. The mean age was 67.23 years (SD = 9.3); 55.5% were female. According to the model, TBHC was statistically significant superior to CG regarding 6 of 19 outcomes: physical activity in hours per week (p = .030) and in metabolic rate per week (p = .048), BMI (p = .009) (although mainly at baseline), measuring blood pressure (p< .001), patient activation (p< .001), and health literacy (p< .001). Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive. Within-group contrasts indicating changes from baseline to follow-ups and significant between-group comparisons regarding these changes supported the findings. Standardized effect sizes were small. TBHC did not show any effect on mental QoL, health status, alcohol, smoking, adherence, measuring blood sugar, foot monitoring, anxiety, depression and distress. Campaign-specific subgroup effects were detected for 'foot monitoring by a physician' and 'blood sugar measurement'. CONCLUSION: TBHC interventions might have small effects on some patient reported and behavioral outcomes. PRACTICE IMPLICATIONS: Future research should focus on analyzing which intervention components are effective and who profits most from TBHC interventions. REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS): DRKS00000584.

Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

INTRODUCTION: Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD. METHODS AND ANALYSIS: The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.

Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER).

INTRODUCTION: Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care. METHODS AND ANALYSIS: The trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions. ETHICS AND DISSEMINATION: Ethical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications. TRIAL REGISTRATION NUMBER AND REGISTRY NAME: ClinicalTrials.gov (NCT03459664), RECOVER PROTOCOL VERSION: 19 March 2020 (V.3.0).

Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.

INTRODUCTION: Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual. METHODS AND ANALYSIS: In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare. TRIAL REGISTRATION NUMBER: NCT03226743.

Development and evaluation of e-mental health interventions to reduce stigmatization of suicidality - a study protocol.

BACKGROUND: Worldwide, approximately 800,000 persons die by suicide every year; with rates of suicide attempts estimated to be much higher. Suicidal persons often suffer from a mental disorder but stigma, lack of available and suitable support, and insufficient information on mental health limit help seeking. The use of internet-based applications can help individuals inform themselves about mental disorders, assess the extent of their own concerns, find local treatment options, and prepare for contact with health care professionals. This project aims to develop and evaluate e-mental health interventions to improve knowledge about suicidality and to reduce stigmatization of those affected. In developing these interventions, a representative telephone survey was conducted to detect knowledge gaps and stigmatizing attitudes in the general population. METHODS: First, a national representative telephone survey with N = 2000 participants in Germany was conducted. Second, e-mental health interventions are developed to address knowledge gaps and public stigma detected in the survey. These comprise an evidence-based health information package about suicidality, information on regional support services, a self-administered depression test-including suicidality-and an interactive online intervention including personal stories. The development is based on a trialogical exchange of experience between persons affected by suicidality, relatives of affected persons, and clinical experts. Australian researchers who developed an e-mental health intervention for individuals affected by rural suicide were invited to a workshop in order to contribute their knowledge and expertise. Third, the online intervention will be evaluated by a mixed methods design. DISCUSSION: From representative telephone survey data, content can be developed to address specific attitudes and knowledge via the e-mental health interventions. These interventions will be easily accessed and provide an opportunity to reach people who tend not to seek professional services, prefer to inform themselves in advance and/or wish to remain anonymous. Evaluation of the online intervention will provide information on any changes in participants' self-stigma and perceived-stigma of suicidality, and any increase in participants' knowledge on suicidality or self-efficacy expectations. TRIAL REGISTRATION: German Clinical Trial Register DRKS00015071 on August 6, 2018.

Long-term use of benzodiazepines and Z drugs: a qualitative study of patients' and healthcare professionals' perceptions and possible levers for change.

BACKGROUND: Although long-term use of benzodiazepines (BZDs) and Z drugs is associated with various side effects, they remain popular among the older population. Possible reasons for this phenomenon could be ineffective ways of transmitting information on the health risks associated with long-term use, and communication gaps between patients and healthcare professionals. AIM: The aim was to investigate the views of patients, physicians, nurses, and pharmacists regarding long-term BZD and Z drug use. DESIGN & SETTING: The qualitative study design used focus group interviews with physicians, pharmacists, and nurses in Hamburg. Patient interviews were conducted in Lippstadt, Germany. METHOD: The interviews were audiotaped with each participant's permission, transcribed, and thematically analysed using a software program for qualitative research (MAXQDA). RESULTS: The data from the four focus groups consisting of 28 participants were analysed. Patients indicated lack of knowledge about risks and side effects, difficult access to alternatives, and fears of ceasing drug use without professional support. Although the physicians were reported to be cautious about prescribing BZDs and Z drugs, the psychosocial problems of older patients are often considered to be complex and treatment knowledge, experience, and resources are frequently unsatisfactory. Nurses described that when BZDs were prescribed, they did not feel it was their responsibility to evaluate their effects. Pharmacists were reported to be strongly ambivalent in informing patients about the risks, which may contradict the prescription advice provided by the physician. CONCLUSION: Patients, physicians, nurses, and pharmacists reported differences in the perception of long-term BZD and Z drug use. Nevertheless, all of the participants described lack of information and expressed the need for greater communication exchange.

The Effectiveness of an Internet Intervention Aimed at Reducing Alcohol Consumption in Adults.

BACKGROUND: In 2012, approximately 3.38 million people in Germany had an alcoholrelated disorder. Internet interventions can help lower alcohol consumption, albeit with mostly small effect sizes. It is still unclear whether the effectiveness of programs aimed at lowering alcohol consumption can be improved by individually adjusting program content for each participant. We studied the effectiveness of Vorvida, a new cognitive-behavioral internet intervention with individual adjustment of content. METHODS: A randomized controlled trial was conducted on 608 adults with problematic alcohol consumption. The primary outcome was self-reported alcohol con - sumption in the past 30 days (as determined by the Quantity-Frequency-Index, QFI) and in the past 7 days (using the Timeline Follow-Back method, TFB). The secondary outcomes were drinking behavior (binge drinking/drunkenness) and satisfaction with Vorvida. Data were collected at three time points: at baseline (t0) and three and six months later (t1, t2). Trial registration: DRKS00006104. RESULTS: The intention-to-treat (ITT) analysis revealed significant differences between groups at time t1 with respect to alcohol consumption (QFI: d = 0.28; TFB: d = 0.42), binge drinking (d = 0.87), and drunkenness (d = 0.39). Satisfaction with the intervention was high (27.4 [standard deviation, SD: 5.3] out of 32 points). All effects persisted, or were stronger, at time t2. Alcohol consumption, as measured by the QFI, declined over the interval from t0 to t2 in both groups: from 63.69 g/day (SD: 61.4) to 32.67 g/day (SD: 39.78) in the intervention group, and from 61.64 g/day (SD: 58.84) to 43.75 g/day (SD: 43.68) in the control group. CONCLUSION: Vorvida was found to be effective in persons with risky, problematic alcohol consumption. Further studies should determine which elements of the program contribute most to effectiveness in routine clinical practice, and what long-term effects can be achieved.

Rationale and design of a systematic review: effectiveness and acceptance of technology-based psychological interventions in different clinical phases of depression management.

INTRODUCTION: Although many effective treatment options exist, depression is still undertreated indicating gaps in the healthcare system. The complementary provision of mental healthcare through technologies (eg, computer, smartphone) has the potential to fill treatment gaps and to overcome access barriers to mental healthcare. Until now, no systematic review integrates the evidence on different technology-based psychological interventions (TBIs) concerning their effectiveness and acceptance in different clinical phases of depression management (bridging waiting periods, acute treatment and aftercare). The aim of this project is to structure evidence on TBIs regarding different phases of depression management, and to determine effectiveness and acceptance for each clinical phase considering both active (eg, face-to-face treatment) and inactive (eg, waitlist) controls as comparators. METHODS AND ANALYSIS: We will include studies on adults with a formal diagnosis of unipolar depression. Treatments delivered by technologies based on scientific psychological theories will be considered as experimental interventions. The primary effectiveness outcome will be depressive symptoms at study endpoint measured by symptom severity rating scales, and the primary acceptance outcome will be dropping out of the study due to any reason. We will consider only randomised controlled trials, which will be identified by key database searches (including Cochrane Central Register of Controlled Trials, Medline, PsycINFO, PSYNDEX, CINAHL) complemented through searches in clinical trial registries (eg, clinicaltrials.gov) and grey literature searches (eg, Open Grey). Two review authors will independently conduct study selection, data extraction and quality assessment of included studies (using the Cochrane Collaboration's tool for assessing risk of bias). Meta-analyses applying random-effect models as well as subgroup, meta-regression and sensitivity analyses will be performed. ETHICS AND DISSEMINATION: Ethics approval is not required for this study, as we conduct research on secondary data. We will disseminate results via peer-reviewed journal publications, presentations on conferences and via plain language summaries. PROSPERO REGISTRATION NUMBER: CRD42016050413; Pre-results.