GPs' Perspective on a Multimodal Intervention to Enhance Guideline-Adherence in Uncomplicated Urinary Tract Infections: A Qualitative Process Evaluation of the Multicentric RedAres Cluster-Randomised Controlled Trial.

Urinary tract infections (UTIs) are among the most common reasons patients seeking health care and antibiotics to be prescribed in primary care. However, general practitioners' (GPs) guideline adherence is low. The RedAres randomised controlled trial aims to increase guideline adherence by implementing a multimodal intervention consisting of four elements: information on current UTI guidelines (1) and regional resistance data (2); feedback regarding prescribing behaviour (3); and benchmarking compared to peers (4). The RedAres process evaluation assesses GPs' perception of the multimodal intervention and the potential for implementation into routine care. We carried out 19 semi-structured interviews with GPs (intervention arm). All interviews were carried out online and audio recorded. For transcription and analysis, Mayring's qualitative content analysis was used. Overall, GPs considered the interventions helpful for knowledge gain and confirmation when prescribing. Information material and resistance were used for patient communication and teaching purposes. Feedback was considered to enhance reflection by breaking routines of clinical workup. Implementation into routine practice could be enhanced by integrating feedback loops into patient management systems and conveying targeted information via trusted channels or institutions. The process evaluation of RedAres intervention was considered beneficial by GPs. It confirms the convenience of multimodal interventions to enhance guideline adherence.

Primary care utilisation, adherence to guideline-based pharmacotherapy and continuity of care in primary care patients with chronic diseases and multimorbidity - a cross-sectional study.

BACKGROUND: To understand how to improve care for patients with chronic diseases and multimorbidity we wanted to describe the prevalence of different chronic diseases and the pattern of multimorbidity and to analyse the associations between occurrence of diseases and primary care utilization, adherence to guideline-based pharmacotherapy, and continuity of care. METHODS: Retrospective cross-sectional study of routine care data of the general population in region Jönköping in Sweden (345 916 inhabitants using primary care services) covering 4.3 years. PARTICIPANTS: Patients fulfilling the inclusion criteria of having ≥ 1 of 10 common chronic diseases and ≥ 3 visits to primary care between 2011 and 2015. PRIMARY OUTCOME MEASURES: In order to determine diseases and multimorbidity, primary care utilisation, adherence to guideline-based pharmacotherapy, frequencies and percentages, interval and ratio scaled variables were described using means, standard deviations, and various percentiles in the population. Two continuity indices were used (MMCI, COC) to describe continuity. RESULTS: Of the general population, 25 829 patients fulfilled the inclusion criteria (7.5% of the population). Number of diseases increased with increasing age, and multimorbidity was much more common than single diseases (mean 2.0 per patient). There was a slight positive correlation (0.29) between number of diseases and visits, but visits did not increase proportionally to the number of diseases. Patients with physical diseases combined with anxiety and/or depression made more visits than others. The number of diseases per patient was negatively associated with the adherence to pharmacotherapy guidelines. There was no association between continuity and healthcare utilisation or adherence to pharmacotherapy guidelines. CONCLUSIONS: Multimorbid patients are common in primary care and for many chronic diseases it is more common to have other simultaneous diseases than having only one disease. This can make adherence to pharmacotherapy guidelines a questionable measure for aged multimorbid patients. Existing continuity indices also revealed limitations. Holistic and patient-centred measures should be used for quality assessment of care for multimorbid patients in primary care.

Effects of a multimodal intervention in primary care to reduce second line antibiotic prescriptions for urinary tract infections in women: parallel, cluster randomised, controlled trial.

OBJECTIVES: To evaluate whether a multimodal intervention in general practice reduces the proportion of second line antibiotic prescriptions and the overall proportion of antibiotic prescriptions for uncomplicated urinary tract infections in women. DESIGN: Parallel, cluster randomised, controlled trial. SETTING: General practices in five regions in Germany. Data were collected between 1 April 2021 and 31 March 2022. PARTICIPANTS: General practitioners from 128 randomly assigned practices. INTERVENTIONS: Multimodal intervention consisting of guideline recommendations for general practitioners and patients, provision of regional data for antibiotic resistance, and quarterly feedback, which included individual first line and second line proportions of antibiotic prescribing, benchmarking with regional or supra-regional practices, and telephone counselling. Participants in the control group received no information on the intervention. MAIN OUTCOME MEASURES: Primary outcome was the proportion of second line antibiotics prescribed by general practices, in relation to all antibiotics prescribed, for uncomplicated urinary tract infections after one year between the intervention and control group. General practices were randomly assigned in blocks (1:1), with a block size of four, into the intervention or control group using SAS version 9.4; randomisation was stratified by region. The secondary outcome was the prescription proportion of all antibiotics, relative within all cases (instances of UTI diagnosis), for the treatment of urinary tract infections after one year between the groups. Adverse events were assessed as exploratory outcomes. RESULTS: 110 practices with full datasets identified 10 323 cases during five quarters (ie, 15 months). The mean proportion of second line antibiotics prescribed was 0.19 (standard deviation 0.20) in the intervention group and 0.35 (0.25) in the control group after 12 months. After adjustment for preintervention proportions, the mean difference was -0.13 (95% confidence interval -0.21 to -0.06, P<0.001). The overall proportion of all antibiotic prescriptions for urinary tract infections over 12 months was 0.74 (standard deviation 0.22) in the intervention and 0.80 (0.15) in the control group with a mean difference of -0.08 (95% confidence interval -0.15 to -0.02, P<0.029). No differences were noted in the number of complications (ie, pyelonephritis, admission to hospital, or fever) between the groups. CONCLUSIONS: The multimodal intervention in general practice significantly reduced the proportion of second line antibiotics and all antibiotic prescriptions for uncomplicated urinary tract infections in women. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00020389.

Analysis of the key themes in the healthcare of older people with multimorbidity in Germany: a framework analysis as part of the LoChro trial.

OBJECTIVES: Multimorbidity challenges healthcare systems. In Germany, coordination of healthcare for older multimorbid patients remains unstructured.This study aims to identify key themes in the healthcare of these patients and the inter-relationships between them. DESIGN: Framework analysis of six cases based on 1-year data of primary and secondary care, patient-answered questionnaires and video material. SETTING: Southern Germany. PARTICIPANTS: Six multimorbid older patients participating in a randomised controlled trial that compared usual care with a local, collaborative, stepped and personalised care management approach for older people with chronic diseases (LoChro-trial). The LoChro care intervention involved a care manager who assisted participants in self-management. The primary outcome was a composite of functional health and depressive symptoms at 12 and 18 months. The LoChro-intervention had no effect on the primary outcome. PRIMARY OUTCOME MEASURE: Key themes in the healthcare of older patients with multimorbidity and the inter-relationships between them. METHODS: One-year data included diagnoses, treatment plans, examinations, assessments and discharge reports. Patient perspectives were assessed using the Patient Assessment of Chronic Illness Care. In three cases, videos of the LoChro intervention showed patients describing their health needs. These data were evaluated by three doctors and public health researchers. Using framework analysis, recurring themes influencing the healthcare situation of multimorbid older patients and their inter-relationships were identified. RESULTS: Participants had an average age of 77, with 13 diagnoses, taking eight medications regularly. The five key themes describing the healthcare situation of these multimorbid patients were as follows: insufficient coordination, overuse and underuse of medical care, doctor and patient roles. Each theme covered three to four subcategories. The most significant inter-relationships between these themes were a lack of coordination leading to overuse and underuse of medical care. These were characterised by redundant inpatient stays, potential prescribing omissions and missed examinations. Deficiencies in vaccinations and secondary prevention were also demonstrated. CONCLUSION: Coordination of care for multimorbid older patients in Germany is still deficient. Future healthcare arrangements should be explored with the participation of physicians and patients. TRIAL REGISTRATION NUMBER: LoChro trial: DRKS00013904.

[General Practitioners' Experiences with COVID-19: a Survey After the First Wave of the Pandemic in March/April 2020]. / Erfahrungen von HausärztInnen mit COVID-19 und der Pandemie ­ ein Survey nach der ersten Pandemiewelle im März/April 2020.

BACKGROUND AND OBJECTIVES: The first wave of the COVID-19 pandemic (Mar-Apr 2020) posed significant challenges for primary care. The goal of this study was to analyse the burden of the crisis situation as experienced by the general practitioners (GPs) at its beginning and over the course of the pandemic and to identify factors predictive of the sense of being overburdened. METHODS: In this cross-sectional study, a total of 6300 randomly selected GPs in four federal states of Germany were contacted per post in order to survey changes in health care they provided and their psychological burden in the context of the pandemic between August and October 2020. RESULTS: The response rate was 23%; 46% of the participants were female. At the beginning of the pandemic, 40% of the participants experienced a high or a very high level of being overburdened; later on, it was only 10%. With increasing numbers of COVID patients, the sense of being overburdened increased, as also their perceived capability to care for COVID patients. Predictors of a sense of being overburdened were, among others, a high level of psychological stress, excessive organising efforts, poor capability to care for COVID patients, and scarce supply of protective equipment. CONCLUSION: Despite a sense of being overburdened initially, GPs felt increasingly capable of caring for COVID patients. To help GPs in future crisis situations like this pandemic, organization of care should be simplified to the extent possible so that they can focus on patient care.

Encouragement of patients' self-management in primary care for the prevention of cardiovascular diseases (DECADE): protocol for a cluster randomised controlled trial.

INTRODUCTION: Cardiovascular diseases are the most common cause of death in Germany and among the most frequent reasons for encounters in primary care. Most patients with cardiovascular risks (CVRs) have difficulties implementing health-promoting behavioural changes. In this study, a complex intervention containing evidence-based patient materials and structured follow-up consultations are intended to strengthen patients' self-management to improve health behaviour. METHODS AND ANALYSIS: In this cluster randomised controlled trial, we investigate the effects of the intervention "Decision aid, action planning and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases" (DECADE) using a 2×2 design. All patients, including the control group (CG), receive a CVR calculation. Three intervention groups (IGs) receive one or both of two different components of the DECADE intervention: IG1 (patient materials), IG2 (follow-up consultations) and IG3 (patient materials and follow-up consultations). The study was planned to be conducted with 77 general practitioners in 3 German regions and a target sample size of 924 patients. The observation period for each patient amounts to 12 months with three patient surveys: baseline (t0), after 6 and 12 months (t1 and t2). The primary outcome is patient activation (Patient Activation Measure 13 (PAM13-D)) at t1. Secondary outcomes include PAM13-D at t2 and further patient-reported and clinical outcomes at t1 and t2. We will also analyse the cost-effectiveness of the intervention, the degree of usage and satisfaction with the intervention. ETHICS AND DISSEMINATION: The study was first approved by the lead ethics committee of the University of Freiburg on 15 April 2021 (vote number: 21-1078) and subsequently by the other ethics committees in the study regions (Ethics committee of medical association Baden-Württemberg (B-F-2021-078), Ethics Committee of the Technische Universität Dresden, Dresden (BO-EK-251052021), Ethics Committee of the State Chamber of Physicians of Saxony (EK-BR-92/21-1), Ethics Committee of the Hamburg Medical Association (2021-200013-BO-bet)). Informed consent is required for patients to participate in the study. The results of this study will be published in peer-reviewed journals and presented at congresses by the DECADE team. The DECADE lead management will communicate the results to the funder of this study. TRIAL REGISTRATION NUMBER: German Clinical Trials Register, DRKS00025401 (registration date: 21 June 2021); International Clinical Trials Registry Platform, DRKS00025401.

Local, collaborative, stepped, and personalized care management for older people with chronic diseases - results from the randomized controlled LoChro-trial.

BACKGROUND: In the aging population of Western societies, an increasing number of older adults have multiple chronic diseases. As multifaceted health problems imply the involvement of several healthcare professionals, multimorbid older people frequently face a fragmentation of health care. Addressing these challenges, we developed a local, collaborative, stepped, and personalized care management approach (LoChro-Care) and evaluated its effectiveness. METHODS: A two-group, parallel randomized controlled trial was conducted comparing LoChro-Care recipients (IG) to participants with usual care (CG). Patients aged 65 + with chronic conditions were recruited at inpatient and outpatient departments of the Medical Center, University of Freiburg. Participants were allocated using block randomization (nIG = 261, nCG = 263). LoChro-Care comprised individualized care provided by chronic care managers with 7 to 13 contacts over 12 months. Questionnaires were given at 3 time points (T0: baseline, T1: after 12 months, T2: after 18 months). The primary outcome was the physical, psychological, and social health status represented by a composite score of functional health and depressive symptoms. Secondary outcomes were the participants' evaluation of their health care situation, health-related quality of life (HRQL), and life-satisfaction (LS). The data were analyzed using linear mixed modelling. RESULTS: We analyzed N = 491 participants (nIG = 244, nCG = 247), aged M = 76.78 years (SD = 6.35). For the composite endpoint, neither a significant difference between IG and CG (p = .88) nor a group-time interaction (p = .52; p = .88) could be observed. Participants in both groups showed a significant decline on the primary outcome between T0 and T2 (p < .001). Post hoc analyses revealed a decline in both functional health (p < .001) and depressive symptoms (p = .02). Both groups did not differ in their evaluation of their health care situation (p = .93), HRQL (p = .44) or LS (p = .32). Relevant confounding variables were female gender and multimorbidity. CONCLUSION: Supporting patients' self-management in coordinating their individual care network through LoChro-Care did not result in any significant effect on the primary and secondary outcomes. A decline of functional health and depressive symptoms was observed among all participants. Potential future intervention adaptations are discussed, such as a more active case management through direct referral to (in-)formal support, an earlier treatment initiation, and the consideration of specific sociodemographic factors in care management planning. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013904 (02.02.2018), https://drks.de/search/de/trial/DRKS00013904.

The Acceptance, Usability, and Utility of a Web Portal for Back Pain as Recommended by Primary Care Physicians: Qualitative Interview Study With Patients.

BACKGROUND: An ever-increasing number of patients seek health information via the internet. However, there is an overabundance of differing, often low-quality information available, while a lack of health literacy makes it difficult for patients to understand and assess the quality and trustworthiness of the information at hand. The web portal tala-med was thus conceived as an evidence-based, up-to-date, and trustworthy information resource for lower back pain (LBP), which could be used by primary care physicians (PCPs) and patients during and following consultations for LBP. The current evidence demonstrates that patients with LBP could benefit from web portals. However, the use of such portals by patients remains low, thus limiting their effectiveness. Therefore, it is important to explore the factors that promote or hinder the use of web portals and investigate how patients perceive their usability and utility. OBJECTIVE: In this study, we investigated the acceptance, usability, and utility of the web portal tala-med from the patient perspective. METHODS: This qualitative study was based on telephone interviews with patients who had access to the web portal tala-med from their PCP. We used a semistructured interview guide that consisted of questions about the consultation in which patients were introduced to tala-med, in addition to questions regarding patient perceptions, experiences, and utilization of tala-med. The interviews were recorded, transcribed, and analyzed through framework analysis. RESULTS: A total of 32 half-hour interviews were conducted with 16 female and 16 male patients with LBP. We identified 5 themes of interest: the use of tala-med by PCPs during the consultation, the use of tala-med by patients, its usability, added values derived from its use, and the resultant effects of using tala-med. PCPs used tala-med as an additional information resource for their patients and recommended the exercises. The patients appreciated these exercises and were willing to use tala-med at home. We also identified factors that promoted or hindered the use of tala-med by patients. Most patients rated tala-med positively and considered it a clear, comprehensible, trustworthy, and practical resource. In particular, the trustworthiness of tala-med was seen as an advantage over other information resources. The possibilities offered by tala-med to recap and reflect on the contents of consultations in a time-flexible and independent manner was perceived as an added value to the PCP consultation. CONCLUSIONS: Tala-med was well accepted by patients and appeared to be well suited to being used as an add-on to PCP consultations. Patient perception also supports its usability and utility. Tala-med may therefore enrich consultations and assist patients who would otherwise be unable to find good-quality web-based health information on LBP. In addition, our findings support the future development of digital health platforms and their successful use as a supplement to PCP consultations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12875-019-0925-8.

Reduction of care-relevant risks to older patients during and after acute hospital care (ReduRisk) - study protocol of a cluster randomized efficacy trial in a stepped wedge design.

BACKGROUND: Older patients are at an increased risk of hospitalization, negatively affecting their health and quality of life. Such patients also experience a lack of physical activity during their inpatient stay, as well as being at increased risk of delirium and inappropriate prescribing. These risk factors can accumulate, promoting a degree of morbidity and the development of cognitive impairment. METHODS: Through the ReduRisk-program, patients at risk of functional impairment, immobility, falls, delirium or re-hospitalization shortly after hospital discharge, will be identified via risk-screening. These patients will receive an individually tailored, multicomponent and risk-adjusted prevention program. The trial will compare the effectiveness of the ReduRisk-program against usual care in a stepped-wedge-design, with quarterly cluster randomization of six university hospital departments into intervention and control groups. 612 older adults aged 70 years or more are being recruited. Patients in the intervention cluster (n = 357) will receive the ReduRisk-program, comprising risk-adjusted delirium management, structured mobility training and digitally supported planning of post-inpatient care, including polypharmacy management. This study will evaluate the impact of the ReduRisk-program on the primary outcomes of activities of daily living and mobility, and the secondary outcomes of delirium, cognition, falls, grip strength, health-related quality of life, potentially inappropriate prescribing, health care costs and re-hospitalizations. Assessments will be conducted at inpatient admission (t0), at discharge (t1) and at six months post-discharge (t2). In the six-month period following discharge, a health-economic evaluation will be carried out based on routine health insurance data (t3). DISCUSSION: Despite the importance of multicomponent, risk-specific approaches to managing older patients, guidelines on their effectiveness are lacking. This trial will seek to provide evidence for the effectiveness of a multicomponent, risk-adjusted prevention program for older patients at risk of functional impairment, immobility, falls, delirium and re-hospitalization. Positive study results would support efforts to improve multicomponent prevention and the management of older patients. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00025594, date of registration: 09/08/2021.

Fluvoxamine for the treatment of COVID-19.

BACKGROUND: Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that has been approved for the treatment of depression, obsessive-compulsive disorder, and a variety of anxiety disorders; it is available as an oral preparation. Fluvoxamine has not been approved for the treatment of infections, but has been used in the early treatment of people with mild to moderate COVID-19. As there are only a few effective therapies for people with COVID-19 in the community, a thorough understanding of the current evidence regarding the efficacy and safety of fluvoxamine as an anti-inflammatory and possible anti-viral treatment for COVID-19, based on randomised controlled trials (RCTs), is needed. OBJECTIVES: To assess the efficacy and safety of fluvoxamine in addition to standard care, compared to standard care (alone or with placebo), or any other active pharmacological comparator with proven efficacy for the treatment of COVID-19 outpatients and inpatients. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register (including Cochrane Central Register of Controlled Trials, MEDLINE, Embase, ClinicalTrials.gov, WHO ICTRP, medRxiv), Web of Science and WHO COVID-19 Global literature on COVID-19 to identify completed and ongoing studies up to 1 February 2022. SELECTION CRITERIA: We included RCTs that compared fluvoxamine in addition to standard care (also including no intervention), with standard care (alone or with placebo), or any other active pharmacological comparator with proven efficacy in clinical trials for the treatment of people with confirmed COVID-19, irrespective of disease severity, in both inpatients and outpatients. Co-interventions needed to be the same in both study arms. We excluded studies comparing fluvoxamine to other pharmacological interventions with unproven efficacy. DATA COLLECTION AND ANALYSIS: We assessed risk of bias of primary outcomes using the Cochrane Risk of Bias 2 tool for RCTs. We used GRADE to rate the certainty of evidence to treat people with asymptomatic to severe COVID-19 for the primary outcomes including mortality, clinical deterioration, clinical improvement, quality of life, serious adverse events, adverse events of any grade, and suicide or suicide attempt. MAIN RESULTS: We identified two completed studies with a total of 1649 symptomatic participants. One study was conducted in the USA (study with 152 participants, 80 and 72 participants per study arm) and the other study in Brazil (study with 1497 high-risk participants for progression to severe disease, 741 and 756 participants per study arm) among outpatients with mild COVID-19. Both studies were double-blind, placebo-controlled trials in which participants were prescribed 100 mg fluvoxamine two or three times daily for a maximum of 15 days. We identified five ongoing studies and two studies awaiting classification (due to translation issues, and due to missing published data). We found no published studies comparing fluvoxamine to other pharmacological interventions of proven efficacy. We assessed both included studies to have an overall high risk of bias. Fluvoxamine for the treatment of COVID-19 in inpatients We did not identify any completed studies of inpatients. Fluvoxamine for the treatment of COVID-19 in outpatients Fluvoxamine in addition to standard care may slightly reduce all-cause mortality at day 28 (RR 0.69, 95% CI 0.38 to 1.27; risk difference (RD) 9 per 1000; 2 studies, 1649 participants; low-certainty evidence), and may reduce clinical deterioration defined as all-cause hospital admission or death before hospital admission (RR 0.55, 95% CI 0.16 to 1.89; RD 57 per 1000; 2 studies, 1649 participants; low-certainty evidence). We are very uncertain regarding the effect of fluvoxamine on serious adverse events (RR 0.56, 95% CI 0.15 to 2.03; RD 54 per 1000; 2 studies, 1649 participants; very low-certainty evidence) or adverse events of any grade (RR 1.06, 95% CI 0.82 to 1.37; RD 7 per 1000; 2 studies, 1649 participants; very low-certainty evidence). Neither of the studies reported on symptom resolution (clinical improvement), quality of life or suicide/suicide attempt. AUTHORS' CONCLUSIONS: Based on a low-certainty evidence, fluvoxamine may slightly reduce all-cause mortality at day 28, and may reduce the risk of admission to hospital or death in outpatients with mild COVID-19. However, we are very uncertain regarding the effect of fluvoxamine on serious adverse events, or any adverse events. In accordance with the living approach of this review, we will continually update our search and include eligible trials as they arise, to complete any gaps in the evidence.

Psychometric properties of the German version of the Psychological Consequences of Screening Questionnaire (PCQ) for liver diseases.

Background: This study aimed to translate the negative and positive items of the Psychological Consequences Questionnaire (PCQ) into German, to adapt this version to the context of screening for cirrhosis and fibrosis of the liver, and to test its psychometric properties. Materials and methods: The three subscales (physical, emotional, and social) were translated into German using a forward-backward translation method. Furthermore, we adapted the wording to the context of liver diseases. In sum, the PCQ comprises twelve negative items and ten positive items. We tested the acceptability, distribution properties, internal consistency, scale structure, and the convergent validity using an analysis sample of 443 patients who were screened for cirrhosis or fibrosis of the liver. Results: We found low non-response and non-unique answer rates on the PCQ items in general. However, positive items had higher non-response rates. All items showed strong floor effects. McDonald's Omega was high for both the negative (ω = 0.95) and the positive PCQ scale (ω = 0.90), as well as for the total PCQ scale (ω = 0.86). Confirmatory factor analysis could reproduce the three dimensions that the PCQ intends to measure. However, it suggests not summing up a total PCQ score and instead treat the subscales separately considering a higher order overall construct. Convergent validity with the short form of the Spielberger State-Trait Anxiety Inventory (STAI-Y-6) was acceptable. Conclusion: Overall, our study results report a successful adaptation of the German PCQ with good performance in terms of acceptability, internal consistency, scale structure, and convergent validity. Floor-effects limit the content validity of the PCQ, which needs to be addressed in future research. However, the German version of the PCQ is a useful measurement for both negative and positive screening consequences - even in a non-cancer setting.

Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep).

INTRODUCTION: It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.

Over- and under-prescribing, and their association with functional disability in older patients at risk of further decline in Germany - a cross-sectional survey conducted as part of a randomised comparative effectiveness trial.

BACKGROUND: Older patients at risk of functional decline are frequently affected by polypharmacy. This is associated with a further loss of independence. However, a relationship between functional disability and medications, such as 'Potentially Inappropriate Medications' (PIMs) and 'Potential Prescribing Omissions' (PPOs), as itemised for (de) prescribing in practice-orientated medication lists, has yet to be established. METHODS: As part of a randomised comparative effectiveness trial, LoChro, we conducted a cross-sectional analysis of the association between PIMs and PPOs measured using the 'Screening Tool of Older Persons' Prescription Criteria / Screening Tool To Alert to Right Treatment' (STOPP/START) Version 2, with functional disability assessed using the 'World Health Organization Disability Assessment Schedule 2.0' (WHODAS). Individuals aged 65 and older at risk of loss of independence were recruited from the inpatient and outpatient departments of the local university hospital. Multiple linear regression analysis was used to model the potential prediction of functional disability using the numbers of PIMs and PPOs, adjusted for confounders including multimorbidity. RESULTS: Out of 461 patients, both the number of PIMs and the number of PPOs were significantly associated with an increase in WHODAS-score (Regression coefficients B 2.7 [95% confidence interval: 1.5-3.8] and 1.5 [95% confidence interval: 0.2-2.7], respectively). In WHODAS-score prediction modelling the contribution of the number of PIMs exceeded the one of multimorbidity (standardised coefficients beta: PIM 0.20; multimorbidity 0.13; PPO 0.10), whereas no significant association between the WHODAS-score and the number of medications was seen. 73.5 % (339) of the participants presented with at least one PIM, and 95.2% (439) with at least one PPO. The most common PIMs were proton pump inhibitors and analgesic medication, with frequent PPOs being pneumococcal and influenza vaccinations, as well as osteoporosis prophylaxis. CONCLUSIONS: The results indicate a relationship between inappropriate prescribing, both PIMs and PPOs, and functional disability, in older patients at risk of further decline. Long-term analysis may help clarify whether these patients benefit from interventions to reduce PIMs and PPOs.

An online program with individualized vs automated support for significant others of depressed individuals - study protocol of a randomized controlled trial.

BACKGROUND: Due to budget restrictions in mental health care, non-professional caregivers are increasingly burdened with the emotional and practical care for their depressed relatives. However, informal family caregiving is mostly a stressful role with negative consequences on the physical and mental health of the caretakers to the extent that they have an elevated risk of experiencing psychiatric disorders themselves. While psychoeducation for relatives of depressed individuals showed positive results both in terms of the caretakers' strain and the depressive symptoms of the affected person, there are major barriers to participate in presence in those programs. Digital programs might be a viable alternative. We found no empirically evaluated digital program available for informal caregivers of depressed patients. METHODS: An online program for relatives of depressed individuals has been developed including four interactive modules on 1) psychoeducation, 2) how to strengthen the relationship with the depressed person, 3) how to deal with the depressive symptoms of the patient, and 4) find the right balance between caring for the depressed person and self-care. We investigate if this self-help program is more effective when used with individualized versus automated e-mail support, and if both supported conditions are more effective than treatment-as-usual (TAU in form of written information material) in terms of the risk of mental diseases in caregivers. The primary outcome is the reduction of the caregiver's nonspecific mental distress as measured by the change of the Kessler Psychological Distress Scale score from baseline to four weeks after randomization. Caregivers (n = 500:500:250) will be randomized to one of the three conditions. DISCUSSION: Psychological support for caregivers of individuals with mental disorders such as depression should be offered as part of integrated services. There is a huge potential to develop and implement interactive online approaches to support informal caregivers of patients with depression to function in their multiple roles and to help them to remain healthy. TRIAL REGISTRATION: DRKS, DRKS00025241 . Registered 5 Mai 2021.

[Health Service Utilization by Homeless Persons: Analysis of the Role of Enabling Factors, Pain and Gender using the Gelberg-Andersen Model]. / Inanspruchnahme medizinischer Versorgung durch wohnungslose Menschen ­ der Einfluss von zugangsförderlichen Faktoren, Schmerzen und Gender untersucht anhand des Gelberg-Andersen-Modells.

The aim of the study was to find factors that influence health service utilization by homeless people. In a field study, a sample of 51 homeless men and 47 homeless women in the German county of Baden-Württemberg participated in face-to-face-interviews with a questionnaire designed for this study. Analyses were performed using multiple logistic regression models. Variables were organized using the Gelberg-Andersen Behavioral Model for Vulnerable Populations. Satisfied subsistence needs (OR 1.33, 95%-CI [1.03-1.72] regarding utilization of vaccinations), a stable source of primary care (OR 12.2 [1.81-82] regarding utilization of early detection examinations; quasi-complete separation regarding use of GP services) social networks (OR 2.9 [1.13-7.5] regarding utilisation of early detection examinations; OR 0.63 [0.41-0.98] regarding emergency department visits) and technological ressources (OR 2.2 [1.13-4.4] regarding use of GP services) had a positive influence on the pattern of health service utilization. Pain was correlated with more emergency department visits (OR 1.72 [1.22-2.4]) and hospitalizations (OR 1.66 [1.19-2.3]). The results showed differences between homeless men and women. The factors of influence found in this study should be addressed in the care of homeless persons. Integration of social care into the regular health care system is necessary for early detection and treatment of complex social and medical needs of vulnerable populations. This requires interprofessional approaches in medical education and training focussing on the situation of vulnerable populations and on social determinants of health.

REDuction of Antibiotic RESistance (REDARES) in urinary tract infections using treatments according to national clinical guidelines: study protocol for a pragmatic randomized controlled trial with a multimodal intervention in primary care.

BACKGROUND: Urinary tract infections (UTIs) are a common cause of prescribing antibiotics in family medicine. In Germany, about 40% of UTI-related prescriptions are second-line antibiotics, which contributes to emerging resistance rates. To achieve a change in the prescribing behaviour among family physicians (FPs), this trial aims to implement the guideline recommendations in German family medicine. METHODS/DESIGN: In a randomized controlled trial, a multimodal intervention will be developed and tested in family practices in four regions across Germany. The intervention will consist of three elements: information on guideline recommendations, information on regional resistance and feedback of prescribing behaviour for FPs on a quarterly basis. The effect of the intervention will be compared to usual practice. The primary endpoint is the absolute difference in the mean of prescribing rates of second-line antibiotics among the intervention and the control group after 12 months. To detect a 10% absolute difference in the prescribing rate after one year, with a significance level of 5% and a power of 86%, a sample size of 57 practices per group will be needed. Assuming a dropout rate of 10%, an overall number of 128 practices will be required. The accompanying process evaluation will provide information on feasibility and acceptance of the intervention. DISCUSSION: If proven effective and feasible, the components of the intervention can improve adherence to antibiotic prescribing guidelines and contribute to antimicrobial stewardship in ambulatory care.  Trial registration DRKS, DRKS00020389, Registered 30 January 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020389 .

The information needs of internet users and their requirements for online health information-A scoping review of qualitative and quantitative studies.

OBJECTIVE: This scoping review has been conducted to summarise the information needs of internet users and their requirements for online health information. METHODS: We searched MEDLINE, Web of Science and Scopus up to July 2019. Qualitative, quantitative and mixed-method studies were included and a thematic synthesis with category formation and exact description of the items was carried out. RESULTS: 118 studies were included. To address all users' needs mentioned in the included studies, we grouped them into nine main categories: authority, comprehension, currency, evidence-based information, exchange with others, independence, purpose, services, user experience. The evaluation showed that website users wanted qualifications of authors to be cited. Users preferred health information that offered interactive elements and resources for relatives, whilst also providing an opportunity for online contact with others. The ease with which information was accessed and the intelligibility of texts were regarded as being very important to users. CONCLUSION: Given the rapid evolvement and changes of online health information, it is crucial to provide up to date insights and a comprehensive overview of the range of criteria. PRACTICE IMPLICATIONS: With the results obtained through this scoping review, the creators of online health information could be assisted in providing user-specific resources.

[Integrated care management for older people with chronic diseases in domesticity: evidence from Cochrane reviews]. / Integriertes Versorgungsmanagement für chronisch erkrankte ältere Menschen in der eigenen Häuslichkeit: Evidenz aus Cochrane-Reviews.

BACKGROUND: The number of multiple chronically ill older people is increasing and multimorbidity is associated with high utilization of health services. Integrated care management is increasingly used to address this problem; however, there is a substantial lack of reliable data on its effectiveness in this target group. OBJECTIVE: To assess the effectiveness of components of integrated care management in adults of all ages and to estimate the transferability to older, multimorbid people in Germany. METHODS: A systematic search was carried out in the Cochrane Library for Cochrane reviews (CR) on (a) the 13 most frequent health problems in old age, which (b) evaluated components of integrated care management in (c) adults of all ages. Experts assessed the transferability of the included CR to multiple chronically ill older people in Germany. RESULTS: Out of 1412 hits 126 CR were included. Regarding independence and functional health outcomes, 25 CR showed clinically relevant results with at least a moderate level of evidence. The following intervention components were estimated to be transferable and could be adapted to be part of an effective integrated care management for multimorbid chronically ill older people, specified by indications and taking identified barriers into account: (1) physical activation, (2) multidisciplinary interventions (3) interventions that enhance self-management, (4) cognitive therapy modalities, (5) telemedical interventions and (6) disease management programs. CONCLUSION: The effectiveness of the identified components in frail older patients should be assessed in care-related and patient-related randomized controlled studies.