A complex intervention on vaccination uptake among older adults (≥ 60 years) in Germany - a study protocol with a mixed methods design.

BACKGROUND: The current uptake of many vaccinations recommended for persons aged 60 and older is unsatisfactory in Germany. Lack of confidence in the safety and efficacy of vaccinations, lack of knowledge and insecurities about possible side effects, and numerous pragmatic barriers are just some of the reasons to be mentioned. General practitioners (GPs) play a central role in the vaccination process. Therefore, effective interventions in this context are needed to address the various barriers and improve the vaccination uptake rates. METHODS: A complex intervention will be implemented and evaluated in 1057 GPs' practices in two German federal states. The components include trainings for GPs and medical assistants on communication psychology, medical aspects, and organisational vaccination processes. The primary outcome influenza vaccination rate and the secondary outcomes vaccination uptake rate of other vaccinations as well as vaccine literacy of patients will be examined. The intervention will be evaluated in a mixed methods study with a controlled design. Survey data will be analysed descriptively and by using mean comparisons as well as multivariable multilevel analyses. The qualitative data will be analysed with qualitative content analysis. The secondary data will be analysed by using descriptive statistics, a pre-post comparison by performing mean comparisons, cluster analysis, and subgroup analyses. DISCUSSION: In this study, a complex intervention to improve vaccination rates in GP practices for the vaccinations recommended for people aged 60 years and older will be implemented and evaluated. Additionally, improvements in patients' vaccine-related health literacy and knowledge, and patients' intention to get vaccinated are expected. The mixed methods design can deliver results that can be used to improve preventive health care for elderly people and to gain more knowledge on vaccination uptake and the intervention's effectiveness. TRIAL REGISTRATION: Trial registration number: DRKS00027252 (retrospectively registered).

Promoting rational antibiotic therapy among high antibiotic prescribers in German primary care-study protocol of the ElektRA 4-arm cluster-randomized controlled trial.

BACKGROUND: The rational use of antibiotics is of great importance in health care. In primary care, acute respiratory infections are the most common cause of inappropriate antibiotic prescribing. Since existing studies aiming to optimize antibiotic use are usually based on the voluntary participation of physicians, general practitioners (GPs) with inappropriate prescribing behavior are underrepresented. For the first time in Germany, the ElektRA study will assess and compare the effects of three interventions on antibiotic prescribing rates for respiratory and urinary tract infections among high prescribers in primary care. METHOD: ElektRA is a 4-arm cluster-randomized controlled trial among German GPs in nine regional Associations of Statutory Health Insurance Physicians. On their behalf, the Central Research Institute of Ambulatory Health Care in Germany (Zi) analyses all outpatient claims and prescription data. Based on this database, high antibiotic prescribing GPs are identified and randomized into four groups: a control group (N=2000) and three intervention arms. We test social norm feedback on antibiotic prescribing (N=2000), social norm feedback plus online training on rational prescribing practice and communication strategies (N=2000), and social norm feedback plus online peer-moderated training on rational antibiotic prescribing, communication strategies, and sustainable behavior change (N=1250). The primary outcome is the overall rate of antibiotic prescriptions. Outcomes are measured before intervention (T0, October 2020-September 2022) and over a period of 15 months (T1, October 2022 to December 2023) after randomization. DISCUSSION: The aim of the study is to implement individualized, low-threshold interventions to reduce antibiotic prescribing among high prescribers in primary care. If successful, a change in behavior among otherwise difficult-to-reach high prescribers will directly improve patient care. The increase in quality of care will ideally be achieved both in terms of the quantity of antibiotics used as well as the kind of substances prescribed. Also, if effective strategies for high prescribers are identified through this study, they can be applied not only to the antibiotics addressed in this study, but also to other areas of prescription management. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95468513.

The impact of having a loved one with alcohol consumption-related problems on subjective health status and health-risk behaviors in a general hospital sample.

Consecutively admitted inpatients of a general hospital in Northern Germany (N = 2903) completed a standardized screening questionnaire in 2005-2006 containing questions about alcohol consumption-related problems in loved ones, their own alcohol consumption, and other health-related aspects. Almost 26.2% reported having a loved one with alcohol consumption-related problems. The proportions of smokers and those who screened positively for at-risk consumption or alcohol abuse were significantly higher in those patients; they were significantly younger and reported worse overall states of health and emotional health. Since those patients showed a high risk of numerous health problems, psychological interventions were implemented. The study's limitation noted.

Optimizing Antibiotic Prescribing for Acute Respiratory Tract Infection in German Primary Care: Study Protocol for Evaluation of the RESIST Program.

BACKGROUND: The emergence and increased spread of microbial resistance is a major challenge to all health care systems worldwide. In primary care, acute respiratory tract infection (ARTI) is the health condition most strongly related to antibiotic overuse. OBJECTIVE: The RESIST program aims at optimizing antibiotic prescribing for ARTI in German primary care. By completing a problem-orientated online training course, physicians are motivated and empowered to utilize patient-centered doctor-patient communication strategies, including shared decision making, in the treatment of patients with ARTI. METHODS: RESIST will be evaluated in the form of a nonrandomized controlled trial. Approximately 3000 physicians of 8 (out of 16) German federal states can participate in the program. Patient and physician data are retrieved from routine health care data. Physicians not participating in the program serve as controls, either among the 8 participating regional Associations of Statutory Health Insurance Physicians (control group 1) or among the remaining associations not participating in RESIST (control group 2). Antibiotic prescription rates before the intervention (T0: 2016, 1st and 2nd quarters of 2017) and after the intervention (T1: 3rd quarter of 2017 until 1st quarter of 2019) will be compared. The primary outcome measure is the overall antibiotic prescription rate for all patients insured with German statutory health insurance before and after provision of the online course. The secondary outcome is the antibiotic prescription rate for coded ARTI before and after the intervention. RESULTS: RESIST is publicly funded by the Innovations funds of the Federal Joint Committee in Germany and was approved in December 2016. Recruitment of physicians is now completed, and a total of 2460 physicians participated in the intervention. Data analysis started in February 2020. CONCLUSIONS: With approximately 3000 physicians participating in the program, RESIST is among the largest real-world interventions aiming at reducing inadequate antibiotic prescribing for ARTI in primary care. Long-term follow up of up to 21 months will allow for investigating the sustainability of the intervention. TRIAL REGISTRATION: ISRCTN Registry ISRCTN13934505; http://www.isrctn.com/ISRCTN13934505. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/18648.

Efficacy of the Community Reinforcement and Family Training for concerned significant others of treatment-refusing individuals with alcohol dependence: A randomized controlled trial.

BACKGROUND: The Community Reinforcement and Family Training (CRAFT) is a promising approach for Concerned Significant Others (CSOs) of alcohol-dependent individuals (ADI) that aims to engage treatment-refusing patients in alcohol treatment and to improve CSO functioning. To date, only two randomized controlled trials (RCTs) of CRAFT-based treatment for CSOs of ADI are available, both conducted in the U.S. For the first time, this study analyses the efficacy of CRAFT in a sample of CSOs outside of the U.S. METHODS: Participants were recruited through the treatment system (general practitioners, psychotherapists, addiction counselling services) and through media solicitation. After brief screening, 94CSOs were randomly allocated to an immediate intervention condition (II) or a wait list condition (WL) that received the CRAFT intervention after 3 months. Data for the follow-up assessments at 3 and 6 months was provided by 78CSOs (II N=42; WL N=36). In addition, a follow-up assessment (f-u) was conducted after 12 months (Response rate 92%). RESULTS: At 3-month f-u, II revealed significant higher ADI engagement rates (40.5%) compared to WL (13.9%); after WL received the CRAFT intervention, engagement rates did not differ between both groups at 6- and 12-month f-u. CSOs in both groups reported significant improvements in terms of mental health and family cohesion after having received the intervention, i.e. II at 3-months f-u and WL at 6-month f-u. CONCLUSIONS: Data show that CRAFT is effective for treating CSOs of alcohol dependent individuals in terms of treatment engagement and improvement of CSOs mental health and family cohesion.