Sustainable reduction of antibiotic-induced antimicrobial resistance (ARena) in German ambulatory care: study protocol of a cluster randomised trial

Background: Despite many initiatives to enhance the rational use of antibiotics, there remains substantial room for improvement. The overall aim of this study is to optimise the appropriate use of antibiotics in German ambulatory care in patients with acute non-complicated infections (respiratory tract infections, such as bronchitis, sinusitis, tonsillitis and otitis media), community-acquired pneumonia and non-complicated cystitis, in order to counter the advancing antimicrobial resistance development. Methods: A three-armed cluster randomised trial will be conducted in 14 practice networks in two German federal states (Bavaria and North Rhine-Westphalia) and an added cohort that reflects standard care. The trial is accompanied by a process evaluation. Each arm will receive a different set of implementation strategies. Arm A receives a standard set, comprising of e-learning on communication with patients and quality circles with data-based feedback for physicians, information campaigns for the public, patient information material and performance-based additional reimbursement. Arm B receives this standard set plus e-learning on communication with patients and quality circles with data-based feedback tailored for non-physician health professionals of the practice team and information material for tablet computers (culture sensitive). Arm C receives the standard set as well as a computerised decision support system and quality circles in local multidisciplinary groups. The study aims to recruit 193 practices which will provide data on 23,934 patients each year (47,867 patients in total). The outcome evaluation is based on claims data and refers to established indicators of the European Surveillance of Antimicrobial Consumption Network (ESAC-Net). Primary and secondary outcomes relate to prescribing of antibiotics, which will be analysed in multivariate regression models. The process evaluation is based on interviews with surveys among physicians, non-physician health professionals of the practice team and stakeholders. A patient survey is conducted in one of the study arms. Interview data will be qualitatively analysed using thematic framework analysis. Survey data of physicians, non-physician health professionals of the practice team and patients will use descriptive and exploratory statistics for analysis. Discussion: The ARena trial will examine the effectiveness of large scale implementation strategies and explore their delivery in routine practice. Trial registration: ISRCTN, ISRCTN58150046 . Registered 24 August 2017

Converting habits of antibiotic use for respiratory tract infections in German primary care – study protocol of the cluster-randomized controlled CHANGE-3 trial

Background: The overuse of antibiotics is a major cause for the worldwide rise of antibiotic resistance. Although it is well known that acute respiratory tract infections (ARTI) are mainly caused by viruses and are often self limiting, antibiotics are too frequently prescribed in primary care. CHANGE-3 examines whether a complex intervention focusing on improving communication and provision of prescribing feedback reduces antibiotic use in patients suffering from ARTI. Methods/design: The CHANGE-3 trial is a cluster-randomized controlled trial nested within a web-based public campaign conducted in two regions in Germany. A total of 114 medical practices will be included. Practices randomized to the intervention will receive a practice-specific antibiotic-prescription feedback and an educational outreach visit. During the visit the whole practice team will receive an introduction to e-learning modules addressing patient-centered communication on antibiotics. Furthermore, the practices will receive tablet PCs with information on antibiotics and the treatment of ARTI to be presented to patients. Practices randomized to the control will provide care as usual. The primary outcome measure is the antibiotic prescribing rate for patients with a history of ARTI. Data collected before the intervention, during the intervention and after the intervention will be compared. The use of narrow- vs. broad-spectrum antibiotics will be analyzed as a secondary outcome. A process evaluation is also part of the trial. Discussion: This study should contribute to the growing body of research on reducing antibiotic prescription. Trial registration: ISRCTN, ISRCTN15061174. Registered retrospectively on 13 July 2018

Ages and Stages: Toddler (12-24 Months) .G2104

During the second year of development, toddlers grow and develop rapidly as they learn new things and explore their world. Learn what milestones to watch for and how you can provide a safe and supportive environment for your child’s development. Children 12 to 24 months old are learning, exploring, and communicating at a rapid rate, growing from dependent infants to more independent toddlers. They may challenge the patience, sense of humor, and even common sense of a parent or caregiver. Be prepared to “baby proof” the entire home, yard, and outside environments. This stage can be fun and rewarding as you guide your toddler through simple learning experiences. Keep in mind the following general developmental milestones for the busy toddler in your life

Ages and Stages: 3-, 4- and 5-Year-Olds .G2106

Three-, four- and five-year-olds are active, imaginative, and increasingly independent. Learn about their developmental milestones and how you can help further develop their skills and confidence. Three-, four-, and five-years-olds are active, imaginative, and eager to engage in the world around them. They are building skills and becoming more confident. At this stage, children have many “why” questions. Parents and caregivers can provide the preschooler with lots of support and a responsive and stimulating environment. As you help the 3- to 5-year-old child become more imaginative and confident, here are a few developmental milestones to consider

Ages and Stages: 2- and 3-Year-Olds .G2105

Two- and three-year-olds are busy, independent, and eager to explore. Learn the milestones of this growth stage and how you can help them develop new and positive skills and abilities. The life of a two- or three-year-old is exciting, busy, and very demanding. Two-year-olds have grown to be very independent, using favorite words such as “Mine,” “No,” and “I do it!” as they strive for autonomy. When caring for a two- or three-year-old, enthusiasm, patience, and a sense of humor are most important. This is a time when just exploring can look more like trouble-making to an adult. Fair rules are important; a loving consistent firmness teaches your child the rules of your home. This is a great time to capture your child’s eagerness for learning, so rejoice in your child’s new skills, abilities, and accomplishments. Following are several developmental milestones to consider

Ages and Stages: Infant (0-12 Months) .G2103

During the first year infants develop quickly, meeting many milestones of early growth. Learn how to recognize these stages and what you can do to help support your infant’s growth and development. Being a parent or caregiver of an infant can be fun and a lot of hard work. Although caring for a baby may seem like an endless cycle of feeding, soothing, and diapering, the first year of a baby’s life is a time for rapid growth and development (Figure 1). By their first birthday, many infants are beginning to crawl and are even taking their first steps. It’s a delight to hear their cooing, babbling, and laughter as they imitate adults and learn to express themselves. Each day in the life of an infant is filled with observation, exploration, and discovery. To help encourage a responsive and stimulating environment during this first year, keep in mind the following general developmental milestones

Additional file 1: of Sustainable reduction of antibiotic-induced antimicrobial resistance (ARena) in German ambulatory care: study protocol of a cluster randomised trial

Intervention description according to TIDieR. (PDF 432 kb