Plain English Summary
Background and study aims
Despite the fact that general practitioners (GPs) and pediatricians know that antibiotics are not indicated for patients suffering from cough, sore throat, earache, or common cold, in primary care antibiotics are too often prescribed for patients with symptoms of acute respiratory infections. There are two reasons for that. First of all doctors perceive that their patients desire antibiotics. Secondly, doctors worry that their patients might develop complications that need be treated with antibiotics anyway. This study will test two procedures to help GPs and pediatricians to optimize prescribing of antibiotics.
Who can participate?
This study will include more than 90 GPs and 90 pediatricians in two German regions. Patients visiting those physicians for an episode of acute respiratory tract infection are asked to agree that data of their symptoms, medication and course of disease may be recorded and scientifically analyzed. More than 30,000 patients who visit their GP or pediatrician with cough, sore throat, earache, or common cold are expected to be followed up.
What does the study involve?
During three successive winter periods patients who visit their GP or pediatrician for acute respiratory infection and who are insured with the German statutory health insurance company AOK are included. Doctors will be allocated by random to one of three groups: (1) an intervention that includes communication training, (2) an intervention that combines communication training with training in using point-of-care tests which may help them to rule out a severe infection, or (3) to a control group with care as usual. Antibiotic prescription rates among all three groups will be compared. Data on reconsultation rates, complications and hospital admissions will also be analyzed.
What are the possible benefits and risks of participation?
Patients of both groups will benefit from their doctor's increased awareness of unnecessary antibiotic prescriptions. In the best case, patients benefit from decreasing rates of inappropriate antibiotic usage. To control for any negative effect of the interventions a study monitor team will check for complications and hospital admissions. An unexpected but theoretically possible increase of complications due to reduced antibiotic prescriptions can lead to a stop of the study.
Where is the study run from?
Universities of Rostock and Freiburg (Germany).
When is the study starting and how long is it expected to run for?
The recruitment of GPs and pediatricians will start in October 2012. Patients will be recruited over three successive winter periods. The whole study will last 3 years.
Who is funding the study?
German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]).
Who is the main contact?
Prof. Attila Altiner
Prof Attila Altiner
Institute for General Practice
Rostock University Medical Center
+49 (0)381 494 2481
Converting habits of antibiotic prescribing for respiratory tract infections in German primary care: the randomized controlled CHANGE-2 trial
The CHANGE-2 trial will test the effectiveness of two interventions aiming at the reduction of inappropriate antibiotic prescriptions for adults and children suffering from respiratory tract infection (RTI) in primary care.
Intervention A includes communication-training
Intervention A+B combines communication-training with point-of-care-testing.
Care as usual serves as control.
University Medicine Rostock Ethics Committe, September 2012
Three arm cluster-randomized controlled trial
Primary study design
Secondary study design
Cluster randomised trial
Patient information sheet
Respiratory tract infection (RTI)
Clusters will consist of participating primary care physicians and their patients. Physicians will be randomized into three groups:
1. Intervention A (communication training)
2. Intervention A+B (communication training + POCT)
Communication training will be organized within one-time small group sessions and will focus on the following topics: Patient expectations and shared decision-making (SDM). In particular, participating physicians will ameliorate their communication techniques in order to explore patients' (or parents') expectations. Also, they will be trained in patients' concepts of disease and patients' actual needs, e.g. ruling out a serious disease or pain relief. Furthermore, an adapted concept of delayed prescribing will be presented to participating physicians.
Physicians randomized into intervention A+B will be encouraged to use POCT kits (CRP and RADT) in accordance to provided clinical algorithms.
Primary outcome measures
Outcome measure is the physicians' antibiotic prescription rate for RTI derived from data of the statutory health insurance AOK that covers more than 50 % of the population in the study regions
Secondary outcome measures
1. Re-consultation rate
2. Use of medical services
3. Hospital admissions
Overall trial start date
Overall trial end date
Participant inclusion criteria
The trial includes general practitioners and practice-based pediatricians and their patients, who ask for consultation due to acute respiratory infection.
Patient inclusion criteria are:
1. Health insurance with the AOK, a statutory health insurance that covers more than 50% of the population in the study regions
2. Three months minimum age
3. Physician consultation visit due to the first episode of acute RTI (upper respiratory infection (URTI) and lower respiratory infection (LRTI)) according to the ICD classes: J00-J04, J06, J13, J20, J22, otherwise healthy. This definition will include all typical acute RTI including bronchitis, tonsillopharyngitis (e.g. sore throat), and otitis media.
Participants are required to give informed consent that includes the acceptance of scientific use of relevant data stored at the AOK. This data will include the period of 12 months before and 6 weeks after recruitment into the study
Target number of participants
188 primary care physicians (94 general practitioners, 94 practice based pediatricians) recruit more than 30,000 patients with RTI
Participant exclusion criteria
1. Underlying chronic diseases, which may affect the immune status in any relevant matter (e.g. malignoma, chronic obstructive pulmonary diseases, cystic fibrosis, immune deficiency of other causes)
2. Patients who are not able to give informed consent
3. Patients who require hospital care
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Rostock University Medical Center
Bundesministerium für Bildung und Forschung
Federal Ministry of Education and Research, BMBF
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23256712
Altiner A, Berner R, Diener A, Feldmeier G, Köchling A, Löffler C, Schröder H, Siegel A, Wollny A, Kern WV, Converting habits of antibiotic prescribing for respiratory tract infections in German primary care--the cluster-randomized controlled CHANGE-2 trial., BMC Fam Pract, 2012, 13, 124, doi: 10.1186/1471-2296-13-124.