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 tests two procedures to help GPs and pediatricians to optimize prescribing of antibiotics.
Who can participate?
This study includes 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 are randomly allocated 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 are compared. Data on reconsultation rates, complications and hospital admissions are also analyzed.
What are the possible benefits and risks of participation?
Patients of both groups may 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 checks for complications and hospital admissions. An unexpected but theoretically possible increase of complications due to reduced antibiotic prescriptions can lead to the study stopping.
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?
February 2012 to February 2016
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
ifa.sekretariat@med.uni-rostock.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Attila Altiner
ORCID ID
Contact details
Institute for General Practice
Rostock University Medical Center
POB 100888
Rostock
18055
Germany
+49 (0)381 494 2481
ifa.sekretariat@med.uni-rostock.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01GY1140
Study information
Scientific title
Converting habits of antibiotic prescribing for respiratory tract infections in German primary care: the randomized controlled CHANGE-2 trial
Acronym
CHANGE-2
Study hypothesis
The CHANGE-2 trial will test the effectiveness of two interventions (communication training and point-of-care testing [POCT]) aiming at the reduction of inappropriate antibiotic prescriptions for adults and children suffering from respiratory tract infection (RTI) in primary care.
Ethics approval
University Medicine Rostock Ethics Committee, September 2012
Study design
Three-arm cluster-randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
http://allgemeinmedizin.med.uni-rostock.de/index.php?id=125
Condition
Respiratory tract infection (RTI)
Intervention
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 + point-of-care testing [POCT])
3. Control (care as usual)
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
01/02/2012
Overall trial end date
29/02/2016
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Mixed
Gender
Both
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
01/10/2012
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Germany
Trial participating centre
Rostock University Medical Center
Rostock
18055
Germany
Sponsor information
Organisation
German Aerospace Center [DLR] (Germany)
Sponsor details
c/o Eva Becher
Heinrich-Konen-Str. 1
Bonn
53227
Germany
+49 (0)22 8382 1152
Eva.Becher@dlr.de
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
Bundesministerium für Bildung und Forschung
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
government organisation
Funding Body Subtype
federal
Location
Germany
Results and Publications
Publication and dissemination plan
Planned publication in a peer-reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.
Intention to publish date
31/12/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23256712
Publication citations
-
Protocol
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.