Respiratory tract infections in primary care
| ISRCTN | ISRCTN01559032 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01559032 |
| Secondary identifying numbers | 01GY1140 |
- Submission date
- 24/08/2012
- Registration date
- 10/09/2012
- Last edited
- 18/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Institute for General Practice
Rostock University Medical Center
POB 100888
Rostock
18055
Germany
| Phone | +49 (0)381 494 2481 |
|---|---|
| ifa.sekretariat@med.uni-rostock.de |
Study information
| Study design | Three-arm cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | http://allgemeinmedizin.med.uni-rostock.de/index.php?id=125 |
| Scientific title | Converting habits of antibiotic prescribing for respiratory tract infections in German primary care: the randomized controlled CHANGE-2 trial |
| Study acronym | CHANGE-2 |
| Study objectives | 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(s) | University Medicine Rostock Ethics Committee, September 2012 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2012 |
| Completion date | 29/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 188 primary care physicians (94 general practitioners, 94 practice based pediatricians) recruit more than 30,000 patients with RTI |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Germany
Study participating centre
18055
Germany
Sponsor information
Industry
c/o Eva Becher
Heinrich-Konen-Str. 1
Bonn
53227
Germany
| Phone | +49 (0)22 8382 1152 |
|---|---|
| Eva.Becher@dlr.de | |
| Website | http://www.dlr.de/ |
"ROR" |
https://ror.org/04bwf3e34 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/12/2012 | Yes | No | |
| Interim results article | 29/09/2020 | 18/11/2021 | Yes | No |
Editorial Notes
18/11/2021: Publication reference added.
23/05/2017: IPD sharing statement added.
19/05/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2015 to 31/12/2015.
2. The overall trial end date was changed from 31/01/2015 to 29/02/2016.
