Promoting rational antibiotic therapy in German primary care
| ISRCTN | ISRCTN95468513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95468513 |
- Submission date
- 09/06/2022
- Registration date
- 22/07/2022
- Last edited
- 01/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims:
Antibiotic overuse is when antibiotics are used when they're not needed. Antibiotics are one of the great advances in medicine. But overprescribing them has led to resistant bacteria (bacteria that are harder to treat). Some germs that were once very responsive to antibiotics have become more and more resistant.
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 optimise antibiotic use are usually based on voluntary participation of physicians, general practitioners (GPs) with inappropriate prescribing behaviour are underrepresented. For the first time in Germany, the ElektRA study will assess and compare effects of three interventions on antibiotic prescribing rates for respiratory and urinary tract infections among high-prescribers in primary care.
Who is included in the trial?
Primary care physicians from one of the nine participating regional Associations of Statutory Health Insurance Physicians (Baden-Württemberg, Bavaria, Bremen, Hesse, Lower Saxony, North Rhine, Saarland, Schleswig-Holstein, Westphalia-Lippe) and with an antibiotic prescribing score less than 2.
What does the study involve?
ElektRA is a 4-arm cluster-randomised 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 data base, high antibiotic prescribing GPs are identified and randomised into four groups: A control group (N=2,000) and three intervention arms. We test social norm feedback on antibiotic prescribing (N=2,000), social norm feedback plus online training on rational prescribing practice and communication strategies (N=2,000), and social norm feedback plus online peer-moderated training on rational antibiotic prescribing, communication strategies and sustainable behaviour change (N=1,250). Primary outcome is the overall rate of antibiotic prescriptions. Outcomes are measured before intervention and over a period of 15 months after start of the intervention.
What are the possible benefits and risks of participation?
Physicians with high antibiotic prescribing rates gain awareness of their own prescribing behaviour. They are encouraged to reflect on this and motivated to change their prescribing behaviour. In this way, the risk of the non-rational prescribing practices can be reduced. Patients benefit from their physicians' increased awareness. Ideally, patients and society in general benefit from decreasing rates of inappropriate antibiotic usage and a slowed development and spread of antibiotic resistance. There are no known risks to participants taking part in this study.
Where is the study run from?
Association of Substitute Health Funds (Vdek) e.V., Berlin, Germany
When is the study starting and how long is it expected to run for?
January 2021 to December 2024
Who is funding the study?
Innovation Fund of the Federal Joint Committee (G-BA) (Germany) (funding code: 01NVF20026)
Who is the main contact?
Maike Schulz, Central Research Institute of Ambulatory Health Care in Germany (Zi), Berlin, Germany (mschulz@zi.de)
Contact information
Public
Central Research Institute of Ambulatory Health Care in Germany (Zi)
Berlin
10587
Germany
| Phone | +49 30 4005-2458 |
|---|---|
| mschulz@zi.de |
Principal Investigator
Central Research Institute of Ambulatory Health Care in Germany (Zi)
Berlin
10587
Germany
| Phone | +49 30 4005-2458 |
|---|---|
| mschulz@zi.de |
Study information
| Study design | 4-arm cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Promoting rational antibiotic therapy among high antibiotic prescribers in German primary care (ElektRA). A 4-arm cluster-randomised controlled trial |
| Study acronym | ElektRA |
| Study objectives | The trial investigates the effects of three interventions on antibiotic prescribing rates for respiratory and urinary tract infections among high-prescribers in primary care. |
| Ethics approval(s) | Approved 30/09/2021, Ethics Committee of the Rostock University Medical Center, Approval-No. A 2021-0221 (St.-Georg-Str. 108, 18055 Rostock, Germany; +49 381 4949900; andreas.buettner@med.uni-rostock.de) |
| Health condition(s) or problem(s) studied | Acute respiratory and urinary tract infections |
| Intervention | Three interventions against the control group are tested: (A) personalised feedback on own prescribing behaviour in comparison to GPs of the region within a visual attention-grabbing graph (social norm feedback); (B) feedback like (A) plus a project's own online training (eLearning) on rational prescribing practice and communication strategies; (C) feedback like (A) plus an online peer-moderated training in quality circle format on the topic of rational antibiotic prescribing, communication strategies and development of individual starting points for a sustainable behaviour change. The total duration of treatment is 3 months; the total duration of follow up is 15 months. Randomisation into four groups (control group and three intervention arms A-C) will be stratified by regional Associations of Statutory Health Insurance Physicians (ASHIP) and will be carried out by the Central Research Institute of Ambulatory Health Care in Germany that is not involved in study conduct and implementation. For randomisation the sql-code, which assigns a random number to all included GPs, is used. The individual GP-random number combinations, ranging from ni to m (number of all GPs that need to be included), are sorted according to the following scheme: If the random number is between 1 and n1 the corresponding GP is assigned to Group A (n1= defined number of GPs in that group), if it is between n1+1 and n2 the GP is assigned to Group B. The procedure for group C and the control group is analogous, whereas m-ni describes the size of the control group. GP-random number combinations greater than m are not assigned to any group. |
| Intervention type | Behavioural |
| Primary outcome measure | Physicians' overall rate of antibiotic prescriptions, measured as the proportion of patients with antibiotic prescriptions out of all patients with a prescription before intervention and after it starts |
| Secondary outcome measures | Physicians' overall prescription rates before and after the intervention for cephalosporins and fluoroquinolones separately |
| Overall study start date | 01/01/2021 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | The recruitment target is 7,250 participants (group A: 2,000; group B: 2,000; group C: 1,250; control group: 2,000)) . The number of clusters is 4,704. On average, 174 patients with acute infections are treated per cluster per quarter. |
| Key inclusion criteria | 1. General practitioners (GP) 2. Registered as physician with the "Association of Statutory Health Insurance Physicians" located in Baden-Wuerttemberg, Bavaria, Bremen, Hesse, Lower Saxony, North Rhine, Saarland, Schleswig-Holstein, Westphalia-Lippe 3. Prescription sum score >2 (sum score ranges from 0 to 6; a GP or GP practice obtains one or two points if its own value in one of the following aspects exceeds the 75% percentile of antibiotic prescribing within the respective region: 3.1. Overall prescription rate (ratio of patients with antibiotic prescriptions to patients with any prescription), one point 3.2. Prescription rate for upper respiratory tract infections (ratio of patients with upper respiratory tract infection to antibiotic prescriptions for these patients), one point 3.3. Prescription rate for lower respiratory tract infections (ratio of patients with lower respiratory tract infection to antibiotic prescriptions for these patients), one point 3.4. Prescription rate of fluoroquinolones; two points: Total prescription rate of fluoroquinolones (ratio of patients with fluoroquinolone to patients with antibiotic) and/or fluoroquinolone prescription rate for urinary tract infection (ratio of urinary tract infection patients with fluoroquinolone to urinary tract infection patients with antibiotics 3.5. Prescription rate of cephalosporins (ratio of patients with cephalosporin to patients with antibiotic); one point |
| Key exclusion criteria | Participation on the predecessor project RESIST |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- Germany
Study participating centres
Berlin
10587
Germany
Stuttgart
70567
Germany
Munich
80687
Germany
Bremen
28209
Germany
Frankfurt
60486
Germany
Hannover
30175
Germany
Duesseldorf
40474
Germany
Saarbruecken
66113
Germany
Bad Segeberg
23795
Germany
Dortmund
44141
Germany
Rostock
18147
Germany
Sponsor information
Other
Askanischer Platz 1
Berlin
10963
Germany
| Phone | +49 30 269310 |
|---|---|
| christin.liebrenz@vdek.com | |
| Website | https://www.vdek.com |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the Central Research Institute of Ambulatory Health Care in Germany“ (Zi) (email: zi@zi.de) in the form of aggregated anonymised raw data. Data will be shared upon request for the purpose of academic research and scientific analyses (such as meta-analysis). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 04/10/2022 | 06/10/2022 | Yes | No |
Editorial Notes
01/02/2023: Internal review.
06/10/2022: Protocol file uploaded
14/06/2022: Trial's existence confirmed by Universitat Rostock
