Abstract
BackgroundWith an average prescription rate of 50%, in German primary care antibiotics are still too frequently prescribed for respiratory tract infections. The over-prescription of antibiotics is often explained by perceived patient pressure and fears of a complicated disease progression. The CHANGE-2 trial will test the effectiveness of two interventions to reduce the rate of inappropriate antibiotic prescriptions for adults and children suffering from respiratory tract infections in German primary care.Methods/DesignThe study is a three-arm cluster-randomized controlled trial that measures antibiotic prescription rates over three successive winter periods and reverts to administrative data of the German statutory health insurance company AOK. More than 30,000 patients in two regions of Germany, who visit their general practitioner or pediatrician for respiratory tract infections will be included. Interventions are: A) communication training for general practitioners and pediatricians and B) intervention A plus point-of-care testing. Both interventions are tested against usual care. Outcome measure is the physicians’ antibiotic prescription rate for respiratory tract infections derived from data of the health insurance company AOK. Secondary outcomes include reconsultation rate, complications, and hospital admissions.DiscussionMajor aim of the study is to improve the process of decision-making and to ensure that patients who are likely to benefit from antibiotics are treated accordingly. Our approach is simple to implement and might be used rapidly among general practitioners and pediatricians. We expect the results of this trial to have major impact on antibiotic prescription strategies and practices in Germany, both among general practitioners and pediatricians.Trial registrationThe study is registered at the Current Controlled Trials Ltd (ISRCTN01559032)
Highlights
With an average prescription rate of 50%, in German primary care antibiotics are still too frequently prescribed for respiratory tract infections
We expect the results of this trial to have major impact on antibiotic prescription strategies and practices in Germany, both among general practitioners and pediatricians
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 infections (RTI) in primary care
Summary
The previously conducted CHANGE trial provides evidence for the effectiveness of doctor-patient communication and patient empowerment for reducing antibiotic prescriptions in German primary care. This finding suggests that distribution of information alone is not sufficient to further reduce prescription rates in low prescription countries Both proposed interventions (communication training with and without POCT) do not aim at reducing antibiotic prescriptions at all costs, but on improving the process of decision-making. This approach will ensure that patients who might benefit from antibiotics will be treated . As we will only include patients insured with the health insurance AOK, a bias on the patient level might be caused This trial will be the first randomized controlled trial in Germany to evaluate the use of communication training and POCTs on antibiotic prescription rates for RTI. The paper was drafted by AA, CL and AD and all authors read and approved the final manuscript
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