Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
QC NDS1
Study information
Scientific title
Acronym
Study hypothesis
Participation of general practitioners in quality circles on rational prescribing, including feedback of prescribing data, leads to improvement of prescribing performance.
Ethics approval
The trial is aimed at implementing evidence-based guidelines into general practice. The intervention is based on peer review groups for General Practitioners (GPs), evidence based guidelines and individual feedback of prescription data to the GPs. In Germany, by the Social Code Book (SGB V) both the regional associations of statutory sick fund doctors (KV) and the regional statutory sick funds like the VdAK/AEV Lower-Saxony are obliged to inform doctors about prescribing and to support them about the use of prescription budgets. In this trial we tried to optimise implementation of what is already asked by the law and measure the effect against a control group.
In a contract signed on July 31st, 2002, between the VdAK/AEV Lower-Saxony, the KV Lower-Saxony (which both are statutory legal institutions) and the research institute it is formulated that the regulations of the law about data protection and protection of patients are to be followed by all partners. A data approval committee of the KV and the VdaK/AEV Lower-Saxony gave positive approval of the contract before it was signed.
Study design
Non-randomised, clustered, controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
N/A
Intervention
Nine meetings of approximately two hours each in a quality circle (eight to 12 members), individual feedback of own prescribing data compared to all practices in the project and compared to all practices in the control group. Background information on prescription drugs, price-comparison lists based on defined daily doses, evidence-based guidelines of the German College of General Practitioners (DEGAM) and the Drug Committee of the German Chamber of Physicians (AKdÄ).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Mean prescription costs in Euros
Secondary outcome measures
1. Percentage of patients who received a prescription
2. Percentage of generic drugs prescription of all potentially generic prescriptions
3. Percentage recommended lipid lowering drugs of all lipid lowering drugs prescriptions
4. Percentage of recommended antibiotics of all antibiotic prescriptions
5. Percentage of recommended antidiabetics of all antidiabetic prescriptions
Overall trial start date
01/10/2002
Overall trial end date
28/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Convenience sample of General Practitioners (GPs)
2. Patients who were insured by the VdAK/AEV (Ersatzkassen) sick fund and treated by the participating GPs
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
525 GPs and 225.000 patients
Participant exclusion criteria
Patients who were not insured by the VdAK/AEV (Ersatzkassen) sick fund
Recruitment start date
01/10/2002
Recruitment end date
28/02/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Weender Landstrasse 11
Göttingen
37073
Germany
Funders
Funder type
Government
Funder name
Association of Statutory Sick Funds (VdAK/AEV) - Niedersachsen branch (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Association of sickness fund doctors (KV) - Lower-Saxony (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list