ISRCTN ISRCTN88343067
DOI https://doi.org/10.1186/ISRCTN88343067
Protocol serial number N/A
Sponsor AOK Saxony-Anhalt (Germany)
Funders AOK sick fund Saxony-Anhalt (Germany), Association of sickness fund doctors (KV) Saxony-Anhalt (Germany)
Submission date
08/07/2006
Registration date
28/03/2007
Last edited
05/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Joachim Szecsenyi
Scientific

AQUA - Institute for Applied Quality Improvement and Research in Health Care
Göttingen
37073
Germany

Study information

Primary study designInterventional
Study designNon-randomised, clustered, controlled trial
Secondary study designNon randomised controlled trial
Scientific titleQuality circles on rational prescribing (project SA4)
Study objectivesParticipation of general practitioners in quality circles on rational prescribing, including feedback of prescribing data, leads to improvement of performance.
Ethics approval(s)The trial is aimed at implementing evidence-based guidelines into general practice. The intervention is based on peer review groups for 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 AOK 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 June 1st, 2001, between the AOK, the KV (which are both statuatory 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 AOK gave positive approval of the contract before it was signed.
Health condition(s) or problem(s) studiedN/A
InterventionNine 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 typeOther
Primary outcome measure(s)

Mean prescription costs in Euros

Key secondary outcome measure(s)

1. Percentage of patients who received a prescription
2. Percentage of generic drugs prescription of all 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

Completion date30/08/2004

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration120
Key inclusion criteria1. Convenience sample of General Practitioners (GPs)
2. Patients who were insured by the AOK Saxony Anhalt sick fund and treated by the participating GPs
Key exclusion criteriaPatients who were not insured by the AOK Saxony Anhalt sick fund
Date of first enrolment01/09/2001
Date of final enrolment30/08/2004

Locations

Countries of recruitment

  • Germany

Study participating centre

AQUA - Institute for Applied Quality Improvement and Research in Health Care
Göttingen
37073
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2009 05/01/2021 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

05/01/2021: Publication reference added.