Quality circles on rational prescribing (Project NDS1)

ISRCTN	ISRCTN22552302
DOI	https://doi.org/10.1186/ISRCTN22552302
Protocol serial number	QC NDS1
Sponsor	Association of Statutory Sick Funds (VdAK/AEV) - Niedersachsen branch (Germany)
Funders	Association of Statutory Sick Funds (VdAK/AEV) - Niedersachsen branch (Germany), Association of sickness fund doctors (KV) - Lower-Saxony (Germany)

Submission date: 19/03/2007
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

Weender Landstrasse 11
Göttingen
37073
Germany

Study information

Primary study design	Interventional
Study design	Non-randomised, clustered, controlled trial
Secondary study design	Non randomised controlled trial
Scientific title	Quality circles on rational prescribing (Project NDS1)
Study objectives	Participation of general practitioners in quality circles on rational prescribing, including feedback of prescribing data, leads to improvement of prescribing 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 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.
Health condition(s) or problem(s) studied	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
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 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
Completion date	28/02/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	525
Key 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
Key exclusion criteria	Patients who were not insured by the VdAK/AEV (Ersatzkassen) sick fund
Date of first enrolment	01/10/2002
Date of final enrolment	28/02/2005

Locations

Countries of recruitment

Germany

Study participating centre

Weender Landstrasse 11

Göttingen
37073
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.