Quality circles on rational prescribing (Project NDS1)

ISRCTN ISRCTN22552302
DOI https://doi.org/10.1186/ISRCTN22552302
Secondary identifying numbers QC NDS1
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

Study website

Contact information

Prof Joachim Szecsenyi
Scientific

Weender Landstrasse 11
Göttingen
37073
Germany

Study information

Study designNon-randomised, clustered, controlled trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)GP practice
Study typeQuality of life
Scientific titleQuality circles on rational prescribing (Project NDS1)
Study objectivesParticipation 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) 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 measureMean prescription costs in Euros
Secondary outcome measures1. 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 study start date01/10/2002
Completion date28/02/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants525 GPs and 225.000 patients
Key inclusion criteria1. 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 criteriaPatients who were not insured by the VdAK/AEV (Ersatzkassen) sick fund
Date of first enrolment01/10/2002
Date of final enrolment28/02/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Weender Landstrasse 11
Göttingen
37073
Germany

Sponsor information

Association of Statutory Sick Funds (VdAK/AEV) - Niedersachsen branch (Germany)
Government

c/o Dr Carsten Göken
Rathenaustr. 1
Hannover
30159
Germany

ROR logo "ROR" https://ror.org/03psr2094

Funders

Funder type

Government

Association of Statutory Sick Funds (VdAK/AEV) - Niedersachsen branch (Germany)

No information available

Association of sickness fund doctors (KV) - Lower-Saxony (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

05/01/2021: Publication reference added.