Condition category
Not Applicable
Date applied
19/03/2007
Date assigned
28/03/2007
Last edited
03/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.a-qz.de

Contact information

Type

Scientific

Primary contact

Prof Joachim Szecsenyi

ORCID ID

Contact details

Weender Landstrasse 11
Göttingen
37073
Germany

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes