Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Joachim Szecsenyi
ORCID ID
Contact details
Department of General Practice and Health Services Research
University of Heidelberg
Voßstrasse 2
Heidelberg
69115
Germany
+49 (0)6 221 564 743
joachim.szecsenyi@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
217-43794-6/8
Study information
Scientific title
Acronym
BiQ
Study hypothesis
1. Benchmarking in quality circles leads to improvement of asthma management in general practices.
2. Benchmarking in quality circles leads to reduction of drug interaction.
Ethics approval
The study was approved by the Medical Ethics Committee of the Medical Faculty of the University of Heidelberg on 12/11/2004 (reference number 371/2004)
Study design
Cluster-randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Asthma
Intervention
The physicians will meet each other for two sessions in quality circles. At the first meeting, problems surrounding drug interactions in general practice will be discussed. The topic at the second meeting will be asthma care.
Traditional quality circles:
in these quality circles, an individual feedback report is given to each physician. The physicians handle their data without showing their practice results to each other. The general practitioners (GPs) receive the feedback report with additional information about the performance of the other physicians in the traditional arm. This allows them to compare their own results with the mean and quartiles of performance of the other physicians. The GPs discuss problems of care under the guidance of a moderator. The most important facts are underlined by the given quality indicators. For example, they discuss the feasibility of a new asthma guideline, management of asthma education or prescription management. In particular, prescribing behaviour will the main focus.
Quality circles with benchmarking:
individual feedback reports will be also given to the participating GPs in these quality circles. Additionally, they receive information about the GP who performed best in their quality circle. The GPs discuss with the identified GP under guidance of the moderator as to how the best practice score was achieved. Additionally, the overall best practice of the whole study arm will be given to enable a comparison with the best benchmark. This multifaceted benchmark intervention should allow learning from the best performer.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Primary outcome measures asthma:
1. Amount of patients with inhaled steroids
2. Amount of patients with medication recommended by guidelines
3. Amount of patients with medication not recommended by guidelines (e.g. fixed combination of cromones + β-agonists, oral sympathomimetics)
Primary outcome measures drug interaction:
1. Amount of patients with potential clinically relevant drug-drug interactions, that have to be avoided
2. Amount of patients with potential clinically relevant drug-drug interactions
3. Association between hospital admission and drug-drug interaction
Secondary outcome measures
Secondary outcome measures asthma:
1. Asthma quality of life questionnaire (AQLQ)
2. Asthma step at day and night
3. Amount of patients with medication treatment according to guidelines
4. Amount of patients with asthma education
5. Amount of patients with a peak flow meter at home
6. Amount of patients with an asthma diary
7. Amount of patients with an individual emergency plan at home
8. Days of sick leave
9. Hospital admissions and unscheduled emergency visits
Secondary outcome measures drug interaction:
1. Patients' opinion on drug information, which they got from their general practitioner (regarding drug interactions, interaction with alcohol, dosage regimen, adverse drug reactions, etc.)
2. Amount of patients with a written medication treatment plan
3. Amount of patients with drug interactions (including all prescribed and over-the-counter drugs)
4. Amount of different active ingredients per medical practice
5. Amount of patients with polypharmacy
6. Amount of patients who exceeded the recommended dose of an interacting drug
Overall trial start date
01/07/2004
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Medication for airway obstruction
2. Medication regime with persistently more than two medications
3. Patients of 18 years and above
4. Able to read and speak German
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
27000 (routine data)
Participant exclusion criteria
1. Younger than 18 years
2. Not able to read and speak German
Recruitment start date
01/07/2004
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Department of General Practice and Health Services Research
Heidelberg
69115
Germany
Sponsor information
Organisation
Ministry of Health (BMG) (Germany)
Sponsor details
Am Probsthof 78a
Bonn
53121
Germany
+49 (0)1 888 441 2173
Helmut-Josef.Kuepper@bmg.bund.de
Sponsor type
Government
Website
http://www.bmg.bund.de/cln_041/nn_600110/EN/Home/homepage__node,param=.html__nnn=true
Funders
Funder type
Government
Funder name
German Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany) (grant ref: 217-43794-6/8)
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