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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00105248
Other study ID # 3200B0-102137
Secondary ID 04B292003/051242
Status Completed
Phase N/A
First received March 10, 2005
Last updated May 10, 2016
Start date January 2004
Est. completion date June 2004

Study information

Verified date May 2016
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a short training program for general practitioners in patient-centered communication to reduce antibiotic prescription for acute respiratory tract infections (ARTI).


Description:

Acute respiratory tract infections (ARTI) constitute the most frequent reason for seeking ambulatory care and for the prescription of antibiotics, despite the mostly viral origin of ARTI. Antibiotic prescriptions for ARTI increase unnecessary drug expenditures and are the main reason for increasing drug resistance of common bacteria. Evidence from intervention studies shows that merely providing physicians with guidelines and educational material for the management of acute respiratory tract infections is not enough to reduce antibiotic prescriptions for these conditions. The main reasons for antibiotic prescription in ARTI are non-medical and related to the physician patient relationship, patients' expectations and beliefs about the benefit of antibiotics. Therefore patient-centered communication could be a promising approach to reduce the rate of antibiotic prescription in ambulatory care.

Comparison: General practitioners (GPs) trained in patient-centered communication in addition to evidence-based guidelines for diagnosis and treatment of ARTI compared to GPs just introduced to evidence-based guidelines.


Recruitment information / eligibility

Status Completed
Enrollment 900
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or older

- Symptoms of an acute respiratory tract infection for >1 and <28 days

Exclusion Criteria:

- Patients without informed consent

- Not fluent in German

- Patients with a psychiatric disorder

- Patients with a recurrent respiratory system infection with antibiotic treatment in the previous 4 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind


Intervention

Behavioral:
patient-centered communication training


Locations

Country Name City State
Switzerland Basel institute for clinical epidemiology Basel

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Basel Institute of Clinical Epidemiology (BICE), Novartis, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Up-take of antibiotic prescription confirmed by pharmacists within 2 weeks following the initial consultation
Secondary Patient satisfaction with consultation (on validated scale)
Secondary patient enablement (on validated scale)
Secondary days with restriction from ARTI within 14 days initial consultation
Secondary side effects from medication
Secondary re-consultation rates
Secondary days off from work
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