Patient Centered Communication Training to Reduce Antibiotic Use in Acute Respiratory Tract Infections

This study has been completed.

Sponsor:

Collaborators:

Basel Institute of Clinical Epidemiology (BICE)

Swiss National Science Foundation

Novartis

Information provided by:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT00105248

First received: March 10, 2005

Last updated: December 7, 2005

Last verified: March 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

March 10, 2005

Last Updated Date

December 7, 2005

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Up-take of antibiotic prescription confirmed by pharmacists within 2 weeks following the initial consultation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00105248 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patient satisfaction with consultation (on validated scale)
patient enablement (on validated scale)
days with restriction from ARTI within 14 days initial consultation
side effects from medication
re-consultation rates
days off from work

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Patient Centered Communication Training to Reduce Antibiotic Use in Acute Respiratory Tract Infections

Official Title ^ICMJE

Multidimensional Intervention Program to Reduce Antibiotic Prescriptions for Acute Respiratory Tract Infections in Adults: a Randomized Controlled Trial in Primary Care

Brief 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).

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training

Condition ^ICMJE

Respiratory Tract Infections

Intervention ^ICMJE

Behavioral: patient-centered communication training

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

900

Completion Date

June 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00105248

Other Study ID Numbers ^ICMJE

3200B0-102137, 04B29, 2003/051, 242/03

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Basel, Switzerland

Collaborators ^ICMJE

Basel Institute of Clinical Epidemiology (BICE)
Swiss National Science Foundation
Novartis

Investigators ^ICMJE

Principal Investigator:

Heiner Bucher, Prof.

University Hospital, Basel, Switzerland

Information Provided By

University Hospital, Basel, Switzerland

Verification Date

March 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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