Respiratory Tract InfectionsNCT00105248
Patient Centered Communication Training to Reduce Antibiotic Use in Acute Respiratory Tract Infections
A study testing patient-centered communication training in people with Respiratory Tract Infections, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- patient-centered communication training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2004to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Symptoms of an acute respiratory tract infection for >1 and <28 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidimensional Intervention Program to Reduce Antibiotic Prescriptions for Acute Respiratory Tract Infections in Adults: a Randomized Controlled Trial in Primary Care
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).
Read the 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.
- Conditions
- Respiratory Tract Infections
- Being tested
- patient-centered communication training
- Keywords
- acute repiratory infections, antibiotic therapy, patient-centred communication, randomized controlled trial
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-centered communication trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Up-take of antibiotic prescription confirmed by pharmacists within 2 weeks following the initial consultation
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2005 (estimated)
- Study startJan 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Basel Institute of Clinical Epidemiology (BICE), Swiss National Science Foundation, Novartis
- Responsible party
- Sponsor
- Investigators
- Heiner Bucher, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105248
- Sponsor's protocol ID
- 3200B0-102137
- Other IDs
- 04B29, 2003/051, 242/03
- Status last verified
- May 2016
- First submitted
- 10 Mar 2005
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Intervention Program to Reduce Antibiotic Prescriptions for Acute Respiratory Tract Infections in Adults: a Randomized Controlled Trial in Primary Care
- ClinicalTrials.gov ID
- NCT00105248
- Acronym / sponsor ID
- 3200B0-102137
- Conditions
- Respiratory Tract Infections
- Keywords
- acute repiratory infections, antibiotic therapy, patient-centred communication, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Basel Institute of Clinical Epidemiology (BICE), Swiss National Science Foundation, Novartis
- Study start
- Jan 2004
- Study completion
- Jun 2004
- First posted
- 11 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Symptoms of an acute respiratory tract infection for >1 and <28 days
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient-centered communication training | Behavioural | – |
Primary outcome
Up-take of antibiotic prescription confirmed by pharmacists within 2 weeks following the initial consultation
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiner Bucher, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient-centered communication training in people with Respiratory Tract Infections, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Up-take of antibiotic prescription confirmed by pharmacists within 2 weeks following the initial consultation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.