BronchitisNCT01240174
Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis
A study testing Demonstration of near zero antibiotic prescribing for patients with acute bronchitis in people with Bronchitis and Cough, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Studies show, guidelines state, and performance measures assert that antibiotic prescribing for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States each year. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchitis, Cough
- What is being tested?
- Demonstration of near zero antibiotic prescribing for patients with acute bronchitis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2014
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- first visit in 30 days, age 18-64, has a cough of less than 3 weeks duration
Who cannot join
- infiltrate on chest x-ray, has chronic lung disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital Jen Center for Primary Care
Boston, Massachusetts, 02115
About this study
Studies show, guidelines state, and performance measures assert that antibiotic prescribing for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States each year. Previous successful interventions have only reduced the antimicrobial prescribing rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis can be brought to near zero percent in actual practice while maintaining patient safety and satisfaction. The goal of this study is to develop an Electronic Health Record (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis with a goal of reducing the antibiotic prescribing rate to near zero percent.
Read the detailed description
We will use a multi-modal implementation - including computerized decision support, reporting tools, and clinician feedback - and quality improvement techniques to ensure adherence to the algorithm and reduce the antimicrobial prescribing rate to near zero percent. The duration of the intervention will be 4 years.
- Conditions
- Bronchitis, Cough
- Being tested
- Demonstration of near zero antibiotic prescribing for patients with acute bronchitis
- Keywords
- Antibiotic, Antimicrobial, Prescribing, Cough, Acute Bronchitis
- Medical subject headings
- Bronchitis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demonstration of near zero antibiotic prescribing for patients with acute bronchitisBehavioural
A controlled, continuously-monitored, implementation of an EHR-integrated diagnosis and treatment algorithm for acute bronchitis in a large, diverse primary care practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Other | Single arm in the study of doctors receiving feedback about their antibiotic prescribing rate for acute bronchitis. Receives: Behavioral: Demonstration of near zero antibiotic prescribing for patients with acute bronchitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescribing rate
The antibiotic prescribing rate for patients with acute bronchitis
Measured: 30 days
Secondary outcomes (5)
Patient symptoms
Measured: 21 days
Patient satisfaction
Measured: 21 days
Patient safety
Measured: 30 days
Healthcare costs
Measured: 30 days
The capture and description of the components that had the greatest effect on the antimicrobial prescribing rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Jeffrey A. Linder, Brigham and Women's Hospital
- Investigators
- Jeffrey A Linder, MD, MPH, Principal investigator, Brigham and Women's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240174
- Sponsor's protocol ID
- 2010P001247
- Status last verified
- Jan 2017
- First submitted
- 10 Nov 2010
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis
- ClinicalTrials.gov ID
- NCT01240174
- Acronym / sponsor ID
- 2010P001247
- Conditions
- Bronchitis, Cough
- Keywords
- Antibiotic, Antimicrobial, Prescribing, Cough, Acute Bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Nov 2010 (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.
Studies show, guidelines state, and performance measures assert that antibiotic prescribing for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States each year. Previous successful interventions have only reduced the antimicrobial prescribing rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis can be brought to near zero percent in actual practice while maintaining patient safety and satisfaction. The goal of this study is to develop an Electronic Health Record (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis with a goal of reducing the antibiotic prescribing rate to near zero percent.
Detailed description
We will use a multi-modal implementation - including computerized decision support, reporting tools, and clinician feedback - and quality improvement techniques to ensure adherence to the algorithm and reduce the antimicrobial prescribing rate to near zero percent. The duration of the intervention will be 4 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Behavioral: Demonstration of near zero antibiotic prescribing for patients with acute bronchitisSingle arm in the study of doctors receiving feedback about their antibiotic prescribing rate for acute bronchitis. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first visit in 30 days, age 18-64, has a cough of less than 3 weeks duration
Key exclusion criteria (1 listed)
- infiltrate on chest x-ray, has chronic lung disease
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 |
|---|---|---|
| Demonstration of near zero antibiotic prescribing for patients with acute bronchitisA controlled, continuously-monitored, implementation of an EHR-integrated diagnosis and treatment algorithm for acute bronchitis in a large, diverse primary care practice. | Behavioural | Intervention Arm |
Primary outcome
Antibiotic prescribing rate
Time frame: 30 days
The antibiotic prescribing rate for patients with acute bronchitis
5 secondary outcomes
Patient symptoms
Time frame: 21 days
Patient satisfaction
Time frame: 21 days
Patient safety
Time frame: 30 days
Healthcare costs
Time frame: 30 days
The capture and description of the components that had the greatest effect on the antimicrobial prescribing rate
Time frame: 3 years
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 1 Feb 2017.
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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.
Jeffrey A Linder, MD, MPH principal investigator
Brigham and Women's Hospital, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demonstration of near zero antibiotic prescribing for patients with acute bronchitis in people with Bronchitis and Cough, run by Brigham and Women's Hospital at 1 site in United States.
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 1 inclusion and 1 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 1 Feb 2017. 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 United States. 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?
Antibiotic prescribing rate (time frame: 30 days). 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 1 Feb 2017.