Acute Respiratory Tract InfectionNCT00981994
Evaluation of an Algorithm to Reduce Antibiotic Prescribing for Acute Bronchitis
A study testing Decision Support for ARI Management in people with Acute Respiratory Tract Infection, run by University of Pennsylvania.
Trial summary
Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant factor contributing to the selection of antimicrobial drug resistant pathogens, which threaten the effectiveness of available therapies to treat common community-acquired bacterial infections. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Respiratory Tract Infection
- What is being tested?
- Decision Support for ARI Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Sep 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary care practice sites within the Geisinger Health System
Who cannot join
- Sites with < 1000 visits per year for acute respiratory infection
About this study
Official title: Development, Implementation, and Evaluation of Novel Strategies to Reduce Inappropriate Antimicrobial Use in Community and Healthcare Settings
Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant factor contributing to the selection of antimicrobial drug resistant pathogens, which threaten the effectiveness of available therapies to treat common community-acquired bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of pneumonia risk among patients with acute cough illnesses. This study will use a cluster randomized trial design within the Geisinger Health System's integrated clinic network to measure the efficacy of an algorithm driven clinical decision support tool to safely reduce the frequency of unnecessary antibiotic prescriptions for adult patients with lower respiratory tract infections.
Read the detailed description
The rapid rise in antibiotic resistance among common bacteria are adversely affecting the clinical course and health care costs of community-acquired infections. Because antibiotic resistance patterns are strongly correlated with antibiotic use patterns, multiple organizations have declared reductions in unnecessary antibiotic use to be critical components of efforts to combat antibiotic resistance. Among humans, the vast majority of unnecessary antibiotic prescriptions are used to treat acute respiratory tract infections (ARIs) that have a viral etiology. In particular, despite the fact that numerous controlled trials have demonstrated no benefit of antibiotic therapy for patients with acute bronchitis, the majority of patients diagnosed with acute bronchitis continue to receive antibiotic therapy across diverse treatment settings. Recently, the National Committee on Quality Assurance adopted the proportion of adult visits diagnosed as acute bronchitis when an antibiotic was NOT prescribed as a quality measure within the HEDIS data set. Recent results from the HEDIS dataset emphasize the continued high rates of antibiotic prescribing for patients with acute bronchitis. One key factor driving overuse of antibiotics in the management of patients with lower respiratory tract infections-such as acute bronchitis-is diagnostic uncertainty and inaccurate risk estimation of underlying pneumonia in such patients. Recently, our study team has observed substantial reductions in antibiotic prescribing following the incorporation of a diagnostic and treatment algorithm into an acute care setting. This acute cough management algorithm incorporates data on vital signs and symptoms distinguishing patients with community-acquired pneumonia from other patients with acute cough illness, specifically those with acute bronchitis. The acute cough management algorithm has become even more valuable in recent years due to the introduction of quality measures that emphasize the timely administration of antibiotics for patients with community-acquired pneumonia. Thus, strong empirical evidence of the effectiveness of such an algorithm could lead to wide adoption of the algorithm and substantial improvements in antibiotic prescribing. The investigative team is proposing a unique partnership with Geisinger Health System, a large integrated health network, to implement and evaluate the algorithm. Utilizing a cluster-randomized trial design across 33 practice sites, we will address the following aims: 1) To measure the reduction in antibiotic prescribing resulting from incorporation of the algorithm compared to usual care sites utilizing two different implementation strategies, one poster-based and one electronic health record-based, 2) To measure revisits, delayed hospitalizations and net economic costs associated with algorithm implementation, and 3) To evaluate local practice characteristics influencing the level of implementation and ultimate performance success at intervention sites. In a final component of the study, the investigators will partner with NCQA to disseminate study results through the national network of participating plans and stimulate wide spread adoption of the algorithm and quality improvement methods.
- Conditions
- Acute Respiratory Tract Infection
- Being tested
- Decision Support for ARI Management
- Keywords
- respiratory infection, antimicrobial drugs, decision support, Adult patients
- 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.
Decision Support for ARI ManagementBehavioural
Use of history and physical examination findings to estimate probability of pneumonia in patients with acute respiratory infections and thereby guide treatment decisions
| Study group | Role | What they receive |
|---|---|---|
| Electronic Decision Support | Experimental | Use of electronic decision support to provide the treatment algorithm for providers managing patients with acute respiratory infections. Receives: Behavioral: Decision Support for ARI Management |
| Paper Decision Support | Experimental | Use of paper based tools to provide the treatment algorithm for providers managing patients with acute respiratory infections. Receives: Behavioral: Decision Support for ARI Management |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of visits to primary care clinic associated with antibiotic prescriptions
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Geisinger Clinic
- Responsible party
- Sponsor
- Investigators
- Joshua P Metlay, MD, PhD, Principal investigator, University of PennsylvaniaRalph Gonzales, MD,MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981994
- Sponsor's protocol ID
- 5R01CI000611
- Status last verified
- Nov 2016
- First submitted
- 14 Sep 2009
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gonzales R, Anderer T, McCulloch CE, Maselli JH, Bloom FJ Jr, Graf TR, Stahl M, Yefko M, Molecavage J, Metlay JP. A cluster randomized trial of decision support strategies for reducing antibiotic use in acute bronchitis. JAMA Intern Med. 2013 Feb 25;173(4):267-73. doi: 10.1001/jamainternmed.2013.1589.
PubMed 23319069
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation, and Evaluation of Novel Strategies to Reduce Inappropriate Antimicrobial Use in Community and Healthcare Settings
- ClinicalTrials.gov ID
- NCT00981994
- Acronym / sponsor ID
- 5R01CI000611
- Conditions
- Acute Respiratory Tract Infection
- Keywords
- respiratory infection, antimicrobial drugs, decision support, Adult patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,300 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Geisinger Clinic
- Study start
- Oct 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Sep 2009 (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.
Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant factor contributing to the selection of antimicrobial drug resistant pathogens, which threaten the effectiveness of available therapies to treat common community-acquired bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of pneumonia risk among patients with acute cough illnesses. This study will use a cluster randomized trial design within the Geisinger Health System's integrated clinic network to measure the efficacy of an algorithm driven clinical decision support tool to safely reduce the frequency of unnecessary antibiotic prescriptions for adult patients with lower respiratory tract infections.
Detailed description
The rapid rise in antibiotic resistance among common bacteria are adversely affecting the clinical course and health care costs of community-acquired infections. Because antibiotic resistance patterns are strongly correlated with antibiotic use patterns, multiple organizations have declared reductions in unnecessary antibiotic use to be critical components of efforts to combat antibiotic resistance. Among humans, the vast majority of unnecessary antibiotic prescriptions are used to treat acute respiratory tract infections (ARIs) that have a viral etiology. In particular, despite the fact that numerous controlled trials have demonstrated no benefit of antibiotic therapy for patients with acute bronchitis, the majority of patients diagnosed with acute bronchitis continue to receive antibiotic therapy across diverse treatment settings. Recently, the National Committee on Quality Assurance adopted the proportion of adult visits diagnosed as acute bronchitis when an antibiotic was NOT prescribed as a quality measure within the HEDIS data set. Recent results from the HEDIS dataset emphasize the continued high rates of antibiotic prescribing for patients with acute bronchitis. One key factor driving overuse of antibiotics in the management of patients with lower respiratory tract infections-such as acute bronchitis-is diagnostic uncertainty and inaccurate risk estimation of underlying pneumonia in such patients. Recently, our study team has observed substantial reductions in antibiotic prescribing following the incorporation of a diagnostic and treatment algorithm into an acute care setting. This acute cough management algorithm incorporates data on vital signs and symptoms distinguishing patients with community-acquired pneumonia from other patients with acute cough illness, specifically those with acute bronchitis. The acute cough management algorithm has become even more valuable in recent years due to the introduction of quality measures that emphasize the timely administration of antibiotics for patients with community-acquired pneumonia. Thus, strong empirical evidence of the effectiveness of such an algorithm could lead to wide adoption of the algorithm and substantial improvements in antibiotic prescribing. The investigative team is proposing a unique partnership with Geisinger Health System, a large integrated health network, to implement and evaluate the algorithm. Utilizing a cluster-randomized trial design across 33 practice sites, we will address the following aims: 1) To measure the reduction in antibiotic prescribing resulting from incorporation of the algorithm compared to usual care sites utilizing two different implementation strategies, one poster-based and one electronic health record-based, 2) To measure revisits, delayed hospitalizations and net economic costs associated with algorithm implementation, and 3) To evaluate local practice characteristics influencing the level of implementation and ultimate performance success at intervention sites. In a final component of the study, the investigators will partner with NCQA to disseminate study results through the national network of participating plans and stimulate wide spread adoption of the algorithm and quality improvement methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electronic Decision Support | Experimental | Behavioral: Decision Support for ARI ManagementUse of electronic decision support to provide the treatment algorithm for providers managing patients with acute respiratory infections. |
| Paper Decision Support | Experimental | Behavioral: Decision Support for ARI ManagementUse of paper based tools to provide the treatment algorithm for providers managing patients with acute respiratory infections. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care practice sites within the Geisinger Health System
Key exclusion criteria (1 listed)
- Sites with < 1000 visits per year for acute respiratory infection
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 |
|---|---|---|
| Decision Support for ARI ManagementUse of history and physical examination findings to estimate probability of pneumonia in patients with acute respiratory infections and thereby guide treatment decisions | Behavioural | Electronic Decision Support, Paper Decision Support |
Primary outcome
Proportion of visits to primary care clinic associated with antibiotic prescriptions
Time frame: 30 days
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 28 Nov 2016.
- Derived from this study: PubMed 23319069Gonzales R, Anderer T, McCulloch CE, Maselli JH, Bloom FJ Jr, Graf TR, Stahl M, Yefko M, Molecavage J, Metlay JP. A cluster randomized trial of decision support strategies for reducing antibiotic use in acute bronchitis. JAMA Intern Med. 2013 Feb 25;173(4):267-73. doi: 10.1001/jamainternmed.2013.1589.
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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.
Joshua P Metlay, MD, PhD principal investigator
University of Pennsylvania
Ralph Gonzales, MD,MS principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support for ARI Management in people with Acute Respiratory Tract Infection, run by University of Pennsylvania.
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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of visits to primary care clinic associated with antibiotic prescriptions (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981994, which also lists 1 linked publication.
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 28 Nov 2016.