Increased Drug ResistanceNCT01099943
Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians
A study testing Intervention: Education, Decision Support Tools in people with Increased Drug Resistance and Infectious Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Hypotheses and Specific Aims: The continued emergence of antibiotic-resistance in the outpatient setting underlines the need to responsibly manage antimicrobial prescribing. It is in this context that we seek to test an effective strategy for reducing the inappropriate use of antibiotics in primary care office… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Increased Drug Resistance, Infectious Diseases
- What is being tested?
- Intervention: Education, Decision Support Tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinic practices within Denver Health's Webb Center for Primary Care,
- Clinic practices within the University of Colorado - Anschutz Campus: General Internal Medicine Clinic,
- Clinic practices within the High Plains Network, and
- Clinical practices within the Wilmington Health Associates System
- The antibiotic prescribing patterns of primary care clinicians in these practices will be monitored over a 2 year period. Practices must be willing to assist in tracking:
- Patient records (pediatric and adult) for conditions related to the International Classification of Diseases (ICD-9) codes associated with common infectious conditions (Upper Respiratory Infection, Acute Bronchitis, Pharyngitis, Acute Sinusitis, Otitis Media, Acute Cystitis, Cellulitis or soft tissue abscess, and Community-acquired Pneumonia) will be assessed for antibiotic prescribing,
- 30-day events (hospitalizations,
- Note: Emergency Department (ED) visits, or grade 3 or grade 4 abnormalities), will also be included in this study.
Who cannot join
- 1. Ob/Gyn related clinic visits will not be included in this study as these visits are not typically associated with high volumes of antibiotic prescribing for the infectious conditions of interest.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health and Hospitals Authority
Denver, Colorado, 80204
About this study
Hypotheses and Specific Aims:
The continued emergence of antibiotic-resistance in the outpatient setting underlines the need to responsibly manage antimicrobial prescribing. It is in this context that we seek to test an effective strategy for reducing the inappropriate use of antibiotics in primary care office practices. Our overall objective is to identify an effective and efficient strategy for decreasing the contribution of primary care clinicians to the emergence of antimicrobial-resistant bacteria in the community and to disseminate widely those strategies found to be effective and sustainable.
Read more
We hypothesize that implementation of a clinician decision support system, with an active education component, will reduce the inappropriate use of antibiotics in primary care office practices. Our hypothesis is based on the premise that most inappropriate prescribing is the result of multiple factors that include difficulty in distinguishing a benign, self-limited viral infection from a more serious bacterial infection; overdiagnosis of a bacterial infection in cases where there is clinical uncertainty as to the true nature of the illness; and constraints on the time available for clinicians to explain to patients the nature of the illness and the reasons an antibiotic is not indicated.
The focus of this proposal will be to compare the impact of clinical decision support and active education to no intervention for enhancing the appropriate use of antimicrobials for common outpatient infections. In this randomized control trial, primary care providers participating in the intervention arm will receive active education coupled with the implementation of a clinical decision support tool, while providers in the control arm will have no intervention. At the end of the study, providers in the control arm will receive a thorough analysis of their antibiotic prescribing patterns and suggested opportunities for improvement, as well as access to the intervention tools once the study has ended.
Our interdisciplinary team will integrate novel methods in implementation science with clinical and laboratory expertise in infectious diseases, antimicrobial stewardship, primary care, information technology, performance improvement, health services research, and biostatistics. The Specific Aims are constructed to validate our hypothesis in the primary care setting by demonstrating two results of our intervention strategy:
- Reduced use of antibiotics to treat conditions for which those drugs are known not to be effective
- Decreased prescribing of broad-spectrum antibiotics to treat common bacterial infections.
The degree of impact in terms of prescriptions per 100 visits for each targeted outpatient infection will be compared with active education and clinical decision support versus no intervention. The study will be able to measure the value of clinical decision support with active education that will inform future efforts in disseminating outpatient antibiotic stewardship interventions.
- Conditions
- Increased Drug Resistance, Infectious Diseases
- Being tested
- Intervention: Education, Decision Support Tools
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Education, Decision Support ToolsOther
Clinic sites randomized to the intervention group will participate in an educational intervention comprised of lectures on antimicrobial resistance and implement decision support tools to guide primary care providers in appropriate antibiotic prescribing for common infectious conditions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Education, Decision Support Tools | Experimental | Clinic sites randomized to the intervention group will participate in an educational intervention comprised of lectures on antimicrobial resistance and implement decision support tools to guide primary care providers in appropriate antibiotic prescribing for common infectious conditions. Receives: Other: Intervention: Education, Decision Support Tools |
| No education, no implemented decision support tools | No intervention | Clinics randomized to the control will not participate in the education intervention and implementation of decision support tools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in antibiotics prescribing behavior
Measured: December 2009 through August 2011
Secondary outcomes (1)
The number and type of changes made to workflow processes when setting up or changing systems to change prescribing methods
Measured: December 2009 through August 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Drug ResistanceStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- David R West, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099943
- Sponsor's protocol ID
- 09-1022
- Other IDs
- HHSA290200710008
- Status last verified
- Oct 2015
- First submitted
- 3 Nov 2009
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians
- ClinicalTrials.gov ID
- NCT01099943
- Acronym / sponsor ID
- 09-1022
- Conditions
- Increased Drug Resistance, Infectious Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Apr 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.
Hypotheses and Specific Aims:
The continued emergence of antibiotic-resistance in the outpatient setting underlines the need to responsibly manage antimicrobial prescribing. It is in this context that we seek to test an effective strategy for reducing the inappropriate use of antibiotics in primary care office practices. Our overall objective is to identify an effective and efficient strategy for decreasing the contribution of primary care clinicians to the emergence of antimicrobial-resistant bacteria in the community and to disseminate widely those strategies found to be effective and sustainable.
We hypothesize that implementation of a clinician decision support system, with an active education component, will reduce the inappropriate use of antibiotics in primary care office practices. Our hypothesis is based on the premise that most inappropriate prescribing is the result of multiple factors that include difficulty in distinguishing a benign, self-limited viral infection from a more serious bacterial infection; overdiagnosis of a bacterial infection in cases where there is clinical uncertainty as to the true nature of the illness; and constraints on the time available for clinicians to explain to patients the nature of the illness and the reasons an antibiotic is not indicated.
The focus of this proposal will be to compare the impact of clinical decision support and active education to no intervention for enhancing the appropriate use of antimicrobials for common outpatient infections. In this randomized control trial, primary care providers participating in the intervention arm will receive active education coupled with the implementation of a clinical decision support tool, while providers in the control arm will have no intervention. At the end of the study, providers in the control arm will receive a thorough analysis of their antibiotic prescribing patterns and suggested opportunities for improvement, as well as access to the intervention tools once the study has ended.
Our interdisciplinary team will integrate novel methods in implementation science with clinical and laboratory expertise in infectious diseases, antimicrobial stewardship, primary care, information technology, performance improvement, health services research, and biostatistics. The Specific Aims are constructed to validate our hypothesis in the primary care setting by demonstrating two results of our intervention strategy:
- Reduced use of antibiotics to treat conditions for which those drugs are known not to be effective
- Decreased prescribing of broad-spectrum antibiotics to treat common bacterial infections.
The degree of impact in terms of prescriptions per 100 visits for each targeted outpatient infection will be compared with active education and clinical decision support versus no intervention. The study will be able to measure the value of clinical decision support with active education that will inform future efforts in disseminating outpatient antibiotic stewardship interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Education, Decision Support Tools | Experimental | Other: Intervention: Education, Decision Support ToolsClinic sites randomized to the intervention group will participate in an educational intervention comprised of lectures on antimicrobial resistance and implement decision support tools to guide primary care providers in appropriate antibiotic prescribing for common infectious conditions. |
| No education, no implemented decision support tools | No intervention | –Clinics randomized to the control will not participate in the education intervention and implementation of decision support tools. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Clinic practices within Denver Health's Webb Center for Primary Care,
- Clinic practices within the University of Colorado - Anschutz Campus: General Internal Medicine Clinic,
- Clinic practices within the High Plains Network, and
- Clinical practices within the Wilmington Health Associates System
- The antibiotic prescribing patterns of primary care clinicians in these practices will be monitored over a 2 year period. Practices must be willing to assist in tracking:
Key exclusion criteria (1 listed)
- 1. Ob/Gyn related clinic visits will not be included in this study as these visits are not typically associated with high volumes of antibiotic prescribing for the infectious conditions of interest.
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 |
|---|---|---|
| Intervention: Education, Decision Support ToolsClinic sites randomized to the intervention group will participate in an educational intervention comprised of lectures on antimicrobial resistance and implement decision support tools to guide primary care providers in appropriate antibiotic prescribing for common infectious conditions. | Other | Intervention: Education, Decision Support Tools |
Primary outcome
Change in antibiotics prescribing behavior
Time frame: December 2009 through August 2011
1 secondary outcome
The number and type of changes made to workflow processes when setting up or changing systems to change prescribing methods
Time frame: December 2009 through August 2011
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 6 Oct 2015.
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.
David R West, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Education, Decision Support Tools in people with Increased Drug Resistance and Infectious Diseases, run by University of Colorado, Denver 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 8 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 6 Oct 2015. 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?
Change in antibiotics prescribing behavior (time frame: December 2009 through August 2011). 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 6 Oct 2015.