Respiratory InfectionsIMPAACTNCT00144040
Improving Antibiotic Use in Acute Care Treatment
A study testing Physician & patient education on appropriate antibiotic use and Rapid C-reactive protein testing to guide antibiotic treatment in people with Respiratory Infections, run by US Department of Veterans Affairs at 9 sites in United States.
Trial summary
Purpose The emergence and rapid rise in antibiotic resistance among common bacteria are adversely affecting the clinical course and health care costs of community-acquired infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Infections
- What is being tested?
- Physician & patient education on appropriate antibiotic use and Rapid C-reactive protein testing to guide antibiotic treatment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2004to Jul 2007
- 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
- Emergency room patient
- Selected VA or Non-VA patients
- Age 18 years or older
- Patient must have acute respiratory illness
- Patient must not have been seen in Emergency Department within 4 weeks
Who cannot join
- Patients less than 18 years of age
- Patient in Emergency Department for non-acute respiratory infection
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, 30904
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: Improving Antibiotic Use in Acute Care Setting
Purpose The emergence and 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 rates 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. Although the rate of antibiotic prescribing for ARIs by office-based physicians in the US has decreased about 16% from its peak in 1997, the rate of antibiotic prescribing in acute care settings (eg, emergency departments and urgent care centers), which account for 1 in 5 ambulatory antibiotic prescriptions in the US, has shown only a modest decline (6%) during this period. Translation of lessons from intervention studies in office-based practices is needed to improve antibiotic use in acute care settings.
Read the detailed description
Objectives:
Specific Aim 1: To evaluate the impact of a multidimensional (patient, system, clinician) intervention on appropriate antibiotic use for adults with acute respiratory tract infections-- identifying factors that influence successful translation across VA hospital and non-VA hospital acute care. Specific Aim 2: To evaluate the impact of a rapid diagnostic test for c-reactive protein on antibiotic use for adults with acute cough illness when added to a multidimensional intervention.
Methods:
We propose to conduct a randomized controlled trial of a quality improvement program consisting of physician education (educational seminar, practice guidelines, performance feedback, and decision support tools) and patient education (waiting room print and audiovisual materials) in 8 VA hospital and 8 non-VA hospital emergency departments. Non VA study sites will be identified from an existing research network of hospital emergency departments--EDNet. VA hospital sites will be selected among academically affiliated hub facilities. Phase one will involve a hospital-level randomized trial of a multidimensional intervention to translate existing evidence based guidelines for antibiotic use in ARIs vs. usual care. Simultaneously, we will validate a new CRP-based diagnostic algorithm and incorporate it into the evidence based guidelines for antibiotic use in ARIs. Phase two will involve a second hospital-level randomized trial of the new antibiotic use guidelines that incorporate the CRP-based diagnostic algorithm vs. the original guidelines. Specific endpoints include the overall success of the intervention in each phase in terms of reducing antibiotic prescribing for ARIs, improving patient outcomes and reducing resource utilization. In addition we will examin the impact of VA and non-VA organizational factors on the successful translation of various components of the intervention in both phases. Data will be collected using existing administrative data as well as on-site enrollment of subjects in prospective follow-up studies.
- Conditions
- Respiratory Infections
- Being tested
- Physician & patient education on appropriate antibiotic use, Rapid C-reactive protein testing to guide antibiotic treatment
- Keywords
- Antibiotics, Respiratory Infections, Quality Assurance, Healthcare, Professional Education, Emergency Services, Medical, Education, Patient
- 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.
Physician & patient education on appropriate antibiotic useBehavioural
Rapid C-reactive protein testing to guide antibiotic treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Physician & patient education on appropriate antibiotic use; Procedure: Rapid C-reactive protein testing to guide antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of all acute respiratory infection visits treated with antibiotics
Secondary outcomes (1)
Delayed antibiotic treatment of acute respiratory infections; Patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionsStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Joshua P. Metlay, MD PhD, Principal investigator, Philadelphia VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144040
- Sponsor's protocol ID
- AVA 03-239
- Other IDs
- R01 HF13915
- Acronym
- IMPAACT
- Status last verified
- Apr 2015
- First submitted
- 31 Aug 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Metlay JP, Camargo CA Jr, Bos K, Gonzales R. Assessing the suitability of intervention sites for quality improvement studies in emergency departments. Acad Emerg Med. 2005 Jul;12(7):667-70. doi: 10.1197/j.aem.2005.01.012.
PubMed 15995102Gonzales R, Camargo CA Jr, MacKenzie T, Kersey AS, Maselli J, Levin SK, McCulloch CE, Metlay JP; IMPAACT Trial Investigators. Antibiotic treatment of acute respiratory infections in acute care settings. Acad Emerg Med. 2006 Mar;13(3):288-94. doi: 10.1197/j.aem.2005.10.016.
PubMed 16514122Vanderweil SG, Pelletier AJ, Hamedani AG, Gonzales R, Metlay JP, Camargo CA Jr. Declining antibiotic prescriptions for upper respiratory infections, 1993-2004. Acad Emerg Med. 2007 Apr;14(4):366-9. doi: 10.1197/j.aem.2006.10.096. Epub 2007 Feb 12.
PubMed 17296803Aspinall SL, Metlay JP, Maselli JH, Gonzales R. Impact of hospital formularies on fluoroquinolone prescribing in emergency departments. Am J Manag Care. 2007 May;13(5):241-8.
PubMed 17488189Metlay JP, Camargo CA Jr, MacKenzie T, McCulloch C, Maselli J, Levin SK, Kersey A, Gonzales R; IMPAACT Investigators. Cluster-randomized trial to improve antibiotic use for adults with acute respiratory infections treated in emergency departments. Ann Emerg Med. 2007 Sep;50(3):221-30. doi: 10.1016/j.annemergmed.2007.03.022. Epub 2007 May 23.
PubMed 17509729Nolt BR, Gonzales R, Maselli J, Aagaard E, Camargo CA Jr, Metlay JP. Vital-sign abnormalities as predictors of pneumonia in adults with acute cough illness. Am J Emerg Med. 2007 Jul;25(6):631-6. doi: 10.1016/j.ajem.2006.11.031.
PubMed 17606087Pines JM, Hollander JE, Lee H, Everett WW, Uscher-Pines L, Metlay JP. Emergency department operational changes in response to pay-for-performance and antibiotic timing in pneumonia. Acad Emerg Med. 2007 Jun;14(6):545-8. doi: 10.1197/j.aem.2007.01.022. Epub 2007 Apr 30.
PubMed 17470905
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Antibiotic Use in Acute Care Setting
- ClinicalTrials.gov ID
- NCT00144040
- Acronym / sponsor ID
- IMPAACT / AVA 03-239
- Conditions
- Respiratory Infections
- Keywords
- Antibiotics, Respiratory Infections, Quality Assurance, Healthcare, Professional Education, Emergency Services, Medical, Education, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Feb 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 2 Sep 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.
Purpose The emergence and 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 rates 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. Although the rate of antibiotic prescribing for ARIs by office-based physicians in the US has decreased about 16% from its peak in 1997, the rate of antibiotic prescribing in acute care settings (eg, emergency departments and urgent care centers), which account for 1 in 5 ambulatory antibiotic prescriptions in the US, has shown only a modest decline (6%) during this period. Translation of lessons from intervention studies in office-based practices is needed to improve antibiotic use in acute care settings.
Detailed description
Objectives:
Specific Aim 1: To evaluate the impact of a multidimensional (patient, system, clinician) intervention on appropriate antibiotic use for adults with acute respiratory tract infections-- identifying factors that influence successful translation across VA hospital and non-VA hospital acute care. Specific Aim 2: To evaluate the impact of a rapid diagnostic test for c-reactive protein on antibiotic use for adults with acute cough illness when added to a multidimensional intervention.
Methods:
We propose to conduct a randomized controlled trial of a quality improvement program consisting of physician education (educational seminar, practice guidelines, performance feedback, and decision support tools) and patient education (waiting room print and audiovisual materials) in 8 VA hospital and 8 non-VA hospital emergency departments. Non VA study sites will be identified from an existing research network of hospital emergency departments--EDNet. VA hospital sites will be selected among academically affiliated hub facilities. Phase one will involve a hospital-level randomized trial of a multidimensional intervention to translate existing evidence based guidelines for antibiotic use in ARIs vs. usual care. Simultaneously, we will validate a new CRP-based diagnostic algorithm and incorporate it into the evidence based guidelines for antibiotic use in ARIs. Phase two will involve a second hospital-level randomized trial of the new antibiotic use guidelines that incorporate the CRP-based diagnostic algorithm vs. the original guidelines. Specific endpoints include the overall success of the intervention in each phase in terms of reducing antibiotic prescribing for ARIs, improving patient outcomes and reducing resource utilization. In addition we will examin the impact of VA and non-VA organizational factors on the successful translation of various components of the intervention in both phases. Data will be collected using existing administrative data as well as on-site enrollment of subjects in prospective follow-up studies.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Physician & patient education on appropriate antibiotic use, Procedure: Rapid C-reactive protein testing to guide antibiotic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Emergency room patient
- Selected VA or Non-VA patients
- Age 18 years or older
- Patient must have acute respiratory illness
- Patient must not have been seen in Emergency Department within 4 weeks
Key exclusion criteria (2 listed)
- Patients less than 18 years of age
- Patient in Emergency Department for non-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 |
|---|---|---|
| Physician & patient education on appropriate antibiotic use | Behavioural | Arm 1 |
| Rapid C-reactive protein testing to guide antibiotic treatment | Procedure or surgery | Arm 1 |
Primary outcome
Proportion of all acute respiratory infection visits treated with antibiotics
1 secondary outcome
Delayed antibiotic treatment of acute respiratory infections; Patient satisfaction
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 7 Apr 2015.
- Results publication: PubMed 15995102Metlay JP, Camargo CA Jr, Bos K, Gonzales R. Assessing the suitability of intervention sites for quality improvement studies in emergency departments. Acad Emerg Med. 2005 Jul;12(7):667-70. doi: 10.1197/j.aem.2005.01.012.
- Results publication: PubMed 16514122Gonzales R, Camargo CA Jr, MacKenzie T, Kersey AS, Maselli J, Levin SK, McCulloch CE, Metlay JP; IMPAACT Trial Investigators. Antibiotic treatment of acute respiratory infections in acute care settings. Acad Emerg Med. 2006 Mar;13(3):288-94. doi: 10.1197/j.aem.2005.10.016.
- Results publication: PubMed 17296803Vanderweil SG, Pelletier AJ, Hamedani AG, Gonzales R, Metlay JP, Camargo CA Jr. Declining antibiotic prescriptions for upper respiratory infections, 1993-2004. Acad Emerg Med. 2007 Apr;14(4):366-9. doi: 10.1197/j.aem.2006.10.096. Epub 2007 Feb 12.
- Results publication: PubMed 17488189Aspinall SL, Metlay JP, Maselli JH, Gonzales R. Impact of hospital formularies on fluoroquinolone prescribing in emergency departments. Am J Manag Care. 2007 May;13(5):241-8.
- Results publication: PubMed 17509729Metlay JP, Camargo CA Jr, MacKenzie T, McCulloch C, Maselli J, Levin SK, Kersey A, Gonzales R; IMPAACT Investigators. Cluster-randomized trial to improve antibiotic use for adults with acute respiratory infections treated in emergency departments. Ann Emerg Med. 2007 Sep;50(3):221-30. doi: 10.1016/j.annemergmed.2007.03.022. Epub 2007 May 23.
- Results publication: PubMed 17606087Nolt BR, Gonzales R, Maselli J, Aagaard E, Camargo CA Jr, Metlay JP. Vital-sign abnormalities as predictors of pneumonia in adults with acute cough illness. Am J Emerg Med. 2007 Jul;25(6):631-6. doi: 10.1016/j.ajem.2006.11.031.
- Results publication: PubMed 17470905Pines JM, Hollander JE, Lee H, Everett WW, Uscher-Pines L, Metlay JP. Emergency department operational changes in response to pay-for-performance and antibiotic timing in pneumonia. Acad Emerg Med. 2007 Jun;14(6):545-8. doi: 10.1197/j.aem.2007.01.022. Epub 2007 Apr 30.
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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
Philadelphia VA Medical Center, Philadelphia, PA
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician & patient education on appropriate antibiotic use and Rapid C-reactive protein testing to guide antibiotic treatment in people with Respiratory Infections, run by US Department of Veterans Affairs at 9 sites 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 5 inclusion and 2 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Proportion of all acute respiratory infection visits treated with antibiotics. 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 NCT00144040, which also lists 7 linked publications.
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 7 Apr 2015.