Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144040
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-08-31
Brief Title:
Improving Antibiotic Use in Acute Care Treatment
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Antibiotic Use in Acute Care Setting
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPAACT
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01 HF13915 | None | None | None |