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Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians

Primary Purpose

Increased Drug Resistance, Infectious Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention: Education, Decision Support Tools
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Increased Drug Resistance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinic practices within Denver Health's Webb Center for Primary Care,
  2. Clinic practices within the University of Colorado - Anschutz Campus: General Internal Medicine Clinic,
  3. Clinic practices within the High Plains Network, and
  4. 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:

  1. 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,
  2. 30-day events (hospitalizations,
  3. Note: Emergency Department (ED) visits, or grade 3 or grade 4 abnormalities), will also be included in this study.

Exclusion Criteria:

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.

Sites / Locations

  • Denver Health and Hospitals Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention: Education, Decision Support Tools

No education, no implemented decision support tools

Arm Description

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.

Clinics randomized to the control will not participate in the education intervention and implementation of decision support tools.

Outcomes

Primary Outcome Measures

Change in antibiotics prescribing behavior

Secondary Outcome Measures

The number and type of changes made to workflow processes when setting up or changing systems to change prescribing methods

Full Information

First Posted
November 3, 2009
Last Updated
October 5, 2015
Sponsor
University of Colorado, Denver
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01099943
Brief Title
Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians
Official Title
Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Increased Drug Resistance, Infectious Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Education, Decision Support Tools
Arm Type
Experimental
Arm Description
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.
Arm Title
No education, no implemented decision support tools
Arm Type
No Intervention
Arm Description
Clinics randomized to the control will not participate in the education intervention and implementation of decision support tools.
Intervention Type
Other
Intervention Name(s)
Intervention: Education, Decision Support Tools
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in antibiotics prescribing behavior
Time Frame
December 2009 through August 2011
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R West, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health and Hospitals Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians

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