Evaluation of an Algorithm to Reduce Antibiotic Prescribing for Acute Bronchitis
Primary Purpose
Acute Respiratory Tract Infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decision Support for ARI Management
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Tract Infection focused on measuring respiratory infection, antimicrobial drugs, decision support, Adult patients
Eligibility Criteria
Inclusion Criteria:
- Primary care practice sites within the Geisinger Health System
Exclusion Criteria:
- Sites with < 1000 visits per year for acute respiratory infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Electronic Decision Support
Paper Decision Support
Usual Care
Arm Description
Use of electronic decision support to provide the treatment algorithm for providers managing patients with acute respiratory infections.
Use of paper based tools to provide the treatment algorithm for providers managing patients with acute respiratory infections.
Usual Care
Outcomes
Primary Outcome Measures
Proportion of visits to primary care clinic associated with antibiotic prescriptions
Secondary Outcome Measures
Full Information
NCT ID
NCT00981994
First Posted
September 14, 2009
Last Updated
November 23, 2016
Sponsor
University of Pennsylvania
Collaborators
University of California, San Francisco, Geisinger Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00981994
Brief Title
Evaluation of an Algorithm to Reduce Antibiotic Prescribing for Acute Bronchitis
Official Title
Development, Implementation, and Evaluation of Novel Strategies to Reduce Inappropriate Antimicrobial Use in Community and Healthcare Settings
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
University of California, San Francisco, Geisinger Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Tract Infection
Keywords
respiratory infection, antimicrobial drugs, decision support, Adult patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic Decision Support
Arm Type
Experimental
Arm Description
Use of electronic decision support to provide the treatment algorithm for providers managing patients with acute respiratory infections.
Arm Title
Paper Decision Support
Arm Type
Experimental
Arm Description
Use of paper based tools to provide the treatment algorithm for providers managing patients with acute respiratory infections.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Decision Support for ARI Management
Intervention Description
Use of history and physical examination findings to estimate probability of pneumonia in patients with acute respiratory infections and thereby guide treatment decisions
Primary Outcome Measure Information:
Title
Proportion of visits to primary care clinic associated with antibiotic prescriptions
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary care practice sites within the Geisinger Health System
Exclusion Criteria:
Sites with < 1000 visits per year for acute respiratory infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua P Metlay, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralph Gonzales, MD,MS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23319069
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of an Algorithm to Reduce Antibiotic Prescribing for Acute Bronchitis
We'll reach out to this number within 24 hrs