Evaluation of an Algorithm to Reduce Antibiotic Prescribing for Acute Bronchitis

Acute Respiratory Tract Infection Clinical Trial

Official title:

Development, Implementation, and Evaluation of Novel Strategies to Reduce Inappropriate Antimicrobial Use in Community and Healthcare Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981994
• Other study ID #: 5R01CI000611
• Status: Completed
• Phase: N/A
• First received: September 14, 2009
• Last updated: November 23, 2016
• Start date: October 2009
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3300
• Est. completion date: September 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Primary care practice sites within the Geisinger Health System

Exclusion Criteria:

• Sites with < 1000 visits per year for acute respiratory infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Behavioral:
• Decision Support for ARI Management
Use of history and physical examination findings to estimate probability of pneumonia in patients with acute respiratory infections and thereby guide treatment decisions

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Geisinger Clinic, University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of visits to primary care clinic associated with antibiotic prescriptions		30 days	No