search
Back to results

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
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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

    First Posted
    September 14, 2009
    Last Updated
    November 23, 2016
    Sponsor
    University of Pennsylvania
    Collaborators
    University of California, San Francisco, Geisinger Clinic
    search

    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