I. TECHNICAL PROPOSAL COVER PAGE PROJECT INFORMATION

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1 I. TECHNICAL PROPOSAL COVER PAGE PROJECT INFORMATION Solicitation Number: RFP: AHRQ-PBRN Request for Task Order (RFTO) #16 Reducing Inappropriate Prescribing of Antibiotics by Primary Care Clinicians - MODIFICATION APPLICANT INFORMATION Proposing Organization: Pediatric Research Consortium (PeRC) The Children s Hospital of Philadelphia Author: Theoklis Zaoutis, MD MSCE Title: Associate Professor of Pediatrics, Division of Infectious Diseases Department: Pediatrics, Division of Infectious Diseases Institution: The Children s Hospital of Philadelphia Address: 34 th & Civic Center Boulevard Philadelphia, PA (Philadelphia County) Telephone: Fax: (215) zaoutis@ .chop.edu INSTITUTION INFORMATION Name: Sara Dubberly Title: Director, Sponsored Projects Department: Sponsored Projects and Research Business Office Institution: The Children s Hospital of Philadelphia Address: Joseph Stokes, Jr. Research Institute 3615 Civic Center Boulevard Philadelphia, PA (Philadelphia County) Telephone: (267) Fax: (215) stokes@ .chop.edu DUNS Number: TIN: CERTIFICATION AND SIGNATURES The undersigned reviewed this proposal for the above-noted solicitation and are familiar with the terms, conditions, and provisions of the Agency for Healthcare Research and Quality (AHRQ) concerning this contract support, and accept the obligation to comply with all such terms, conditions, and provisions. Theoklis Zaoutis, MD MSCE Applicant Signature Date Sara Dubberly Institutional Official Signature Date

2 Background & Specific Aims Antibiotic overuse in the ambulatory setting presents a significant threat to public health by promoting antimicrobial resistance and causing avoidable drug-related adverse effects. Inappropriate antibiotic prescribing occurs both for viral infections, for which antibiotics are not indicated, and for bacterial infections amenable to narrow spectrum antibiotic therapy, for which broad spectrum antibiotics are given. Although the most effective means to influence physician antibiotic prescribing remains unclear, studies suggest that active physician education; guideline development with attention to potential barriers to adherence; and audit and feedback of physician prescribing with benchmarking may improve antibiotic use. Based upon these principles, we designed and implemented a cluster-randomized trial to improve antibiotic prescribing for respiratory tract infections throughout a large, diverse pediatric primary care network. Specifically, the intervention coupled clinician education with audit and feedback of antibiotic prescribing targeting 1) antibiotic prescribing for viral infections and 2) broad-spectrum antibiotic prescribing for conditions for which narrow-spectrum agents are indicated. Our preliminary data suggest that this intervention has reduced inappropriate antibiotic prescribing. Considering this, we propose to expand upon our initial goals by 1) evaluating the durability of the intervention; 2) describing clinician impressions and acceptance of the intervention; and 3) packaging the intervention for broad dissemination. Aim 1: To extend the period of observation following the initial intervention to determine the durability of its effect on antibiotic prescribing. (Hypothesis: Clinicians from the intervention group will maintain post intervention antibiotic prescribing rates for 12 months beyond the final feedback reports.) Aim 2: To gather qualitative data describing clinician impressions of the intervention and attitudes toward outpatient antimicrobial stewardship. (Hypothesis: We will obtain qualitative data from clinicians exposed to the intervention that will inform further studies designed to improve antibiotic prescribing by this cohort.) Aim 3: To standardize and package the outpatient antimicrobial stewardship bundle to facilitate its dissemination to additional primary care practices. (Hypothesis: A generic, user-friendly instructional package of clinician education materials and technical guidance for creating feedback reports can be developed.) Preliminary Data In addition to identifying significant variability in antibiotic prescribing across practices, our preliminary data suggest that inappropriate antibiotic prescribing has declined in the intervention group at a greater rate that that seen in the controls (Figures 1 and 2). Data from 9 intervention sites and 9 control sites, all members of the CHOP Care Network, were collected from June 2009 through January The education and feedback intervention described in the initial Task Order submission began in June Demographic characteristics of the cohort are displayed in Table 1. Table 1: Characteristics of study cohort, June 2009-January 2011 Characteristic Total Intervention Practices Control Practices Number of providers (50%) 78 (50%) Number of unique patients 161,962 80,109 (49%) 81,853 (51%) Total office visits 768, ,196 (50%) 382,629 (50%) Office visits with antibiotic Rx 147,006 76,212 (20%) 70,794 (19%) Median age in years (IQR) 7 (3, 12) 7 (3, 12) 7 (2, 12) Office visits for viral dx 40,607 23,118 (6%) 17,489 (5%) Office visits for Group A Strep 10,693 5,900 (2%) 4,793 (1%) Office visits for sinusitis 13,518 6,532 (2%) 6,986 (2%) Office visits for pneumonia 3,707 1,906 (1%) 1,801 (1%) We observed the rates of broad-spectrum antibiotic prescribing by clinicians in control (0) and intervention (1) sites (Figure 1). The intervention group experienced approximately an 8% decrease in the rate of broad antibiotic prescription between June 2010 (month 0) and January 2011 (month 7), and an approximate overall decrease of 15% between June 2009 (month -12) and January 2011 (month 7). The control group experienced

3 approximately a 5% decrease in the rate of broad antibiotic prescription between June 2010 (month 0) and January 2011 (month 7), and an approximate overall decrease of 6% between June 2009 (month -12) and January 2011 (month 7). The control group experienced approximately a 3% decrease in the rate of broad antibiotic prescription between May 2010 (month -1) and January 2011 (month 7), while the intervention group experienced a decrease of 9% in the rate of broad antibiotic prescription in the same time period. This measurement was calculated in order to assess drift in the rate of utilization not associated with treatment but due to randomization of the intervention sights. Figure 1: Broad antibiotic use among intervention and control sites, June 2009-January 2011 Figure 2: Broad antibiotic use for bacterial respiratory tract infections among intervention and controls sites, June 2009-January 2011

4 We observed the rates of broad antibiotic utilization among control (0) and intervention sites (1) for the treatment of common bacterial respiratory tract infections (GAS, sinusitis, pneumonia) (Figure 2). The intervention group experienced approximately a 9% decrease in the rate of broad antibiotic prescription between June 2010 (month 0) and January 2011 (month 7), and an approximate overall decrease of 25% between June 2009 (month -12) and January 2011 (month 7). The control group experienced approximately a 6% decrease in the rate of broad antibiotic prescription between June 2010 (month 0) and January 2011 (month 7), and an approximate overall decrease of 13% between June 2009 (month -12) and January 2011 (month 7). The control group experienced approximately a 7% decrease in the rate of broad antibiotic prescription for RTIs between May 2010 (month -1) and January 2011 (month 7), while the intervention group experienced a decrease of 12% in the rate of broad antibiotic prescription for RTIs in the same time period. Again, this measurement was calculated in order to assess drift in the rate of utilization not associated with treatment but due to randomization of the intervention sights. Research Design and Methods Approach Although our preliminary analyses reveal an effect of the intervention on antibiotic prescribing, the durability of this effect has not been determined, which will inform the frequency and intensity required to change practice. Thus, the study design for Aim 1 will involve an extension of the observation period following the ongoing, cluster-randomized controlled trial of education and audit & feedback of prescribing data to improve inappropriate antibiotic use. Again, although the unit of observation is the practitioner, we randomized the physician intervention at the practice level; thus, all physicians within a particular geographic practice were assigned to the same group. In addition to the 12 months of retrospectively obtained baseline prescribing data and 12 months of data following the start of the intervention, we will observe antibiotic prescribing for 12 months from the end of the intervention. A manuscript will be prepared and submitted to a peer-reviewed journal summarizing the results of this extended observation. The goal of Aim 2 is to gather qualitative data from clinicians who received the intervention to identify ways to improve its effectiveness. The goal of this data acquisition will be to improve the format of the final product for dissemination (outlined in Aim 3); these data will not be analyzed for the purpose of publication. To accomplish this, we will conduct focus groups and structured interviews of participating clinicians. In these sessions, Dr. Kristen Feemster, an epidemiologist with training and experience in mixed methods who was not part of the group presenting the intervention, will moderate each focus group. The goals will include assessing clinician perceptions of the intervention, including the effectiveness of the education, feedback, and impedance to workflow; identifying clinician attitudes toward antimicrobial stewardship, guidelines, and incentive-based practice; and collecting suggestions for improvements to the design. Dr. Feemster will work with the current research team to develop an appropriate script to facilitate such discussion, and with Dr. Localio to analyze these data. A maximum of 9 clinicians will be included in each group (representing the size of the largest practice group in the intervention), and sessions will be conducted during scheduled, on-site monthly practice meetings with breakfast or lunch provided (as with the initial education session). The purpose of Aim 3 is to standardize and package the outpatient antimicrobial stewardship bundle to facilitate its dissemination to additional primary care practices. This package will include 1) a template for clinician education on antibiotic prescribing for common respiratory tract infections, consisting of a narrated PowerPoint presentation with indications of topics that may require site-specific customization (e.g. following local antibiograms for drug selection, adapting for adolescent-heavy practices), and 2) a list of required data fields to perform an effective prescribing audit along with a macro for analyzing results and generating feedback reports. The goal is to develop a practice and EMR vendor agnostic mechanism for mimicking the outpatient antimicrobial stewardship bundle. The materials will be 508 compliant and suitable for AHRQ-led dissemination without additional support from CHOP. Subjects Of 24 eligible CHOP Primary Care Center sites, 22 enrolled. Of these, two groups of three sites were staffed by the same group of clinicians; thus, 18 sites were randomized to intervention and control groups (9 in each). Aims 1 and 2 will target these same subjects.

5 Data analysis Aim 1 will examine the effect of the proposed intervention on the process of care, where endpoints are (1) inappropriate prescribing of antibiotics, and (2) inappropriate use of broad-spectrum antibiotics. We will employ both descriptive analysis of changes within and among sites, as well as multivariable repeated measures analysis using generalized linear models. Again, individual clinicians will be followed over time and the repeated measures will allow each clinician to serve as his or her control. This design benefits from the both the strength of a randomized control group not subject to selection bias and the strength of quasi-experimental designs in which individuals are followed over time after a baseline period of assessment. Aim 2 will use a mixed methods approach to identify common themes from focus groups to describe practitioner impressions and improve the intervention. Data Collection and management will occur as described in the original proposal. Deliverables and Timeline The proposed work will take 12 months, beginning in September 2011: Year 1 Task/Deliverable Qtr 1 Qtr 2 Qtr 3 Qtr 4 IRB approval Data collection Arrange focus group sessions Conduct focus group sessions Data analysis Manuscript prep Deliverables Monthly ARRS progress report Monthly progress calls with COTR Final project and analysis plans Draft manuscript of extended obs Final manuscript of extended obs Draft final report Final report Key Personnel Theoklis E. Zaoutis MD MSCE, the Principal Investigator for this application, is Associate Professor of Pediatrics and Epidemiology at the University of Pennsylvania School Of Medicine and Associate Chief in the Division of Infectious Diseases at CHOP. He will supervise all aspect of the study. Jeffrey S. Gerber MD, PhD, MSCE, a co-investigator for this application, is Instructor of Pediatrics in the Division of Infectious Diseases and Director of the Antimicrobial Stewardship Program at CHOP. Dr. Gerber will be responsible for protocol development, supervising the study coordinator regarding the collection and management of study data, and contributing to data interpretation and publication of results. Kristen A. Feemster, MD, MPH, a co-investigator for this application, is Assistant Professor of Pediatrics in the Division of Infectious Diseases at CHOP. Dr. Feemster will help design, conduct, and interpret and analyze the results of clinician focus groups. Russell Localio, PhD is Associate Professor of Biostatistics and Epidemiology at the Penn Center for Clinical Epidemiology and Biostatistics. Dr. Localio will help plan all aspects of data collection; monitor all data collection and management; and both plan and conduct the statistical analyses. James Massey, RN, BSN, CCRC is Network Director for PeRC, responsible for the operational oversight of the network. He will serve as the Administrator for this task order, facilitating protocol review and acceptance by PeRC leadership and overseeing implementation into the outpatient practices. Priya Prasad, MPH, the study coordinator, will coordinate focus group office visits with investigators and participants, participate in data collection, management, and analysis, and handle IRB submissions and continuing reviews. Mark Ramos, an informatics expert, will be responsible for retrieval of data from the electronic medical record a task he has performed effectively through the first 2 years of this contract.