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Ranji SR, Steinman MA, Shojania KG, et al. Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies (Vol. 4: Antibiotic Prescribing Behavior). Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Jan. (Technical Reviews, No. 9.4.)

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Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies (Vol. 4: Antibiotic Prescribing Behavior).

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Appendix ASummary of Key Studies

Antibiotic Treatment Decision Studies

Finkelstein et al: Reducing antibiotic use in children: a randomized trial in 12 practices (Pediatrics 2001; 108(1): 1–7)

This quasi-randomized controlled trial, conduced in 12 Managed Care Organizations (MCOs) in Massachusetts and Washington state, demonstrates the effectiveness of repeated, active clinician education in combination with parent education in reducing antibiotic prescribing to children.

In this trial, practices were randomly assigned to intervention or comparison groups (after stratification by size and baseline prescribing rate). The clinician intervention consisted of academic detailing sessions, led by a practicing pediatrician “peer leader”; at these interactive 90-minute small-group sessions, the groups engaged in discussions on potential ways to prevent overuse of antibiotics. Approximately 4 months later, the peer leaders conducted another educational session at which the groups received feedback on their practice- and clinician-specific prescribing practices. In the parent intervention (conducted contemporaneously), each family in the MCO was mailed CDC-produced pamphlets, 44 reinforced by pamphlets and posters in waiting rooms. The control groups did not receive either clinician or parent education.

During this trial, which was conducted in the late 1990s, there was a substantial secular trend toward reduced antibiotic prescribing; in the comparison groups, antibiotic prescribing declined by 0.17 – 0.33 prescriptions per person-year (for children 36 – 72 months old and 3 – 36 months old, respectively). Despite this, the intervention still achieved a 12 – 16% relative reduction in prescribing rates in the two groups. At the practice level, this resulted in absolute reductions of 0.23 fewer antibiotic courses per person-year for children aged 3 – 36 months, and 0.13 fewer antibiotic courses per person-year for children aged 36–72 months. To arrive at these results, the investigators carried out statistical analyses accounting for clustering of patients within clinics.

This study used an intensive clinician and patient education intervention to achieve significant reductions in antibiotic prescribing in a managed care setting. This trial clearly demonstrates the value of active, repeated clinician education. It also demonstrates that a quality improvement intervention can successfully reduce inappropriate prescribing even while prescribing rates are declining overall.

Gonzales et al: Decreasing antibiotic use in ambulatory practice: Impact of a multidimensional intervention on the treatment of uncomplicated acute bronchitis in adults (JAMA 1999; 281: 1512–1519)

This study provides an example of a rigorously conducted, comprehensive intervention targeting clinicians and patients in a health maintenance organization (HMO). Conducted in Kaiser Permanente clinics in Denver, Colorado, this non-randomized controlled trial targeted antibiotic prescribing for acute bronchitis in adults.

The study contained three sites: a “full intervention” site, a “limited intervention” site, and a control site. Before the trial, the investigators conducted preliminary studies to identify why clinicians prescribed antibiotics and why patients expected antibiotic treatment for bronchitis. The intervention was then targeted to specifically address these factors. In both intervention sites, each enrolled patient household received mailed educational materials (such as refrigerator magnets and pamphlets). Office-based educational materials directed at clinicians and patients included colorful posters and pamphlets placed in waiting rooms and examination rooms. The importance of reducing inappropriate antibiotic prescribing was emphasized through a letter to all patients from the medical director of the organization. The “limited intervention” site received only the office-based and household educational materials; the “full intervention” site received the office and household educational materials as well as a clinician education session, a one-time educational intervention conducted at regularly scheduled staff meetings. This intervention consisted of education on the evidence-based management of acute bronchitis, advice on communication skills to deal with patient expectations, and practice-specific feedback on baseline prescribing rates. This intervention was conducted by the medical director of the clinic.

The study was conducted in a methodologically rigorous fashion; in addition to conducting preliminary studies to identify a specific quality gap and target the intervention, the study used a comparable comparison group with contemporaneous measurements, with outcomes assessors blinded to treatment group assignment. The statistical analysis took into account potential clustering of clinician prescribing practices by site.

The full intervention significantly reduced antibiotic prescribing. At baseline, 74% of patients received antibiotics for acute bronchitis; this fell to 48% after the intervention. Little change in prescribing rates was seen in both the limited intervention site and control site (prescribing rates went from 78% to 76% and 82% to 77%, respectively). In addition to measuring prescribing rates, the investigators also assessed the safety of the intervention by measuring the percentage of patients diagnosed with pneumonia at a return visit (there was no difference between groups). They also addressed potential confounders such as “code shifting.” (Theoretically, an intervention to reduce antibiotic prescribing for bronchitis could have resulted in clinicians shifting diagnoses to conditions more likely to warrant antibiotics, such as acute sinusitis.) They found no evidence of it.

This study highlights several key intervention characteristics. First, the use of preliminary studies to identify reasons for inappropriate prescribing allowed the investigators to tailor their intervention appropriately. While the purely passive limited intervention had no effect, when the more active clinician education session was added (the full intervention), the results were striking. Pairing the focused clinician intervention with high-visibility strategies such as exam room posters likely helped reinforce the message to clinicians. The involvement of high-level management may also have helped the success of the intervention. Finally, the methodological rigor of the study as well as the attention paid to documenting the absence of potentially harmful consequences of the intervention reinforces the conclusions.

Perz et al: Changes in antibiotic prescribing for children after a community-wide campaign (JAMA 2002; 287(23): 3103–3109)

This study demonstrates the effectiveness of a community-wide campaign to reduce inappropriate antibiotic prescribing to children for respiratory infections. The intervention in this non-randomized controlled trial took place in Knox County, Tennessee, with a control group consisting of three other Tennessee counties. The study measured the effect on antibiotic prescriptions for children under 15 years of age enrolled in the Tennessee Medicaid Managed Care Program (TennCare).

The intervention targeted clinicians, parents, and the general public through a multifaceted approach. The main goals of the intervention were to reduce antibiotic prescribing for non-bacterial illnesses, particularly acute respiratory infections (ARIs); and to increase the prescribing of narrow-spectrum antibiotics for bacterial illnesses. Clinicians received an intensive educational intervention consisting of lectures and presentations in a variety of settings (hospital staff meetings, grand rounds, CME seminars, and resident conferences). Prescribing guidelines for ARIs were distributed to clinicians, and articles on the campaign were mailed to all physicians in Knox County. Parent education pamphlets (developed by the CDC 44 were distributed to parents of all children in day care and grades K-3, as well as to parents of all newborns. Clinicians also received patient education materials to distribute in their offices. An effort to reach the entire population was made by distributing over 100,000 pamphlets to hospitals, clinics, dental offices, and pharmacies; the campaign was further publicized through mass media efforts such as television, radio, and newspaper public service announcements. The control counties engaged in no organized efforts to reduce or rationalize antibiotic prescribing during this time.

Investigators used negative binomial regression models to determine the effect of the intervention on adjusted prescription rates, with a random-effect model used to account for heterogeneity within the counties. The visit rates for respiratory illnesses was measured as well, to account for the possibility that changes in prescribing could be confounded by changes in visit rates. The rates of antimicrobial resistance among cases of invasive Streptococcus pneumoniae infection were also measured.

After the year-long intervention, an 11% intervention-attributable decline in total antibiotic prescriptions for children was found in the intervention county. This translates to an approximate savings of 23 antibiotic prescriptions per 1000 children per year. No change in respiratory illness visit rates was found, indicating that physicians were truly prescribing antibiotics to a smaller proportion of patients. Antimicrobial resistance rates were high at baseline (>50% for penicillin) and did not change over the 3-year study period.

The investigators multifaceted approach, targeting the general public, parents, and clinicians, achieved impressive reductions in antibiotic prescribing. This demonstrates the viability of a community-based campaign to reduce general antibiotic prescribing in an area where baseline prescribing rates were high. This study was one of the few to use mass media advertisements to educate the public on the problem of inappropriate prescribing. The study was methodologically sound, using appropriate models to determine the effect of the intervention.

Antibiotic selection studies

Hux et al: Confidential prescriber feedback and education to improve antibiotic use in primary care: a controlled trial (Canadian Medical Association Journal 1999; 161: 388–92)

Conducted in Ontario in the mid-to-late 1990s, this randomized controlled trial provides a case example of the effectiveness of passively-delivered clinician feedback and education.

Study investigators provided mailed packages of feedback on antibiotic prescribing practices (based on claims data obtained from the province's prescription drug claims database), accompanied by brief educational bulletins to primary care physicians. These packages were sent every 2 months over a 6-month period. The goal of the intervention was to encourage use of first-line antibiotics as suggested by guidelines written by a provincial panel. The comparison group was consented but was provided no materials during the study period, although it was promised feedback information after completion of the study.

Among the 250 participating physicians, the proportion of visits in which a first-line antibiotic was prescribed was 67.2% in the intervention group and 68.5% in the comparison group at baseline. After implementation of the intervention, the proportion of visits involving first-line antibiotic prescriptions rose by 2.6% in the intervention group, compared with a 1.7% decline in the comparison group, a statistically significant difference.

This study highlights the general finding that passively-delivered feedback and education can result in statistically significant improvements in antibiotic selection, but that the magnitude of the change tends to be small.

MacCara et al: Impact of a limited fluoroquinolone reimbursement policy on antimicrobial prescription claims (Annals of Pharmacotherapy 2001; 35: 852–8)

This study is a case example of the potential power of regulatory interventions. In this interrupted time series analysis conducted in the mid-to-late 1990s in Nova Scotia, the investigators evaluated the impact of a change in provincial guidelines governing the reimbursement of fluoroquinolones for elders aged 65 and older enrolled in the province's pharmaceutical care program.

In early 1997, new guidelines were instituted that required completion of additional paperwork certifying that the drug was being prescribed for one of several guideline-approved uses, which was delivered with the prescription to the pharmacy. Data was obtained from the province's drug plan claims database.

In the 12 months before and after institution of the policy, fluoroquinolone use fell from 20.2% to 4.2% of antibiotic prescriptions for elders, a relative reduction of 80%. This reduction was immediate. Use of other antibiotics rose, such that overall antibiotic use remained stable.

This study demonstrates the power of regulatory interventions, which in this case resulted in an immediate and dramatic decline in fluoroquinolone use. Like other research in this area, this study did not report the impact of the intervention on quality indicators or on potential patient harms, for example the number of patients whose clinical situation merited a fluoroquinolone but who did not receive the drug.

Schaffner et al: Improving antibiotic prescribing in office practice: a controlled trial of three educational methods. (JAMA 1983; 250: 1728–1732)

Conducted in the early 1980s in Tennessee, this non-randomized controlled study provides important insight into the relative value of different forms of educational outreach and mailed materials.

The investigators delivered three separate interventions to 300 physicians in geographically distinct areas of the state: (1) a mailed brochure; (2) visits by a pharmacist who was trained as a “drug educator,” and (3) visits by physicians who were trained as “physician counselors.” Each type of visit lasted less than 15 minutes. A fourth area of the state served as a comparison group. The goal of the interventions was to reduce use of non-recommended antibiotics, and to reduce use of the oral cephalosporins (as a cost-saving measure). Data on antibiotic utilization were measured using Medicaid claims data for the year before and after the intervention.

The prescribing practices of physicians receiving the mailed brochure were very similar to the comparison group, and the two groups were combined for analyses. In this combined comparison group, use of both types of medications declined substantially (41% relative reduction in prescriptions for non-recommended antibiotics, and 33% for oral cephalosporins). In the intervention arms, the use of physician counselors was the most effective intervention, resulting in an 85% relative reduction in non-recommended antibiotic use, and a 50% reduction in oral cephalosporin use. Pharmacist drug educators were less effective in reducing the use of non-recommended antibiotics (67% relative reduction); they were no more effective than mailed brochures in reducing the use of oral cephalosporins (35%).

This study highlights several important points. First, it exemplifies the general finding that active educational outreach is more effective than passive forms of education (such as mailed brochures). Second, it highlights that not all forms of outreach are equally effective; what is unclear is whether the differences were due to the relative effectiveness of a physician vs. a pharmacist in general, or due to individual characteristics of the persons conducting the outreach. Third, this study highlights the importance of controlling for secular trends in antibiotic use, which may be substantial. Finally, it provides a model for examining different types of interventions head-to-head, thereby addressing the problems intrinsic to inter-study comparisons.

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