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Agency Information Collection Activities: Proposed Collection; Comment Request

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Agency for Healthcare Research and Quality, HHS.




This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Standardizing Antibiotic Use in Long-term Care Settings.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.


Comments on this notice must be received by January 14, 2011.


Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by e-mail at

Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.

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Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by e-mail at

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Proposed Project

Standardizing Antibiotic Use in Long-term Care Settings

This project seeks to contribute to AHRQ's mission by optimizing antibiotic prescribing practices in nursing homes. Nursing homes serve as one of our most fertile breeding grounds for antibiotic-resistant strains of bacteria. Nursing home residents, with their combination of the effects of normal aging and multiple chronic diseases, have relatively high rates of infection. With high rates of respiratory, urinary, skin, and other infection comes a very high rate of antibiotic use that gives rise to Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococci (VRE), fluoroquinolone-resistant strains of a variety of bacteria, and multi-drug resistant organisms (MDROs). Inappropriate antibiotic prescribing practices by primary care clinicians caring for residents in long-term care (LTC) communities is becoming a major public health concern. Antibiotics are among the most commonly prescribed pharmaceuticals in LTC settings, yet reports indicate that a high proportion of antibiotic prescriptions are inappropriate.

In an effort to reduce antibiotic overprescribing, Loeb and colleagues Start Printed Page 69678developed minimum criteria for the initiation of antibiotics in LTC setting. The criteria have been tested in several studies, but their implementation and tests of validity have been limited. In particular, though Loeb and colleagues developed distinct minimum criteria for several types of infection (skin and soft-tissue, respiratory, urinary tract, and unexplained fever), a rigorous evaluation has been conducted only for urinary tract infections.

This project will assess an approach to using the Loeb criteria that requires minimal changes in facility procedures and, therefore, is likely to be widely adopted by nursing homes. The intervention makes use of a Communication and Order Form (COF), which has been designed by the researchers and will be used by the nurses and physicians to guide their decisionmaking about whether to order an antibiotic for a specific resident experiencing a specific infection. Twelve nursing homes will participate in this project with eight assigned to the intervention and four serving as controls. The eight intervention sites will be divided into two groups of four sites each, with one group receiving an additional follow-up training 2 months after the intervention.

The objectives of the study are to:

1. Implement a quality improvement (01) intervention program to optimize antibiotic prescribing practices;

2. Evaluate the effect of the 01 intervention on antibiotic prescribing practices including validation of the Loeb minimum criteria; and

3. Develop and execute a dissemination plan to ensure wide dissemination of the findings and recommendations for improving antibiotic prescribing behaviors in LTC settings.

This study is being conducted by AHRQ through its contractor, the American Institutes for Research (AIR), pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a (a) (1) and (2).

Method of Collection

The following data collection activities and trainings will be implemented to achieve the first two objectives of this project:

1. Loeb criteria communication and Order Form—This form will be completed by staff in the eight intervention nursing homes to determine if the Loeb criteria have been met. The COF provides a logical decision model for determining the need for an antibiotic. Facility staff will complete the paper form and the data from the forms will be entered into a database by the project researchers. Based on a preliminary review of the infection logs at 4 nursing homes, we estimate that staff nurses will complete an average of 17 COFs per month per nursing home at the 8 nursing homes that will use the COF during the 6-month intervention period.

2. Medical record reviews (MMR)—To be conducted by research staff to collect outcome data to determine antibiotic prescribing practices and their effects and to assess the resident's health and functional status, which are potentially important control variables. Outcome and control variables will be obtained by monthly chart review and review of the Nursing Home Minimum Data Set (MDS) for a period of nine months: three months preceding the initiation of the 01 intervention (for which the charts of all eligible residents will be abstracted for a 3-month period at one time), and every other month during a 6-month period following the inception of the intervention (for which the charts of all eligible residents will be abstracted for the preceding two months. AHRQ's contractor will conduct the data abstraction at all 12 facilities (treatment and control). Since this data collection will not impose a burden on the facility staff, OMB clearance is not required.

3. Staff training—Prior to implementation, the staff (administrators, nurses, and physicians) at all eight intervention sites will be trained in the proper use of the Loeb Criteria COF. Staff at four of the intervention sites will be trained a second time 2 months after the initial training. We estimate that an average of 24 nurses and 2 physicians will be trained at each nursing home.

4. Pre-implementation semi-structured interview—The purpose of this interview is to gain an understanding of: (1) How the staff and the department(s) and/or wider facility perceive quality improvement, in general; (2) the amount of experience the site has in QI and its processes for handling infections; (3) why the facility decided to adopt the Loeb Criteria COF; and (4) the facility's goals for the Loeb Criteria COF implementation. Four staff members will be interviewed at each nursing home: two champions (likely the administrator, director of nursing, and/or the assistant director of nursing), one line nurse, and one staff physician. Questions vary by respondent type.

5. Post-training semi-structured interview—The purpose of this interview is to measure the staff's: (1) Perceived adequacy of the training; (2) their reactions to the training; and (3) their plans for implementation. The same four persons at each nursing home who were interviewed for the pre-implementation semi-structured interviews will participate in this interview. Questions vary by respondent type.

6. Post-implementation semi-structured interview—The purpose of this interview is to identify: (1) Facilitators and barriers to implementation; (2) how barriers were overcome; (3) what barriers remain; (4) perceived impacts of the Loeb Criteria COF on the use of antibiotics within the facility; and (5) the facility's view on the business case for Loeb Criteria COF. The same four persons at each nursing home who participated in the previous semi-structured interviews will participate in this interview. Questions do not vary by respondent type.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the nursing homes' time to participate in this project. All of the data collections and training in Exhibit 1 pertain only to the eight intervention nursing homes. The Loeb Criteria COF will be completed approximately 17 times a month for 6 months (102 total) by staff at each nursing home and will require about 5 minutes to complete. Staff training will be attended by all nursing and medical staff members at each nursing home (an average of 24 nurses and two physicians per facility) and will last 1 hour. All eight intervention facilities will receive training once at the start of the intervention and four of the eight facilities will receive a second training one month later to see if reinforcement results in improved performance. The pre-implementation, post training and post-implementation semi-structured interviews will be completed by the same four staff members at each nursing home consisting of two champions (likely the administrator, director of nursing, and/or the assistant director of nursing), one line nurse, and one staff physician. Each interview will be scheduled for 1 hour. The total annual burden is estimated to be 476 hours.

Exhibit 2 shows the estimated annual cost burden associated with the respondents' time to participate in this project. The total annual cost burden is estimated to be $17,508.Start Printed Page 69679

Exhibit 1—Estimated Annualized Burden Hours

Form nameNumber of nursing homesNumber of responses per nursing homeHours per responseTotal burden hours
Loeb Criteria COF Staff training81025/6068
Initial Training8261208
Pre-implementation semi-structured interview84132
Post training semi-structured interview84132
Post-implementation semi-structured interview84132

Exhibit 2—Estimated Annualized Cost Burden

Form nameNumber of nursing homesTotal burden hoursAverage hourly wage rate*Total burden
Loeb Criteria COF Staff training868$33$2,244
Initial Training8208367,488
Pre-implementation semi-structured interview832421,344
Post training semi-structured interview832421,344
Post-implementation semi-structured interview832421,344
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2009, “U.S. Department of Labor, Bureau of Labor Statistics.” $33 is the average wage for nurses who will complete the COF. $36 is the weighted average wage of 24 nurses at $33 per hour and 2 physicians at $70 per hour who will be trained. $42 is the weighted average wage of 3 nurses and administrators at $33 per hour and 1 physician at $70 per hour who will be interviewed.

Estimated Annual Costs to the Federal Government

Exhibit 3 shows the estimated total and annual cost to the government for funding this project. Although data collection will require less than one year, the entire project will span 2 years. The total cost of this research is estimated to be $999,554.

Exhibit 3—Estimated Total and Annualized Cost

Cost componentTotal costAnnualized cost
Project Development$103,498$51,749
Data Collection Activities361,178180,589
Data Processing and Analysis193,83096,915
Publication of Results48,49724,249
Project Management65,33432,667

Request for Comments

In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

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Dated: November 4, 2010.

Carolyn M. Clancy,


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[FR Doc. 2010-28367 Filed 11-12-10; 8:45 am]