[Federal Register Volume 75, Number 20 (Monday, February 1, 2010)]
[Notices]
[Pages 5084-5086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: 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: ``Evaluation of the GuideLines Into Decision Support 
(GLIDES).'' In accordance with the Paperwork Reduction Act of 1995, 44 
U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this 
proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on November 27th, 2009 and allowed 60 days for 
public comment. No comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by March 3, 2010.

ADDRESSES: Written comments should be submitted to: AHRQs OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
e-mail at [email protected] (attention: AHRQ's desk 
officer).
    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.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by e-mail at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

Evaluation of the GuideLines Into Decision Support (GLIDES)

    With this project AHRQ proposes to evaluate how the translation of 
clinical knowledge into clinical decision support can be routinized in 
practice and taken to scale in ways that improve the quality of 
healthcare delivery for children in the U.S. Previously in the GLIDES 
project, AHRQ designed and implemented decision support tools based on 
guidelines for the prevention of pediatric overweight and obesity and 
the management of chronic asthma in the pediatric population 
(publication forthcoming). In this phase of the project, conducted for 
AHRQ through a contract with Yale University and Nemours, physicians 
will be surveyed about their experiences with the decision support 
tools developed in the previous phase. The participating study 
institutions (Yale University and Nemours) are geographically and 
organizationally diverse, and include a wide range of patients from a 
variety of social, economic and ethnic backgrounds. This project 
directly addresses AHRQ's mission of improving health systems 
practices, in particular for priority populations, including low-income 
groups, minority groups, women, children, and individuals with chronic 
diseases. See 42 USC 299(c)(1)(B).
    The evaluation plan includes a physician survey component and an 
extraction of electronic medical record data. Participating physicians 
will be surveyed about their experiences with the decision support 
tools developed for this project. This will allow AHRQ to evaluate the 
fulfillment of knowledge transformation goals and the effectiveness of 
the decision support tools in improving the quality of health care at 
the chosen sites. Without such an evaluation, it would be difficult to 
determine whether this project has met AHRQ's goals of enhancing the 
``quality, appropriateness and effectiveness of health services.'' See 
42 USC 299(b); 42 USC 299a(a)(1). Consequently, it is necessary to 
collect this information to fulfill AHRQ's mission.

Method of Collection

    Self-administered questionnaires will be used to elicit physicians' 
general opinions of guideline-based care and clinical decision support 
tools on a five point Likert-type scale. Results from low-utilizing 
physicians will be compared to high-utilizing physicians to determine 
whether general opinions of guidelines and technology correlate with 
actual practice. Results will also be analyzed by demographic 
characteristics included in the survey questionnaire to determine 
whether opinions vary by age, degree of computer experience and skill, 
level of training and professional degree. These analyses will be 
important to future studies and decision support designers because they 
will help us understand whether interventions need to be targeted 
differently to different audiences. For example, senior level 
specialists may have less desire or need for clinical decision support 
tools than novice generalists have. In-person qualitative interviews 
lasting approximately 30 minutes will be conducted with key personnel 
at each site (including physicians, nurse practitioners, and 
respiratory therapists). Participants will remain anonymous in the 
transcribed interviews. The interviews will be analyzed using standard 
qualitative techniques to explore barriers and facilitators to using 
the clinical decision support tool. The Human Investigation Committee 
(HIC) at Yale University has reviewed this protocol. The HIC found the 
survey study to be exempt from review under 45 CFR 46.101(b)(2). The 
HIC approved the interview study and required signed informed consent 
from participants.
    Electronic medical record data will be extracted into an electronic 
spreadsheet for analysis. This extraction will occur at regular 
intervals to ensure continued maintenance and uptake of the tool. 
Utilization of the decision support tools at the provider and site 
level will be assessed based on the rate of electronic chart 
documentation. This is important to determine the rate of uptake of the 
intervention, as well as to determine whether there are any flaws in 
the design of the tool. Congruence of actual

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practice with guideline recommendations will be assessed based on 
automatically generated disagreement flags in the electronic medical 
record as well as by manual chart review. This data collection, 
including the manual chart review, will be performed by project staff 
and will not impose a burden on the participating sites. In addition, 
project staff will directly observe a random sampling of clinicians 
using the tool in clinical settings to determine how the tool affects 
workflow. These observations will not require any effort, time or 
action on the part of the clinicians themselves and will not impose a 
burden on the participating sites.
    Signed informed consent will be obtained prior to any observations. 
The Human Investigation Committee at Yale University has reviewed this 
protocol. It approved the medical record review, approved direct 
observation of clinicians and interviews of clinicians, required signed 
informed consent from clinicians, granted a waiver of informed consent 
from patients per 45 CFR 46.116(d), and granted a waiver of HIPAA 
authorization.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this research. The Asthma 
Management and Clinical Decision Support System Usability and User 
Satisfaction Survey (asthma questionnaire) will be completed by 172 
health care professionals across 3 sites and is expected to require 
about 6 minutes to complete. The Obesity Prevention and Clinical 
Decision Support System Usability and User Satisfaction Survey (obesity 
questionnaire) will be completed by 82 health care professionals across 
2 sites and is expected to require about 6 minutes to complete. The in-
person interviews will be conducted with a total of 50 clinicians at 3 
sites and are expected to last 30 minutes each. The total burden is 
estimated to be 51 hours.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondents' time to participate in this research. The total 
cost burden is estimated to be $2,781.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                Number of
                Form name                  Number of sites    responses per       Hours per       Total burden
                                                                  site            response            hours
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Asthma questionnaire--Yale..............                 2                31              6/60                 6
Asthma questionnaire--Nemours...........                 1               110              6/60                11
Obesity questionnaire--Yale.............                 1                57              6/60                 6
Obesity questionnaire--Nemours..........                 1                25              6/60                 3
In-person interviews--Yale..............                 2                15             30/60                15
In-person interviews--Nemours...........                 1                20             30/60                10
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    Total...............................                 8  ................  ................                51
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                              Total burden     Average hourly      Total cost
                Form name                  Number of sites        hours          wage rate*          burden
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Asthma questionnaire--Yale..............                 2                 6            $59.83              $359
Asthma questionnaire--Nemours...........                 1                11             59.83               658
Obesity questionnaire--Yale.............                 1                 6             47.25               284
Obesity questionnaire--Nemours..........                 1                 3             47.25               142
In-person Interviews--Yale..............                 2                15             53.54               803
In-person Interviews--Nemours...........                 1                10             53.54               535
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    Total...............................                 8                51  ................             2,781
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*Based upon the mean of the average wages for other physicians and surgeons, general pediatricians, and
  pediatric trainees (asthma questionnaire), and general pediatricians and pediatric trainees (obesity
  questionnaire), National Compensation Survey: Occupational wages in the United States 2008, ``U.S. Department
  of Labor, Bureau of Labor Statistics,'' and Yale Pediatric Residency Program, 2008.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the total and annualized cost for this research. 
Since this project will not exceed one year the total and annualized 
costs are identical. The total cost is estimated to be $5,703.

             Exhibit 3--Estimated Total and Annualized Cost
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           Cost component                Total cost      Annualized cost
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Project Development.................            $1,406            $1,406
Data Collection Activities..........               416               416
Data Processing and Analysis........               780               780
Publication of Results..............             1,601             1,601
Project Management..................               200               200
Overhead............................             1,299             1,299
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    Total...........................             5,703             5,703
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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 health care research, quality improvement and 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.

    Dated: January 25, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-1894 Filed 1-29-10; 8:45 am]
BILLING CODE 4160-90-M