[Federal Register Volume 74, Number 227 (Friday, November 27, 2009)]
[Notices]
[Pages 62327-62329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28210]


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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.

DATES: Comments on this notice must be received by January 26, 2010.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail at 
[email protected].
    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

[[Page 62328]]

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 U.S.C. 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 U.S.C. 299(b); 42 U.S.C. 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 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     responses per     Hours per     Total burden
                                                       sites           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
                                                 ---------------------------------------------------------------
    Total.......................................               5              na              na              51
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[[Page 62329]]


                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                       sites           Hours         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
Interviews--Yale................................               1              15           53.54             803
Interviews--Nemours.............................               1              10           53.54             535
                                                 ---------------------------------------------------------------
    Total.......................................               5              51              na           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
----------------------------------------------------------------------------------------------------------------
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
                                                               -------------------------------------------------
    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: November 16 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-28210 Filed 11-25-09; 8:45 am]
BILLING CODE 4160-90-M