[Federal Register: November 21, 2008 (Volume 73, Number 226)]
[Notices]               
[Page 70651-70653]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no08-62]                         

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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: ``Improving implementation of the U.S. Preventive Services 
Task Force recommendation for prophylactic aspirin use among adults at 
risk for cardiovascular disease.'' 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 20, 2009.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail at 
doris.lefkowitz@aahrq.hhs.gov.
    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 
doris.lefkowitz@ahrq.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

    ``Improving implementation of the U.S. Preventive Services Task 
Force recommendation for prophylactic aspirin use among adults at risk 
for cardiovascular disease.''
    This proposed information collection aims to identify, test and 
disseminate methods to improve patient-physician communication about 
aspirin prophylaxis in health care systems. This project falls under 
AHRQ's Accelerating Change and Transformation in Organizations and 
Networks (ACTION) program and will be conducted for AHRQ by Abt 
Associates in collaboration with Geisinger Health Systems. ACTION 
promotes innovation in health care delivery by accelerating the 
development, implementation, diffusion, and uptake of demand-driven and 
evidence-based products, tools, strategies and findings. ACTION 
develops and diffuses scientific evidence about what does and does not 
work to improve health care delivery systems. The program emphasizes 
projects--that are broadly responsive to user needs and operational 
interests and which are expected to be generalizable across a number of 
settings.
    In this project, a randomized controlled trial with two 
intervention arms and one control arm will be conducted to evaluate two 
interventions designed to improve physician-patient communication and 
decision-making regarding the use of prophylactic aspirin use among 
adults at risk for cardiovascular disease. Each of the three study arms 
will take place in one of three similar clinics.
    The first intervention uses a paper ``pre-visit summary'' handout 
describing the benefits and possible harms of daily low-dose aspirin 
use to prevent heart attack in men and stroke in women. The handout is 
given to patients in the waiting room of non-emergency outpatient 
clinics. The content of the handout, including baseline cardiovascular 
event risk and the magnitude of potential benefits and harms of aspirin 
use, is generated specifically for each patient using data in his or 
her electronic health record. The purpose of the handout is to increase 
the patients' knowledge of their own cardiovascular risk and increase 
awareness of prophylactic aspirin regimens as a-treatment option. The 
study will assess whether the handout is effective in stimulating 
subsequent discussion with physicians about cardiovascular risk and 
aspirin.
    The second intervention also uses the pre-visit summary handout, 
but adds a computer-based clinical decision support tool. During the 
patient's visit with the physician, the electronic health record 
software used by the physician will alert the physician of the 
patient's elevated cardiovascular risk and prompt the physician to 
discuss prophylactic aspirin use with the patient. If the physician 
chooses to do so, he or she can use a computer-based tool as a decision 
aid during the discussion with the patient. The tool displays the 
patient's risk of cardiovascular event (heart attack or stroke) and the 
potential risk-reducing effect of daily aspirin use. The tool also 
shows the likelihood of potential harms of aspirin use (e.g., 
gastrointestinal bleeding). The tool is interactive and allows the 
patient and doctor to explore the expected effects of behavior change 
related to modifiable cardiovascular risk factors (e.g., smoking 
cessation) as well as prophylactic aspirin use.
    The proposed data collection supports the ACTION program mission by 
promoting health care quality improvement. The overall aim of the study 
is to explore the effectiveness of innovative health care delivery 
methods in improving patient health behaviors (i.e., using aspirin 
prophylaxis). The study has been constructed to produce results that 
will be helpful in a broad range of clinic settings including those 
utilizing electronic health records and those that rely on paper-based 
record systems. The proposed data collection will assess the study's 
main outcome: initiating a discussion about prophylactic aspirin use 
between at-risk patients and their physicians in order to facilitate a 
shared decision-making process, and is therefore a necessary and 
integral element of the overall research study and of the ACTION 
program mission.
    This project is being conducted pursuant to AHRQ's statutory 
authority to conduct and support research on health care and on systems 
for the delivery of such care, including activities with respect to the 
quality, effectiveness, efficiency, appropriateness and value of health 
care

[[Page 70652]]

services 42 U.S.C. 299a(a)(1). The parties involved in the study will 
comply with the Health Insurance Portability and Accountability Act 
(HIPAA) Privacy Rule, 45 CFR parts 160 and 164, and the study will be 
required to obtain approval of the institutional review boards of 
Geisinger Health Systems and Abt Associates.

Method of Collection

    Data for this study will be collected directly from study 
participants (patients, doctors, and clinic staff) and indirectly from 
patients' electronic health records and observation of the intervention 
in clinic waiting rooms. The first phase of the direct data collection 
will occur after a patient gives his or her informed consent to 
participate in the study and written authorization for the use of his 
or her protected health information for this study. Patients will 
complete a 5-minute pre-visit questionnaire. Fourteen days after a 
patient's visit, he or she will be contacted to complete a one-time, 
25-minute telephone follow-up questionnaire to assess aspirin use, 
knowledge, and the relevant patient/physician encounter. Data will be 
collected from participating physicians through 30-minute semi-
structured interviews. Similarly, a 10-minute semi-structured interview 
of participating clinic staff will also be administered to gather 
information about the feasibility and perceived effectiveness of the 
intervention.

Estimated Annual Respondent Burden

    Exhibit 1 presents an estimate of the annual reporting time burden 
on respondents participating in the data collection process. Time 
estimates are based on experience with similar instruments used with 
comparable respondents. A total of 1,000 patients are expected to 
participate in the study, distributed into approximately equal groups 
across the three arms of the study. The pre-visit questionnaire will be 
completed by 1,000 respondents and will take about 5 minutes. The 
telephone follow-up questionnaire will be completed by 1,000 
respondents and will take about 25 minutes. Qualitative interviews will 
be conducted with 10 physicians and 8 staff members from each of the 
two intervention clinics; the physician interview will require about 30 
minutes while the staff interview will last about 10 minutes. The total 
estimated burden hours for the respondents' time to participate in this 
data collection is 513 hours.
    Exhibit 2 shows the estimated cost burden based on the respondents' 
time to participate in this project and their hourly wage. The 
estimated cost burden is $10,388.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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Pre-Visit Questionnaire.........................           1,000               1            5/60              83
Telephone Follow-up Questionnaire...............           1,000               1           25/60             417
Qualitative Interviews: Physicians..............               2              10           30/60              10
Qualitative Interviews: Clinic Staff............               2               8           10/60               3
                                                 ---------------------------------------------------------------
    Total.......................................           2,004              na              na             513
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate*        burden
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Pre-Visit Questionnaire.........................           1,000              83          $19.29          $1,601
Telephone Follow-up Questionnaire...............           1,000             417           19.29           8,044
Qualitative Interviews: Physicians..............               2              10           66.11             661
Qualitative Interviews: Clinic Staff............               2               3           27.44              82
                                                 ---------------------------------------------------------------
    Total.......................................           2,004             513              na          10,388
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*National Compensation Survey: Occupational wages in the United States, June 2006, U.S. Department of Labor,
  Bureau of Labor Statistics.

Estimated Annual Costs to the Federal Government

    The total cost to the government of this two-year project is 
expected to be $300,000. Exhibit 3 details the costs associated with 
this project, which include $74,206 for project development, $42,760 
for data collection activities, $29,510 for data processing and 
analysis, $31,165 for the publication of results, $27,136 for project 
management and $95,222 for overhead.

                        Exhibit 3--Estimated Cost
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                                                              Annualized
                Cost component                   Total cost      cost
------------------------------------------------------------------------
Project Development...........................      $74,206      $37,103
Data Collection Activities....................       42,760       21,380
Data Processing and Analysis..................       29,510       14,755
Publication of Results........................       31,165       15,583
Project Management............................       27,136       13,568
Overhead......................................       95,222       47,611
                                               -------------------------
    Total.....................................      300,000      150,000
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[[Page 70653]]

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 6, 2008.
Carolyn M. Clancy,
Director.
 [FR Doc. E8-27523 Filed 11-20-08; 8:45 am]

BILLING CODE 4160-90-M