Agency information collection activities; proposals, submissions, and approvals,

[Federal Register: March 11, 2005 (Volume 70, Number 47)]

[Notices]

[Page 12219-12220]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11mr05-71]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-05-0424X]

Proposed Data Collections Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 371-5976 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Human Resources and Housing Branch by fax to (202) 395-6974. Written comments should be received within 30 days of this notice.

Proposed Project

Evaluating Tools for Health Promotion and Disease Prevention--New-- Office of Genomics and Disease Prevention (OGDP), Centers for Disease Control and Prevention (CDC).

Background

Although family history is a risk factor for most chronic diseases of public health significance, it is underutilized in the practice of preventive medicine and public health for assessing disease risk and influencing early detection and prevention strategies. It has been known for years that people who have close relatives with certain diseases (such as heart disease, diabetes, and cancers), are more likely to develop those diseases themselves. Geneticists have long recognized the value of family history for discovering inherited disorders, usually the result of single gene mutations. Although single gene disorders are typically associated with a large magnitude of risk, they account for a small proportion of individuals with a genetic risk for common, chronic diseases. Most of the genetic susceptibility to these disorders is the result of multiple genes interacting with multiple environmental factors. Family history is more than genetics; it reflects the consequences of inherited genetic susceptibilities, shared environment, shared cultures and common behaviors. All of these factors are important when estimating disease risk. In early 2002, the CDC Office of Genomics and Disease Prevention (OGDP) in collaboration with several CDC programs and NIH institutes began an initiative to develop a family history tool for identifying apparently healthy people who may be at increased risk for a number of common diseases. The major activities of this initiative have included: (1) Reviews of the literature for approximately 25 diseases; (2) assessments of family history tools currently in use or under development; (3) a meeting of experts to provide input into the process; (4) development of criteria for determining which diseases to include in the tool; (5) development of a framework for evaluating a family history tool and the development of a tool.

As a result of this initiative, a personal computer-based familial risk assessment tool was developed to be used as a public health strategy to improve health and prevent disease. The assessment tool is called, ``Family Healthware.'' This tool will be used to collect information about the disease history of a person's first- and second- degree relatives (mother, father, children, siblings, grandparents, aunts, and uncles), use family history information to assess risk for common diseases of adulthood, and influence early detection and prevention strategies. The current version of the tool focuses on six diseases--heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancers.

The proposed project is a study to evaluate the clinical utility of the ``Family Healthware'' tool by determining whether family history risk assessment, stratification, and personalized prevention messages have any impact on health behaviors, and use of medical services. In 2003, CDC awarded funding to three research centers to collaborate on a study set in primary care clinics to assess the clinical utility of the family history tool. Eligibility for the study will be determined by a brief screening test completed by patients from the primary care clinic. It is anticipated that only a small number will be ineligible to continue since the majority of patients will be pre-screened for eligibility based on a medical record review prior to the screening test.

The primary care clinics affiliated with the three research centers will be randomized into two groups. Patients participating in the study will all complete the pre-test, post-test and family history tool, however, the order in which they do so is dependent upon the group to which they are randomized. In the intervention group, patients attending the primary care clinics will be asked to complete the family history tool and a pre-test that includes an assessment of risk factors, preventive behaviors, use of medical services, and perception of risk. The patients will be provided with an assessment of their familial risk (average, above average, much above average) for each of the six diseases and information about preventive measures (e.g., diet, exercise, screening tests) that is tailored to their level of familial risk for each of the six diseases. After 6 months, the patients will be asked to complete a post-test that assesses their risk factors, use of medical services, interest in modifying health behaviors, and changes in risk perception. In the control group, patients will initially complete the pre-test only (not the family history tool) and will be given standard public health messages about preventing the six diseases of interest (messages will not be tailored to risk level). After 6 months, the patients in the control group will also complete the post- test and the family history tool. Physicians will complete a post-visit assessment if they have a visit with a participating patient during the course of the study.

The purpose of having patients in the control group complete the family history tool post intervention is so that the analysis can be stratified by familial risk level in both patient groups. The hypothesis to be tested in this study is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services. There is no cost to respondents participating in this

[[Page 12220]]

study other than their time. The estimated annualized burden is 5,922 hours.

Annualized Burden Table

Average time Type of respondents

Number of

Type of response Frequency of per response respondents

response

(in hrs)

Patients..............................

4180 Screening...............

1

2/60 .............. Questionnaire (pre-test

2

30/60 and post-test). .............. Family HealthwareTM Tool

1

20/60 Physicians............................

140 Post Visit Assessment...

30

3/60

Dated: March 7, 2005. Betsey Dunaway, Acting Reports Clearance Officer, Centers for Disease Control and Prevention.

[FR Doc. 05-4803 Filed 3-10-05; 8:45 am]

BILLING CODE 4163-18-P