2011-14422. Agency Forms Undergoing Paperwork Reduction Act Review

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Proposed Project

Focus Group Study for Raising Public Awareness of Deep Vein Thrombosis/Pulmonary Embolism—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Division of Blood Disorders, located within the National Center on Birth Defects and Developmental Disabilities, implements health promotion and wellness programs designed to prevent secondary conditions in people with bleeding and clotting disorders.

There are few public health problems as serious as deep vein thrombosis (DVT) and pulmonary embolism (PE), yet these conditions receive little attention. DVT/PE is an underdiagnosed, serious, preventable medical condition that occurs when a blood clot forms in a deep vein. These clots usually develop in the lower leg, thigh, or pelvis, but they can also occur in the arm. In more than one third of people affected by DVT, clots can travel to the lungs and cause PE, a potentially fatal condition.

The precise number of people affected by DVT/PE is unknown, but estimates range from 300,000 to 600,000 annually in the United States. DVT/PE is associated with substantial morbidity and mortality: One third of people with DVT/PE will have a recurrence within 10 years and one third of people die within 1 month of diagnosis. Among people who have had a DVT, one third will have long-term complications (post-thrombotic syndrome), such as swelling, pain, discoloration, and scaling in the affected limb. In some cases, the symptoms can be so severe that a person can become disabled. More troubling, sudden death is the first symptom in about one quarter of people who have a PE.

The Division of Blood Disorders submitted questions to the 2007 HealthStyles survey to determine the public's knowledge of DVT, its common symptoms, and risk factors. Although over 60% of respondents identified pain and swelling as symptoms, 60% did not identify tenderness (often the first sign of DVT) as a symptom. Only 38% of respondents knew that a DVT was a blood clot in a vein, and most could not identify common risk factors for DVT such as sitting for a long period of time (e.g., during air travel); having a leg or foot injury; having a family member who has had a DVT; taking birth control pills; or getting older; and certain groups could not identify risk factors that specifically applied to their risk. The results of this survey demonstrate the need for greater awareness of DVT and its risk factors and the data show that there are many opportunities to develop audience specific messages that are age specific and culturally appropriate.

Much of the morbidity and mortality associated with DVT/PE could be prevented with early and accurate diagnosis and management. DVT/PE is preventable. It is important for people to be able to recognize the signs and symptoms and know when to seek care and available treatment. Individuals, families, and their support communities can reduce their risk by understanding DVT/PE and its risk factors. DVT/PE affects people of all races and ages. Many of the acquired risks such as obesity, advanced age, air travel, chronic diseases, cancer, and hospitalization are increasing in the United States, and we can expect to see increasing numbers of people affected by DVT/PE.

The CDC's Division of Blood Disorders will conduct focus groups to develop messaging concepts that will be used in a public awareness campaign to build knowledge and awareness of DVT/PE, increase recognition of the symptoms and risk factors for DVT/PE, and empower people to take action.

The project will address these objectives in two stages: in the first stage the Contractor selected will conduct eight (8) formative focus groups with nine (9) participants in each focus group to explore consumer knowledge, attitudes, and beliefs (KABs) toward DVT. Message concepts will be developed from insights emerging from this exploratory research phase. The Contractor will conduct eight (8) focus groups with nine (9) participants in each focus group during the second stage to test the message concepts and identify possible ways to present the messages.

The Contractor selected will work with CDC to identify and recruit focus group participants. Formative research participants will include adults (aged 25-64) who have been hospitalized in the last year and seniors (aged 65-80). Message testing participants will include adults (aged 25-64) who have been hospitalized in the last year and seniors (aged 65-80). Participants will be recruited to participate in one of sixteen in-person focus groups that will be conducted in the following cities:

• Atlanta, Baltimore, Pittsburgh, and Tampa (formative research task), and
• Atlanta, Baltimore, Pittsburgh, and Tampa (message testing task).

It is estimated that a total of 144 respondents will have to be screened in order to recruit 36 focus group participants for each year. There are no costs to the respondents other than their time. The estimated annualized burden hours are 125.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number responses per respondent	Average burden per response (in hours)
Seniors (65-80)	Participant Screener	144	1	5/60
Adults (25-64) recently hospitalized
Seniors (65-80)	Participant Re-screener	36	1	9/60
Adults (25-64) recently hospitalized
Seniors (65-80)	Moderator's Guide: Formative Research Focus Groups	36	1	1.5
Adults (25-64) recently hospitalized
Seniors (65-80)	Moderator's Guide: Message Testing Focus Groups	36	1	1.5
Adults (25-64) recently hospitalized
Seniors (65-80)	Informed Consent Form	36	1	6/60
Adults (25-64) recently hospitalized

Dated: June 3, 2011.

Daniel L. Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.