Request for Approval

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0920-0919)

TITLE OF INFORMATION COLLECTION:

Raising Public Awareness for Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE)

PURPOSE:

The purpose of this project is to develop messaging concepts that can 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.

Message concepts were developed from insights emerging from formative research on consumer knowledge, attitudes, and beliefs (KABs) toward DVT. The current stage of the research will test the message concepts, identify effective ways to present the messages, and identify effective channels to disseminate the messages.

This Plan focuses on the message testing stage of the project and will investigate:

What messaging frameworks increases recognition of symptoms and risk factors for DVT/PE and empower people to take action?

Specifically, the message testing research will help develop message concepts and determine most effective channels to capture the attention of and motivate DVT/PE-related action by the target audience. Eight focus groups will be conducted in Atlanta, Georgia and Baltimore, Maryland. During the focus groups, participants will be presented with a worksheet of message concepts, a set of print ads, and a slideshow. These message materials will be tested to:

• assess comprehension;

• assess overall appeal;

• identify confusing, sensitive or controversial written or visual elements;

• determine personal relevance;

• assess credibility;

• assess the effectiveness of the calls to action;

• identify desired dissemination channels; and

• identify credible messengers.

DESCRIPTION OF RESPONDENTS:

Respondents will be recently hospitalized and representing a mix of demographic factors, including age and gender. We focus on these audiences, as recent hospitalization is a leading risk factor for DVT/PE and these participants will be more likely to relate to the risk factors associated with injury and being sedentary. In order to promote active group dynamics, all groups will be separated by gender. Because we encountered age-specific responses to the messaging in the formative research, we also recommend segmenting these message testing groups by age. We recommend conducting groups of young and middle aged to capture a wider breadth of opinions of this target. Older aged groups will be conducted to capture whether message concepts are relevant to this audiences’ age-specific needs. Table A.1 below outlines our proposed segmentation design.

Table A.1. Segmentation Design

Males hospitalized in last 12 months: surgery, trauma (falls, car accidents), cancer treatment		Females hospitalized in last 12 months: surgery, trauma (falls, car accidents), birth, cancer treatment
No. of Groups	Ages	No. of Groups	Ages
1	18-39	2	18-39
2	40-64	1	40-64
1	65-80	1	65-80
TOTAL: 4 focus groups in Atlanta, GA / 4 focus groups in Baltimore, MD

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[X] Focus Group [ ] Other: ______________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name: _________Cynthia A. Sayers ([email protected])________________________________

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ ] Yes [X ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [ ] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ X ] Yes [ ] No

Justification

It is proposed that respondents will be given $75 for their participation, effort, transportation, and possible childcare costs. This amount is comparable to what has been the level of reimbursement for the target audiences in similar CDC funded activities. Focus groups require a bigger commitment from participating individuals than other forms of data collection (Krueger & Casey, 2009)¹ and the payment of incentives can provide significant advantages to the government in terms of direct cost savings and improved data quality.

Because we are conducting in-person focus groups, success of the study relies on a set of participants traveling to a common location at a specified time and actively participating in the research. Our focus is people who were hospitalized in the last 12 months for medical incidents that include cancer treatments, surgery, falls, car accidents, and childbearing for younger female groups to gauge their awareness and knowledge of DVT/PE. Recent CDC data shows that 6% of Americans experienced an overnight hospital stay in the last 12 months, and this proportion decreases among adults under age 65, which comprise six of our eight focus groups (Adams et al, 2010).² Because this is a low incidence population, it may be challenging to locate and recruit eligible participants. Respondents will be recruited from a 30 mile radius for groups to be held in Baltimore, Maryland, and in Atlanta, Georgia, 90 percent of respondents will be recruited from a 50 mile radius with 10 percent outside of this metropolitan range. These participants will incur additional time and costs as some will travel from long distances to attend. Moreover, two of our eight groups will be of recently hospitalized women ages 18-39. Women of childbearing age are often more difficult to recruit because they often have children and need to cover childcare costs to be able to attend the focus group session (It is assumed that the $75 incentive received for participating in the groups would go toward the transportation costs for participants to arrive at the facility, as well as the cost for off-site childcare to make it possible for them to attend.

There have been citations in the literature referencing the importance of monetary compensation for focus group participation. Krueger and Casey (2009) indicates that offering minimal levels of monetary compensation will help ensure that sufficient numbers of participants will attend thereby yielding useful results. Further, in a meta-analysis of 38 experiments and quasi-experiments, Church (1993)³ found that providing cash incentives for participation was far more effective than nonmonetary gifts in generating survey response, and prepaid monetary incentives yielded an average increase of 19.1 percentage points over comparison groups. 

Offering a monetary incentive at the proposed level will help ensure that respondents honor their commitment of participating in the focus group, and show up on time. Lower incentives could actually result in higher recruiting costs due to the need to over recruit by higher percentages (Krueger & Casey, 2009). Conversations with our focus group facilities have indicated that offering a lower incentive would necessitate recruiting 50% more people in order to assure a show rate of 8-9 participants.

For more details, please see our discussion below on Methods to Maximize Response Rates and reduce Non-Response.

BURDEN HOURS

Table A.2: Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Seniors (65-80) recently hospitalized	Participant Screener and Recruitment Script	192	1	5/60	16
Adults (40-64) recently hospitalized
Adults (18-39) recently hospitalized
Seniors (65-80) recently hospitalized	Re-screener; Informed Consent	96	1	15/60	24
Adults (40-64) recently hospitalized
Adults (18-39) recently hospitalized
Seniors (65-80) recently hospitalized	Moderator’s Guide	72	1	1.5	108
Adults (40-64) recently hospitalized
Adults (18-39) recently hospitalized
TOTAL			—	—	148

FEDERAL COST: The estimated annual cost to the Federal government is $160,200

The average annualized cost to the Federal Government to collect this information is $160,200. This estimate is based on eight message testing focus groups and cost of the Federal Project Officer (see Table A.3). These figures include the costs of study design, materials development, facility rental, participant tokens of appreciation, data collection, analysis, and report writing.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [X ] Yes [ ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

Sampling Method

A series of 8 focus groups will be conducted. Participants will be recruited from a database of participants that is developed and maintained by the individual focus group facilities. No probability-based sampling methods will be used to select respondents for the study; rather, the facility will use criteria provided by Westat and will recruit from the subset of participants that meet these criteria. For more details, please see attached screening instruments. Each focus group will seat 8-9 participants, for an approximate total of 72 human subjects. The audience for the messaging is potentially the general public since anyone is at risk for DVT. However, risk is higher for recently hospitalized therefore audience is segmented among this group and by a mix of demographic factors, including age and gender: Male and female adults ages 18-39, 40-64, and 65-80.

The groups will be conducted in:

• Atlanta, GA (Atlanta Outloud, Inc.)

• Baltimore, MD (Baltimore Research)

These two cities were selected by CDC on the basis that (1) these MSAs provide for more diversity of age and race for recently hospitalized, (2) DVT/PE incidence rates and numbers of cases in these cities, (3) cost associated with conducting focus groups in these locations, and (4) conveniently located to Westat and CDC offices.

Identifying and Contacting Participants

Respondents will be selected through focus group facilities that maintain lists of interested participants from the general population that are new to this study. These participants will include adults 18-39, 40-64, and 65-80 who have been recently hospitalized. For purposes of calculating burden, we assume that 50% of the participants contacted will screen into the group. Possible reasons for not screening into the group may include not meeting the screening criteria or being unavailable at the scheduled time for the focus group. Westat will specify standard over-recruitment strategies to assure attendance by 8-9 participants. Westat will consult with the focus group facilities for over-recruit recommendations based on their experience. For all groups, we anticipate recruiting 12 participants to ensure that 8-9 are seated in each of the 8 focus groups. Because anyone can be at risk for DVT/PE, participants will be recruited using standard focus group recruitment methods, by calling their household and administering a screening questionnaire to pre-qualify them (see Attachments). Most will come from an existing database (or list) owned and maintained by each focus group facility of potential participants new to the study.

During the recruit, focus group facilities will provide recruitment updates to Westat at least twice a week. Westat will work with the selected focus group facilities to monitor the recruitment, ensuring that the facility is recruiting appropriate respondents, on schedule, getting a demographic mix, etc. These reports will be compiled into an overall summary report for each focus group.

Methods to Maximize Response Rates and Address Non-Response

To maximize response rates, professional recruitment firms will be used in each city to meet the target sample size. Professional agencies are able to recruit participants very efficiently and can ensure that the appropriate number of participants is available for the focus groups. These firms have been briefed on the requirements of the focus groups.

To further maximize response rates, focus groups will be held during the afternoon for senior adults, and after working hours for younger adults in settings that allow participants to feel comfortable and to articulate their views and feelings. The market research firms in each selected city are located within close proximity to potential participants.

Research has consistently shown the value of offering a modest remuneration for motivating respondents to participate in a research study. For participating in the focus group, recently hospitalized participants will receive the following incentive:

• Atlanta, GA participants will receive $75

• Baltimore, MD participants will receive $75

The recruiting firm in each city will follow up with a reminder phone call to each participant a few days prior to the focus group, reminding them of their participation and confirming their attendance.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[ ] Telephone

[X] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [X ] Yes [ ] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

Instructions for completing Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback”

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is the subject of the request. (e.g. Comment card for soliciting feedback on xxxx)

PURPOSE: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

DESCRIPTION OF RESPONDENTS: Provide a brief description of the targeted group or groups for this collection of information. These groups must have experience with the program.

TYPE OF COLLECTION: Check one box. If you are requesting approval of other instruments under the generic, you must complete a form for each instrument.

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

BURDEN HOURS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households;(2) Private Sector; (3) State, local, or tribal governments; or (4) Federal Government. Only one type of respondent can be selected.

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey or participate in a focus group)

Burden: Provide the Annual burden hours: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Provide an estimate of the annual cost to the Federal government.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents. Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.

Administration of the Instrument: Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or facilitators (e.g., for focus groups) used.

Please make sure that all instruments, instructions, and scripts are submitted with the request.

1 Krueger, RA, and Casey, MA (2009). Focus Groups: A Practical Guide for Applied Research, 4^th ed. Sage: Thousand Oaks, CA.

2 Adams PF, Martinez ME, Vickerie JL, Kirzinger WK. Summary health statistics for the U.S. population: National Health Interview Survey, 2010. National Center for Health Statistics. Vital Health Stat 10(251). Available online at: http://www.cdc.gov/nchs/data/series/sr_10/sr10_251.pdf [accessed 3/27/2012]

3 Church, A.H. (1993). Estimating the Effect of Incentives on Mail Survey Response Rates: A Meta-Analysis. Public Opinion Quarterly, 57, 62 –79.

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