genIC Request for Approval

Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

CIO: NCBDDD

PROJECT TITLE: FORMATIVE RESEARCH TO ASSESS PEDIATRIC HEALTHCARE PROVIDERS KNOWLEDGE, ATTITUDES AND PRACTICES AROUND ZIKA VIRUS

PURPOSE AND USE OF COLLECTION:

The American Academy of Pediatrics (AAP) has received funding from the Centers for Disease Control and Prevention (CDC) through a cooperative agreement (6NU38OT000167-04-06) to implement Zika virus response activities. One of the required activities is to conduct a survey to delineate pediatrician knowledge, attitudes, and practices specific to Zika virus. A select group of healthcare providers treating children (board-certified pediatricians who are members of the AAP) will be surveyed. The specific objectives are to 1) better understand knowledge gaps and barriers to guidance adherence; 2) explore current sources of trusted information for practitioners and preferences in receiving updates and messaging; and 3) gather information on which types of strategies might be most useful to help practitioners understand and implement guidance and recommendations during a public health emergency. Information collected will be used internally and will not be generalizable to broader populations. Results will not state any prevalence estimates based on data.

The AAP has been conducting surveys like this for several decades and has an established process that includes having the AAP staff complete an intent form which is submitted to the AAP Department of Research and formation of a Survey Working Group that includes identified AAP pediatrician member subject matter experts. The AAP Department of Research staff determines draft survey question domains or theme areas and offers specific wording for survey questions.

For this survey, the Survey Working Group was identified by the AAP, and included Amy Houtrow, MD, PhD, MPH, FAAP (physiatry); Sean O’Leary, MD, FAAP (infectious disease); Scott Needle, MD, FAAP (primary care); and Edwin Trevathan, MD, MPH, FAAP (neurology). Drafts of the survey questions were developed by the AAP Department of Research staff, and shared with the Survey Working Group, the AAP disaster preparedness staff, 5 AAP members-at-large, and select CDC representatives for review. After review, the questions were finalized by the AAP. Once Office of Management and Budget (OMB) determination is achieved, the survey will be sent to 1,600 AAP member pediatricians through the mail (with e-mail reminders). Results will be used internally by AAP and CDC to understand the interests, attributes and needs of select pediatricians and improve tools and methodologies in response to the Zika virus or future public health emergencies.

DESCRIPTION OF RESPONDENTS:

The survey will be administered to a voluntary sample of approximately 1,600 US-based, non-retired members of the AAP that are randomly selected (using a computer selection process) from the AAP member database. The survey sample is representative of select AAP member pediatricians but is not intended to be generalizable to the general population.

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. Information gathered will not be used to substantially inform influential policy decisions.

5. The study is not intended to produce results that can be generalized beyond its scope.

6. The information gathered will inform ongoing practices. It will not be used to create a prevalence estimate.

The resulting data from the survey will benefit the CDC in its future work with the AAP and will help clarify the extent to which select AAP member pediatricians are aware of clinical guidance and other information shared by the AAP and CDC on Zika virus. The survey results will also assist the AAP in deciding how to disseminate information and focus educational outreach on the Zika virus and other potential emerging infectious disease threats. It is not intended that the survey results would inform influential policy decisions; results would be used to guide future messaging and educational outreach to pediatrician audiences as well as inform ongoing practices.

Name: Catlin Green

To assist review, please answer the following questions:

Personally Identifiable Information:

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

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

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

The survey contains a section that requests demographic information from respondents. The completed surveys are returned to the AAP Department of Research staff; the AAP disaster preparedness and response staff (i.e., those who are administering the project) will not have access to any identifying information – only a summary of data and results. The survey is mailed in paper form to the address on file of the selected AAP pediatrician members, and the mailing envelope includes the two-dollar bill as an incentive. In the following weeks, those who have not responded will receive additional mailings, up to seven rounds, without the incentive. Additionally, two email reminders will be sent (typically coinciding with the second and forth mailing) containing a link to an electronic version of the survey that respondents can use instead of the paper version. As soon as a respondent returns their survey, they are taken off the list for future reminders.

Gifts or Payments:

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

Respondents will receive a two-dollar bill in the envelope with the survey as an incentive to complete the questionnaire. This is done primarily for two reasons:

1. To optimize survey response rates: the survey methodology literature indicates that even small monetary incentives improve response rates without negatively impacting the reliability or validity of survey responses. Internal research on previous AAP surveys indicates that including a two-dollar bill as a survey incentive increases the response rates for these surveys by 5-10 percentage points.

2. To say thank you to the survey respondents: By including the small monetary incentive as a token of appreciation, the AAP actively conveys to the respondents that leadership values and respects their time and input when completing the survey.

BURDEN HOURS

Category of Respondent	Form Name	No. of Respondents	Participation Time (minutes)	Burden in Hours
AAP member pediatricians, non-retired, U.S. based	AAP Zika Virus Survey Questionnaire	1,600	20 minutes	533 hours
Totals		1,600	20 minutes	533

FEDERAL COST: The estimated annual cost to the Federal government is $79,014.66

AAP Department of Research Staff Salary Compensation = $30,814*
Staff Compensation Fringe Benefits = $11,401.18
Printing of Surveys = $3,400
Postage = $6,868
Supplies (Envelopes/Two Dollar Bills) = $3,500
Total Expenses = $55,983.18
Indirect Costs = $23,031.48
Total = $79,014.66

* This includes time to identify survey questions, complete forms, finalize and process survey materials, review, analyze, and summarize survey results in a format suitable for potential publication.

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? [XX] 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?

The AAP Department of Research uses a computer-based selection process to identify non-retired, US-based pediatrician members of the AAP randomly from the AAP member database. The system selection process ensures that potential respondents are practicing pediatricians or pediatric specialists who have not recently completed an AAP survey. The AAP has more than 66,000 members, and the survey is sent to a randomized sample of 1,600 members. This approach is used to simplify and automate the selection of survey respondents.

Administration of the Instrument

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

[XX] Web-based - email reminders will be sent to respondents

[ ] Telephone

[ ] In-person

[XX] Mail – printed surveys will be mailed to respondents

[ ] Other, Explain

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

Please make sure all instruments, instructions, and scripts are submitted with the request. The materials included in this request are:

• Supporting Statement A

• Supporting Statement B

• Attachment A - Final AAP Survey Questions

• Attachment B - IRB Exempt Approval Letter

• Attachment C - Survey Cover Letter

• Attachment D - Survey Electronic Cover Letter

• Attachment E - Federal Register Notice 2016-16558

• Attachment F - Part II_ Frm Rcsh pf Knowledge Attitudes Practices around Zika Virus

• Attachment G - AAP Survey Incentives

Instructions for completing genIC Request for Approval for

CDC/ATSDR Formative Research and Tool Development

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is requested.

PURPOSE and USE: 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: Briefly describe the targeted group/groups for this collection.

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.

Form: Provide the title of the information collection form.

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 in Minutes: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Estimate the annual cost to the Federal government for this collection.

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.