GenIC Template

Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

CIO: NCBDDD/DCDD/PRTB/PAOSET

PROJECT TITLE: American Academy of Pediatrics Neurodevelopmental ECHO (Extension for Community Health Outcomes)

PURPOSE AND USE OF COLLECTION:

Fetal Alcohol Spectrum Disorders (FASDs) are the result of prenatal exposure to alcohol. FASD is an umbrella term that encompasses several, more specific, diagnoses. These conditions are associated with lifelong physical and neurodevelopmental abnormalities, including growth problems and prenatal brain damage, which may lead to developmental, behavioral and neurocognitive impairments. Infants with a FASD are rarely recognized at birth by hospital staff. Further, at later ages, these children may be overlooked or misdiagnosed. While there is no cure for FASDs, early identification and intervention can mitigate adverse effects.

Pediatricians are typically the first clinician that parents turn to when developmental or behavioral issues arise. Given this role, pediatricians are critical in the process of early identification, referral and ongoing care in the medical home of children with FASDs. To facilitate and strengthen pediatricians’ role, with CDC funding, the American Academy of Pediatrics (AAP) established a neurodevelopmental ECHO training program. ECHO stands for Extension for Community Health Outcomes.

The AAP Neurodevelopmental Screening ECHO is a tele-mentoring program that leverages video conference technology to connect a multidisciplinary team of specialists with primary care providers in local communities. The project aims to build a bi-directional learning community whereby a faculty team and all participants will provide guidance aimed at improving the quality of care provided to children and youth affected by neurodevelopmental and neurobehavioral disorders, with an emphasis on children with an FASD.

The one-hour ECHO sessions occur monthly for 9 months. Each session includes 1) introduction with review of purpose and procedures, 2) a short didactic session on selected topics and 3) case presentation with faculty and participant discussion of clinical care. Included in the session are six faculty members with expertise in diagnosis and care of children with neurodevelopmental disorders and their families as well as up to 15 participant pediatricians. The 15 participant pediatricians are selected by a brief application to the AAP. All participation is voluntary. The ECHO program will be conducted for a one year period. The intent of the project is to improve pediatrician capacity for identification and care of children with neurodevelopmental disorders, particularly prenatal exposure to alcohol, in the medical home. The purpose and use of the session satisfaction data will be to assure that specific information is conveyed and understood by participants for each monthly session, ongoing improvement and refinement of sessions and used inform subsequent neurodevelopmental ECHO projects.

The project will be monitored using four instruments: monthly chart reviews to monitor incorporation of presented material or suggestions (20 charts per month), monthly session satisfaction survey, one overall program satisfaction survey and a structured one hour debriefing conference call at the end of the project. The instruments are in Attachments A1-4:

• Attachment A1 – Monthly chart review

• Attachment A2 – Monthly session satisfaction survey

• Attachment A3 – Overall program satisfaction survey

• Attachment A4 – Overall debriefing conference call guide

No private information or personally identifiable data is collected. CDC staff will provide technical assistance in development of ECHO sessions and all information collection instruments. This role will allow CDC to monitor of the conduct and success of the project as well as quickly identify is issues to be addressed. Such monitoring ensures a high-quality program that will contribute to CDC programs to build clinical capacity regarding children with FASDs and their families.

DESCRIPTION OF RESPONDENTS: Actively practicing pediatricians

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary. YES

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

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

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

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

Name: Jacquelyn Bertrand, PhD

To assist review, please answer the following questions:

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 [ X ] No

Gifts or Payments:

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

BURDEN HOURS

Category of Respondent	Form Name	Annual # of Respondents	Participation Time (minutes)	Burden in Hours
Pediatricians	Monthly chart review	15	12 minutes/chart X 20 charts/month) = 240min X 8 months = 1920 minutes annually	480
	Session satisfaction survey	15	5 minutes * 8 months = 40 minutes annually	10
	Program satisfaction survey	15	10 minutes annually	2
	Program satisfaction debriefing call	15	60 minutes	15
Totals				507

FEDERAL COST: The estimated annual cost to the Federal government is $97,804

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?[ ] Yes[ X ] 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?

Administration of the Instrument

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

[ X ] Web-based or other forms of Social Media

[ X ] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

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

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

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.

2