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Poison Center Collaborations for Public Health Emergencies

OMB Control No. 0920-NEW

New Generic Clearance

Supporting Statement Part B –

June 2016

Project Officer

Royal Law, MPH

National Center for Environmental Health

Centers for Disease Control and Prevention

4770 Buford Highway NE, MS F-60

Atlanta, Georgia 30341

Phone: (770) 488-3416

Fax: (770) 488-3450

Email: [email protected]

Table of Contents

B.1. Respondent Universe and Sampling Methods 4

B.2. Procedures for the Collection of Information 4

B.3. Methods to Maximize Response Rates and Deal with Nonresponse 5

B.4. Tests of Procedures or Methods to be Undertaken 5

B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 6

List of Attachments

Attachment 1 – Authorizing Legislation

Attachment 2 – 60-Day Federal Register Notice

Attachment 3 – Map of United States Poison Centers

Attachment 4 – CDC and AAPCC Data License Agreement

Attachment 5 – Step-by-Step How to Use the Generic Clearance

Attachment 6 – Advanced Notification Email for OMB

Attachment 7 – GenIC Request for Approval Form

Attachment 8 – Sample Consent and Assent Forms

Attachment 9 – Sample Questionnaire – Adult

Attachment 10 – Sample Questionnaire - Adolescent

Attachment 11 – Sample Questionnaire – Parent or Guardian

Attachment 12 – Poison Center Burden Memo

Attachment 13 – NCEH Research Determination

Attachment 14 – Example Dataset from Questionnaire

Part B. Collections of Information Employing Statistical Methods

B.1. Respondent Universe and Sampling Methods

There are 55 poison centers in the United States that service all states and US territories (Attachment 3). Some states have a single poison center servicing the whole jurisdiction, some states have multiple poison centers servicing the state, and some states have poison centers outside the state that are servicing their jurisdiction. A free national hotline is available 24 hours a day, seven days a week to speak to poison center experts related to poison exposures. Callers using the national hotline will be automatically routed to the poison center closest to their location.

For a public health emergency to be selected for additional data collection under this Generic Information Collection Request (Generic ICR); an event must meet the criteria below:

1. The event is a public health emergency causing adverse health effects.

2. Timely data are urgently needed to inform rapid public health action to prevent or reduce injury, disease, or death.

3. The event is characterized by (1) a natural or man-made disaster; (2) contaminated food/water; (3) a new or existing consumer product; or (4) an emerging public health threat.

4. The event has resulted in calls to a poison center, and the poison center agrees to conduct the call-back data collection.

5. The event is domestic.

6. Data collection will be completed in 60 days or less.

Additional criteria for the investigations, also called generic information collections (GenICs) under the Generic ICR, include:

1. No request for technical assistance by state, local, or regional public health is required to initiate a GenIC.

2. The investigations will be non-research GenICs designed to identify, characterize, and to assist with an immediate public health emergency and the knowledge gained will directly benefit the affected community.

Respondents selected for poison center investigations will comprise those who initially call a poison center about triage and treatment of potential poison exposures related to the select public health emergency. CDC will identify and recruit the respondents based on information already collected in NPDS. In their daily operations, poison centers track a caller’s contact information for the purposes of medical follow-up; this information will be used to contact the caller for the call-back data collection. These respondents to the poison center investigations include:

• Adults (18 years and older)

• Adolescents (15 up to 18 years)

• Parents or guardians of children (less than 15 years)

B.2. Procedures for the Collection of Information

Once an event is approved under this Generic ICR, information for the follow-up will be collected by poison center staff using a consent/assent/permission consent form derived from the template in Attachment 8 and a questionnaire derived from the template in Attachments 9-11. The consent and the questionnaire will be administered to a convenience sample of callers to poison centers, either all those who called about a particular exposure during the select public health emergency within a given time frame or a subset of those callers, such as those who were hospitalized. The sample of callers to poison centers for follow-up will be decided by CDC and will depend on the particular information needs of the select public health emergency. For example, if there was illicit drug incident and information already collected in NPDS suggests many callers were reporting a particularly usual and severe symptom such as respiratory depression, then CDC may choose to identify respondents as those who reported respiratory depression after using the illicit drug and exclude those not reporting respiratory depression.

CDC does not expect unusual problems requiring specialized sampling.

The interviewers for poison center investigations are trained public health professionals who conduct interviews regularly in their roles as poison center representatives. Prior to beginning interviews, poison center staff will be oriented to the consent procedures and the questionnaire forms. Quality control procedures will be implemented in each poison center investigation to the extent possible given the rapid nature of the data collection to collect high quality data. These will be one-time data collections.

Data collected by poison center staff will be entered directly into a secure Microsoft Access database, and data will be reviewed by the staff for accuracy by comparing notes and the questionnaire results.

B.3. Methods to Maximize Response Rates and Deal with Nonresponse

The poison center team will take the following steps to improve the response rates, including:

• Recontacting potential respondents at least twice more if the first attempt to reach them is unsuccessful

• Rescheduling the interview to a time that is more convenient for the respondent

• Providing a toll-free number for individuals to return calls

The response rates for previous data collections of a similar nature were only tracked at the local poison centers and an overall response rate could not be estimated. However, per their normal operations, poison centers follow up with all exposure calls to ascertain medical outcome following the exposure. Participation rates for these follow ups are high (over 80%) and we estimate participation rates for this data collection to be high as well.

B.4. Tests of Procedures or Methods to be Undertaken

The sample questionnaires (Attachment 9-11) were derived using questionnaires from two previous data collections (i.e., Hurricane Sandy; Lamp Oil) for which CDC collaborated with poison centers. For these previous data collections, basic descriptive statistics were used to analyze the data.

The questionnaires were reviewed by other CDC staff as well as representatives from local poison centers and the AAPCC.

Limitations to data collection are that all reported exposures and questionnaire responses are self-report, so there is no confirmation of exposure or response information. Not all exposures are reported to poison centers so the information collection lacks representativeness. Conclusions drawn from aggregate data may not be representative of individuals within the affected area.

B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

The CDC investigators guiding the poison center data collection and analyzing the data will be trained in epidemiology. CDC investigators will collaborate extensively with poison center staff throughout the process of data collection. While CDC staff will supervise the investigation, only poison center staff will actually collect data.

The following CDC staff will be involved in consultation of statistical design and responsible for collection and data analysis.

Table B5-1. Personnel consulted on statistical design and data analysis

Name	Title	Affiliation	Phone			Email
FEDERAL AGENCY
Dana Flanders, PhD	Statistician	NCEH	(770) 488-3472	[email protected]
Stephanie Kieszak, MS	Statistician	NCEH	(770) 488-3407		[email protected]
Owen Devine, PhD	Statistician	NCEH	(678) 628-8233		[email protected]

Table 5-2. Personnel responsible for collection and analysis of information

Name	Title	Affiliation	Phone	Email
Royal Law, MPH	Epidemiologist	NCEH	(770)488-3416	[email protected]
Stephanie Kieszak, MS	Statistician	NCEH	(770) 488-3407	[email protected]
Josh Schier, MD	Toxicologist	NCEH	(770)488-3401	[email protected]

Because the investigations will be public health responses and not planned research studies, the analysis is largely descriptive. Statisticians will be consulted if sampling or a more complex analysis is needed.

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