Burden Memo - Undetermined Risk Factors for Fentanyl-related Overdose Deaths - Ohio

Drug Overdose Response Investigation (DORI) Burden Memo

Burden Memo for the Generic Clearance

Drug Overdose Response Investigation (DORI) Data Collection (OMB#: 0920-1054)

GenIC No.:	0920-16BL
EPI AID No. (if applicable):	2016-003
Requesting entity (e.g., jurisdiction)	Ohio Department of Health
Title of Investigation:	Undetermined risk factors for fentanyl-related overdose deaths – Ohio, 2015
Purpose of Investigation: (Use as much space as necessary)	In 2013, there were a total of 84 fentanyl-related unintentional overdose deaths in Ohio. In 2014 in Ohio, preliminary data show 500 fentanyl-related unintentional overdose deaths in this year, almost a 500% increase. These deaths in 2014 account for 20% of all drug poisoning deaths in Ohio, compared with 4% in 2013. Identifying the circumstances and risk factors that are contributing to this increase in deaths is critical to implementing prevention strategies that will prevent additional deaths. Therefore, the Ohio Department of Health has requested technical assistance from CDC to assist in investigating the increase in fentanyl-related overdose deaths in the state.
Duration of Data Collection
Date Began:	October 26, 2015
Date Ended:	November 13, 2015
Lead Investigators
Name:	Erica Spies (Lead EIS officer) and John Halpin (Science Officer)
CIO/Division/Branch:	NCIPC/DUIP/PDO
E-mail Address:	[email protected]
Telephone No.:	770 488 4653
Mail Stop:

INTRODUCTION

Describe any need and circumstances of changes to the initial submitted DORI. In case of no changes specify no changes to initial DORI.

Prior to arriving in Ohio, the study protocol included a component in which drug users would be recruited and individually interviewed to obtain qualitative information about risk factors for fentanyl overdose and patterns of drug abuse in this population. Upon arrival however, in discussion with the Ohio Dept. of Health and the Ohio Dept. of Mental Health and Addiction Services, it became clear that the state already has a robust program which conducts such interviews on a regular basis around the entire state. The Office of Substance Abuse Monitoring (OSAM), an office within the Dept of MH and Addictive services, conducts such interviews in 8 regions of the state of Ohio on a twice per year basis with 40 users per region. It was felt that this data was very similar to the data that was proposed to be collected for the EpiAid, and thus that this effort would be redundant and unnecessary.

In response, a decision was made to widen the scope of the Key Stakeholder meetings which were already planned as part of the EpiAid. These meetings were planned as group sessions in which various key stakeholder groups, including Coroners, Law Enforcement, State and local Public Health, Harm Reduction groups, and Addiction Service providers, would attend and be given an opportunity to describe their role in the overall response to Opioid overdose and addiction, and their perspective on the rise in fentanyl-related fatalities in particular. Question guides were utilized by CDC to ensure that these sessions were conducted efficiently, but these questions were only meant to guide the group discussion, and were not utilized as a strict protocol.

Complete the following for each instrument used during the investigation.

Data Collection Instrument 1

Name of Data Collection Instrument: Key Stakeholder Meeting Questions Guide

Type of Respondent

[X] State and local government staff

[X] State and local health department staff

[ ] Overdose victim

[ ] Overdose victim’s family/friends

[ ] General public

[ ] Member groups at heightened risk for injury

[X] Health care providers/pharmacists/dispensers

[X] Law enforcement personnel

[X] EMS first responders)

[X] Representatives of community organizations

[ ] Other: [describe]

Data Collection Methods (check all that apply)

[ ] Epidemiologic Study (indicate which type(s) below)

[ ] Descriptive Study (describe):

[ ] Cross-sectional Study (describe):

[ ] Cohort Study (describe):

[ ] Case-Control Study (describe):

[ ] Other (describe):

Data Collection Mode (check all that apply)

[ ] Survey Mode (indicate which mode(s) below):

[ ] Face-to-face Interview (describe):

[ ] Telephone Interview (describe):

[ ] Self-administered Paper-and-Pencil Questionnaire (describe):

[ ] Self-administered Internet Questionnaire (describe):

[ X] Other (describe): Key stakeholder meetings to obtain qualitative data on the Opioid abuse issue in the state of Ohio, and the rise in fentanyl-related fatalities.

[ ] Medical Record Abstraction (describe):

[ ] Other (describe):

Response Rate (if applicable)

Total No. Responded (A):	73
Total No. Sampled/Eligible to Respond (B):	1
Response Rate (A/B):	73

(Additional Data Collection Instrument sections may be added if necessary.)

Complete the following burden table. Each data collection instrument should be included as a separate row.

Burden Table (insert rows for additional respondent types if needed)

Data Collection Instrument Name	Type of Respondent	No. Respondents (A)	No. Responses per Respondent (B)	Burden per Response in Minutes (C)	Total Burden in hours (A x B x C)/60
Key Stakeholder meeting question guide	State and Local government	73	1	60	70

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection completion to the IRB/OMB liaison (e-mail: [email protected]).