Supporting Statement

Opioid Public Education Program

Focus Groups Exploring the Attitudes, Perceptions, and Behaviors of Individuals At-Risk for Prescription Opioid Misuse

Product Activity to be assessed

The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Prevention (CSAP), is requesting OMB approval for one new focus group tool consisting of the following:

• Focus Group Protocol (Tab A)

• Screening Protocol and Questionnaires (Tab B)

• Consent and Confidentiality Forms (Tab C)

• Facilitator’s Guide (Tab D)

The opioid crisis is one of the most devastating public health issues facing America, recently inspiring a Presidential Declaration of a Nationwide Public Health Emergency.¹ The public health infrastructure at the local, state, and federal level is responding in a comprehensive and coordinated effort to save lives and enable communities and individuals to recover. As a key component of SAMHSA’s response, the Health Communications and Marketing for Public Engagement contract in CSAP is increasing its focus on opioids, beginning with a focus on the diversion and misuse of prescription opioid pain relievers.

Prescription pain relievers, such as Vicodin and OxyContin, were and continue to be key elements in the crisis both as common substances for the initiation of opioids and as continued substances of misuse. An important factor is the sheer number of prescription opioids in circulation. While prescriber education and other programs have decreased the annual number of prescriptions from 255 million in 2012, there were still more than 214 million new opioid prescriptions written in 2016.² The result is a large pool of opioids available for diversion and misuse. The 2016 National Survey of Drug Use and Health found that in addition to the 37.5 percent of misused pills acquired through a health care provider, 53 percent were acquired through a friend or family member.³

While the 37.5 percent is being addressed by prescriber education and monitoring programs, the 53 percent offers a potential target for intervention through consumer education and disposal programs. Forty-two percent of patients reported storing medications, some of whom kept them for as long as three years.⁴ There are large amounts of prescription sharing and a lack of awareness about proper storage and disposal.⁵ Only about nine percent of patients keep their opioids in a locked place.⁶ In addition, an alarming number of people seem to be unaware of the dangerous, addictive nature of prescription pain relievers.^7,8,9 The combined effect is seen in the devastation caused by the opioid epidemic.

It is critical that SAMHSA increase its efforts to combat the opioid epidemic, specifically the prescription sharing that occurs between family and friends. The motivations for this behavior are complex and more information is needed in order to develop education programs that accurately target the beliefs, attitudes, and practices of individuals at risk for opioid misuse, such as those who save leftover medication or who do not store and/or dispose of them properly.

Brief Statement of Objectives

The overall objective of these focus groups is to learn more about the values, attitudes, perceptions, motivations, and behaviors of individuals who have prescription opioids and are at risk for sharing the medications with their families and friends. More specifically, these individuals at high risk for sharing medications with friends and family members are those who (1) believe all medications prescribed by a doctor are safe to use and (2) save leftover medication prescribed by a doctor in case they (or someone else) need it later. These focus groups will also inform the best ways to reach this target audience; preferences for receiving information related to opioid use and safekeeping; gaps in awareness and knowledge surrounding opioid misuse; and the messages and/or materials that would best motivate them to not share their prescription opioid medications with friends and family. Results from these focus groups will inform initial key messaging and creative concepts for the development of a public education program designed to prevent prescription opioid misuse. Input from the target audience is critical and will ensure that the education program’s messaging and materials are both accurate and relevant.

Overview of Methods for Information Collection

Data Collection Method

SAMHSA is seeking to conduct six focus groups in three geographic locations with high concentrations of individuals at risk for prescription opioid misuse. The locations for the focus groups will aim to recruit individuals from diverse socio-economic, cultural, educational, and demographic backgrounds that have taken and/or been prescribed medication from their doctor in the past three years. Diversity in participants’ backgrounds will yield a range of perceptions, experiences, and behaviors to inform potential education program materials and products.

The three proposed geographic locations in which the focus groups will take place are: Bedford, NH; Charlestown, WV; and Phoenix, AZ.

Each focus group session will be 120 minutes long. All participants will be pre-screened and participants will be asked to sign informed consent forms prior to participating in the focus group.

SAMHSA, through the Health Communications and Marketing for Public Engagement contract with Vanguard Communications, will provide screening questionnaires to Focus Pointe Global to use in recruiting the focus group participants. This ensures the individuals participating in each group will meet the needs of the program. SAMHSA will provide guidance on timing and set up for the focus groups and work with Vanguard Communications to meet or adjust the logistical requirements as needed.

Identifying Participants and Providing Incentives

SAMHSA will conduct two (2) focus groups in each of the following geographic locations: Bedford, NH; Charlestown, WV; and Phoenix, AZ. Each focus group will have no more than nine (9) participants. SAMHSA will recruit eighteen (18) potential participants who meet the eligibility criteria in each of the geographic locations in order to ensure that each group has between six to eight participants. The focus groups will be conducted in person. In total, SAMHSA will recruit fifty-four (54) potential participants (18 from each of the three geographic locations), with anticipation that twelve (12) to sixteen (16) people will show up to participate in the focus groups at each geographic location.

Participant recruitment will be based on the results of a screening questionnaire to be applied by SAMHSA’s Health Communications and Marketing for Public Engagement contractor, Vanguard Communications.

• Focus groups will be conducted preferably after work hours, based on potential participants’ availability.

• At the beginning of each session, participants will complete a release/consent form of use of the information provided.

• To gain participants and reduce recruiting time and cost, SAMHSA will offer participants $50 cash.

Participant recruitment and session dates will be determined based on receipt of clearance and approval from OMB to proceed.

Frequency of Data Collection

SAMHSA is seeking to conduct the proposed six focus groups only one time. Each focus group will be 120 minutes long and each respondent will have the opportunity to participate in the discussion to inform future efforts regarding opioid misuse prevention. The moderator will ensure all participants have an equal amount of time to participate.

Methods for Identifying Duplication

The team conducted a literature review to locate existing research focusing on target audience behaviors concerning medication sharing, as well as an environmental scan to review relevant campaigns and educational efforts. The information needed is specific to the education program’s key messaging and materials and has not been collected anywhere else.

Annualized Response Burden Estimate

Participant	No. of Respondents	Responses per respondent	Total Number of Responses	Hours per Response	Total hour burden	Wage per hour	Total hour cost
Individuals (Focus Group participation)	54 (max)	1	54	2	108	$25.00	$2700.00
Totals	108 (max)		108		121.5

The estimated annualized cost to respondents for the proposed data collection activities is $2700. For the purposes of estimating annual cost, it is assumed that the participants will participate once. The average burden was estimated based on independent review of the focus groups by the contractor and federal staff.

Estimates of Annualized Cost to the Government

The estimated annualized cost to the government for the proposed data collection activities is $25,376 and includes the cost to the contract as well as the GPO cost.

Position	Percent FTE	Annual Hours	Rate	Total Annual Cost
CSAP GPO		40	$59.40/hr	$2,376
Contractor(s) – Health Communications and Marketing for Public Engagement		n/a	n/a	$23,000
Totals	varies	varies	varies	$25,376

Methods Used to Develop Questions

The methods used to develop the focus group discussion questions included consult with experts in formative research and focus group facilitation. These questions reflect industry standards for ascertaining attitudes and behaviors around critical public health issues.

Consultants within SAMHSA and Outside the Agency

The common measures here for OMB approval are the result of lengthy consultation and discussion among SAMHSA personnel and contract representatives. The final selection of these measures was made by SAMHSA senior officials.

Project Officer: David Wilson, Public Health Analyst, SAMHSA/CSAP, (240) 276-2588; Alternate COR, Marion Pierce, Public Health Analyst, SAMHSA/CSAP, (240) 276-2551

Contractor/Project Director: Lisa Swanberg, Vanguard Communications, (202) 248-5489

List of Attachments

Tab A: Focus Group Protocol

Tab B: Screening Protocol and Questionnaires

Tab C: Consent and Confidentiality Forms

Tab D: Facilitators Guide

1 https://www.whitehouse.gov/the-press-office/2017/10/26/president-donald-j-trump-taking-action-drug-addiction-and-opioid-crisis

2 Center for Disease Control and Prevention. U.S. Prescribing Rate Maps. Available at: https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html. Accessed 11/2017

3 Substance Abuse and Mental Health Services Administration (SAMHSA). 2016 National Survey on Drug Use and Health (NSDUH). Table 2.53B— Source Where Pain Relievers Were Obtained for Most Recent Misuse among Past Year Misusers Aged 12 or Older, by Age Group: Percentages, 2015 and 2016. Available at: https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.htm#tab6-53B. Accessed 11/17.

4 Anderson, P. (2015). Survey: Doctors, NPs, patients concerned about opioid dangers. Medscape & WebMD. Retrieved from http://www.medscape.com/viewarticle/856589

5 Kennedy-Hendricks, A., Gielen, A., McDonald, E., McGinty, E. E., Shields, W., & Barry, C. L. (2016). Medication sharing, storage, and disposal practices for opioid medications among US adults. JAMA internal medicine, 176(7), 1027-1029

6 Kennedy-Hendricks, A., Gielen, A., McDonald, E., McGinty, E. E., Shields, W., & Barry, C. L. (2016). Medication sharing, storage, and disposal practices for opioid medications among US adults. JAMA Intern Med, 176(7), 1027–1029. Retrieved from http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2527388

7 Conrardy, M., Lank, P., Cameron, K. A., McConnell, R., Chevrier, A., Sears, J., ... & McCarthy, D. M. (2016). Emergency department patient perspectives on the risk of addiction to prescription opioids. Pain Medicine, 17(1), 114-121.

8McCauley, J. L., Back, S. E., & Brady, K. T. (2013). Pilot of a brief, web-based educational intervention targeting safe storage and disposal of prescription opioids. Addict Behav, 38(6), 2230–2235. doi:10.1016/j.addbeh.2013.01.019

9 Reddy, A., de la Cruz, M., Rodriguez, E. M., Thames, J., Wu, J., Chisholm, G., & Bruera, E. (2014). Patterns of storage, use, and disposal of opioids among cancer outpatients. Oncologist, 19(7), 780–785.

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