OMB Control No. 0910-0847
Expiration date: 11/30/2020
According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0847 and the expiration date is 11/30/2020. The time required to complete this information collection is estimated to average 10 minutes per person to answer the questions to determine eligibility.
Attachment A
Focus Group Screening Questionnaire
Health Care Providers’ Understanding of Opioid Analgesic Abuse-Deterrent Formulations: Focus Groups
Provider Segment |
Primary Care Practice |
Specialty Practice [each FG must have at least 3 different specialties] |
Total Focus Groups |
Physicians |
3 |
3 |
6 |
Physician assistants |
2 |
2 |
4 |
Nurse practitioners |
2 |
2 |
4 |
Pharmacists |
N/A |
N/A |
2 |
Total |
8 |
8 |
16 |
Hello. We are recruiting healthcare professionals for a research study sponsored by the U.S. Food and Drug Administration. May I please speak to_____________? [RESTATE FIRST SENTENCE IF THE FIRST PERSON YOU SPOKE TO IS NOT THE POTENTIAL PARTICIPANT.]
I work for [RECRUITMENT FIRM NAME], a market research firm. We are working with RTI International, a nonprofit research organization, conducting 90-minute focus groups to gather input from healthcare professionals nationwide.
May I ask you a few questions now to see if you qualify to be in the study?
Yes – Continue
No – Thank and end call
Are you a physician, physician assistant, nurse practitioner, or pharmacist?
Yes, physician Continue for physician segment
Yes, physician assistant Continue for physician assistant segment
Yes, nurse practitioner Continue for nurse practitioner segment
Yes, pharmacist Continue for pharmacist segment
No TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
Have you ever worked for …? [READ LIST and obtain a response to each item]
Any office, division, or agency within the Department of Health and Human Services (HHS) TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
A pharmaceutical company TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
A market research or marketing company TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
RTI International TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
None of the above CONTINUE
In the last 6 months, have you participated in any focus groups or individual interviews about prescription opioid analgesics?
Yes – Thank and end call
No – Continue
RECRUITER: CONTINUE IF PHYSICAN, PHYSICIAN ASSISTANT, OR NURSE PRACTITIONER; IF PHARMACIST, SKIP TO Q14
Please indicate your area of practice [READ LIST AND RECRUIT EITHER TO PRIMARY CARE GROUP OR RECRUIT MIX OF SPECIALTIES FOR SPECIALTY GROUP]:
Primary care/family practice/general medicine/internal medicine Continue for primary care groups
Rheumatology Continue for specialty groups
Neurology Continue for specialty groups
Anesthesiology Continue for specialty groups
Pain Management Continue for specialty groups
Emergency Medicine Continue for specialty groups
Surgery Continue for specialty groups
Orthopedics Continue for specialty groups
Physical Medicine/Rehabilitation Continue for specialty groups
Other TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
On average, what percentage of your time each month is spent on direct patient care?
50% or more Continue
Less than 50% TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
In the past 30 days, for about how many patients have you prescribed opioid analgesics? ________ patients [Write down the number; recruit a mix]
Zero TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
In the past 30 days, for about how many of these patients have you prescribed opioids for chronic non-cancer pain that has lasted for longer than 3 months? __________ patients (Write down the number and ensure Q6≥Q7) [RECRUIT A MIX]
Zero TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
In the past 30 days, about how many prescriptions have you written for opioid analgesics?
________ [RECORD NUMBER AND RECRUIT A MIX]
Zero TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
In the past 30 days, about what percentage of the opioid prescriptions you prescribed fell into each of the following daily dose ranges? [RECORD PERCENTAGES AND RECRUIT A MIX OF 3 RANGES]
_______ 1-50 morphine milligram equivalents (MME) daily [IF NEEDED: for example, 50 MME daily is equivalent to 50 mg of hydrocodone (10 tablets of hydrocodone/acetaminophen 5/300) or 33 mg of oxycodone (about 2 tablets of oxycodone sustained-release 15 mg)]
_____ 51-90 morphine milligram equivalents (MME) daily [IF NEEDED: for example, 90 MME daily is equivalent to 90 mg of hydrocodone (9 tablets of hydrocodone/acetaminophen 10/325) or 60 mg of oxycodone (about 2 tablets of oxycodone sustained-release 30 mg)]
_____91 or greater morphine milligram equivalents (MME) daily [IF NEEDED: for example, 120 MME daily is equivalent to 120 mg of hydrocodone (12 tablets of hydrocodone/acetaminophen 10/325) or 80 mg of oxycodone (about 2 tablets of oxycodone sustained-release 40 mg)]
In the past 30 days, what percentage of the opioid prescriptions you prescribed were for chronic non-cancer pain that has lasted for longer than 3 months?
__________% [RECORD NUMBER AND RECRUIT A MIX]
In the past 30 days, about how many prescriptions for abuse-deterrent opioid analgesics have you prescribed? Examples of abuse-deterrent opioid analgesics include OxyContin, Hysingla ER, MorphaBond ER, Xtampza ER, Arymo ER, and RoxyBond.
__________ [RECORD NUMBER, ENSURE Q10<Q7, AND RECRUIT A MIX]
In which medical setting do you practice most often? [RECRUIT A MIX]
Private/small group practice (10 or fewer providers)
Large group practice (11 or more providers)
Community hospital
Academic hospital
Outpatient clinic
Other outpatient setting (e.g., infusion center, dialysis clinic)
Other (specify) __________________________
About what percentage of your patients are covered by each of the following types of health insurance? [DO NOT OFFER “DON’T KNOW” AS AN OPTION, BUT RECORD IF STATED SPONTANEOUSLY]
____Private health insurance CONTINUE TO Q18
____Medicaid CONTINUE TO Q18
____Medicare CONTINUE TO Q18
____Other CONTINUE TO Q18
____[DO NOT READ] Don’t know CONTINUE TO Q18
RECRUITER: CONTINUE IF PHARMACIST; FOR PRESCRIBERS, SKIP TO Q18
In the past 30 days, about how many prescriptions have you dispensed for opioid analgesics?
________ prescriptions [Write down the number; recruit a mix]
Zero TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
In the past 30 days, for about how many patients have you dispensed prescriptions for opioid analgesics? ________ patients [Write down the number; recruit a mix]
Zero TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
In the past 30 days, for about what percentage of the patients for whom you dispensed opioid analgesic prescriptions did you provide patient education, such as talking with them about directions for use and advice on side effects?
________% [RECORD NUMBER AND RECRUIT A MIX]
In the past 30 days, about how many prescriptions for abuse-deterrent opioid analgesics have you dispensed? Examples of abuse-deterrent opioid analgesics include OxyContin, Hysingla ER, MorphaBond ER, Xtampza ER, Arymo ER, and RoxyBond.
___________ [RECORD NUMBER AND RECRUIT A MIX]
RECRUITER: Continue for all segments
How many years have you been in practice post-residency? If you did not do a residency, how many years have you been in practice? _____years [Write down a number] [RECRUIT A MIX]
Less than 10 years
10-29 years
30 years or more
What is your gender? [RECRUIT A MIX]
Male
Female
What is your age? [RECRUIT A MIX]
25-34 years old
35-54 years old
55 or older
Are you Hispanic, Latino or of Spanish origin? [RECRUIT A MIX]
No
Yes
What is your race? [READ LIST ONLY IF NECESSARY AND RECRUIT A MIX]
White
Black or African American
Asian
Native Hawaiian or Other Pacific Islander
American Indian or Alaska Native
[DON’T READ] Other
Would you consider your primary practice location to be…? [RECRUIT A MIX]
Urban
Suburban
Rural
In what state do you practice most often? STATE: ____________________ [LIST]
REGION [DO NOT ASK; REFER TO LIST]: _____________________ [RECRUIT A MIX OF REGIONS]
Northeast: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, and Pennsylvania
South: Delaware, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, Washington D.C., West Virginia Alabama, Kentucky, Mississippi, and Tennessee, Arkansas, Louisiana, Oklahoma, and Texas
Midwest: Illinois, Indiana, Michigan, Ohio, and Wisconsin, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota
West: Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, and Wyoming, Alaska, California, Hawaii, Oregon, and Washington
Closing Scripts
Ineligible - Closing Script
I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.
Eligible – Closing Script
Great! You qualify for our study.
In appreciation for your time, [you will receive $300 [at the end of the session FOR IN PERSON GROUP]/in the mail 4-6 weeks after you participate FOR ONLINE GROUP].
The [online/in-person] focus group discussions will be held on [DATES] at [TIMES] and will last about 90 minutes. Which of those dates/times works with your schedule? [RECORD]
The discussion will be audio and video recorded, and project team members may observe the discussion.
Would you like to participate in the group discussion at [TIME] on [DATE] (to be determined based on the person’s availabilities as noted above)?
Yes Continue to informed consent instructions and verify contact info
What is your reason for not wanting to participate?
Honorarium is too low Continue ONLY for specialists, Thank and end call for all others
Dates/times don’t work with my schedule Thank and end call
Changed my mind Thank and end call
Other [RECORD] _____________________ Thank and end call
[FOR SPECIALISTS ONLY] Would you be willing to participate if we increased the honorarium to $400? [If no, ask] How much would you expect to receive for your participation? $_______Record answer______
[If yes, say] You will receive this amount [at the end of the session for IN PERSON groups]/[IN THE MAIL 4-6 WEEKS AFTER YOU PARTICIPATE for ONLINE group]. Would you like to participate in the group discussion at [TIME] on [DATE]?
Yes Continue to informed consent instructions and verify contact info
No Thank and end call
Informed Consent Instructions
[FOR ONLINE GROUPS ONLY] We will send you two copies of an informed consent form that includes more information about the research study along with a reminder letter and instructions for the focus group. You MUST return a signed copy of this consent form before the date of the focus group to participate in the focus group. I can email the form to you so you can sign, scan, and email or fax it back, or send it by U.S. mail and you can mail it back. Which option do you prefer?
[READ INSTRUCTIONS FOR THE OPTION SELECTED]
OK, I will mail you two copies of the consent form along with a reminder letter and instructions for the focus group. Please read and sign one copy of the consent form and return it to us in the postage-paid envelope prior to [DATE OF FOCUS GROUP]. The other copy is for you to keep. Please remember that we must receive the signed consent form from you before the date of the focus group to participate in the group.
If you have any questions about the information in the consent form, you can contact the RTI project director, Brian Southwell, at (919) 541-8037 or [email protected].
I will send you the consent forms by email to [email address]. Please send a scanned copy of the signed form to [EMAIL FOR RECRUITER] or fax a signed copy of the form to [FAX # for RECRUITER].
If you have any questions about the information in the consent form, you can contact the RTI project director, Brian Southwell, at (919) 541-8037 or [email protected].
We will send you a confirmation letter with directions for attending the focus group scheduled on [DATE/TIME], so may I please have your mailing and/or e-mail address and telephone number? We will use this information to send you a reminder letter and to call and remind you of the focus group. We will destroy all contact information at the conclusion of the focus groups and none of this information will be shared with the FDA or RTI.
[Verify contact information]
**NOTE** THIS PAGE MUST BE STORED SEPARATELY FROM THE SCREENER AND DATA. PLEASE DESTROY UPON COMPLETION OF FOCUS GROUPS.
NAME: ____________________________________________________________
ADDRESS: ________________________________________________________
CITY: _________________________________________________
ZIP CODE: _________________________________________________
E-MAIL_______________________________________________________
What is the best time to reach you? What is the best telephone number to reach you at that time?
BEST TIME TO BE REACHED: ________________________________________
BEST PHONE NUMBER: ________________________________________
Is there another time and number we can try if we miss you?
ALTERNATE TIME:
ALTERNATE PHONE NUMBER:
Thank you. That’s all the questions I have today. If you have any questions or find that you are unable to attend, please call [recruiter’s phone number] as soon as possible so that we can try to find someone to replace you as a participant in this important research. Thank you again for your time. We look forward to seeing you at [TIME] on [DATE].
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Alexander, Jennifer |
| File Modified | 0000-00-00 |
| File Created | 2021-01-15 |