Pretest

Telephone Screener (Pretest and Main Study)

Introduction

Ask to speak to someone 18 years or older.

Hello, my name is _______________ and I’m from [name of company]. I’m calling on behalf of RTI International, a non-profit research organization, about a study being sponsored by a public health agency. We’re calling to recruit people to take part in a research study about advertisements. I’m not selling or promoting any product. RTI will be conducting online surveys at our location, and we would like to see if you are eligible. We have various time slots available and will work with you to find a time that fits your schedule. To see if you are eligible, I’d like to ask you some questions. If you are eligible and choose to participate, we will reimburse you $50 after you complete the survey.

May I continue?

Yes  CONTINUE

No  [Thank respondent and end call.]

CORE ELIGIBILITY CRITERIA

1. Have you participated in any market research interviews such as a focus groups or one-on-one interview in the past three months?

Yes	 TERMINATE
No	 CONTINUE

2. What is your current occupation?

Healthcare Provider (e.g., Physician, Nurse, Counselor, Physical therapist)  TERMINATE

Pharmaceutical Employee (e.g., Pharma Rep)  TERMINATE

Market Research employee/Advertising employee  TERMINATE

All Other Occupations (including student, unemployed, or retired)  CONTINUE

3. How old are you?

17 YEARS OR YOUNGER	 TERMINATE
18-25 YEARS	 CONTINUE
26-39 YEARS	 TERMINATE
40-49 YEARS	 CONTINUE
50-59 YEARS	 TERMINATE
60-74 YEARS	 CONTINUE
75 YEARS OR OLDER	 CONTINUE
*RECORD TO FILL QUOTAS*

4. What is your sex?

Male	 CONTINUE
Female	 CONTINUE
SCREEN FOR A MIX

5. What is the highest level of education you have attained?

Less than high school	 CONTINUE
High school graduate (or GED)	 CONTINUE
Some college or technical school (No degree)	 CONTINUE
College graduate (2- or 4-year degree)	 CONTINUE
Some graduate school (No degree)	 CONTINUE
Graduate school degree	 CONTINUE
SCREEN FOR A MIX

6. Which of these racial groups best describes you? [Read options below]

White	 CONTINUE
Black / African American	 CONTINUE
American Indian or Alaskan Native	 CONTINUE
Asian	 CONTINUE
Native Hawaiian or Pacific Islander	 CONTINUE
Other	 CONTINUE
SCREEN FOR A MIX

7. Have you ever been diagnosed with a hearing loss or hearing impairment?

Yes	 CONTINUE
No	 CONTINUE

8. Do you currently use or wear a hearing aid or other listening device?

Yes	 CONTINUE
No	 CONTINUE

Interview Invitation:

Thank you for answering all of my questions. Based on your responses, you appear eligible to participate in our study.

Your participation in the study will last about 45 minutes and should be very interesting. The study involves reviewing a few advertisements on a computer and answering some questions about what you watched in an online survey. In addition, you will also participate in a short hearing test with a certified audiologist. During this hearing test, you will be asked to wear a special device in your ear to record your hearing. The audiologist will provide you a short report explaining the results of the test, and will provide a resource to get additional information if necessary.

[READ FOR ALL PARTICIPANTS]: One step in this study will be having your hearing tested.   In order for the test to be done correctly, you ears will need to be clear of excessive wax.  If you have a history of excessive wax, please have your ears cleaned or clean them yourself using self-care as recommended by your doctor or other health care professional. If you normally wear or use a hearing aid or listening device, it is important that you bring it with you that day.

No one will try to sell you anything, and no one will call you later because you participated. We will reimburse you $50 for your time and participation. Can I schedule your participation?

The surveys will take place on [DATES AND TIMES TBD]. Which date and time would work best for you?

Your participation in this study is very important. If for some reason you will not be able to attend, please let us know right away. You can call us anytime at [insert phone number], and if we are not here, please leave a message.

Closing for Ineligible Participants:

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.

Participant Information

NAME: ________________________________________________________

ADDRESS: ________________________________________________________

CITY: ________________________________________________________

ZIP CODE: ________________________________________________________

EMAIL ________________________________________________________

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 PHONE NUMBER:

Recruiter: ____________________

Informed Consent (Pretest & Main Study)

Introduction and Purpose:

Thank you for agreeing to participate in this research study. The purpose of the study is to conduct a hearing test and to get your thoughts on various aspects of prescription drug advertisements. You will see an advertisement before looking at the survey questions.

RTI International, a non-profit research organization in North Carolina, is conducting the study. We will be conducting interviews in Raleigh, NC, and Baltimore-Washington, DC. You are one of approximately [Pretest: 640; Main study: 1,056] people being asked to participate in this phase of the study.

Procedures:

There are two parts to this study. If you agree to participate, you will first meet with an audiologist who will conduct a hearing assessment. If you wear hearing aids, you will remove them for this portion of the study. The audiologist will ask you a few questions about your hearing and conduct a physical exam of your ear (called an otoscopy) to make sure that there is nothing that could affect testing or prohibit you from participating further.

You will then use earphones inserted in the external auditory canal to listen to some sounds and answer some questions about what you hear. The audiologist will advise you of any issues observed and provide you a short report explaining the results of the test. You will receive resources for getting more information if necessary. The hearing assessment will take approximately 20 minutes.

You will then watch an ad and complete an online survey asking about your reactions to, preferences for, and understanding of the ad. You will complete the survey on a laptop computer set up at a workstation. During the survey, you will wear headphones so you can both see and hear the ad. You will be in a room with other participants that are also taking the survey, but they will not be able to see your responses. The ad viewing and survey will last approximately 25 minutes.

Benefits:

You will be given the results of your hearing test, along with information on how to follow-up for further testing if necessary.

Risks:

There are no known risks to participating in this study. However, it is possible that some participants may feel anxiety about the status of their hearing or the results of the hearing test. In addition, while the survey questions we ask are not meant to be sensitive, there is always a chance that you may feel uncomfortable with some of the questions. You do not have to answer any question that you don’t want to answer.

Confidentiality:

All information collected in this study will be kept confidential to the extent allowable by law. The study team will not disclose your name or any of your hearing test results or comments, and your personal information (name, address, phone number) will not be linked to any of your responses or shared in any report.

Observation:

No one except project staff will observe the hearing test. Some project staff will be available in the room while you take the survey to assist with technology issues or to answer general questions. They will not be able to see or record your responses to specific survey items.

Reimbursement:

In appreciation for your time and travel, we will reimburse you $50 after you complete the survey.

Right to Refuse or Withdraw:

Your participation in this study is voluntary. You can choose not to talk about any topic, and you can withdraw from the study for any reason at any time without penalty.

Persons to Contact:

If you have questions about the study, you can call the associate project director, Sarah Ray, at 1-800-334-8571, ext. 24934. She can be reached between 9:00 AM and 5:00 PM Eastern Time Monday to Friday. If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.

Authorization and Consent:

I have read this consent form. I understand the audiologist conducting the hearing study is a covered entity and as such, the hearing test may be considered protected health information or PHI under the Health Insurance Portability and Accessibility Act of 1996 (HIPAA). I understand that the results of the hearing test will be disclosed to RTI as part of the study and will be used only for this study. The audiologist will not retain any information after the test is conducted and the results are provided to RTI. This consent will expire at the end of this study or if I change my mind about participating in the study. If I change my mind, I understand that I must do so in writing. I understand that information obtained prior to my written cancellation was made at my request and with my consent.

I had a chance to ask questions, and my questions were answered. I was given a copy of this consent form. I agree to participate in the study.

_________________________________ _________________

Signature of Participant Date

_________________________________ _________________

Signature of Person Obtaining Consent Date