GenIC Clearance for CDC/ATSDR
Formative Research and Tool Development
Contact:
Rudith Vice
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Atlanta, Georgia 30333
Phone: (404)718-7292
Email: [email protected]
1. Respondent Universe and Sampling Methods 2
2. Procedures for the Collection of Information 4
3. Methods to maximize Response Rates and Deal with No Response 5
4. Tests of Procedures or Methods to be Undertaken 5
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 5
The proposed data collection is qualitative and will not employ any statistical methods. No generalizations will be made beyond the particular respondents.
Data collection involves two overarching audiences: consumers and human healthcare providers. The data collection involves focus groups (FGs) and in-depth interviews (IDIs). All data collection will be completed by a contractor, KRC Research. See Table 1 for a summary of data collection activities for all audiences.
Table 1. Audience and Methodology Overview
Consumers |
|
Healthcare Professionals (HCPs) |
|
||
Adults age 20-59
|
2 FGs |
Primary care physicians |
2 IDIs |
||
Adults age 60+
|
2 FGs |
Primary care nurse practitioner (NP) |
1 IDI |
||
Primary physician associates/assistant (PA) |
1 IDI |
||||
Parents of children age 0-6
|
2 FGs |
Hospital physicians |
2 IDIs |
||
Hospital NP |
1 IDI |
||||
|
|
Hospital PA |
1 IDI |
||
Audience total |
6 FGs |
Audience total |
8 IDIs |
||
Consumers
Eight participants will be recruited for each focus group. Consumers will be required to meet the following fundamental criteria.
All must be full-time U.S. residents, age 20 or above.
Parents groups must be parents or full-time guardians and act as primary health decision maker of at least one child age 0-6.
Participants in three groups will be college graduates, and participants in the other three groups will not be college graduates.
Human Healthcare Professionals
For interviews, healthcare professionals will be required to meet the following fundamental criteria.
All must be licensed Medical Doctors or Doctors of Osteopathic Medicine (physicians), Physician Associates/Assistants (PAs), or Nurse Practitioners (NPs).
All must have direct patient care as a primary responsibility.
Primary care physicians and PAs and NPs must provide comprehensive primary care (health services that cover a range of prevention, wellness, and treatment for common illnesses) and must specialize in internal medicine, family medicine, or combined internal medicine and pediatrics (med-peds).
Hospitalist physicians and hospital PAs and NPs must provide comprehensive medical care to hospitalized patients (inpatient care) and must specialize in internal medicine, family medicine, med-peds, or infectious diseases. Emergency providers (ER doctors, ER nurses, ER PAs) will be excluded to ensure greater commonality of roles and responsibilities in the groups.
The qualitative nature of the interviews and the small sample size mean the results are not intended to be precisely representative or generalizable to a larger population. For this reason, and to minimize burden on potential participants, the screening instruments (Attachment 1 and 2) collect only the necessary minimum information to ensure broad inclusion and representation from different types of individuals within target audiences. In particular, the race and ethnicity question reflects the latest March 2024 OMB guidance on question format but ask minimum categories only, with examples as specified in the guidance, rather than the much more detailed format with multiple checkboxes and write-in response area with example groups. The nature of the proposed data collection does not require this additional detail, and results will not be analyzed based on race or ethnicity.
B. Recruitment
To recruit focus groups and interviews, KRC will work with a recruitment panel provider to identify, screen, and invite qualified individuals from their panel lists, which are made up of individuals who have opted in to participate in studies like these.
The panel provider will send an invitation to screen for the focus groups or interviews to members of its panel, starting with those whose profiles suggest they are most likely to qualify. The recruitment can be conducted online or via a phone call with a panel staff recruiter. The beginning of screening will identify CDC as the sole sponsor and inform each individual that the purpose is to review and provide feedback on an important health-related topic. Individuals will not be told the specific topic; this is to discourage respondents from doing “homework” or educating themselves on the topic in advance of the conversation. The individual will read or hear a confidentiality message, which includes that participation is voluntary and that responses will be confidential: statements made will never associated with specific names or other personally identifiable information (PII) in confidential and reporting to CDC.
Individuals will then be asked if they are interested in participating in a focus group or interview. If they are interested, they will answer KRC’s approved screener questions (Attachments 1 and 2) and confirm they can be at a laptop or desktop computer for the session. Individuals must complete and pass the screening questionnaire without being disqualified based on their answers or due to quotas limits. Once it is determined that a respondent qualifies, they will be asked whether they would like to participate in a focus group or interview that will require up to 90 minutes (focus group) or 60 minutes (interview) and require them to be at a computer with internet access and a camera and microphone in a quiet place. In keeping with best practices for market research, participants will be offered a $75 token of appreciation for their participation.
Once scheduled, KRC will send a confirmation message to the participants with logistical information, as well as the date and time of the group or interview. Prior to the session, participants will be required to sign and date a consent form (Attachments 3 and 4) that outlines the details about the session, such as confidentiality and incentive. They will be sent the form electronically and required to sign it electronically within the panel provider’s system. KRC will keep copies of the consent form files until the end of the project, after which they will be destroyed.
A day or two prior to the session, participants will receive a reminder email and once again be given the opportunity to change their mind. At the start of each session, KRC will give a brief verbal reminder of the consent form details.
After completing screening and scheduling, six focus groups and eight interviews will be conducted. Focus groups will last 90 minutes and interviews will last 60 minutes. Trained moderators from KRC will conduct all focus groups and interviews as well as oversee recruitment and screening (described in Section 1). The moderator will use a semi-structured discussion guide tailored to each audience for all sessions (Attachments 5 and 6). The questions in the guides explore participants’ reactions and assessments of test creative stimuli (Attachment 7) that have been developed for use in a potential communications campaign about antimicrobial resistance (AR).
For consumers, KRC will use one screening questionnaire (Attachment 1) to recruit participants for all six focus groups and will use one discussion guides (Attachment 5) for the moderator to guide the discussion and review of the test creative concepts (Attachment 7).
For healthcare professionals, KRC will use a screening questionnaire (Attachment 2) to recruit participants for all eight in-depth interviews and will use one discussion guide (Attachment 6) for the moderator to guide the discussion and review of the test creative concepts (Attachment 7).
With the consent of each participant, focus groups and interviews will be audio and video recorded to capture the content of the discussion. Recordings will be used to develop written transcriptions which will be used for analytic purposes in the development of a report. Field notes will be taken during the discussions to capture key quotes or expressions. No recordings or transcripts with personally identifiable information will be shared outside of the KRC Research and CDC team conducting and analyzing the discussions.
By design, all potential participants will be drawn from panels of individuals who have opted in to participate in activities like this one. The use of panel sampling helps to maximize the efficiency of recruiting, since all possible participants are familiar with the process and many will have been contacted before. Additionally, to maximize response, the screening questionnaires (Attachments 1 and 2) have been intentionally designed to collect only the minimum amount of information needed to determine the qualifications and useful mix of participants, and quotas for several demographic variables are “loose,” meaning that there is no exact number of individuals who must be recruited with certain criteria. For example, recruiting a mix of geographic settings within each group rather than an exact number in rural, suburban, or urban settings. This reduces the number of individuals who will be screened.
For focus groups and interviews, it is sometimes the case that participants do not sign in on time for their discussion, either for unexpected personal reasons, forgetfulness, or urgent professional obligations. To minimize the instances of this occurring, respondents are given several days’ advance notice of the group or interview and are sent reminder emails the day before and day of the discussion. Should they still not appear, the interviewing team at KRC Research has protocols in place so that the recruiting team can quickly email or call the participant to confirm availability or troubleshoot. Additionally, it is a common practice in market research to plan for one or two “no show” participants when planning focus groups and to tailor the conversation as needed to adjust for a slightly smaller group.
At the beginning of each data collection, participants will be reminded that their participation is voluntary, and they do not need to answer any question that they are not comfortable answering.
No pre-tests are planned for this project.
The following individuals are working under contract with NCEZID and have been consulted throughout the development and design of this data collection. These individuals will lead the data collection once the package is approved.
Mike Ruddell Vice President, KRC Research |
Mark Richards Executive
Vice President, KRC Research |
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