Ssb

GenIC Clearance for CDC/ATSDR

Formative Research and Tool Development

Formative Communications Assessment on Antimicrobial Resistance

OMB Control No. 0920-1154

February 12, 2024

Supporting Statement B

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: nhr9@cdc.gov

Table of Contents

1. Respondent Universe and Sampling Methods 2

2. Procedures for the Collection of Information 2

3. Methods to maximize Response Rates and Deal with No Response 2

4. Tests of Procedures or Methods to be Undertaken 2

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 2

The proposed data collection will only involve statistical methods to sample respondents for the survey with policy influencers. The sampling methods are detailed in Section 1. The qualitative data collection will not employ any statistical methods. For all methodologies, no statistical generalizations will be made beyond the particular respondents.

1. Respondent Universe and Sampling Methods

A. Respondent Universe

Data collection involves three overarching audiences: human health providers, consumers, and policy influencers. The data collection involves focus groups (FGs), in-depth interviews (IDIs), and a survey. 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

Human Health Providers		Consumers		Policy Audiences
Primary care physicians	1 FG	Younger adults age 20-39	1 FG	Policy audiences	1 survey, n=100
Primary care physician assistants/associates (PAs) & nurse practitioners (NPs)	1 FG	Older adults, age 60+	1 FG
Hospitalist physicians	1 FG	Parents of children age 0-6	1 FG
Hospital PAs and NPs	1 FG	Caregivers of adults age 60+	1 FG
Medical association experts	Up to 3 IDIs	Adults, past bacterial or fungal antimicrobial-resistant infection	Up to 3 IDIs
Audience total	4 FGs Up to 3 IDIs	Audience total	4 FGs Up to 3 IDIs	Audience total	1 survey
Grand total	8 FGs, up to 6 IDIs, and 1 survey

Human Health Providers

For focus groups, providers will be required to meet the following basic criteria:

• All must be licensed Medical Doctors or Doctors of Osteopathic Medicine (physicians) or Physician Assistants/Associates or Nurse Practitioners (PAs and NPs).

• All must have direct patient care as a primary responsibility.

• Primary care providers (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.

For interviews, participants will be leaders or experts at medical associations and will be invited to participate through direct outreach by CDC based on preexisting relationships; no screening or other recruitment is involved.

Consumers

For focus groups, consumers will be required to meet the following criteria:

• All must be full-time U.S. residents, age 18 or above.

• Parents group must be parents or full-time guardians and act as primary health decision maker of at least one child age 0-6.

• Caregivers group must tend to the health needs or concerns of an adult over age 60 with health conditions that require ongoing care, must be relied upon by the person in their care or that person’s health care provider(s) to support decisions about health, and must not be a professional caregiver (e.g., home health aide, personal care assistant).

For interviews, respondents will be required to have been diagnosed with a bacterial or fungal antimicrobial-resistant infection in the past three years by their healthcare provider.

Policy Audiences

For the survey, policy audiences will be required to meet the following criteria:

• All must be full-time U.S. residents age 25 or above.

• None may be an elected government official or employed in executive or judicial branches.

• All must work around or with those who impact health policy:

  • Are employed in a multilateral government organization, a private or publicly traded company, a not-for-profit organization, or federal legislative staff.

  • Work in a role related to public policy that involves researching, analyzing, evaluating, or interpreting public policy issues; communicating facts or opinions about public policy; shaping or influencing public policy proposals; or interpreting or enforcing public policy.

  • Follow or have expertise in public policy areas related to health and adjacent fields.

For the survey, participants will be randomly sampled from an existing policy panel of individuals who have opted into complete surveys and similar activities.

B. Recruitment

Focus Groups and Interviews

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 exception is interviews with medical association experts, which will be scheduled based on direct outreach by CDC to existing contacts.

For all other panel-recruited participants, 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 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 4, 5) 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.

Survey

As with focus groups and interviews, KRC will work with a recruitment panel provider to identify, screen, and invite qualified survey participants from their panel list, which is made up of individuals who have opted in to participate in studies like these and, in this case, is composed of thousands of individuals whose work, expertise, or experience overlaps with public policy. The sampling universe for the policy influencer panel from which KRC will draw from includes registered lobbyists, non-elected federal and state government employees, interest-group leaders, and academic researchers in public health fields. It does not include elected officials.

To create the panel, the recruitment panel provider has built a complete sampling universe of all qualifying profiles leveraging employment directories, professional networks, and license data. To recruit participants to the panel, the provider has contacted contacts eligible individuals directly and obtained consent to be contacted for future studies. When recruiting for a project like this one, the panel provider starts by drawing a random sample of policy influencers for inclusion in the sampling frame. Each potential respondent in the sample will receive a series of email and peer-to-peer text message invitations to participate in the study. Respondents can opt out at any time and unsubscribe from further invitations.

2. Procedures for the Collection of Information

Focus Groups and Interviews

After completing screening and scheduling, eight focus groups and up to six interviews will be conducted. Focus groups will last 90 minutes and interviews will be 60 minutes long. 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. The questions in the guides explore the knowledge, attitudes, beliefs, and needs of the audiences related to antimicrobial resistance (AR).

For providers, KRC will use a screening questionnaire (Attachment 1) to recruit participants and a discussion guide (Attachment 6) for the moderator to guide the discussion. The screener and guide will be used for all four focus groups. For medical association experts, a separate interview guide will be used (Attachment 9), but no screener will be involved due to the direct outreach method of scheduling.

For consumers, KRC will use one screening questionnaire (Attachment 2) to recruit participants for all four focus groups and will use two discussion guides (Attachments 7, 8) for the moderator to guide the discussion: one for the young adults and older adults groups, and one for the parents and caregivers groups. For the in-depth interviews, KRC will use a separate screener (Attachment 3) and discussion guide (Attachment 10).

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.

Survey

Prior to recruitment, KRC will work with its panel partner to program the online survey (Attachment 11) and ensure it is thoroughly tested for accuracy. The survey includes necessary screening questions to ensure that participants meet the specific criteria of the study.

Individuals will be asked whether they would like to participate in a survey; the invitation will reference the survey format (accessible online) and survey length (time in minutes). After reviewing this information, participants will opt in and begin with screening questions to ensure they match the profile of the intended audience. Those who pass the screening questions will proceed to the content of the survey and will be counted as a complete once they finish all questions.

Only basic descriptive statistical analyses will be conducted with software for manipulation and tabulation of survey data to aid in interpretation of results. For example, mean or median scores may be calculated for response categories including Strongly Agree, Agree Somewhat, Disagree Somewhat, and Strongly Disagree.

3. Methods to Maximize Response Rates and Deal with No Response

By design, all potential participants will be drawn from panels of individuals who have opted in to participate in activities like this one (with the exception of medical association experts who will be sourced directly through their connections to CDC). 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, 2, 3) 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 other reasons. 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.

4. Tests of Procedures or Methods to be Undertaken

No pre-tests are planned for this project. However, the survey will be tested for accuracy and functionality prior to collecting data among the target policy influencer audience.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

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 733 10th St NW Washington, DC 20001 Phone: 202-585-2946 Email: mruddell@krcresearch.com

Mark Richards Executive Vice President, KRC Research 733 10th St NW Washington, DC 20001 Phone: 202-585-2982 Email: mrichards@krcresearch.com

6