GenIC Clearance for CDC/ATSDR
Formative Research and Tool Development
In-Depth Interviews with Healthcare Professionals about C. Diff Materials
OMB Control No. 0920-1154
April 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) 718-1616
Email: [email protected]
1. Respondent Universe and Sampling Methods 2
2. Procedures for the Collection of Information 3
3. Methods to Maximize Response Rates and Deal with No Response 3
4. Test of Procedures or Methods to be Undertaken 4
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 4
The data collection will not involve any statistical methods and no statistical generalizations will be made beyond the particular respondents.
To participate in the in-depth interviews (IDIs), participants must meet the following primary inclusion criteria:
Be a physician (MD or DO), physician associate/assistant (PA), nurse practitioner (NP), or dentist (DDS)
For physicians, PAs, and NPs, work in: a primary care role (2), an urgent care role (2), a hospital (non-emergency department) role (3), or an emergency department role (2)
Practice in any of nine states where community onset C. diff hospitalization rates are relatively high
For dentists: work in general dentistry (2)
Spend 20 or more hours per week in direct patient care, of which 50% or more is adult care
Potential participants are drawn from a national panel of individuals who have opted in to participate in interviews on various topics. The contractor KRC Research will direct a subcontracted panel provider to distribute an invitation to screen for the interviews to members of its panel, starting with those individuals whose panel profiles suggest they are most likely to qualify (e.g., have already identified as a physician in a target state, etc.). When an individual receives the invitation to screen, they will either complete a screening questionnaire online (Attachment 1) or via the phone in a call with a panel provider staff member. Individuals must pass the screening questionnaire without being disqualified based on their answers or due to quotas reached on certain characteristics.
A total of 11 participants will be purposively selected from this pool of eligible participants. Within the parameters of the healthcare professional population, participants will be selected to ensure a level of diversity across U.S. states, gender, age, ethnicity and race, practice setting (where relevant), and urban-suburban-rural status.
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 instrument (Attachment 1) collects only the necessary minimum information to ensure broad inclusion and representation from different types of individuals within target healthcare roles. 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 detail, and results will not be analyzed based on race or ethnicity.
Selected participants will be invited to confirm their interest and availability in participating. Once confirmed, a confirmation message will be sent to the participants with logistical information, as well as the date and time of the interview. A day or two prior to the scheduled interview, participants will receive a reminder email. To incentivize participation, IDI participants will be offered a $75 incentive for their time, in line with market research recruitment standards for this audience. If, at the time of invitation, the participant declines to participate, a replacement participant will be selected from the pool of eligible participants.
A contracting company will conduct all recruitment and screening activities.
After completing screening, 11 interviews will be conducted that will last 60 minutes. Prior to the interview, participants will be required to sign and date a consent form that outlines the details about the interview, such as confidentiality and incentive (Attachment 2). They will be sent the form electronically and required to sign it electronically. Project records will be maintained in accordance with the federal record retention requirements. Additionally, at the start of each interview, respondents are given a brief verbal reminder of the consent form details.
Trained moderators from the contracted firm KRC Research will conduct all interviews as well as oversee recruitment and screening (described in Section 1). The interviewer will use a semi-structured interview guide for all interviews (Attachment 3). The questions in the interview guide explore knowledge, attitudes, and beliefs about C. diff, experiences with patient conversations about C. diff, and assessments of healthcare professional- and patient-focused C. diff fact sheets.
With the consent of each participant, interviews will be audio and video recorded to capture the content of the discussion. Recordings will be transcribed into transcripts which will be used for analytic purposes in the development of a report. Field notes will be taken during the interviews to capture key quotes or expressions. No recordings or transcripts with personally identifiable information will be shared outside of the KRC Research team conducting and analyzing the interviews. Files will be deleted within 30 days of NCEZID approval of the final report of findings.
By design, all potential participants in these interviews will be drawn from a panel of individuals who have opted in to participate in studies like this one. The use of panel sampling helps to maximize the efficiency of recruiting, since all possible participants are familiar with the recruiting contractor and many will have been contacted before. Additionally, to maximize response, the screening questionnaire (Attachment 1) is intentionally designed to collect only the minimum amount of information needed to determine the qualifications and ensure a diversity of participants. Quotas for several demographic variables are “loose,” meaning that there is no exact number of individuals who must be recruited with certain criteria. This reduces the number of individuals who will be screened.
It is sometimes the case that participants do not sign in on time for their interview, usually because of either unexpected demands on their time or due to forgetfulness. To reiterate the importance of participation and remind participants of their agreement to participate, respondents are given several days’ advance notice of the interview and are sent reminder emails the day before and day of the interview. 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 reschedule as needed. If the respondent is entirely unresponsive, they may be replaced after the day of the planned interview.
At the beginning of each interview itself, participants will be reminded that their participation is voluntary, they do not need to answer any question that they are no comfortable answering, and they may end the interview at any time if desired.
No pre-tests are planned for this project.
The following individual is working under contract with NCEZID and has been consulted on the development and design of this data collection. This individual will lead the interviews once the package is approved.
Mike Ruddell
Vice
President, KRC
Research
733 10th St. NW
Washington, DC 20001
Phone: 202-585-2946
Email: [email protected]
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | CDC User |
| File Modified | 0000-00-00 |
| File Created | 2025-05-19 |