Supporting Statement B

Virtual Focus Groups with Primary Care Physicians and OBGYNs:
Attitudes about Proposed Hepatitis C Screening Guidelines
DVH 2019

Generic Information Collection under Formative Research and Tool Development

OMB #0920-0840

Section B: Supporting Statement

September 27, 2019

CONTACT

Cynthia Jorgensen, DrPH

Alycia Downs, MPH

NCHHSTP/DVH/OD Communication Team Lead
Co-Principal Investigators

Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

Division of Viral Hepatitis
1600 Clifton Road, NE, Mailstop G-37

Atlanta, GA 30333
Phone: 404-718-8534

E-mail: [email protected]

TABLE OF CONTENTS

1. Research Objectives 3

2. Method, Respondent Universe, and Screening Criteria 3

3. Sampling and Recruitment 4

4. Procedures for the Collection of Information 5

5. Methods to Maximize Response Rates and Deal with No Response 6

6. Tests of Procedures or Methods to be Undertaken 6

7. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 6

LIST OF ATTACHMENTS

Attachment 11 Approved IRB Protocol

1. RESEARCH OBJECTIVES

The primary objective of this qualitative research effort is to understand primary care physicians’ (PCP) and obstetrics and gynecology physicians’ (OBGYN) reactions and attitudes towards CDC’s proposed screening guideline that recommends routine testing for hepatitis C among adults aged 18+ and pregnant women during each pregnancy. Guiding research questions are:

• What are physicians’ current attitudes on screening patients for hepatitis C?

• What are physicians’ reactions to CDC’s proposed universal hepatitis C screening recommendation?

• What are physicians’ reactions to CDC’s proposed prevalence-based hepatitis C screening recommendation?

• What are physicians’ reactions to CDC’s proposed hepatitis C screening recommendation for women during each pregnancy?

• What are physicians’ reactions to CDC’s proposed prevalence-based hepatitis C screening recommendation for women during each pregnancy?

• What are physicians’ reactions to the rationale behind CDC’s proposed screening recommendations?

2. METHOD, RESPONDENT UNIVERSE, AND SCREENING CRITERIA

Research Support and Method

The Division of Viral Hepatitis (DVH) has a communication support contract with Weber Shandwick to support all the training, education, and communication efforts undertaken by the division. KRC Research (KRC), is part of the Weber Shandwick contract, and is an independent research arm with extensive experience in designing and conducting both quantitative and qualitative research for federal agencies, including CDC. KRC will conduct sixteen 75-minute virtual focus groups, eight among primary care physicians (PCPs) and eight among obstetrician-gynecologists (OBGYNs) who completed medical school and who are licensed to practice in the United States. Details of the recruitment and implementation of the groups are described below.

Respondent Universe

KRC will recruit and screen physicians for eligibility for the virtual focus groups. Participants will be identified and recruited from a large proprietary national database managed by KRC’s recruitment partner, Reckner Healthcare (Reckner). Providers in the database have already agreed consented to be invited to participate in health related research studies, including focus groups. Reckner’s database have almost 100,000 PCP and OBGYN physicians registered in their database.

Recruitment Screening Criteria

Criteria for eligibility for these virtual focus groups are similar for PCPs and OBGYNs. PCPs must identify as having one of the following medical subspecialties: family physician, general internist, general practitioner, or combined internal medicine and pediatrics. OBGYNs must practice obstetrics or obstetrics and gynecology. Recruitment will include a diversity of gender, age, and race/ethnic identity. Other requirements are summarized below.

Exhibit 1.1 Summary of Recruitment Targets

All focus group participants will be required to meet the following criteria:

• Licensed Medical Doctors (MDs or DOs)

• Graduated from medical school in the United States

• Completed their primary care physician residency between 1980 and 2017

• Primary responsibility is direct patient care, and as such dedicate:

  • 20 or more hours per week to direct patient care

  • 50% or more time to adult care

  • For those with a subspecialty, practice less than half time in that subspecialty

• Work in any of the following practice settings: solo practice, single specialty group practice, multi-specialty group practice, Staff Model Health Maintenance Organization or HMO, Other model HMO, Managed Care Organization, Network managed care systems such as PPOs, Mixed model practice, or Hospital-based practice

3. SAMPLING AND RECRUITMENT

KRC’s recruitment partner is Reckner Healthcare (Reckner). Potentially qualifying study participants will be drawn from the Reckner Healthcare physician panel, a volunteer national panel of physicians.

The sample of potential focus group participants will be drawn using stratified random sampling. Stratified regional samples for each of the physician segments will be drawn within each U.S. Census region using computer-based random selection/list-generating software. Participants are pre-screened for being either a PCP or OBGYN.

Potentially qualified participants will be sent an email from Reckner (Attachment 2) that explains the purpose of the virtual focus groups, and encourages those interested to complete screening. If potential participants are interested in participating, Reckner will screen them by telephone using a screening tool (Attachment 3) to determine if they qualify.

Physicians who do not respond to the initial outreach email will be contacted by Reckner via telephone and asked if they are interested in participating in the project. If they are interested, Reckner will ask the qualifying screener questions (Attachment 3).

Once it is determined that a physician qualifies for the study, he or she was asked whether or not they would like to participate in a virtual focus group that will require about 75 minutes of their time. Qualified physicians will be given a choice of groups in which to participate to make participation as convenient as possible.

CDC will be identified as the sole sponsor of the activity. Individuals will be advised that participation is voluntary and their responses will be treated with confidentiality. They will be asked to read and sign a consent form (Attachment 4).

Reckner will protect the names and any other personal identifiable information (PII) on the physicians, which will be kept on password protected computers accessible only to Reckner staff.

Personally identifiable information from qualifying individuals will not be distributed outside of Reckner. Other information gathered by Reckner from qualifying respondents in the screening tool will be summarized in an anonymized spreadsheet which will be distributed to KRC Research and CDC (Attachment 6).

Thus, only Reckner staff will have access to personally identifiable information (full respondent name, phone number, and email). PII will not be shared with CDC. CDC staff will not be involved with sample recruitment and will never know the identities of any study respondents.

Once scheduled, a confirmation email or letter (Attachment 5) will be sent to the participants confirming the appointment and outlining technology requirements. 

4. PROCEDURES FOR THE COLLECTION OF INFORMATION

Each 75-minute focus group will be moderated by a professional and experienced KRC moderator using Civicom, an easy-to-use adobe-based online platform, and telephone for voice. Civicom is web-based platform and does not require a downloaded file to a person’s personal computer. Participants and viewers need only have an internet connection and the latest version of Adobe on their computers to use the platform.

Civicom allows for virtual focus groups with webcams to be conducted seamlessly, drawing upon all of the benefits of in-person focus groups without the limitation of geography. Respondents will be able to see and hear each other, and interact in real-time. The technology also allows the research team to show content and materials, to get “hand counts,” and to show images or video.

At the time of the group, respondents both call in and log on to the platform. Once all participants are on the line and connected, the technician connects them to the moderator and remains available for the duration of the group. Both respondents and the moderator use their own telephones to talk during the focus groups. Should anything go wrong with their internet connection, conversation can continue seamlessly while the technician works to troubleshoot.

The platform can accommodate observers from CDC and the project team, similar to a “backroom” of a focus group facility. CDC observers have the option of watching and listening in by logging onto the platform and listen either through their computers or telephone lines. Only first names are used to protect identities. Participants will be advised (Consent form, Attachment #4) that project staff members may listen in on the focus groups and take notes during the groups.

5. METHODS TO MAXIMIZE RESPONSE RATES AND DEAL WITH NO RESPONSE

KRC will use the following procedures to maximize cooperation and to achieve high levels of participation:

• Use of a voluntary and pre-screened panel in which respondents have consented to be included;

• The project will be identified as sponsored by CDC, which can be appealing to physicians;

• A $100 token of appreciation will be provided to key participants upon completion of the interview;

• All recruitment materials indicate the voluntary nature of the study.

As in the case with qualitative research, no response rate is calculated.

6. TESTS OF PROCEDURES OR METHODS TO BE UNDERTAKEN

N/A

7. INDIVIDUALS CONSULTED ON STATISTICAL ASPECTS AND INDIVIDUALS COLLECTING AND/OR ANALYZING DATA

Exhibit 5.1 below lists the project team members who were consulted on the aspects of research design and those who will be collecting and analyzing the data.

The CDC staff and KRC Research are primarily responsible for the design of the research. KRC is responsible for the implementation of the research; data collection and analyzing data. CDC and KRC will jointly prepare and present findings at meetings and in publications.

The CDC staff will neither collect data from nor interact with research participants. Data will be collected by KRC staff listed below. No individual identifiers will be linkable to collected data, and no individually identifiable private information will be shared with or accessible by CDC staff. All members of the research team will work together to analyze the data and generate reports containing summaries of the findings.

Exhibit 1: Statistical Consultants and Project Team Members

Team Member	Organization	Phone	Email
Cynthia Jorgensen, DrPH	CDC	404-718-8534	[email protected]
Alycia Downs	CDC	404-718-8509	[email protected]
Mark Richards, PhD	KRC Research	202-230-8767	[email protected]
Lindsay Gutekunst	KRC Research	202-585-2922	[email protected]

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