Sup Sta B

Extensively Drug Resistant Tuberculosis Contact Investigation: A Cost Assessment

OSTLTS Generic Information Collection Request

OMB No. 0920-0879

Supporting Statement – Section B

Submitted: 07/21/2016

Program Official/Project Officer

Samuel Shillcutt PhD

Prevention Effectiveness Fellow

Centers for Disease Control and Prevention: Division of Tuberculosis Elimination

1600 Clifton Rd, Mailstop E-10, Atlanta GA, 30333

404-718-8963

[email protected]

Table of Contents

Section B – Information Collection Procedures 3

1. Respondent Universe and Sampling Methods 3

2. Procedures for the Collection of Information 3

3. Methods to Maximize Response Rates Deal with Nonresponse 4

4. Test of Procedures or Methods to be Undertaken 4

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

LIST OF ATTACHMENTS – Section B 5

Section B – Information Collection Procedures

1. Respondent Universe and Sampling Methods

Respondents will consist of state or county officials who were involved in a contact investigation of an extensively drug resistant tuberculosis (XDR-TB) patient who arrived in the United States in April 2015. Respondents will be identified via TB controllers from 14 states and 1 local health department. Each TB controller will be asked to recommend up to 2 staff for participation in this study (n = up to 30). Respondents are expected to hold the titles of program manager and accountant within each jurisdiction. A total of 45 respondents will be included in this data collection. No sampling will be included.

2. Procedures for the Collection of Information

To identify respondents, the analyst will set up an introductory phone call (Attachment_B_Introduction_to_the_TB_controller_and_solicitation_of_data_collectors_instrument; Attachment_F_Notification_email_to_TB_controller) with the TB controllers in 14 states and 1 local health jurisdiction. On these calls, the analyst will explain the purpose of the study, establish rapport, and ask the TB controllers to identify up to two staff persons to participate in the information collection. Respondent types are expected to consist of one program manager and one accountant per jurisdiction. Once the pool of respondents has been identified (n = up to 30), procedures for data collection will be as follows:

• Phase I: The analyst will send instructions for the spreadsheet instrument (Attachment_Ca_Data_Collection_instructions, Attachment_Cb_State_and_county_representative_data_collection_spreadsheet_instrument, Attachment_G_Notification_email_to_data_collector) to all respondents identified by TB controllers, and a notification email to set up a time to meet (Attachment_H_Reminder_email). Each respondent will have the option to complete the spreadsheet in their office and fax their findings to the analyst, or communicate results during an interview with the analyst (Attachment_Da_Information_transmitting_interview_guide_instrument_program_manager, Attachment_Db_Information_transmitting_interview_guide_instrument_accountant). If the respondent has completed the spreadsheet in advance, during the interview the analyst will review the information provided, clarify questions, and fill in any missing information. All information gathered in this process will be documented on a master spreadsheet held by the analyst.

• Phase II (Attachment_I_Email_to_set_up_validation_call, Attachment_E_Phone_script_followup_instrument): After the conduct of all interviews, the analyst will contact the original respondents (n = up to 30) again to discuss data quality and any data are missing, inconsistent or incomplete.

After CDC finalizes data collection, the analyst will calculate results in Microsoft Excel in a file stored on password protected computers at the CDC. Results will include total costs and cost per state and local health department calculated according to an ingredients approach. The interviews described previously will provide quantities and local values of each component consumed. Direct costs will be analyzed to provide results from a government perspective, with further modeling to provide a societal perspective. In both perspectives, costs of the contact investigation will be modeled across two years including identification of contacts, testing them, providing treatment, and following up of high risk contacts and contacts with latent tuberculosis infection (LTBI).

3. Methods to Maximize Response Rates and Deal with Nonresponse

Recognizing that participation is voluntary, we will use several methods to maximize our response rate. DTBE program consultants will facilitate introductions between the CDC analytic lead and state and local TB controllers to initiate communication. State TB controllers will use their authority to delegate data collection responsibilities and encourage task completion. The CDC interviewer will receive informal training from an experienced DTBE consultant in strategies for engaging respondents, fostering cooperation, and ensuring completion of data collection. The team will communicate using semi-structured telephone interviews for transmitting findings to increase the likelihood of obtaining data, and respondents will be notified with plenty of time in advance to allow them to schedule activities. Calls will be scheduled according to each respondent’s availability.

4. Test of Procedures or Methods to be Undertaken

The time burden associated with each component of the study, based on pilot testing with four public health professionals, includes the following:

1. Introductory Phone Call: The introductory phone call that will be used to introduce the analyst to the TB controllers to identify participants (n = up to 30) for data collection activities is estimated to take no more than 30 minutes. See Attachment_B_Introduction_to_the_TB_controller_and_solicitation_of_respondents_instrument.

2. Data collection: Data collection using the Spreadsheet instrument is estimated to take a total of 2.5 hours for program managers, and 1.5 hours for accountant (including time to review instructions and compile data). Specifically, 1 hour has been estimated for all respondents to review instructions, and 1.5 hours is estimated for program managers to complete the spreadsheet instrument and 30 minutes for accountants to complete the spreadsheet instrument. See

Attachment_Ca_Data_Collection_instructions, and Attachment_Cb_State_and_county_representative_data_collection_spreadsheet_instrument

3. Phone interview: This call is estimated to take up to 1 hour for program managers and 30 minutes for accountants if data is transmitted during the call. If spreadsheets are completed in advance, the time necessary for the call will be less. See Attachment_Da_Information_transmitting_interview_guide_instrument_program_manager,

Attachment_Db_Information_transmitting_interview_guide_instrument_accountant for each version of this call.

4. Follow-up phone interview: The average time for the follow-up phone interview across respondents is estimated to take no longer than 20 minutes. See Attachment_E_Phone_script_followup_instrument

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

Data collection will be performed by selected state and local health department staff of the 14 affected states and McHenry County, IL, and communicated to the analyst to record onto a master spreadsheet. The analyst has the statistical experience to perform the analysis under the supervision of senior DTBE personnel. These researchers are members of the Centers of Disease Control and Prevention / Office of Infectious Disease / National Center for HIV/AIDS, Hepatitis, STD, and Tuberculosis Prevention / Division of Tuberculosis Elimination, Data Management, Statistics, and Evaluation Branch; Field Services Branch; Surveillance, Epidemiology, and Outbreak Investigation Branch; and Communications, Education, and Behavioral Studies Branch. Other researchers from the Division of Global Migration and Quarantine will be involved in providing data and description of activities.

• Dr. Samuel Shillcutt, DTBE – 404-718-8963, [email protected]

• Ms. Suzanne Marks, DTBE – 404-639-5343, [email protected]

• Mr. Paul Regan, DTBE – 404-639-6496, [email protected]

• Dr. Sundari Mase, DTBE – 404-639-5336, [email protected]

• Mr. Bruce Bradley, DTBE – 404-639-6489, [email protected]

• Ms. Dawn Tuckey, DTBE – 404-639-5323, [email protected]

• Ms. Gail Burns Grant, DTBE – 404-639-5344, [email protected]

• Ms. Kate Roland, DTBE – 404-639-0982, [email protected]

• Dr. Krista Powell, DTBE – 404-639-5337, [email protected]

• Ms. Rebecca Hall, DGMQ – 404-718-4772, [email protected]

• Ms. Tina Objio, DGMQ – 404-498-0777, [email protected]

• Dr. Susan Lippold, DGMQ – 404-498-0763, [email protected]

LIST OF ATTACHMENTS – Section B

• Attachment_A_State_and_county_collaborators

• Attachment_B_Introduction_to_the_TB_controller_and_solicitation_of_respondents_instrument

• Attachment_Ca_Data_Collection_instructions

• Attachment_Cb_State_and_county_representative_data_collection_spreadsheet_instrument

• Attachment_Da_Information_transmitting_interview_guide_instrument_program_manager

• Attachment_Db_Information_transmitting_interview_guide_instrument_accountant

• Attachment_E_Phone_script_followup_instrument

• Attachment_F_Notification_email_to_TB_controller

• Attachment_G_Notification_email_to_Respondent

• Attachment_H_Reminder_email

• Attachment_I_Email_to_set_up_validation_call