Form 0920-1208 NHIS Follow-up Health Study Invitation to Participate Qu

Attachment 1c National Health Interview Survey (NHIS) Follow-up Health Study Invitation to participate data collection form and associated help screen

Form Approved

OMB No. 0920-1208

Notice – CDC estimates the average public reporting burden for this collection of information as 5 minutes per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road, MS D-74, Atlanta, GA 30333; ATTN: PRA (0920-0950).

Assurance of Confidentiality – We take your privacy very seriously.  All information that relates to or describes identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes.  NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m) and the Confidential Information Protection and Statistical Efficiency Act (Title III of the Foundations for Evidence-Based Policymaking Act of 2018 (Pub. L. No. 115-435, 132 Stat. 5529 § 302)).  In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you.

Expires: 8/31/2023

NHIS Follow-up Health Study Invitation to Participate Questions

Questions below will be administered by the field interviewer at the conclusion of the Sample Adult section of the NHIS interview in all households selected for the study sample (one adult per household).

Note that the instrument will automatically skip this section in interviews with Sample Adults whose interviews are completed by proxy.

All screens will have a link at the top of the page to the help screen.

All references in this document to the brochure refer to Attachment 1d.

All text in blue and grey is not read out loud.

[BIOLANG] Was this Sample Adult interview conducted entirely in English?

CAPI Instructions:

<1> [goto BIOINT1_A]

<2> [exit BIO section]

[BIOINT1_A] Before we finish today, the study sponsor, the National Center for Health Statistics, or NCHS, which is part of the CDC, would like to invite you to participate in a follow-up health study. The goal of the study is to develop methods to collect important health data that cannot be obtained from an interview. If you participate, you will receive $75. The Census Bureau does not have a role in this study.

For this study, a trained health representative will come to your home at a day and time that is convenient for you. The health representative will measure your height, weight, waist, blood pressure, resting heart rate and will collect a blood sample. You will also be asked to provide a urine sample and feedback about your study experience. Your blood and urine will be tested for standard health measures such as liver and kidney function, and for the presence of COVID-19 antibodies. You will receive your personal results and, as mentioned, $75. At the end of the study, NCHS will combine your results with the results of all the other participants. This information will ONLY be used for statistical purposes.

Read if necessary: Strict federal laws prevent NCHS and its contractors from releasing information that could identify you or your family to anyone else without your permission. All identifying information is removed from the data.

CAPI Instructions:

<1 to continue> [goto BIOINT2_A]

<RF> [goto BIORFWHY_A]

[BIOINT2_A] This visit will take about an hour and your participation is voluntary. If you choose, you can complete just part of the study.

In person interview: Here is a brochure that explains in more detail what the study will be about.

Hand over study brochure.

Phone interview: I am happy to answer questions, and I can also send you a brochure explaining more about the study.

If the respondent agrees to be contacted, mail study brochure after the end of the interview

CAPI Instructions:

<1 to continue> [goto BIONAME_A]

<RF> [goto BIORFWHY_A]

[BIONAME_A] <Contractor Name> is collecting the study data for NCHS. May NCHS provide them with your name, age, and gender, along with your address, and phone number so they may contact you to schedule an appointment?

Read if necessary: <Contractor Name> will ONLY use this information for the purpose of scheduling and completing your home health visit. No other information about your health will be provided to <Contractor Name>.

Read if necessary: Study staff will use your age and gender to interpret the results from your home health visit.

CAPI Instructions:

<1> [goto TLNO_BIO_SA]

<2,RF,DK> [goto BIORFWHY_A]

[TLNO_BIO_SA] (This brings up a screen called Phone_Contact which says…) What phone number is best for the study representative to call you?

CAPI Instructions:

<1-98> [goto BIODAY_A]

<0,RF,DK> goto ERROR

[TLNO_BIO_SA ERROR] Your phone number is needed to participate in the follow-up study. Could you please provide a phone number?

Read if necessary: Study staff will need to call you to schedule your appointment.

[BIODAY_A] What are the best days for the study representative to contact you? Would you say weekdays, weekends, or both?

CAPI Instructions:

<1-3,RF,DK> [goto BIOTIME_A]

[BIOTIME_A] What is the best time of day for the study representative to contact you? Would you say mornings, afternoons, evenings, or anytime?

Enter all that apply, separate with commas.

CAPI Instructions:

<1-4> if more than one answer selected and 4 IN BIOTIME_A [goto ERR1_BIOTIME_A] (cannot mark Anytime and another type)

else [goto BIOTEXT_A]

[BIOTEXT_A] If they have difficulty reaching you by phone, is it OK for a study representative to text you?

If respondent says phone can't receive texts, enter 'no'.

CAPI Instructions:

<1,2,RF,DK> [goto BIOEMAIL_A]

[BIOEMAIL_A] If they have difficulty reaching you, the study representatives could try contacting you via email. May I have your e-mail address? Enter e-mail address. Enter 'N' for none.

CAPI Instructions:

[exit BIO section]

[BIORFWHY_A] There are several reasons why someone may not want to take part in a study. Please tell me the main reason why you don’t want to take part in this study?

Read if necessary: The study sponsor wants to understand your concerns so they can plan better versions of this study in the future.

Use your best judgement. If respondent is hostile or agitated, don't ask this question, just enter CTRL-R. You will be asked in the Back section to record your impression of the respondent's reason(s) for refusal.

CAPI Instructions:

<verbatim,RF,DK> [exit BIO section]

NHIS Follow-up Health Study Invitation to Participate Questions Help Screen

{Remember, you can always end your answers with: You can also ask the study staff for more information when they call you to schedule your appointment. or This is something you can discuss with the study staff when they call to schedule your appointment.}

WHY is CDC/NCHS doing this study/How will this study help people?

They will use what they learn from this study to better understand cardiovascular, liver, and kidney health at the national level. This will help policymakers and public health professionals make more informed decisions about programs and funding.

What is the Census Bureau’s role in this study?

The Census Bureau does not have a role in this follow up study. This follow up study is being conducted by NCHS with data collected by <Contractor Name>.

Can I participate if I don’t want to do all the parts?

YES. You can choose which parts you want to complete – but the more parts you do, the more complete and valuable your results will be.

Will my DATA be kept PRIVATE?

YES. Strict federal laws prevent NCHS and its contractors from releasing information that could identify you or your family to anyone else without your permission. Study staff have taken an oath to protect your privacy and are subject to a jail term of up to five years, a fine of up to $250,000, or both if they willfully disclose ANY identifiable information about you.

BLOOD and URINE

Will my BLOOD, and URINE be kept SAFE?

YES. Your samples will be tested by a laboratory that meets industry standards for privacy, quality, and safety. Your samples will be kept for 7 days after testing and then will be destroyed by the lab.

How will my blood and urine be kept safe between my house and the lab?

Samples are shipped to the lab the same day as the health visit, in most cases. They are packaged following rigorous safety guidelines, the same ones followed by doctor’s offices, and are tracked by study staff through the shipping process.

What will my BLOOD/URINE be TESTED for and not tested for?

TESTED FOR: Your samples will be tested for standard health measures such as cholesterol, diabetes, anemia, cardiovascular disease, high blood pressure, liver and kidney function,

and for the presence of COVID-19 antibodies. The full list of tests is in the brochure.

NOT TESTED FOR: Your samples will not be tested for drugs, alcohol, pregnancy or genetic ancestry. Your samples will NOT be shared with law enforcement. The full list of tests is in the brochure.

COVID

What is a COVID antibody test?

The COVID-19 antibody test will ONLY tell you whether or not you have COVID-19 antibodies in your blood. For more information, you can see the CDC COVID antibodies page.

What is NCHS/<Contractor Name> doing to keep me SAFE from COVID?

The health representative must confirm that they do not have any COVID-19 symptoms before going to work each day. The health representative will be wearing personal protective equipment including a face shield, surgical mask, lab coat or long sleeves under scrubs, gloves, and close-toed shoes). NCHS recommends you wear a facemask during the visit. All reusable equipment will disinfected before the visit. <Contractor Name> staff will follow standard safety procedures during the visit.

<Contractor Name> STAFF

What kind of TRAINING/experience do the <Contractor Name> staff have?

All phlebotomists (health workers trained to draw blood) hired by <Contractor Name> must pass extensive background checks, provide proof of a minimum of 100 verifiable blood draws, be certified in phlebotomy, and maintain appropriate licenses as needed. <Contractor Name> staff have been fully trained on all study-specific protocols and confidentiality protection procedures.

How will I know the person at the door is from <Contractor Name>?

The <Contractor Name> health representative will present their <Contractor Name> photo ID.

I don't like doctors and the way they tell me how to live my life. Is the health representative going to give me a lecture?

No. The health representatives will follow the study protocol without comment. They will provide you with your results, your $75 prepaid card, and nothing more.

Will <Contractor Name> keep my information and use it to contact me for marketing purposes?

No. <Contractor Name> will only have access to your contact information to schedule and conduct your home health visit. <Contractor Name> will not keep any of your information.

PROCEDURES

What PHONE NUMBER will they be calling/texting from?

Due to COVID, some schedulers are working from home, so calls may not come from a local area code. Texts will come from 35842.

How do I prepare for the health visit?

It will be similar to the steps you take before a wellness visit with your doctor. You will be given instructions for the visit when you speak with the health representative from <Contractor Name>.

Will I need to refrain from eating before the health visit?

If you fast beforehand, some of your blood test results will be more accurate and useful. But many will be accurate and useful whether or not you fast, and you can still participate if you don’t fast.

Does the health representative have to come INSIDE my home?

To protect your privacy, NCHS recommends that the visit be inside the home. You can discuss with the study staff when they call to schedule your appointment.

When and how will I get my RESULTS?

You will get a report with your body measurements, heart rate, and blood pressure at the end of the home visit. You will get a complete report with those results and all your blood and urine test results in the mail a few weeks after the home health visit. A medical officer from NCHS will be available to answer questions about your results.

When and how will I get the $75 PREPAID CARD?

At the end of the home visit you will get a prepaid card that you can use in stores, restaurants, and to make purchases on-line.

Will I still get the $75 if I don’t do all the parts?

Yes.