CMS-10549.GenIC#3 - MCBS Cognitive Testing Self-Management Items - Mini Supporting Statement

Application to Use Burden/Hours from Generic PRA Clearance:

Generic Clearance for Questionnaire Testing and Methodological Research for the Medicare Current Beneficiary Survey (MCBS) (CMS-10549)

Generic Information Collection (GenIC #3):

Cognitive Testing of Self-Management of Chronic Conditions Items

Office of Enterprise Data and Analytics (OEDA)

Centers for Medicare & Medicaid Services (CMS)

Under the CMS Generic Clearance (OMB No. 0938-1275, exp.05/31/2021) for the Medicare Current Beneficiary Survey (MCBS), CMS requests approval to conduct cognitive testing on a newly developed set of questions on self-management of chronic conditions.

Background Information about Cognitive Testing of Questionnaires

The methodological design of this proposed study is consistent with the design of typical cognitive testing research. As you know, the purpose of cognitive testing is to obtain information about the processes people use to answer survey questions as well as to identify any potential problems in the questions and their response categories. The analysis will be qualitative.

Justification for developing new questions that measure self-management of chronic conditions

As a nationally representative survey, the MCBS sample includes all Medicare beneficiaries. Over 65 percent of Medicare beneficiaries have two or more chronic conditions. The Department of Health and Human Services’ Framework for Addressing Multiple Chronic Conditions recognizes the importance of self-management in preventing and managing multiple chronic conditions. The survey currently asks questions about self-management of diabetes but does not ask a parallel series for other chronic conditions. In addition, the survey does not have questions that ask about the presence of community supports or the utilization of community supports for beneficiaries who report having chronic conditions. Therefore, there is currently no systematic way to measure how much self-management or self-management support is occurring among Medicare beneficiaries. To fill this measurement gap, CMS and NORC, in consultation with the Centers for Disease Control and Prevention, have collaborated to draft a new set of self-management items that would be administered to respondents who report a chronic condition.

Cognitive Testing Plan

CMS’ contractor for the MCBS is NORC at the University of Chicago; NORC staff will conduct the cognitive interviews. Up to 18 participants who are Medicare beneficiaries aged 18 and over will be recruited. Only Medicare beneficiaries who have at least one chronic condition of interest will be eligible for participation. Chronic conditions of interest are listed in both the recruitment flyers and eligibility screening instrument. We hope to achieve 10 English- and 8 Spanish-language interviews. Although not a scientific sample, our recruitment targets are shown in Table 1 below:

Table 1. MCBS Self-Management of Chronic Conditions Cognitive Testing Demographic Recruitment Targets Among English- and Spanish-speaking Participants

	English-Language (n=10)	Spanish-Language (n=8)
Sex
Male	5	4
Female	5	4
Ethnicity
Hispanic	3	6
Non-Hispanic	7	2
Race
White	5	4
Non-White	5	4
Education
Less than High School	5	4
At least High School	5	4

Recruitment will be carried out via two primary mechanisms:

1. Posting flyers and word-of-mouth: Flyers will be posted in public locations where they are likely to be seen by Medicare-eligible individuals. The Recruitment Flyer (Attachment A) will advertise eligibility criteria. Potential participants who respond to the flyer by contacting the project team by phone or email will be screened by phone to determine their eligibility for participation. A recruitment script that will be used with potential participants during phone conversations is included as Attachment B. The Eligibility Screener (Attachment C) will be used to confirm that potential participants meet eligibility criteria.

2. On-site recruitment, screening, and interviewing events where, with permission from appropriate administrative staff, staff will set up a table in Chicago-area senior community centers, independent living locations, or other public locations to recruit participants. Staff will contact sites by phone or in-person to gain their cooperation and make an appointment for an on-site event; a recruitment script for this purpose is also included in Attachment B.

English- and Spanish-language cognitive interviews will be conducted in-person at NORC or a location convenient for the individual participant for no more than 60 minutes. In rare cases, such as when a respondent suffers from extreme mobility limitations, an interview may be conducted in a respondent’s home. Spanish-language interviews will be administered by staff who are native Spanish speakers. The interviews will be audio recorded with participants’ permission to allow researchers to ensure the quality of their interview notes.

After participants have been briefed on the purpose of the study and the procedures routinely taken to protect human subjects, participants will be asked to read and sign the Participant Consent Form included as Attachment D. The interviewer will ask the participant to confirm that he/she understands the information in the Participant Consent Form, and the participant will indicate with a check-mark whether he/she agrees to audio recording or not. Should the participant decline to be recorded, the interview will still be conducted but audio will not be captured. The recorder will be turned on once consent is obtained, and the interviewer will administer the Cognitive Testing Questionnaire contained in Attachment E. During the interview, Showcard HF5 will be used (included as Attachment F).

Study participants will receive an incentive of $40 (cash) for the one-hour cognitive interview, as documented in our clearance package. Participants will sign the Participant Fee Receipt Form included as Attachment G.

All data will be stored digitally on secure NORC servers. All paperwork from the interviews will be stored in secured locked cabinets at NORC’s offices and will be destroyed in accordance with Disposition Authority N1-440-95-1, Item 5b.

In total, for this project, the maximum respondent burden will be 21.5 hours. This accounts for an estimated five potential participants who will complete the Eligibility Screener but not be eligible for the interview.¹ A burden table for this project is shown below:

Projects	Number of Participants	Number of Responses/ Participant	Average hours per response	Response Burden
Eligibility Screener Questionnaire – Medicare Beneficiaries	23	1	0.15	3.5
2) Cognitive Testing Interview - Medicare Beneficiaries	18	1	1.0	18

After cognitive testing is complete, CMS will request OMB approval to add the final set of questions to the Health Status and Functioning (HFQ) section of the MCBS Community questionnaire beginning in Fall 2020. These items will be administered annually based on beneficiaries’ responses to a series of questions about chronic condition diagnoses. After confirming diagnoses with beneficiaries and identifying the condition of most concern, they will be asked about changes in their condition, any self-management actions taken, and the extent of self-management support they have experienced. For the MCBS (clearance number 0938-0568), we estimate that the addition of these questions, as currently designed, will result in an annual increased respondent burden of 3 minutes, for a total of 484 hours across all Baseline and Continuing respondents. We will be able to refine this estimate at the conclusion of cognitive testing and will submit this change in burden as appropriate under the MCBS clearance.

If you have any questions or would like to discuss this request, please do not hesitate to contact the CMS MCBS Project Director, Debra Reed-Gillette.

Attachments:

A- Recruitment Flyers

B- Recruitment Script

C- Eligibility Screener

D- Participant Consent Form

E- Cognitive Testing Questionnaire

F- Showcard HF5

G- Participant Fee Receipt Form

H- Medicare Beneficiary Frequently Asked Questions For Use During Self-Management of Chronic Conditions Cognitive Testing

1 Approximately 83% of MCBS respondents report at least one chronic health condition. This burden estimate assumes a similar frequency among potential participants for cognitive interviewing.

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