Ssa

Supporting Statement A

GenIC: Direct Care Worker Pilot Study

Generic IC:

Developmental Studies to Improve the National Health Care Surveys

OMB No. 0920-1030

Exp. Date 02/28/2026

Manisha Sengupta

Acting Chief, Long-Term Care Statistics Branch

Division of Health Care Statistics

National Center for Health Statistics

Phone: 301.458.4754

Fax: 301.458.4693

Email: [email protected]

May 16, 2023

Table of Contents

1. Circumstances Making the Collection of Information Necessary 3

2. Purpose and Use of the Information Collection 3

3. Use of Improved Information Technology and Burden Reduction 4

4. Efforts to Identify Duplication and Use of Similar Information 4

5. Impact on Small Businesses or Other Small Entities 4

6. Consequences of Collecting the Information Less Frequently 5

7. Specific Circumstances Relating to the Guidelines of 5 CFR 1320.5 5

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency 5

9. Explanation of Any Payment or Gift to Respondents 5

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents ...5

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 7

12. Estimates of Annualized Burden Hours and Costs 7

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 8

14. Annualized Cost to the Federal Government 8

15. Explanation for Program Changes or Adjustments 8

16. Plans for Tabulation and Publication and Project Time Schedule 8

17. Reason(s) Display of OMB Expiration Date is Inappropriate 9

18. Exceptions to Certification for Paperwork Reduction Act Submissions 9

List of Attachments

Attachment A.1: Director mailing-NCHS’ Cover Letter with FAQ

Attachment A.2: Direct care worker mailing-NCHS’ Cover Letter with FAQ

Attachment A.3: NCHS’ Strictly Confidential Brochure

Attachment B.1: Sampling appointment setting call

Attachment B.2: Sampling call confirmation and prep letter or email

Attachment B.3: Sampling call

Attachment C: Direct care worker question list

Attachment D.1: Thank you and reminder letters

Attachment D.2: Prompting emails

Attachment E: Human Subjects Research Determination

A. Justification

1. Circumstances Making the Collection of Information Necessary

The National Center for Health Statistics (NCHS) has OMB approval for Developmental Studies to Improve the National Health Care Surveys Generic Clearance (OMB No. 0920-1030, Expiration Date 02/28/2026) to conduct developmental studies on survey design and data collection activities that are part of the National Health Care Surveys (NHCS).

Under this approval, GenIC proposals are submitted within the scope of this collection without the need for additional federal register notices. OMB endeavors to conduct its initial review within ten business days, pending conflicting commitments.

The specific GenIC project for this clearance is to conduct a pilot study of direct care workers (DCWs), which builds upon the NCHS’ National Post-acute and Long-term Care Study (NPALS) infrastructure, to allow NCHS to design and test a sampling protocol, questionnaires, and contact strategies that could be used in a national DCW survey in the future.

The specific data collection activities will be to contact about 120 residential care communities (RCCs), about 120 adult day services centers (ADSCs), and about 120 nursing homes (NHs) in the 50 states and the District of Columbia. Based on response rates in recent NPALS waves, we expect about 50 directors in each setting to respond and to conduct:

• a 5-minute telephone call for directors to set up the sampling appointment and confirm eligibility;

• a 15-minute telephone call for the directors to sample and answer a few questions about the sampled DCWs; and

• a 30-minute mail or web questionnaire for two DCWs from each setting.

2. Purpose and Use of the Information Collection

A new national survey of direct care workers is needed to understand what has changed since the last national surveys of these workers, to evaluate trends, to better understand the impact of the COVID-19 pandemic on the direct care workforce, and to better understand the current trend of increased use of contract workers in providing direct care to nursing home populations. It is also of interest to assess whether the increased use of contract workers in direct care exists in other settings. The collected data will allow NCHS to design and test a sampling protocol, questionnaires, and contact strategies that could be used in a national DCW survey in the future.

Using two-stage sampling, the DCW pilot survey will be administered by mail, web, and telephone, and data will be collected from about 50 residential care communities (RCCs), about 50 adult day services centers (ADSCs), and about 50 nursing homes (NHs) in the 50 states and the District of Columbia. RCC and ADSC directors that completed the 2022 NPALS, and directors of NHs in the 2022 NPALS administrative data frame will be contacted. Two DCWs per provider will be sampled and contacted from each of the settings.

Data collection includes three components: a 5-minute telephone call for directors to set up the sampling appointment and confirm eligibility (Attachment B-1); a 15-minute telephone call for the directors to sample and answer a few questions about the sampled DCWs; (Attachment B-3) and a 30-minute mail or web questionnaire for the sampled DCWs (Attachment C).

Direct care workers (DCWs), such as personal care aides, nursing assistants and home health aides play an essential role in the health and well-being of over 20 million Americans who receive long-term support and services (LTSS). These workers assist older adults and people with disabilities in completing self-care and other daily tasks such as activities of daily living, and instrumental activities of daily living such as housekeeping, errands, and appointments. PHI estimates there are approximately 4.6 million direct care workers, including home care workers, those in residential care homes, nursing homes and other settings. According to data from the 2018 National Post-acute and Long-term Care Study (NPALS) (OMB No. 0920-0943 Exp. 7/31/2025), personal care aides provide more hours of care in residential care communities, adult day service centers and nursing homes than do any other staff type. They have critical roles in providing care to vulnerable populations but often receive low pay and rarely receive benefits. Yet the last time a national survey of these workers was conducted was more than 15 years ago—the 2004 National Nursing Assistant Survey (OMB No. 0920-0353, Discontinued 02/28/2017) and the 2007 National Home Health Aide Survey (OMB No. 0920-0298, Discontinued 07/31/2009), sponsored by the Assistant Secretary for Planning and Evaluation (ASPE) and carried out in partnership with ASPE and the National Center for Health Statistics’ (NCHS).

The pilot data to be collected from directors includes a few estimates about the sampled DCWs (Attachment B-3). We plan to ask the sampled DCWs questions that ask about: (1) background information (2) benefits and wages, (3) job satisfaction and challenges, (4) health and workplace safety, and (5) demographics (Attachment C). Most questions have been drafted from previously used questions in the following surveys: 2004 National Nursing Assistant Survey (NNAS) (OMB No. 0920-0353, Discontinued 02/28/2017), 2007 National Home Health Aide Survey (NHHAS) (OMB No. 0920-0298, Discontinued 07/31/2009), and 2012-2022 National Post-acute and Long-term Care Study (NPALS)( (OMB No. 0920-0943 Exp. 7/31/2025). A Technical Expert Panel (TEP) meeting was held in December 2022 to solicit feedback on the draft DCW questions.

No individually identifiable information (IIF) is being collected.

3. Use of Improved Information Technology and Burden Reduction

The DCW pilot study includes the use of improved information technology through a web- and telephone-based questionnaire.

NCHS has designed the protocol to be brief. The two calls with directors will be limited to 20 minutes in total. DCW data collection will include mail and web modes to reduce burden on the respondent. We estimate that it will take 30 minutes on average to complete the questionnaires. Burden is reduced by limiting the number of questionnaire items to those that can be answered in the allotted time. Burden is also reduced by using the smallest reference period feasible to produce valid estimates when asking questions, as longer reference periods would require additional respondent burden to calculate.

There are no technical or legal obstacles to burden reduction.

4. Efforts to Identify Duplication and Use of Similar Information

There is currently no up-to-date national data available on DCWs. The most recent NCHS surveys on DCWs were the 2007 National Home Health Aide Survey (NHHAS) and the 2004 National Nursing Assistant Survey (NNAS). This pilot study will provide important information that could be used to fill data gaps.

5. Impact on Small Businesses or Other Small Entities

A number of RCCs, ADSCs, and NHs could be considered small businesses. In order to minimize burden, the timing in the protocol has purposely been held to the minimum required. Further, telephone, mail, and web data collection modes allow directors and DCWs to complete the questionnaires when it is most convenient for their schedules. This is particularly valuable for directors of and DCWs in small facilities, where the director and DCW is more likely than in larger facilities to be spending time providing care to residents/participants.

6. Consequences of Collecting the Information Less Frequently

This is a one-time data collection.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. Federal Register Notice

• In compliance with 5 CFR 1320.8(d), a 60-day Federal Register notice was published in the Federal Register on December 20, 2022, Volume 87, Number 243 pages 77836-77838. No additional comment period is required for GenICs submitted under this generic.

B. Efforts we have made to consult outside the agency include:

• Consulted with the contractor that conducted the 2022 NPALS and ASPE who sponsored the 2007 NHHAS.

• A technical expert panel was help in December 2022 to discuss the DCW questions list (Attachment C).

9. Explanation of Any Payments or Gifts to Respondents

There will be no payments, gifts, or incentives.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

This submission has been reviewed for Privacy Act applicability by the NCHS Privacy Act Officer and it has been determined that the Privacy Act does apply as data on individuals are being collected. The applicable System of Records Notice (SORN) is 09-20-0167, Health Resources Utilization Statistics (59 FR 48331). All procedures and methods for maintaining confidentiality have been reviewed and approved by NCHS’ Confidentiality Officer, when necessary.

Confidentiality provided to respondents is assured by adherence to Section 308(d) of the Public Health Service Act (42 U.S.C. 242m) which states:

"No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under section...306 (NCHS legislation),...may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined under regulations of the Secretary) to its use for such other purpose and (1) in the case of information obtained in the course of health statistical or epidemiological activities under section...306, such information may not be published or released in other form if the particular establishment or person supplying the information or described in it is identifiable unless such establishment or person has consented (as determined under regulations of the Secretary) to its publication or release in other form,..."

In addition, legislation covering confidentiality is provided according to the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 3561-3583), which states:

“Whoever, being an officer, employee, or agent of an agency acquiring information for exclusively statistical purposes, having taken and subscribed the oath of office, or having sworn to observe the limitations imposed by this section, comes into possession of such information by reason of his or her being an officer, employee, or agent and, knowing that the disclosure of the specific information is prohibited under the provisions of this subchapter, willfully discloses the information in any manner to a person or agency not entitled to receive it, shall be guilty of a class E felony and imprisoned for not more than 5 years, or fined not more than $250,000, or both.”

The data collection components of the pilot study will be conducted by NCHS’ contractor using a solid and well-established Enhanced Security Network (ESN), which is certified and accredited at the Federal Information Processing Standard Publication 199 (FIPS 199) moderate level for confidentiality, integrity, and availability. Standard access security features inside the ESN include user identification and password lockout of accounts upon repeated entry of an invalid password, New Technology File System (NTFS) file- and directory-level security, periodic backups, anti-virus software, and administrator-defined user groups. Only project staff that have signed the necessary confidentiality agreements and received the appropriate training will be permitted access to the project files and directories.

NCHS’s contractor will set up a public-facing interface to the ESN to allow self-administered web surveys to be accessible without sacrificing confidentiality. The protocol will be to send a randomly generated username and password along with the URL for the survey. Establishments that elect to take the web-based survey will use these credentials to connect to a web site outside of the ESN to take the survey. All response data will be stored in the ESN, and establishments will have access only to their own survey, and only using the credentials supplied to them. Surveys may be broken off and resumed later, but once the establishments have finalized and completed their survey, the credentials will be deactivated.

Data will be treated in a confidential manner so that individual facilities and DCWs cannot be identified. The process of informing respondents of the procedures used to keep information confidential begins with provider package materials mailed to directors and DCWs (see Attachments A-1 and A-2). Materials include specific references to protections of the confidentiality of the information. These materials also emphasize and detail procedures intended to keep information confidential by the data collectors.

The pilot study includes respondent contact materials that will inform the directors and DCWs of the purpose and content of the study (see Attachments A-1 to A-3), in particular the NCHS cover letters (Attachment A-1 and A-2). In addition to explaining the confidentiality of the information provided and voluntary participation, the letters includes a reference to the legislative authority for the study, and an explanation of how the data will be used. The letters also emphasize that data collected will never be linked to their names or other identifying features.

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

IRB Approval

According to the NCHS Human Subjects Contact, this data collection does not meet the definition of human subjects research as stated in 45 CFR 46.102(f). Information collection was approved by the NCHS Ethics Review Board without further review (Attachment E).

Sensitive Questions

Items in the pilot study are not sensitive in nature. Data collected will not include protected health information or personal identifiers. Study protocols and questionnaires do not contain questions about sensitive issues, such as sexual preferences or attitudes, or about potentially illegal behaviors, such as use of illicit drugs. Nor do we ask about religious preferences or beliefs. There is a gender identity question but we have included the following three categories with a select all that apply option to make it less sensitive for the respondents: 1. Female, 2. Male, and 3. Transgender, non-binary, or another gender.

12. Estimates of Annualized Burden Hours and Costs

A. Burden Hours

Table 1 includes the average annual burden for the DCW pilot study. About 360 total directors of RCCs, ADSCs, and NHs in the 50 states and the District of Columbia will be contacted (120 from each of the three settings). Based on recent response rates in NPALS, we expect 150 total directors (50 from each of the three settings) will participate in the study. Burden for the 360 directors is estimated at 5 minutes for an eligibility telephone call and 15 minutes for a sampling telephone call. Two DCWs from each place will be sampled (about 720 total) and invited to complete a 30-minute questionnaire. The total estimate of annualized burden for Directors and DCWs is 480 hours.

Table 1: Estimated Annualized Burden Hours

Type of Respondent	Form Name	Number of Respondents	Number of Responses/ Respondent	Average Burden/ Response (in hours)	Response Burden in Hours
Directors	Eligibility Telephone call	360	1	5/60	30
Directors	Sampling Telephone Call	360	1	15/60	90
Direct Care Workers	Questionnaire	720	1	30/60	360
Total	480

B. Cost to Respondents

The only cost to respondents is their time. The estimated annualized cost for data collection for the frame development is $10,940 (See Table 2).

Table 2: Estimated Annualized Costs for Frame Development

Type of respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost
Directors	120	$48.72	$5,846
Direct Care Workers	360	$14.15	$5,094
Total	$10,940
Information on directors’ and DCWs’ hourly wage rates gathered from the Bureau of Labor Statistics’ website, and can be accessed at the following links: https://www.bls.gov/ooh/management/medical-and-health-services-managers.htm and https://www.bls.gov/ooh/healthcare/home-health-aides-and-personal-care-aides.htm

13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

There are no additional costs.

14. Annualized Cost to the Federal Government

The estimated total cost to the government is $469,514 and details are shown in Exhibit 1.

Exhibit 1: Estimated Annualized Costs to the Government

Item/Activity	Details	$ Amount
NCHS oversight of contractor and project	Cost for staff and supplies	$93,903
DCW pilot study (Contractor)	Field staff costs, including data collection costs and other direct costs	$375,611
Estimated Total Cost		$469,514

15. Explanation for Program Changes or Adjustments

This is a one-time data collection; a GenIC. There are no program changes or adjustments.

16. Plans for Tabulation and Publications and Project Time Schedule

Data collection for the DCW pilot study will begin once we have OMB approval. The collected data will enable users to see the feasibility of conducting a national DCW study within NPALS. The results from this methodologic pilot survey will focus on lessons learned from the survey and will be made public via NCHS reports and presentations. A restricted-use data file will also be made available via the NCHS Research Data Center if requested.

17. Reason(s) Display of OMB Expiration Date is Inappropriate.

The display of the OMB expiration date is appropriate.

18. Exceptions to Certification for Paperwork Reduction Act Submission

The certifications are included in this submission.

13