Supporting Statement Part A

This information collection is being conducted using the Generic Information Collection mechanism of the OSTLTS OMB Clearance Center (O2C2) – OMB No. 0920-0879. The respondent universe for this information collection aligns with that of the O2C2. Data will be collected from a total of 49 State Health Department staff and their delegates in 7 selected states (Arizona, Minnesota, Oregon, Pennsylvania, Rhode Island, Texas, and Washington). Respondents, acting in their official capacities, include 14 State Health Department staff (two in each selected state), 7 state Medicaid office staff (one in each selected state), and 28 delegates in CHW networks and organizations implementing state CHW certification (four in each selected state).

This information collection is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241). This information collection falls under the essential public health service(s) of:

1. Monitoring health status to identify community health problems

2. Diagnosing and investigating health problems and health hazards in the community

3. Informing, educating, and empowering people about health issues

4. Mobilizing community partnerships to identify and solve health problems

5. Development of policies and plans that support individual and community health efforts

6. Enforcement of laws and regulations that protect health and ensure safety

7. Linking people to needed personal health services and assure the provision of health care

when otherwise unavailable

8. Assuring a competent public health and personal health care workforce

9. Evaluating effectiveness, accessibility, and quality of personal and population-based health

services

10. Research for new insights and innovative solutions to health problems¹

The U.S. Community Guide to Preventive Services recommends interventions that engage Community health workers (CHWs) to prevent cardiovascular disease and diabetes. ²

CHWs serve as connectors between “health care consumers and providers to promote health among groups that have traditionally lacked access to adequate health care.”³ Robust evidence demonstrates the value of CHW services to improve cardiovascular disease and diabetes outcomes and reduce costs. Despite this evidence, there are still challenges to integrating CHWs into the health care system. A 2002 Institute of Medicine (IOM) report identified several barriers to the effective use of CHWs in multidisciplinary health care teams, including inconsistent CHW scopes of practice, training, and qualifications; sustainable funding mechanisms; and recognition by other health professionals.⁴ States have implemented a variety of policies to overcome the barriers identified by the IOM and integrate CHWs into the health care system. One approach being considered is CHW certification. As of June 2016, 23 states and D.C. had laws pertaining to CHWs.⁵

Building capacity for an integrated and sustainable CHW workforce aligns with the mission of CDC's Division for Heart Disease and Stroke Prevention (DHDSP) which works to improve cardiovascular health through public health strategies and policies that promote access to early and affordable detection and treatment as well as CDC’s Division of Diabetes Translation (DDT) which seeks to reduce the preventable burden of diabetes through public health leadership, partnership, research, programs, and policies that translate science into practice. Both DHDSP and DDT currently provide funding and support to state health departments to increase engagement of CHWs to promote linkages between health systems and community resources for adults with high blood pressure and adults with prediabetes or at high risk for type 2 diabetes.

The purpose of this information collection is to inform both CDC as well as state funded grantees and other decision makers including health plans, insurers, and professional associations about effective strategies and challenges associated with state level actions and organizing structures relevant to CHW certification. To do this, DHDSP and DDT, working in collaboration with ChangeLab Solutions through a cooperative agreement, seek to capture information related to (1) the strategies, activities and partnerships states are using to implement multiple types of CHW certification structures; (2) barriers, facilitators and unintended consequences associated with implementation of various structures guiding CHW certification; (3) resource estimates related to the development, implementation, and support of pertinent CHW certification activities; and (4) contextual factors thought to influence implementation as well as mediating processes believed to influence outcomes. The information collected will be used by DHDSP and DDT to identify and examine issues related to implementation of CHW certification with the intent of supporting engagement of CHWs to promote linkages between health systems and community resources for adults with high blood pressure and adults with prediabetes or at high risk for type 2 diabetes. Information collected will also be used to develop technical assistance material for state grantees that will be disseminated via conference presentations, webinars, fact sheets and implementation guides.

Overview of the Information Collection System

Data will be collected from a total of 49 State Health Department staff and their delegates in 7 selected states (Arizona, Minnesota, Oregon, Pennsylvania, Rhode Island, Texas, and Washington). Respondents, acting in their official capacities include 14 State Health Department staff (two in each selected state), 7 state Medicaid office staff (one in each selected state), and 28 delegate leaders in CHW networks and organizations implementing state CHW certification (four in each selected state). Data will be collected via telephone informant interviews.

Using a standard interview guide (see Attachment A – Telephone Interview Guide), information will be collected, via telephone informant interviews, on the process of developing CHW certification within the state; state roles in implementing CHW certification; description of CHW roles, scope of practice, and training within the state; and sustainability and outcomes of CHW certification. Interviews will be recorded in order to capture the conversation accurately and subsequently transcribed. Verbal permission to be recorded will be obtained from the participant prior to the beginning of the interview.

CDC is partnering with ChangeLab Solutions, an independent, non-profit policy research organization, to conduct this information collection. ChangeLab Solutions’ contracted partners, Carl Rush with Community Resources, LLC and Dr. Ashley Wennerstrom with Tulane University are subject matter experts with extensive experience working with the CHW workforce and have served in multiple leadership roles within the American Public Health Association’s CHW Section. ChangeLab Solutions along with Mr. Rush and Dr. Wennerstrom are responsible for developing the information collection instrument, leading data collection, analyzing qualitative data and preparing a data summary for CDC. CDC is responsible for providing consultation on the development of the information collection instrument, assisting with data collection and analysis, and interpreting the collected data.

The information collection instrument was pilot tested by 3 public health professionals. Feedback from these individuals was used to refine questions as needed and establish the estimated time required to complete the interview guide. In order to minimize response burden, all interviews will be limited to no more than 90 minutes.

Items of Information to be Collected

The data collection instrument (see Attachment A – Telephone Interview Guide) consists of a total of 23 open- ended questions. The instrument will capture information on the following:

Respondent demographic information- regarding their role in working with CHW certification and the current status of CHW certification in their respective state (2 questions)
Process of developing CHW certification within the state (6 questions)
State government roles in implementing CHW certification (4 questions)
Description of CHW qualifications, scope of practice, training within the state (6 questions)
Sustainability and outcomes of CHW certification within the state (5 questions)

The information collected will be used to identify and examine issues related to implementation of CHW certification and to develop technical assistance material for state grantees and other decision makers. Demographic information will be used to provide context about the respondents’ experience and roles in CHW certification. Questions addressing the process of developing CHW certification and state government roles in implementing CHW certification will provide a description of the selected states’ practices for CDC planning and technical assistance purposes and will not be generalized. Similarly, information collected about CHW roles, scope of practice and training within each state as well as sustainability and outcomes related to CHW certification will inform CDC planning related to key audience needs and will inform the scope and content of technical assistance materials and will not be generalized. The data collection instrument (see Attachment A – Telephone Interview Guide) will be administered by telephone by a two-member team: one interviewer and one note taker. Data collection teams will consist of Mr. Rush, Dr. Wennerstrom and CDC CHW assessment team members.

Purpose and Use of the Information Collection

The purpose of this information collection is to inform CDC and state-level decision makers including health department staff, health plans, insurers, and professional associations about effective strategies and potential challenges associated with state level actions and organizing structures relevant to CHW certification. To do this, CDC, working with ChangeLab Solutions and their contracted partners seek to capture information via telephone informant interviews related to (1) the strategies, activities and partnerships states are using to implement multiple types of CHW certification structures; (2) barriers, facilitators and unintended consequences associated with implementation of various structures guiding CHW certification; (3) resource estimates related to the development, implementation, and support of pertinent CHW certification activities; and (4) contextual factors thought to influence implementation as well as mediating processes believed to influence outcomes.

The information gleaned from the qualitative analysis will be used to identify and examine issues related to implementation of CHW certification with the intent of supporting engagement of CHWs to promote linkages between health systems and community resources for adults with high blood pressure and adults with prediabetes or at high risk for type 2 diabetes. The information will also be used to develop technical assistance material for state grantees and other decision makers that will be disseminated via conference presentations, webinars, fact sheets and implementation guides.

Use of Improved Information Technology and Burden Reduction

All information will be collected via telephone informant interviews. The one-on-one data collection format will help to reduce the burden on respondents by focusing the discussion on the most pertinent issues specific to each respondent. Telephone interviews will also help to minimize the burden on respondents and project staff by reducing the time required for follow-up—teams can verify responses and request clarification as needed during the information collection process. The information collection instrument was designed with particular focus on streamlining questions to allow for skipping based on responses to previous questions and to collect the minimum information necessary for the purposes of this project (i.e., limited to 23 questions).

Efforts to Identify Duplication and Use of Similar Information

The information that will be collected through this project is not available from other data sources or through other means. During concept development, the project team reached out several times to the CDC CHW Workgroup and spoke with several national partners engaged in CHW-related issues to ensure that there are no similar information sources available that meet the needs of the proposed information collection. Additionally, a detailed evidence review of the CHW certification literature was completed in August 2016 demonstrating that no one has collected this information in the past.

Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this information collection.

Consequences of Collecting the Information Less Frequently

This request is for a one time information collection. There are no legal obstacles to reduce the burden. If no data are collected, CDC will be unable to:

Capture in-depth information about best practices in CHW certification and supporting structures
Assess the linkages between state CHW certification infrastructure, implementation, and outcomes
Provide information to state decision makers about the facilitators and challenges of CHW certification and supporting structures, including contextual factors that may impede uptake
Develop resource estimates related to the development, implementation, and support of pertinent CHW certification activities
Aid state-level decision-makers in CHW-related program implementation

Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances with this information collection package. This request fully complies with the regulation 5 CFR 1320.5 and will be voluntary.

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

This information collection is being conducted using the Generic Information Collection mechanism of the OSTLTS OMB Clearance Center (O2C2) – OMB No. 0920-0879. A 60-day Federal Register Notice was published in the Federal Register on May 16, 2014, Vol. 79, No. 95; pp. 28513. No comments were received.

CDC partners with professional STLT organizations, such as the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials (NACCHO), and the National Association of Local Boards of Health (NALBOH) along with the National Center for Health Statistics (NCHS) to ensure that the collection requests under individual ICs are not in conflict with collections they have or will have in the field within the same timeframe.

Explanation of Any Payment or Gift to Respondents

CDC will not provide payments or gifts to respondents.

Protection of the Privacy and Confidentiality of Information Provided by Respondents

The Privacy Act does not apply to this information collection. STLT governmental staff and / or delegates will be speaking from their official roles. Although CDC will collect some individually identifiable information (IIF), including respondent names, titles and years in their current role, all information will be kept on secure, password protected servers accessible only to project team members. Information collected during the assessment will be shared only in aggregate form. No IIF will be distributed.

This information collection is not research involving human subjects.

Institutional Review Board (IRB) and Justification for Sensitive Questions

No information will be collected that are of personal or sensitive nature.

Estimates of Annualized Burden Hours and Costs

The estimate for burden hours is based on a pilot test of the information collection instrument by 3 public health professionals. In the pilot test, the average time to complete the instrument including time for reviewing instructions, gathering needed information and completing the instrument, was approximately 60 minutes (range: 45 to 90 minutes). For the purposes of estimating burden hours, the upper limit of this range (i.e., 90 minutes) is used.

Because informants will include mostly leadership and senior staff in public and some private organizations, estimates for the average hourly wage for respondents are based on the Department of Labor (DOL) Bureau of Labor Statistics for occupational employment for Top Executives http://www.bls.gov/oes/current/oes_nat.htm. Based on DOL data, an average hourly wage of $59.71 is estimated for all 49 respondents. Table A-12 shows estimated burden and cost information.

Table A-12: Estimated Annualized Burden Hours and Costs to Respondents

Information collection Instrument: Form Name	Type of Respondent	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Telephone Interview Guide	Senior state health department and Medicaid staff	21	1	90/60	32	$59.71	$1910.72
Telephone Interview Guide	State delegates implementing CHW certification	28	1	90/60	42	$59.71	$2,507.82
	TOTALS	49	1		74		$4,418.54

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

There will be no direct costs to the respondents other than their time to participate in each information collection.

Annualized Cost to the Government

There are no equipment or overhead costs. Cooperative agreement partners, however, are being used to support development of the assessment tool, data collection, and data analysis. The only cost to the federal government would be the salary of CDC staff and cooperative agreement partners. The total estimated cost to the federal government is $20,612.40. Table A-14 describes how this cost estimate was calculated.

Table A-14: Estimated Annualized Cost to the Federal Government

Staff (FTE)	Average Hours per Collection	Average Hourly Rate	Average Cost
Health Scientist, GS 13 –Tool Development	10	$42.45/hour	$424.50
Health Scientist, GS 13 – Data Collection	72	$42.45/hour	$ 3056.40
Health Scientist, GS 13 – Data Analysis	10	$42.45/hour	$424.50
ChangeLab Solution Contracted Partner; Community Resources LLC and Tulane University–Tool Development	15	$125/hour	$1,875.00
ChangeLab Solution Contracted Partners; Community Resources LLC and Tulane University – Data Collection	72	$125/hour	$9,000.00
ChangeLab Solution Contracted Partner; Tulane University – Data Analysis	144	$40.50/hour	$5,832.00
Estimated Total Cost of Information Collection			$20,612.40

Explanation for Program Changes or Adjustments

This is a new information collection.

Plans for Tabulation and Publication and Project Time Schedule

Once the information collection period has closed, interview audio files and supporting documents shared by respondents will be assigned an ID number. Interview files will then be transcribed, cleaned and analyzed using Atlas.ti software. A qualitative analysis approach will be used to conduct a thematic analysis of responses to open-ended questions. The process will include independently coding each interview based on the list of variables and constructs to be analyzed. At several predefined points in the coding process, codes will be refined, collapsed, and/or eliminated, as appropriate based on data collected.

Once coding is completed, information will be grouped into larger themes and examined in relationship to other themes, interviewees, and states. The constructs to be explored through qualitative analysis of interview transcripts will address process variables including the reasons for developing certification, facilitators and barriers to CHW involvement in certification, perceptions of certification, and the use of various approaches to drive or support certification efforts. Other constructs to be explored will address: the role of state government in CHW certification, including its participation and collaboration with other entities in administering certification; strategies to define community membership and CHW scope of practice in relation to certification; certification requirements, and curriculum content; stakeholder views about CHW certification; and outcomes of certification, including the proportion of certified CHWs, changes in CHW scope of practice and employment, and perceptions of CHWs by providers, payers, and patients/clients.

Using the thematic analysis, CDC, ChangeLab Solutions, Community Resources, LLC, and Tulane University will create an aggregate summary report. The report will conclude with an overview of lessons learned regarding major elements of CHW certification and resources for certification. CDC will also explore the development of complimentary, technical assistance material for state grantees and other decision makers that will be disseminated via conference presentations, webinars, fact sheets and implementation guides.

Project Time Schedule

Design questionnaire (COMPLETE)

Develop protocol, instructions, and analysis plan (COMPLETE)

Pilot test questionnaire (COMPLETE)
Prepare OMB package (COMPLETE)
Submit OMB package (TBD)

OMB approval (TBD)
Conduct assessment (Assessment open 8 weeks)
Code, quality control, and analyze data (8 weeks)
Prepare reports (4 weeks)
Disseminate results/reports (4 weeks)

Reason(s) Display of OMB Expiration Date is Inappropriate

We are requesting no exemption.

Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320.9.

LIST OF ATTACHMENTS – Section A

Note: Attachments are included as separate files as instructed.

Attachment A- Telephone Interview Guide

REFERENCE LIST

Centers for Disease Control and Prevention (CDC). "National Public Health Performance Standards Program (NPHPSP): 10 Essential Public Health Services." Available at http://www.cdc.gov/nphpsp/essentialservices.html. Accessed on 8/14/14.
The Community Guide to Preventive Services Task Force. Cardiovascular Disease Prevention and Control: Interventions Engaging Community Health Workers; 2015. https://www.thecommunityguide.org/cvd/CHW.html. &The Community Guide to Preventive Services Task Force. Diabetes: Interventions Engaging Community Health Workers. https://www.thecommunityguide.org/findings/diabetes-interventions-engaging-community-health-workers
Witmer A. Community health workers: integral members of the health care work force. Am J Public Health. 1995;85:1055.
Institute of Medicine. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington, DC: National Academies Press; 2002.
Centers for Disease Control and Prevention. A Summary of State Community Health Worker Laws;2017 [in development].

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	Community Health Worker Case Study: Public Health Law Research Collaboration
Author	gel2
File Modified	0000-00-00
File Created	2021-01-22