SS_Part A_052412

CDC National Healthy Worksite Program

New

Supporting Statement: Part A

Program official/project officer: Jason Lang, MPH, MS

Team Lead, Workplace Health Programs (OD/CDC/NCCDPHP)

Tel: (770) 488-5597

Fax :( 770) 488-5962

Email: [email protected]

May 24, 2012

Table of Contents

Section A

A-1 Circumstances Making the Collection of Information Necessary

A-2 Purpose and Use of the Data

A-3 Use of Improved Information Technology and Burden Reduction

A-4 Efforts to Identify Duplication and Use of Similar Information

A-5 Impact on Small Businesses or Other Small Entities

A-6 Consequences of Collecting the Data Less Frequently

A-7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

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

A-9 Explanation of Any Payment or Gift to Respondents

A-10 Assurance of Confidentiality Provided to Respondents

A-11 Justification for Sensitive Questions

A-12 Estimates of Annualized Burden Hours and Costs

A-13 Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

A-14 Annualized Cost to the Government

A-15 Explanation for Program Changes or Adjustments

A-16 Plans for Tabulation and Publication and Project Time Schedule

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

A-18 Exceptions to Certification for Paperwork Reduction Act Submissions

Attachments

Attachment A-1 Authorizing Legislation

Attachment A-2 Authorizing Legislation

Attachment A-3 Patient Protection and Affordable Care Act Prevention and Public Health Fund (P.L. 111-148, Section 4002

Attachment B-1 Federal Register Notice – 60 day

Attachment B-2 NHWP Summary of Public Comments

Attachment B-3 NHWP Federal Register Notice Program Announcement

Attachment C-1 Program Objective - Survey Instrument Crosswalk

Attachment C-2 Projected Profile of NHWP Employer / Employee Participation

Attachment C-3 Employers and Employees Data Flow Diagram

Attachment C-4 NHWP Data Flow Diagram Program Provider

Attachment C-5 NHWP Risk Stratification Logic

Attachment D-1 Employer Eligibility Requirements

Attachment D-2 NHWP Employer Phone Interview Guide

Attachment D-3 NHWP Employer Interview Script

Attachment E-1 NHWP Organizational Assessment

Attachment E-2 Employee Eligibility File

Attachment E-3 NHWP Employer Information Form

Attachment E-4 NHWP Health Screening Site Interview Form

Attachment E-5 NHWP Employer Discussion Guide – Employer Steering Committee

Attachment E-6 NHWP Employer Discussion Guide – Wellness Committee

Attachment E-7 NHWP Employer Follow Up Survey

Attachment E-8 NHWP Worksite Health Training Survey Parts I-III

Attachment E-9 NHWP Worksite Health Training Survey Part IV

Attachment E-10 NHWP Community Participant Engagement Feedback Survey

Attachment F-1 NHWP All Employee Survey

Attachment F-2 NHWP Employee Health Assessment

Attachment F-3 NHWP Success Story Consent Form

Attachment F-4 NHWP Satisfaction Survey

Attachment F-5 Wellness Challenge Logs

Attachment F-6 Nutrition and Physical Activity Tracking Log / Lifestyle Tracker

Attachment G-1 NHWP Health Screening Consent / Contact Form

Attachment G-2 Health Screening Forms – HIPAA Privacy Practices

Attachment G-3 Health Screening Forms – Physician Referral Form

Attachment G-4 Health Screening Forms - Understanding Your Health Screening Results

Attachment G-5 NHWP Employee Frequently Asked Questions

Attachment H-1 NHWP Community Director Discussion Guide

Attachment H-2 NHWP Health Coach Discussion Guide

Attachment I-1 IRB Statement – Implementation Contractor (University of Connecticut Health Center)

Attachment I-2 IRB Statement - Evaluation Contractor (RTI International)

Overview

This is a new Information Collection Request (ICR) supporting establishment and evaluation of CDC’s National Healthy Worksite Program (NHWP), a comprehensive workplace health program designed to improve the health of workers and their families. CDC will work with a select group of approximately 100 employers to implement and evaluate evidence-based health programs focusing on positive behavior changes - such as healthy eating, physical activity, and tobacco cessation - that are known to reduce risk for chronic diseases such as obesity, heart disease, diabetes, and cancer. CDC requests OMB approval by May/June 2012 in order to recruit and enroll participating employers. Program implementation will begin by June/July 2012, starting with individual (employee) level assessments (e.g., health risk assessments and needs and interests surveys), and organizational (employer) level assessments (e.g., surveys of current workplace health capacity and activity), that are critical to developing tailored and specific worksite health improvement plans, selecting priority interventions for individual participating worksites, and evaluating changes in organizational practice. OMB approval is requested for three years.

Section A. Justification

1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC) is the primary Federal agency for protecting health and promoting quality of life through the prevention and control of disease, injury, and disability. CDC is committed to programs that reduce the health and economic consequences of the leading causes of death and disability, thereby ensuring a long, productive, healthy life for all people (see authorizing legislation in Attachment A-1, Sections 1703(a) (2) and 1703(a) (4) of the Public Health Service Act as amended (42 U.S.C.300u-2) and Attachment A-2, Sections 301 (a) and 317 (k) of the Public Health Service Act).

Chronic diseases – such as heart disease, stroke, cancer, obesity, and diabetes – are among the most prevalent, costly, and preventable of all health problems. Chronic diseases negatively affect the lives of individuals, the health care system in the U.S., and productivity in the workplace. The use of effective workplace health programs and policies can reduce health risks and improve the quality of life for American workers. Maintaining a healthier workforce can lower direct costs such as insurance premiums and worker’s compensation claims for employers. It will also positively impact many indirect costs such as absenteeism and worker productivity.^1,2 As a result, many employers are turning to workplace health programs to help employees lower their risk of developing chronic diseases. A truly comprehensive workplace health program consists of a coordinated set of activities, policies, benefits, and environmental supports that target both organizational (employer) practices and individual (employee) behaviors, moreover, workplace health programs can be tailored to the needs of a specific employer, worksite, or industry. For example, since many employers have a long history and experience with implementing safety practices at the worksite, workplace health programs may be integrated with occupational health and safety programs.

In October 2011, the National Healthy Worksite Program (NHWP) was established by the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) at the Centers for Disease Control and Prevention (CDC). The NHWP seeks to keep workers healthier for longer periods of time, improve disability and productivity outcomes, and help maintain employers’ competitiveness. The NHWP is authorized through the Patient Protection and Affordable Care Act Prevention and Public Health Fund (PPHF, P.L. 111-148, Section 4002, see Attachment A-3), which was enacted to address the underlying drivers of chronic disease and to help the country move from today’s sick-care system to a true “health care” system that encourages health and well-being. The PPHF is designed to expand and sustain the necessary infrastructure to prevent disease, detect it early, and manage conditions before they become severe.

The three primary goals of the NHWP are:

1. To reduce the risk of chronic disease among employees and their families through science-based workplace health interventions and promising practices.

2. To promote sustainable and replicable workplace health activities such as establishing a worksite committee, having senior leadership support, and forming community partnerships and health coalitions.

3. To promote peer-to-peer business mentoring that encourages employers to be active leaders and role models in their communities around health.

Through the NHWP, employers will be provided with the support and technical assistance they need to establish new workplace health programs or strengthen existing programs. The NHWP will emphasize science and practice‐based prevention and wellness strategies leading to specific, measureable health outcomes related to the rate or severity of illness and disability attributable to chronic diseases such as diabetes, obesity, and hypertension. Each participating employer, with assistance from CDC, will build the capacity and skills for an onsite healthy worksite program by establishing the infrastructure needed to manage their programs including employee and leadership engagement, wellness committees, internal communications, and community partnerships. Additionally, based on employee needs and employer goals, each participating employer will implement a core set of three to five science-based interventions from an available menu of options (See Question #9 a-c Attachment D-1 for menu of interventions). The interventions include a mix of strategies that target physical activity, nutrition, and tobacco use in the employee population.

Examples include:

• Health screenings, assessments, and “wellness challenges” to improve nutrition, manage weight, or increase physical activity.

• Physical fitness, health and lifestyle education and coaching programs.

• Establishing tobacco-free campus policies and facilitating referrals to counseling for smoking cessation,

• Promoting work schedules and environments that allow employees to be more physically active, e.g., stairwell enhancement and walking trails/clubs.

• Promoting the availability of healthy food choices in the workplace through worksite farmers’ markets or modified selections in workplace cafeterias and vending machines.

Beginning in 2012, the National Healthy Worksite Program will engage and recruit employers in selected communities and lead them through the process of creating a sustainable workplace health program, building worksite capacity, and improving workplace health culture. A core principle of the initiative is to maximize employer and employee participation in designing and implementing each worksite program. The process of building the workplace health program will include the following components:

1. Assessing employer and employee needs, interests, health risks and existing capacity.

2. A planning process to produce a customized workplace health improvement plan for guiding the worksite through program development.

3. Establishing or strengthening infrastructure within each worksite for program implementation, evaluation, and long-term sustainability.

4. Implementing programs, policies, and practices to address employee lifestyle risk factors related to physical activity, nutrition, and tobacco use.

5. Participating in NHWP-sponsored programmatic activities, training, technical assistance, and evaluation.

Initially, CDC plans to select and collaborate with a group of approximately 100 small, mid-size, and large employers in seven communities across the country (“NHW Program Participants”). The initial group of NHW Program Participants will represent a variety of employer types and will be grouped in communities that provide geographic and workforce diversity.

The NHWP is envisioned as a strategic partnership involving CDC, NHWP communities, employers, and employees. To be eligible for participation in the NHWP, employers must meet defined inclusion criteria (e.g., offer health insurance to all eligible employees), agree to participate fully in program implementation (e.g., allow employees to participate in employer-sponsored workplace health programming during work hours), and agree to become active participants in community coalitions, partnerships, and a network of national Health Worksites (see Attachment D-1). Employers must also demonstrate a commitment to establishing the infrastructure necessary for supporting the comprehensive worksite health program. Two committees will be essential to this process: (1) an Employer Steering Committee comprised of senior management who have the authority to allocate resources to the worksite health program and link the program to business strategic objectives (e.g., company President, General Manager, Chief Executive Officer, Chief Finance Officer, Chief Operating Officer); and (2) a Health Promotion Program Wellness Committee (also called a Wellness Team, Wellness Champion Team, Wellness Committee, Worksite Health Team, or Worksite Health Champions). The Wellness Committee will be composed of employees from across the organization who can provide input into specific interventions, policies, and environmental supports that will be supported and drive a healthy culture and address the organization's health risk factors. The organizational needs assessment will involve input from these committees as well as individual employees, who will participate in program offerings on a voluntary basis. The effectiveness of the organizational planning process, the degree to which social norms and culture become more health promoting, and the number of employees who voluntarily engage in programmatic activities are outcomes of interest for the NHWP.

CDC will provide intensive technical assistance to NHW Program Participants by supporting a number of key staff positions, including seven Community Directors (one for each group of employers in the seven participating NHWP communities) and a number of Health Coaches who will be assigned to each participating NHWP employer. The designated Community Director will coordinate all site-specific activities such as needs assessments, program planning and implementation, and data collection and reporting. In addition, the Community Director will lead community forums involving NHW Program Participants and Community Participants, and coordinate activities such as training that are shared by all employers in the NHWP community. Finally, the Community Director will manage the certified Health Coaches who will provide administrative assistance to the Community Director, provide employer-level support through communications distribution; work with employer contacts to develop and implement worksite health programs, policies, and practices; and provide individual health coaching and brief interventions with a focus on motivational interviewing and brief intervention techniques. Health Coaches will be scheduled for regular hours at each worksite to provide either individual or group-based health coaching, and refer participants to community and health plan resources. Community Directors and Health Coaches will be supported through CDC’s NHWP program implementation contractor.

NHW Program Participants will be selected by CDC after review of applications in spring/summer 2012. The projected profile of participating employers and the total number of expected employee participants is included in Attachment C-2. Additional sites may be added if CDC receives increased funding for the NHWP.

A number of employers in NHWP communities may be interested in establishing workplace health programs, but ineligible for inclusion in the initial group of NHWP participants or unable to accommodate the intensive planning and implementation process that will take place from 2012-2014. These employers may choose to participate in community-based education and peer-to-peer mentoring offered through the NHWP (“Community Participants”). The community participant option will allow CDC to increase the number of employers who receive technical assistance through the NHWP, and to compare the experiences of employers who receive intensive support to the experiences of employers who receive a reduced level of support in establishing worksite health programs.

CDC requests OMB approval for three years to collect the information needed to plan, implement, and conduct initial evaluation of the NHWP. Respondents will include NHW Program Participants and their employees, Community Participants and other Interested Employers not receiving intensive onsite support,, and the program-supported staff who facilitated program implementation and community-based activities.

Information will be collected for the following three main purposes to support the NHW Program primary goals:

1. Establish the National Healthy Worksite Program

1. To recruit and select employers for participation in the NHWP.

2. To understand employer intentions to participate in community-based training and peer-to-peer networking provided by the NHWP.

3. To describe the process of implementing tailored, customized comprehensive workplace programs, including employer and employee assessment, planning, program implementation, including challenges encountered and means to overcome them, such as people or practices that have facilitated implementation and lessons learned along the way.

2. Evaluate the Impact of the National Healthy Worksite Program

d. To evaluate outcomes and the ways in which participating employers have achieved the desired program, policy, and environmental support changes.

e. To understand how participating employers have leveraged and sustained existing health promotion and health protection programs and practices and integrated the NHWP into their organizational structure.

f. To quantify changes to aggregate employee level health risk and health status.

g. To describe changes to organizational culture and social norms and how they may relate to workplace health program sustainability.

3. Establish Best Practices for Future Employers who want to Establish a National Healthy Worksite Program

h. To describe the usefulness of worksite health training for participating employers and community participants and the impact of training on overcoming barriers to implementing a comprehensive workplace health program.

i. To understand factors that affect the sustainability of the workplace health program.

j. Characteristics, including sustainability, of workplace health programs that do not receive the intensive support provided by the NHWP.

k. To describe the type and number of qualified employers who are willing, motivated, and interested in becoming NHWP participants, or the barriers -based on employer size or industry sector- that factored into employer decision-making not to participate in the NHWP.

A summary of program objectives as they relate to specific information collection instruments is provided as Attachment C-1.

Overall, this effort will collect qualitative and quantitative information to describe the process of implementing comprehensive worksite health promotion programs in a variety of employer settings; document changes in knowledge, awareness, access and opportunity to engage in healthy lifestyle behaviors as a result of workplace health programs; and evaluate program outcomes in terms of reductions in individual employee health risk factors as well as changes in organizational practice, culture, and social norms around health promotion. Findings will be used to improve immediate efforts of participating employers and inform future efforts to achieve the goals of spreading and replicating workplace-based strategies for promoting health and preventing chronic disease through reductions in obesity and tobacco use, particularly among small to mid-size employers who are much less likely to have comprehensive workplace health programs available to their employees and would benefit from the tools, resources, and guidance produced by the NHWP.³

CDC requests OMB approval by May/June 2012 in order to begin program implementation by June/July 2012.

Privacy Impact Assessment

Overview of Information Collection

Information will be collected from the following types of respondents: employers who are interested in participating in the NHWP; employers selected for full participation in the NHWP (NHWP participants); employees who are affiliated with NHWP participants; employers who receive only training through the NHWP (community participants); and employees of CDC’s implementation and evaluation contractors. Information will be collected over a three-year period consisting of a two-year implementation phase and a one-year follow-up evaluation phase. During the first two years, information collection will be focused on employer recruitment and enrollment into the NHWP; organizational and employee-level assessments needed to design workplace health programs that are tailored to the needs of participating sites; program implementation; documentation of individual risk reduction; and employee satisfaction. In the third year, information will be collected to capture strategies for successful program implementation and sustainability, and to identify barriers to efficient program implementation. The primary modes of information collection will be semi-structured interviews and paper forms. NHWP participants will receive substantial support from CDC’s on-site implementation contractor, Viridian Health Management, and CDC’s evaluation contractor, RTI. Both organizations are experienced in the collection and management of personal, identifiable, and/or sensitive information.

In order to conduct employer- and employee-specific needs assessment, and to provide meaningful feedback to employers and employees, some information will be collected in identifiable form. Viridian will be the only organization to collect, store, and maintain individual identifiable information and personally identifiable health information. Viridian has consulted with CDC information security experts to review the data acquisition, storage, and processing procedures proposed for the NHWP. Information collection and management will be conducted according to a plan that has been approved by CDC’s Office of the Chief Information Security Office, and will comply with the Privacy Act and required government data privacy and security procedures.

Only de-identified data will be used for program evaluation, and CDC will not attempt to identify individuals by data linkages involving demographic, geographic, or outcome information, contact individual participants, or disclose any participant-level data. A summary of program objectives as they relate to specific information collection instruments is provided as Attachment C-1.

Items of Information to be Collected

At the organizational (employer) level for participating employers, CDC will assess elements of the workplace structure, culture, practices and policies related to health and safety such as health benefits, health promotion programs, occupational health programs, work organization, and leadership and management support (CEO/C-Suite) for workplace health and safety initiatives. Additionally, environmental elements of the physical workplace such as facilities and settings where employees work as well as access and opportunities for health promotion, workplace safety initiatives, and services provided by the surrounding community where employees live will be explored. CDC will conduct an organizational readiness assessment, environmental audit, culture survey, and hold meetings with leadership, employee, and their representatives (e.g., unions if applicable) to accomplish the organizational assessment.

At the individual (employee) level, CDC will assess elements of an employee's health through onsite non-diagnostic health screening, including lipid profile, glucose, and blood pressure, body composition and waist circumference; health behaviors related to physical activity, nutrition, and tobacco; and current health status through a self-reported health risk assessment. Employees will also complete a survey regarding organizational climate, culture, and environmental supports that promote healthy behaviors in the worksite. Employees will also complete a satisfaction survey quarterly during the implementation period. at the end of the program implementation period. Selected employees from participating employers will complete an interviewer-assisted interview to document key factors for success for program implementation. Detailed data flow diagrams are included in Attachment C-3 and Attachment C-4.

Program providers, including Community Directors and Health Coaches, will complete interviewer-assisted surveys to capture contributors and barriers to program success.

Respondents and their respective assessment tools are categorized as follows:

Organization (Employer) Data

A. Interested Employers. Includes employers who wish to be considered for inclusion in the NHWP as Program Participants; these data represent organizational entities (employers), not individuals. A senior leader from each employer who has indicated that their organization meets the program eligibility requirements and submitted their contact information on the CDC program website as part of the employer participation / certification process will be contacted for a phone interview using the Employer Interview Guide (Attachment D-2). The phone interview will verify program eligibility based on published eligibility requirements (Attachment D-1), and obtain additional information to objectively score and select employers to be included in the program. Employers must be located in one of the seven community locations to be contacted for a phone interview. Two types of information will be collected: objective criteria used for scoring, and subjective criteria to gauge employer commitment and motivations for participating in the program. Phone interviews will be conducted using a uniform Employer Interview Guide and Employer Interview Script (Attachments D-2 and D-3). Information obtained via telephone interview will be collected once, and employer information will not be publicly available.

B. Program Participants. Includes organizations (employers) who are selected to participate in the National Healthy Worksite Program. These data represent organizational entities.

The data elements collected from employers include an Organizational Assessment (Attachment E-1) and an employee program eligibility file (Attachment E-2), as well as additional employer and site level information for program planning and implementation captured by an Employer Information Form (Attachment E-3) and a Health Assessment Site Interview Form (Attachment E-4). Challenges and successes to implement a successful worksite health program will be captured by Employer Discussion Guides (Attachments E-5 and E-6). As part of the program evaluation, the evaluation contractor will also conduct an Employer Follow–up Survey (Attachment E-7) to evaluate program sustainability approximately 8 months following the end of the two-year program implementation period.

Organizational Assessment

The Organizational Assessment (Attachment E-1) allows for a pre- and post-evaluation of employer policies, environmental supports, and programs that support a culture of health related to the following domains:

• Organizational Supports

• Links to Community Resources

• Lifestyle Behaviors

  • Tobacco Cessation

  • Physical Activity

  • Nutrition

  • Weight Management

  • Stress Management

• Reduction in Chronic Disease

  • Diabetes

  • High blood pressure

  • High Cholesterol

• Depression Screening and Referrals

• Signs – Heart Attack and Stroke

• Response – Heart Attack and Stroke

• Lactation Support

• Occupational Health and Safety

At least two representatives from each employer will jointly complete a paper and pencil interviewer – assisted questionnaire to evaluate and benchmark each organization’s culture of health at the beginning (pre-program implementation) and end (post-program implementation) of the program. The information collected through individual (employee) and organizational (employer) level assessment during pre-program implementation will also be instrumental in developing tailored and specific health improvement plans and selecting priority interventions for individual worksites. It is important in the pre-program assessment period that this tool be administered / facilitated by an interviewer to clarify questions, question responses, and interpret results. The paper and pencil surveys will be sent to the implementation contractor for data entry and analysis.

Eligibility File

NWHP participating employers will also submit a quarterly eligibility file (Attachment E-2) for employees eligible to participate in the program. The eligibility file includes demographic information (age, contact information, ethnicity), and employment information including hire date, location, shift, and job type. The file will be submitted quarterly via FTP upload to the implementation contractor. The employee-specific eligibility file information will be used to link data elements across employee assessments described in Category 2 below.

Employer Steering Committee Members Interviews

From among the approximately 10 worksites selected for the case studies, one to three staff members from each worksite who served on the health promotion program steering committee will be invited to discuss their experiences. The interviews will be conducted via telephone with individuals or small groups from a single worksite using the attached discussion guide (Attachment E-5). These discussions will focus on challenges to and strategies for successful program implementation and sustainment. The evaluation contractor will hold these discussions at month 20, near the end of program implementation.

Employer Wellness Committee Member Interviews

From among the worksites selected for the case studies, two to five staff members who served on the health promotion program wellness committee (or served as program champions) will be invited to discuss their experiences. These interviews will be conducted via telephone with individuals or small groups from a single worksite using the attached discussion guide (Attachment E-6). These discussions will focus on their opinions about programming and workplace changes. The evaluation contractor will hold these discussions at month 20, near the end of program implementation.

Employer Follow-Up Survey

The evaluation contractor will conduct a short web-based follow-up survey to provide information about program maintenance and sustainability. The purpose of this survey is to determine to what extent each employer is continuing to implement the NHWP elements, what changes have been made, what barriers have been encountered, and what lessons were learned. We will administer the survey to a representative from each employer, such as the wellness committee champion or human resources staff, approximately eight months after the formal program implementation ends (Attachment E-7).

C. Community Participants. Includes employers who are located in one of the seven selected program communities who are not selected or chose not to be program participants but who may choose to participate in community-based education and peer-to-peer mentoring to gain insight into training needs, barriers to participation, and other issues related to program sustainability.

Community Participants: Worksite Health 101 Training Surveys

The evaluation contractor will conduct short web-based surveys to provide feedback about the usefulness of a series of Worksite Health training sessions, as well as the resources and barriers for successful implementation of a comprehensive healthy worksite program. The survey will also provide information on the impact of training on Community Participants’ ability to implement programs, policies, and environmental supports in absence of intensive onsite support. The survey will be administered to an employer representative from 300 employers approximately two months following both Part 1 and Part 2 of the community-based training (Attachments E-8 and E-9).

Community Participants / Engagement Feedback Survey

The evaluation contractor will conduct a short web-based follow-up survey to help CDC understand the impediments to program participation and determine if there are any systematic differences, such as size or industry, between employers who agreed to participate and those who declined. The purpose is to identify knowledge of NHWP activities; current health program offerings; and barriers to program participation, such as time commitment, that factored into employer decision-making not to participate in the NHWP. The survey will be administered to an employer representative from 15 employers in each of the NHWP community program sites, approximately two months after the formal program recruitment period ends (Attachment E-10).

Individual (Employee) Data

Employees who elect to participate in their employer’s worksite wellness program as part of the National Healthy Worksite program will be asked to complete assessments to evaluate their perception of workplace culture (Attachment F-1), their health status (Attachment F-2) and satisfaction with the program (Attachment F-4). Employees may also voluntarily submit individual success stories to be featured in program communications (Attachment F-3).

All-Employee Survey

Employees will be asked to complete a paper and pencil, 40-question survey to capture their perception of worksite culture, and organizational and social norms related to a healthy corporate culture (Attachment F-1). The survey takes approximately 5 minutes to complete and is a validated and coherent shortened version of longer commonly used survey items. It serves as a complement to the measured biometric tests and the health assessment which is more directed to personal behaviors and biometric risk factors. The All-Employee Survey includes questions that support NHWP goals and objectives related to improvements in organizational culture and social norms, in addition to health risk areas not addressed in a traditional health assessment. The All-Employee Survey was developed based on input from a variety of subject-matter experts including NIOSH-funded applied research described in section A-8.

Accordingly, while meant for wide scale practical application, the survey is particularly suitable for the type of inter-site compilation and comparison which is essential to the community program nature of this project.

Non-diagnostic Health Screening and Health Assessment

Employees who elect to participate in their employer’s health screening events will be asked to complete a self-reported health risk assessment (Attachment F-2) and complete non-diagnostic health screening tests (Attachment G-1). The data elements collected from individual employees include non-self-reported biometric health indicators collected during an onsite health screening and self-reported personal health status and health behaviors related to nutrition, physical activity, tobacco use, mental wellbeing, and readiness to change.

Non-diagnostic health screening data allows the NHWP to stratify participants based on their risk factors (Attachment C-5) for referral into lifestyle interventions and provide outcomes data on risk reduction, biometric improvement, health behaviors, and readiness to change. CDC will accommodate low literacy and language barriers through translation or reading the documents to participants. Each participant will receive a form that includes their health screening results with an explanation of each value (Attachment G-4). Participants whose health screening results are not in normal ranges will referred to their health care provider for further follow up using a Physician Referral Form (Attachment G-3).

The health screening includes the following non-diagnostic tests for each participant:

1. Blood Pressure / Pulse

2. Blood Draw (Lipid Panel / Glucose)

3. Body Composition (Height, Weight, Waist Circumference and Body Mass Index)

4. Exit Counseling / Health Coaching to review results

Following the screening, each participant will receive a Health Screening Results Form (Attachment G-4) that explains their results.

During the health screening process, employees will be asked to complete a self-reported health assessment that includes the following:

• Relationship with a primary care physician

• Compliance with preventive exams

• Personal medical history

• Medication use

• Lifestyle habits, including physical activity, nutrition, and tobacco use

• Indicators of depression

• Readiness to change in program areas (physical activity, nutrition, nutrition)

Participants will be specifically asked about their current use of cigarettes to predict individual and aggregate future disease risk / burden for lung cancer and chronic obstructive pulmonary disease (COPD). Participants will be asked about their use of all forms of tobacco products to evaluate the effectiveness of NHWP interventions including individual tobacco cessation counseling, environmental supports, and policies on the use of tobacco in the workplace.

Participating employees who complete the health screening and health assessments during the pre- and post-implementation period will be stratified into low, moderate, and high risk categories outlined in the risk stratification methodology (Attachment C-5). The risk stratification allows us to evaluate risk migration during the implementation period, and effectively refer individuals into appropriate lifestyle interventions.

The Success Story Consent Form (Attachment F-3) will be completed by employees who have given consent to have their success story published in NHWP publications for the promotion of the program. The employee will complete the consent form and questionnaire in paper form and return it to their health coach.

Participating employers will be asked to complete a Satisfaction Survey (Attachment F-4) to gauge employee perception of program quality and effectiveness. Employees will complete an online or paper assessment and return it to their health coach, Community Director, or send it to the implementation contractor via mail or fax.

Program Provider Data

Program providers, including Community Directors and Health Coaches, will be interviewed using the attached discussion guides to capture key learnings. Community Directors (seven to ten implementation contractor staff members) will participate in group discussions, via telephone, during their regularly scheduled group meeting times whenever possible. These discussions will focus on employer engagement and retention, and organizational level changes. The evaluation contractor will hold these discussions at 6, 12, 18 and 24 months (Attachment H-1).

Health Coaches (20 implementation contractor health coaches) will participate in interviews or small group discussions, via telephone, during their regularly scheduled group meeting times whenever possible. These discussions will focus on employee participation, strategies for encouraging behavior change and success stories. The evaluation contractor will hold these discussions at three months after the start of the program and again at approximately 18-20 months (Attachment H-2).

Program providers will also document all program activities in the contractor’s care management system, including participation and engagement by program topic, attendance, goal attainment, biometric improvement, and program completion.

Additional programmatic data collection tools as part of supplemental health education activities will be used to monitor behavior changes as well as satisfaction surveys and individual or small group interviews to document lessons learned, including barriers to program success and successful strategies throughout the program. The evaluation contractor will also conduct additional small group discussions with program providers, employers, and employees.

Identification of Website(s) and Website Content Direct at Children Under 13 Years of Age

No information collection involves children under 13 years of age. The Employer Follow-Up Survey for participating employers and Community Participants will be administered via a web-based survey. The Worksite Health evaluation surveys will be administered via a web-based survey.

2. Purpose and Use of the Data

CDC, through its program implementation and evaluation contractors, will conduct assessments throughout the program to select participating employers, document processes and outcomes, and set the parameters for future workplace health cooperative agreements or contracts. The collection of this data is necessary for the successful planning, implementation, and evaluation of the core workplace health interventions at both the individual and organizational level.

The lessons learned from this project may be of interest to several other ongoing activities including:

1. Provide feedback and support the implementation efforts of employers participating in the NHWP.

1. Improve technical assistance given to participating employers.

2. Inform future program efforts at CDC and other Federal agencies such as:

1. CDC will use this information to refine key success elements and best practices in workplace health to operationalize future surveillance activities in framing potential questions that represent important elements of effective program. These data would provide information nationally on employer workplace health promotion practices and gaps. CDC will also use the information gained and described from the NHWP to produce case studies and success stories to provide greater technical assistance to employers seeking guidance on building or maintaining workplace health promotion programs.

2. HHS and the Department of Labor (DOL) can use this information to compare the approach described for the National Healthy Worksite Program with the models reviewed as part of the HHS/DOL Wellness Programs Study examining incentives.

3. Provide models for replication through the development of tools, resources, and guidance.

1. CDC will develop tools, resources, and guidance to support broader workplace health efforts.

2. Employers will be able to utilize the public domain instruments for their own worksite assessments and use the information to plan and implement workplace health programs.

3. Federal agencies such as OPM can use the tools and resources developed for their employee health promotion programs such as policy handbooks and its annual Wellcheck assessment.

3. Use of Improved Information Technology and Burden Reduction

CDC designed this information collection to minimize the burden to respondents and to the government, to maximize convenience and flexibility, maximize employer and employee program participation and engagement, and to ensure the quality and utility of the information collected. Several assessment tools, including the Organizational Assessment and Discussion Guide, will be administered / facilitated by an interviewer to clarify questions, question responses, and interpret results. An online (electronic) form and instructions may be available for the post-program assessment. Employee assessments will be obtained via paper and pencil since employees are in a variety of settings which makes web-based collection infeasible. Paper-based tools are also easier to translate into multiple languages if needed, and the health coach can assist employees in completing their assessments at the time of the onsite health screening and can verify that the forms are completed accurately. Program evaluation assessment via a Follow-up Survey to Program and Community Participants will be web-based to maximize convenience.

4. Efforts to Identify Duplication and Use Similar Information

The National Healthy Worksite Program is a new initiative with new requirements to address both program implementation and evaluation of comprehensive workplace health programs. No publically available instruments were available in a complete form that met both CDC’s needs to effectively implement a successful program for employers and gave CDC the information needed to evaluate these program in small and mid-size employer worksites. The data collection instruments were derived in part on information available from the broader field including CMS work developing a Health Risk Assessment for Medicare patients, the HHS Office of Disease Prevention and Health Promotion National Worksite Health Promotion Survey, the HHS/DOL Wellness Programs Study which is not evaluating workplace health interventions and is focused on larger sized employers, and prior CDC work in developing individual and organizational workplace health assessment tools. The program team carefully considered the content, need, and structure of the questions so that they are brief, easy to use, understandable and relevant to the program objectives.

5. Impact on Small Businesses or Other Small Entities

The National Healthy Worksite program includes employers with 1,000 or fewer full-time employees. The program specifically targets small (fewer than 100 employees), medium (101 – 250 employees) and large (251-1000 employees) employers for participation in the program. We anticipate that approximately 30% of employers will be small businesses.

Since the program is voluntary and the employer has indicated their desire to participate by acknowledging an understanding of the eligibility requirements (Attachment D-1), the impact of the data collection on respondents—including small businesses—is expected to be minimal.

CDC will provide technical assistance on an ongoing basis. It is possible that small businesses may need, and receive, more technical assistance than large businesses.

To determine the least burdensome method of collecting the information needed to implement and evaluate the program, CDC will work with existing employer infrastructure and provide the resources necessary to complete the surveys with minimal impact to small businesses.

6. Consequences of Collecting the Data Less Frequently

Information collection will take place for approximately 15 months (May/June, 2012 – September, 2013) during the pre- and post-program implementation phase, and through September, 2014 for the program evaluation phase. Pre and post assessments are required to characterize changes resulting from program efforts. Less frequent reporting would not allow CDC to evaluate the following program goals:

1. To reduce the risk of chronic disease among employees and their families through science-based workplace health interventions and promising practices.

2. To promote sustainable and replicable workplace health activities such as establishing a worksite committee, having senior leadership support, and forming community partnerships and health coalitions.

3. To promote peer-to-peer business mentoring that encourages employers to be active leaders and role models in their communities around health.

If information is collected less frequently, CDC will not be able to effectively conduct the planning, implementation, and evaluation activities required to meet the program objectives and document outcomes. If the worksite wellness programs are not planned, implemented and evaluated effectively, the program will be ineffective and could potentially be harmful to the reputation of NCCDPHP, and undermine efforts to encourage employers to participate in future CDC programs.

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 of the Agency

1. CDC published a Notice in the Federal Register on February 15, 2012, Vol. 77, No. 31, pp. 8,874-8,875 (see Attachment B-1). CDC received one public comment and provided a courtesy reply (see Attachment B-2).

2. CDC developed the data collection plan in collaboration with subject matter experts at CDC, NIOSH, Viridian Health Management, the University of Connecticut Health Center, Center for the Promotion of Health in the New England Workplace (CPH-NEW), and RTI International. CDC also discussed the NHWP and proposed data collection with a broad variety of colleagues and interested parties, including representatives from HHS and OPM; state, local, and county public health departments; community health coalition stakeholders; wellness program providers; and the National Partnership for Women and Families. Additionally, the protocol was discussed with the HHS Healthy Weight Workplace Workgroup made up of subject matter experts from several HHS agencies including NIH and HRSA. Most of the outreach was targeted to government agencies or organizations that are actively conducting projects in workplace health with the intent of creating synergies with the data being collected and reducing any duplication of effort as well as accessing expertise in the field of workplace health promotion. The majority of consultations included review of draft materials that support the NHWP data collection plan. Additionally, CDC published an informational Federal Register Notice announcing the NHWP and a series of informational webinars describing the program on Nov 29, 2011, which generated a variety of public comments from interested parties (Attachment B-3). Their comments can be grouped into four broad categories: editorial comments, supportive comments, requests for clarification, and requests for additions or revisions.

Editorial comments were primarily focused on redundancy within or among specific data collection tools; inconsistent use of terminology; the length of specific data collection tools, and suggestions for rewording specific clauses or sentences for readability or clarity. All documents and data collection tools were reviewed and edited for length, clarity, consistency, and readability.

Supportive Comments were received by multiple stakeholders representing business groups, public health, education, health coalitions, and health management service providers or brokers who expressed their interest and support for the program and indicated a desire to utilize the surveys and questionnaires for their own work and leverage the activities of the NHWP.

Requests for clarification focused primarily on the data collection tools and how they are described in the Supporting Statements. The comments focused on the need to clarify the respondent universe, the meaning of certain terms or acronyms, and a more detailed description of the data collection methodology. CDC responded by clearly defining the terms used within the data collection tools, and further describing the sampling methods and data collection and analysis within the Supporting Statements.

Commenting organizations also had requests for additions of revisions to the data collection tools. Examples of these requests included: the addition of questions on employer leave policies (paid time off) in the Organizational Assessment (Attachment E-1); addition of the Breastfeeding Support module to the Organizational Assessment (Attachment E-1); request to reorder the questions in the All Employee Survey (Attachment F-1); request to use identical BRFSS questions in the Employee Health Assessment (Attachment F-2) for national comparisons; requests to add questions to the Employee Health Assessment including questions about seat belt use, excessive alcohol, arthritis, and mental wellbeing; request to add the medical insurance effective date on the employee eligibility file; request to add a mechanism to capture cell phone and email addresses for participants; several suggestions for additions or revisions to the Employer Follow-up Survey (Attachment E-7) to capture participation in community coalitions and lessons learned. All of these suggestions were added to the appropriate data collection tools. It was not possible to capture whether employees have medical insurance other than through their employer.

Table 8-a. Staff within the Agency and Consultants outside the Agency Consulting on Data Collection Plan and Instrument Development

Staff from CDC and NIOSH
Jason Lang Team Lead, Workplace Health Programs CDC/ONDIEH/NCCDPHP	Phone: (770) 488-5597 Email: [email protected]
Dyann Matson-Koffman Health Scientist Division for Heart Disease and Stroke Prevention CDC/ONDIEH/NCCDPHP	Phone: (770) 488-8002 Email: [email protected]
Pamela Allweiss Medical Officer Division of Diabetes Translation CDC/ONDIEH/NCCDPHP	Phone: (770) 488-1154 Email: [email protected]
Tina Lankford Public Health Analyst Division of Nutrition, Physical Activity and Obesity CDC/ONDIEH/NCCDPHP	Phone: (770) 488-5171 Email: [email protected]
Wendy Heaps Senior Policy Advisor Office of the Associate Director for Policy CDC/OD/OADP/PRADO	Phone: (404) 639-5254 Email: [email protected]
Casey Chosewood Senior Medical Officer for Total Worker Health™ National Institute for Occupational Safety and Health	Phone: (404) 498-2483 Email: [email protected]
Staff from OPM
Elena M. Garabis Health Economist U.S. Office of Personnel Management Office of Planning and Policy	Phone: (202) 606-1810 Email: [email protected]
Staff from HHS
Wilma M. Robinson, PhD, MPH Senior Health Policy Analyst Assistant Secretary for Planning and Evaluation Office of Health Policy US Department of Health and Human Services	Phone: 202-205-8841 (Office) Email: [email protected]
Barbara E. Moquin, Ph.D., APRN, BC-P Health Science Administrator (Detail) Center for the Clinical Trials Network National Institute on Drug Abuse National Institutes of Health	Phone: (301) 496-9004 Email: [email protected]
Staff from VHA
Ebi Awosika, MD, MPH Director Employee Health Promotion Disease Prevention Veterans Health Administration	Phone: (612)-467-4589 Email: [email protected]
Implementation and Evaluation Contractors
Brenda Schmidt President, Viridian Health Management Executive Director, Health Promotion Institute	Phone: (602) 443-5264 Email: [email protected]
Andy Spaulding Director, Viridian Center for Community and Worksite Health Viridian Health Management	Phone: (207) 650-7889 Email: [email protected]
Martin Cherniack Director, Ergonomic Technology Center Co-Director, CPH-NEW University of Connecticut Health Center	Phone: (860) 679-4916 Email: [email protected]
Tim Morse Professor Occupational Health Center and Dept. of Community Medicine University of Connecticut Health Center	Phone: (860) 679-4720 Email: [email protected]
Jim Hersey Research Triangle Institute International	Phone: (202) 728-2486 x22486 Email: [email protected]
Laurie Cluff Research Triangle Institute International	Phone: (919) 541-6514 Email: [email protected]
Laura Linnan Department of Health Behavior and Health Education University of North Carolina	Phone: (919) 843-8044 Email: [email protected]

9. Explanation of Any Payment or Gift to Respondents

No payments or gifts will be offered to employers or employees that complete assessments or data collection instruments, including the organizational assessment, employee survey, biometric screening, or health assessment. Employers may elect to incentivize their employees to participate in the program, but no program funds will be used for this purpose. CDC will document voluntary employer incentives provided to employers to determine the potential impact on program participation and outcomes.

10. Assurance of Confidentiality Provided to Respondents

Data collection for the NHWP is for the purpose of program evaluation, and does not constitute research with human subjects. IRB approval is not required. Documentation of relevant determinations is included in Attachments I-1 and I-2.

1. Privacy Act Determination

CDC has reviewed this Information Collection Request and has determined that the Privacy Act applies to the identifiable employee-level information collected in the Eligibility File (Attachment E-2), the Employee Health Screening Consent/Contact Form (Attachment G-1), the All Employee Survey (Attachment F-1), the Success Story Consent Form (Attachment F-3), the Wellness Challenge Logs (Attachment F-5 and F-6), and the Physician Referral Form (Attachment G-3). The only entity that will have access to information in identifiable form is CDC’s implementation contractor, Viridian Health Management. Information will be managed as specified by the applicable System of Records Notice, 09-20-0160, Records of Subjects in Health Promotion and Education Studies.

The Eligibility File will be initially collected for three purposes: 1) To verify employer and employee eligibility for NHW program offerings; 2) To allow the NHWP to provide customized personal feedback to employees who participate in wellness challenges, without the need to recollect contact information for every activity and thus minimizing burden to individual employees; and 3) To create a unique, randomly generated 10-digit employee ID code for each employee enrolled in NHW activities. The Eligibility File will include name, date of birth and address but does not include SSN. Viridian will be the only entity with access to the file that links employee identifiers such as names to unique employee ID codes. All information transmitted from Viridian to its subcontractor (CPH-NEW) or the NHW program evaluation contractor (RTI) will be transmitted with the unique employee ID code as the only identifier, or stripped of all identifiers and aggregated for analysis. Use of the unique employer ID code will enable reporting but will prevent inadvertent disclosure of personal assessment and evaluation information. Employers will periodically submit their updated Eligibility File to Viridian. This will allow the implementation contractor to update its contact records for participating employees, and to identify new employees who may wish to participate in the NHW activities.

The Privacy Act does not apply to 1) employee-level data collections that are conducted without identifiers (e.g., Attachment F-4, the NHWP Satisfaction Survey), or 2) information collections in which the respondent is identifiable, but is not providing personal information (e.g., Attachments E-5, E-6, and E-7, Employer discussion guides and surveys).

2. Safeguards

Technical safeguards. The implementation contractor, Viridian Health Management, will be the only organization to collect, store, and maintain individual identifiable information and personally identifiable health information. Viridian has consulted with CDC’s Office of the Chief Information Security Officer to review the data acquisition, storage, and processing procedures to ensure that they comply with the Privacy Act and required government data privacy and security procedures. Viridian will only transmit de-identified employee data (no PII data elements) to CPH-NEW via secure File Transfer Protocol (FTP). The file will be in a pre-determined .CSV file template and will be coded with the employee ID code and an employer code. No other data or miscellaneous items in identifiable or coded form will be transmitted. CPH-NEW will only transmit aggregate non-employee specific report data to Viridian in the format of a pre-defined employer aggregate report template. This aggregate reporting data will be merged into Viridian’s reporting template for aggregate report generation.

Viridian will comply with all applicable federal and state laws, including, but not limited to, the nondiscrimination provisions included in the Health Insurance Portability and Accountability Act (HIPAA) of 1996, the Employee Retirement Income Security Act (ERISA) of 1974, and the Genetic Information Nondiscrimination Act (GINA) of 2008. Health Assessment, health screening, and All-Employee Survey results will be collected by Viridian Health Management staff and stored in compliance with National Institute of Standards and Technology (NIST) data privacy and security standards and policies.

Viridian follows industry best practices for role-based access and conducts quarterly reviews of access controls as well as quarterly reviews of database integrity to protect against data corruption, inadvertent loss, and unexpected results. Annual security and privacy training is mandatory. System security is monitored full-time. If a real or potential incident is discovered, a log is made and the appropriate escalated contact is made to initiate corrective action.

All doors are key-card protected to prevent unauthorized access. IT servers and data rooms have additional security. All hard drives on the server are encrypted.

Additional safeguards. Viridian will generate feedback reports to employers for site-specific program planning and evaluation. If the employer has fewer than 50 total employees and there are a limited number of employees with specific types of characteristics, the identity of individual employees contributing to such reports could be “presumed” or “inferred” for small sample sizes. Viridian will only generate comprehensive aggregate reporting in these circumstances. Viridian will not disclose individually identifiable employee biometric data or other personal information to employers. Attachment G-2 contains a summary of HIPPA privacy practices for personal health information. Viridian Health Management will protect all data collected to the extent allowed by law.

3. Consent

Organizational / employer consent is implied by committing to participate in the National Healthy Worksite program. The NWH program will offer employees multiple opportunities to participate in programmatic activities to maintain or improve their health on a voluntary basis. Participation in programmatic activities is considered public health practice, not research, therefore the consent process is not formalized for participating in the program as a whole to accommodate the public health context of the program. Employees can participate in as many or few of the activities that interest them. Employees are not constrained to a particular intervention or activity and they can reconsider their choices throughout the duration of the NHW program. Participants will be asked to sign a consent form to participate in health screening.

Employees will participate in NHW program offerings on a voluntary basis. Individual employees will complete a contact and consent form (Attachment G-1) prior to participating in the program. The signed consent will be obtained for Health Screening and Contact (Attachment G-1) so that personalized feedback and recommendations can be provided to each participating employee as a follow-up to the assessment. Employees will also provide a signed consent/permission form to authorize use of their personal information for program success stories (Attachment F-3). In addition, because CDC and program implementation staff will have multiple contacts with employees, a general purpose Frequently Asked Questions (FAQ) document (Attachment G-5) has been designed to provide 1) periodic reminders to employers and employees about the voluntary nature of their participation, and 2) periodic opportunities to follow-up on any questions employees may have about participation in NHW program activities. The FAQs will be made available to employers and employees in a number of ways: (i) as a leave behind at all NHWP onsite worksite events where a data collection occurs; (ii) as an uploaded document as part of the NHWP program website; (iii) as a support document to health coaches and other program staff; and (iv) as a general information document made available in a format and at location(s) where employees would typically seek out information about the program (e.g., company intranet site, cafeteria bulletin board, break room, etc.).

4. Nature of Response.

Participation by employers is voluntary, however CDC seeks to identify employers with strong potential for completing the three-year planning and evaluation process. CDC expects a high level of commitment from employers based on the program eligibility requirements and selection process. The NWH program is envisioned as a partnership between NHW Program Participants and CDC. CDC will gauge interested employers’ level of commitment based on their interview guide responses and a signed commitment letter if they are selected as a Program Participant. Interested employers will be interviewed by CDC and/or the implementation contractor to assess their availability and commitment (see Attachments D-2 and D-3). Gauging level of commitment is one of the purposes of the Interview Guide. Employers may withdraw at any time, but CDC seeks to identify employers with strong potential for completing the three- year planning and evaluation process. To minimize changes of employer drop-out, the enrollment interview includes estimates of the time commitment associated with various NHW program activities. Should an employer withdraw from the program, they will be given the opportunity to complete the Employer Follow-Up Survey (Attachment E-7).

Employees will participate in NHW program offerings on a voluntary basis. Employees will have multiple options and opportunities to participate in programs and interventions, and these will vary by employer. Employees have the opportunity to participate in one or more programs and can opt-in or out of programs throughout the duration of the program. Employees may refuse to answer questions or withdraw from the National Healthy Worksite Program at any time. No withdrawal notification is required.

11. Justification of Sensitive Questions

CDC does not expect to collect any data that would be considered highly sensitive. Biometric Data (Blood Pressure / Pulse, Lipid Profile, Glucose and Body Composition Measurements) might be considered sensitive information and is protected by patient privacy laws. It is essential that this information provided to the implementation contractor for participants who voluntarily participate in the program. Without this information, the implementation contractor will not be able to effectively assess the risk status of each participant which is necessary to deliver appropriate programs and resources.

During the program the implementation contractor will collect identifiable information regarding health improvements for individual participants (such as weight loss and tobacco use status). This information might be considered sensitive but is necessary to assess the success of NHWP lifestyle interventions and impact of policies and environmental supports.

Complete data flow diagrams are included in Attachments C-3 and C-4.

12. Estimates of Annualized Burden Hours and Costs

1. Burden Hours

Over the requested three-year clearance period, CDC will implement the NHWP in up to 100 small, mid-size, and large employers (or 33 per year on an annualized basis) in seven communities across the country. Approximately equal number of employers in each size category will be included. CDC estimates that a total of approximately 20,050 employees (Attachment C-2) will be eligible to participate in the program. Annualized estimates of the number of respondents involved in each data collection activity are provided below.

Organizational (Employer Data)

The Employer Phone Interview Guide (Attachment D-2) will be completed by a senior representative(s) of the employers who expressed interest in being a NHWP Participating Employer and will be used by the NHW Program to verify eligibility requirements and select the 100 participating employers. The total estimated burden to 207 employer respondents is 23 hours (20 minutes per response).

Organizational Assessment. Respondents are the employee representative(s). Each respondent will complete the Organizational Assessment on behalf of the organization (Attachment E-1) at the beginning and at the end of the NHWP. The Organizational Assessment will be provided in hard copy and guided by the Community Director. The estimated annualized burden to respondents is 66 hours (30 minutes per response).

The Eligibility File (Attachment E-2) will be obtained from an employer representative quarterly during the program implementation period to identify eligible employees including hire date, medical insurance status, and department and shift information. This information will be utilized transmitted electronically. The total estimated burden to respondents is 33 hours (15 minutes per response).

The Employer Information Form (Attachment E-3) and the Health Screening Site Interview Form (Attachment E-4) will be obtained via an in-person or telephone interview. The Health Screening Site Interview Form will be administered at the beginning and at the end of the program to coincide with two separate employee screening events. The total estimated burden for both tools is 50 hours (30 minutes per response).

The Discussion / Interview Guides (Attachment E-5 and E-6) will be used to gather information from Employer Steering Committee Members (1-3 individuals per participating employer for a total of 300 respondents or 100 per year on an annualized basis) and Employer Wellness Committee Members (2-5 individuals per participating employer for a total of 500 respondents or 166 per year on an annualized basis) to gather information regarding the planning and implementation of the program. The total estimated burden to respondents for steering committee members is 50 hours (30 minutes per submission), and wellness champion interview guides is 83 hours (30 minutes per response). This information will also drive the creation of ten employer case studies.

The Employer Follow-Up Survey (Attachment E-7) will be completed by a representative from each of the participating employers, to obtain information about program maintenance and sustainability. The survey will be conducted in a web format. The total estimated burden to respondents for the employer follow-up survey is 8 hours for participating employers (15 minutes per response).

The Community Participant Engagement Feedback Survey (Attachment E-10) will be conducted with a random sample of employers who were not selected or chose not to be program participants but who could participate in community-based education and peer-to-peer mentoring. The total estimated burden to respondents for all interview guides is 6 hours (10 minutes per response).

The Worksite Health Training Survey Parts I-III (Attachment E-8) and Part V (Attachment E-9) will be conducted with approximately 100 employers annually who have registered to participate in healthy worksite 101 training. These surveys ask about employers’ level of knowledge and feedback on the trainings as well as their intentions to, and progress toward, implementing effective science-based workplace health strategies and interventions. The total estimated burden to respondents for both training surveys is 34 hours (10 minutes per response).

Employee Data

The All Employee Survey (Attachment F-1) will be voluntarily completed by employees. The All Employee Survey will be completed on paper and collected from each employee by a Community Director or Health Coach at the beginning and the end of the program. The total estimated burden to respondents is 833 hours (30 minutes per response). We estimate that information will be collected from 5,000 respondents on an annualized basis. This represents a 75% response rate for the 20,050 total employees eligible for participation over the three-year clearance period (20,050 x .75 / 3 = 5,000).

The Employee Health Assessment (Attachment F-2) will be completed by employees who elect to participate in their employer’s worksite health program. The Health Assessment will be completed on paper and collected from each employee by the Community Director, Health Coach, or biometric health screening staff at the beginning and at the end of the program. The total estimated annualized burden to respondents is 833 hours (30 minutes per response) on an estimated 5,000 respondents (see above).

The Success Story Consent Form (Attachment F-3) will be completed by employees who have expressed the desire and given consent to have their success story published (newsletter, bulletin boards) for the promotion of the National Healthy Worksite program. The employee will complete the consent form and questionnaire in paper form and return it to their health coach. The total estimated burden to respondents is 11 hours (10 minutes per response).

The Satisfaction Survey (Attachment F-4) will be completed by employee participants quarterly during the implementation period to gauge employee perception of program effectiveness. The employee will complete the survey either electronically or via paper and pencil and return it to the Community Director or implementation contractor office via mail or fax. The total estimated burden to respondents is 2,000 hours (15 minutes per response) based on a 30% response rate (20,050 x .30 /3 = 2,000).

During the program employees can voluntarily participate in program activities such as wellness challenges or campaigns to create peer support networks and support a healthy culture. Participation will include the completion of a challenge log for one or more of the following Wellness Challenges: Lower Your Weight by Eight, Step into Health, Mix it Up, Maintain Don’t Gain, Quench Your Thirst and Feel Fit with Fiber (Attachment F-5).

The challenge logs will be completed in paper format and maintained by the participant throughout the challenge. At the conclusion of each challenge participants will return the challenge log directly to the health coach. The total estimated burden to respondents is 8,000 hours (30 minutes per response for the Step into Health, Mix it Up, Feel Fit with Fiber and Quench Your Thirst Challenges and 1.0 hour per submission for the Lower Your Weight by Eight and Maintain Don’t Gain Challenges). We estimate that 2,000 employees will participate in each challenge on an annualized basis.

Participants who enroll in individual health coaching can also elect to complete the Nutrition and Physical Activity Tracking Log and Lifestyle Tracker (Attachment F-6) which will allow them to track their nutritional intake and physical activity on a daily basis. These logs will be reviewed by the participant’s health coach and will serve as a resource in evaluating the areas of nutritional improvement for each participant. The total estimated burden to respondents is 1,000 hours (30 minutes per response).

Total estimated burden hours to employee respondents for the employee wellness challenges and campaigns are based on a 30% response rate for the estimated 20,050 total employees available to participate over the three-year clearance period.

Program Providers

The Discussion / Interview guides (Attachments H-1 and H-2) will be used by the evaluation contractor to gather information from Community Directors and Health Coaches regarding the planning and implementation of the program. Because the Community Directors and Health Coaches are paid positions supported through the implementation contract, information collected for them is not included in the burden table.

A.12.1 Estimated Annualized Burden Hours and Cost to Respondents

Table A. Estimated Annualized Burden Hours

Type of Respondent	Form Name	Number of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)
Interested Employer	Employer Phone Interview Guide	69	1	20/60	23
Participating Employer	Organizational Assessment	66	2	30/60	66
	Employee Eligibility File	33	4	15/60	33
	Employer Information Form	33	1	30/60	17
	Health Screening Site Interview Form	33	2	30/60	33
	Discussion Guide for Steering Committee Members	100	1	30/60	50
	Discussion Guide for Wellness Committee Members	166	1	30/60	83
	Employer Follow-Up Survey	33	1	15/60	8
Community Participant	Community Participant Engagement Feedback Survey	35	1	10/60	6
	Worksite Health Training Survey Parts I-III	100	1	10/60	17
	Worksite Health Training Survey Part IV	100	1	10/60	17
Employee	Health Screening Consent / Contact Form	5,000	1	10/60	833
	All Employee Survey	5,000	2	5/60	833
	Health Assessment	5,000	2	15/60	2,500
	Success Story Consent Form	67	1	10/60	11
	Satisfaction Survey	2,000	4	15/60	2,000
Employee: Wellness Challenge Log / Program Participant	Lower Your Weight by Eight Challenge Log	2,000	1	1	2,000
	Step into Health Challenge Log	2,000	1	30/60	1,000
	Mix it Up Challenge Log	2,000	1	30/60	1,000
	Quench Your Thirst Challenge Log	2,000	1	30/60	1,000
	Feel Fit with Fiber Challenge Log	2,000	1	30/60	1,000
	Maintain Don’t Gain Challenge Log	2,000	1	1	2,000
	Nutrition and Physical Activity Tracking Log / Lifestyle Tracker	2,000	1	30/60	1,000
Total					15,530

Table A12-2. Estimated Annualized Cost to Respondents (based on burden hours)
Type of Respondent	Form Name	Number of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)	Hourly Wage Rate	Annualized Cost
Interested Employer	Employer Phone Interview Guide	69	1	20/60	23	$36.25	$833.75
Participating Employer	Organizational Assessment	66	2	30/60	66	$36.25	$2,392.50
	Employee Eligibility File	33	4	15/60	33	$15.50	$511.50
	Employer Information Form	33	1	30/60	17	$15.50	$263.50
	Health Screening Site Interview Form	33	2	30/60	33	$15.50	$511.50
	Discussion Guide for Steering Committee Members	100	1	30/60	50	$15.50	$775.00
	Discussion Guide for Wellness Committee Members	166	1	30/60	83	$15.50	$1,286.50
	Employer Follow Up Survey	33	1	15/60	8	$15.50	$124.00
Community Participating Employer	Community Participant Engagement Feedback Survey	35	1	10/60	6	$15.50	$93.00
	Worksite Health Training Survey Parts I-III	100	1	10/60	17	$15.50	$263.50
	Worksite Health Training Survey Part IV	100	1	10/60	17	$15.50	$263.50
Employee	Health Screening Consent / Contact Form	5,000	1	10/60	833	$15.50	$12,911.50
	All Employee Survey	5,000	2	5/60	833	$15.50	$12,911.50
	Health Assessment	5,000	2	15/60	2,500	$15.50	$38,750.00
	Success Story Consent Form	67	1	10/60	11	$15.50	$170.50
	Satisfaction Survey	2000	4	15/60	2,000	$15.50	$31,000
Employee Wellness Challenge Log / Campaign Participant	Lower Your Weight by Eight Challenge Log	2,000	1	60/60	2,000	$15.50	$31,000
	Step into Health Challenge Log	2,000	1	30/60	1,000	$15.50	$15,500
	Mix it Up Challenge Log	2,000	1	30/60	1,000	$15.50	$15,500
	Quench Your Thirst Challenge Log	2,000	1	30/60	1,000	$15.50	$15,500
	Feel Fit with Fiber Challenge Log	2,000	1	30/60	1,000	$15.50	$15,500
	Maintain Don’t Gain Challenge Log	2,000	1	60/60	2,000	$15.50	$31,000
	Nutrition and Physical Activity Tracking Log / Lifestyle Tracker	2,000	1	30/60	1,000	$15.50	$15,500
						TOTAL	$242,562.25

*Included in implementation contract

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

We do not anticipate that organizations / employers, employees or record keepers will incur any additional burden hours or costs. There may be some NHWP participating employers who do not routinely capture the eligibility file data elements in a single file; in these instances we will work with the participating employers and their existing systems and procedures to capture all the necessary information in a manner that does not place additional burden on them.

14. Annualized Cost to the Government

The current data collection costs include the cost of CDC personnel for oversight of NHW program planning, implementation and evaluation, and costs associated with two contracts: one with a workplace health implementation contractor, Viridian Health Management (Phoenix, Arizona), and one with a workplace health evaluation contractor, Research Triangle Institute (RTI) International (Research Triangle Park, North Carolina). A full-time CDC employee will serve as the technical monitor for the project, directing regular planning and coordination meetings with the contractor staff. These meetings serve to plan and coordinate the programs and activities of the National Healthy Worksite Program including: communications with internal and external stakeholders; planning and developing protocols for the onsite worksite assessments, health promotion program interventions, and individual worksite and national evaluations. The role of the CDC employee also involves regular reporting and review of all materials and products before acceptance by the government by coordinating input from multiple CDC National Center for Chronic Disease Promotion and Health Promotion Division (Division of Diabetes Translation, Division for Heart Disease and Stroke Prevention, Office on Smoking and Health, Division of Population Health, and Division for Nutrition, Physical Activity, and Obesity) and the CDC National Institute for Occupational Safety and Health targeting the health risk factors and health conditions of interest to the NHWP.

Viridian Health Management will provide operational management of the health promotion program and coordinate activities among the NHW Program Participants. Viridian’s responsibilities include conducting individual and organizational assessments, program planning and assisting NHWP participants with selection of priority interventions, providing implementation support, and data collection. Viridian will also provide guidance in establishing the program management infrastructure; assist in communication activities such as reporting progress to CDC and preparing reports and publication materials; and provide training to NHWP Program Participants and Community Participants.

Under a subcontract with Viridian, NHW Program Participants and Community Directors will receive additional support from the University of Connecticut / Center for Health Promotion in New England Workplace (CPH-NEW), a NIOSH-funded center of excellence. CPH-NEW will provide expertise in health protection and safety, specifically training and general use tools for ergonomics, and consultation on worksite organization decisions that impact health protection and promotion. CPH-NEW will assist with development and analysis of the All-Employee Survey and the Health Assessments; generate feedback reports for employers; and conduct de-identified linkage and analysis of the Health Assessment and All-Employee survey with organizational culture metrics.

RTI will be responsible for evaluation of the NHWP using a mix of qualitative and quantitative methods. Some information such as an employee health assessment will be self-reported. Other information such as organizational programs, policies, and practice assessments will be collected by the implementation contractor staff, aggregated/de-identified and shared with RTI. RTI will conduct analyses to describe adoption, reach, and sustainability of the interventions offered through the NHWP.

The ongoing data collection costs and associated project support costs are assumed constant for the useful life of the program. The average annualized cost of the contracts with respect to data collection is estimated at $961,608 per year for 9,616 hours of labor (@$100/hour).

The total estimated annualized cost to the Federal government is $1,017,108 (TOTAL).

Table A.14-A Annualized Costs to the Government

Cost Category	Avg. Annual Cost
Data Collection Implementation Contractor Assessment planning $30,000 Organizational Survey $150,000 Individual Health assessment $180,000 Biometric screening $294,333 CPH-NEW Data Analysis $30,000 Program Provider Surveys $98,000	$782,333
Data Collection Evaluation Contractor	$179,275
CDC GS-14 50% GS-14 @ $111,000/year	$55,500
Total	$1,017,108

15. Explanation for Program Changes or Adjustments

This is a new information collection.

16. Plans for Tabulation and Publication and Project Time Schedule

The assessment and project timeline are outlined below in Table 16A.

Table 16A. Project Assessment Time Schedule

Respondents/Sources	Method	Content	Timing/Frequency	Attachment #
OMB Approval – Participating Employer Selection (estimated)
OMB Approval	N/A	N/A	June 2012 (estimated) for telephone interviews for employer selection	N/A
Interested Employers who complete the online certification process	Telephone Interview	Verification and scoring of employer eligibility based on program inclusion criteria	Once to select participating employers	D1 – D3
OMB Approval - Survey Instruments / Assessments (estimated)
OMB Approval	N/A	N/A	June, 2012 (estimated) for survey instruments	N/A
Employer Information:
Employers (All worksites)	Organizational Assessment	Status of worksite policy/practices/programs across priority health areas	Baseline & at end of implementation	E-1
Employers (HR staff) (All worksites)	Employee demographic and eligibility data	Eligibility file (to link employee data)	Enrollment and quarterly for program duration	E-2
Employers (HR staff) (All worksites)	Administrative Data	Employer and site – specific administrative and demographic information	Following employer commitment	E-3 – E-4
Employer steering committee (1-3 per participating employer) /wellness coordinators (2-5 per participating employer) for ~10 Case studies	Employer-Level Discussions (HR or wellness committee)	Challenges and strategies for success	Month 20 (near the end of implementation)	E-5 – E-6
Employer Representative (HR or chair of wellness committee, program champion) -- all worksites	Employer Follow-Up Survey (conducted by RTI)	Program continuation; Employee participation; Challenges & strategies for success	Approx. 8 months into year 3	E-7
Community Participants in selected communities	Employer Follow-up survey (conducted by Research Triangle International)	Reasons for not becoming a Program Participant; intent to participate in training; demographics and health culture	Approximately 60 days after employer recruitment ends	E-10
Participants in Worksite Health 101 Training Part I-III	Training evaluation	Usefulness of Part 1 training modules	Approx. 2 months following each training event	E-8
Participants in Worksite Health 101 Training Part V	Training evaluation	Usefulness of Part 2 training modules	Approx. 2 months following each training event	E-9
Employee Health Status; Perceptions of Workplace Culture; Needs and Interests; Program Satisfaction
Employees	All Employee Survey	Perceptions of workplace culture, health behavior, presenteeism	Enrollment & end of implementation (around month 20)	F-1
	Health Assessment / Health Screening (de-identified – linked)	Biometric indicators, self-reported health behavior, health status	Enrollment and end of implementation (de-identified linked data)	F-2
	Success Story Consent Form	Permission to use Individually Identifiable Information to share participant success stories	Throughout the program implementation period	F-3
	Satisfaction Survey	Perception of program delivery and effectiveness	Quarterly during program implementation	F-4
Data Tabulation for Program Planning and Reporting	Aggregate Reports presented to Employers	Tabulated Aggregate Results	One month following employer / employee assessment or month 10	N/A
Employees participating in Health Coaching	Wellness Challenge logs or Nutrition Logs	Self-monitoring tools to track health behaviors	Health coaching enrollment or quarterly with employer wellness challenge implementation	F-5 – F-6
Participating Employees ~10 Case study sites (3-6 employees/site)	In-depth or small-group telephone discussions	Opinions about programming and workplace changes	Month 20 (near end of implementation)	N/A
Process Information: (from NHWP Implementation Contractor)
Community Directors	Small Group Discussions	Recruitment & Retention	At worksite recruiting, 6 months, & end of implementation	H-1
Health Coaches	Small Group Discussions	Strategies to encourage participation and follow-up of medical recommendation; strategies to encourage behavior change; worksite policy changes; Strategies to encourage participation; Success stories	2-3 times, depending on length of implementation	H-2
	Intake and Tracking Form; Care Management System (Health Coaches)	Employee participation and engagement by program area; referrals; program completion	Quarterly	N/A
Cost Information:
Viridian & Employers	Viridian invoices/records	Program costs	Annual	N/A
	Worksite Profile Employer Provided Incentives Employer Follow-up Survey	# employees; # WHP participants; Incentives to employees; Staff time	Annual	N/A

A combination of qualitative and quantitative data elements will be used for the overall evaluation of the NHWP. The outcome evaluation will include a descriptive component as well as statistical models to determine the extent to which the program affected the target outcomes. These analyses will be supplemented with interview data collected for approximately 10 case studies.

Descriptive Analysis

In the descriptive analysis, we will first examine baseline differences between worksites and between communities in terms of pre-implementation worksite characteristics, such as organizational structure and the percentage of employees who have access to the workplace health program activities. For categorical variables, we will display relative and absolute frequencies in tables or histograms. For continuous variables we will report means, standard deviations, and distribution plots. The second part of the descriptive analysis will examine, at the worksite, community, and national level, the change in key outcomes between the time of the baseline and follow-up data collection. These outcomes include employee behaviors (e.g., tobacco use, physical activity, nutritional choices), and attitudes (e.g., perceptions of worksite culture) and work-related outcomes (e.g., productivity). The changes over time will be summarized both numerically and graphically. Observed differences within and between time points will be tested for statistical significance with paired t-tests, chi-squared tests, and analysis of variance (ANOVA).

Statistical Modeling

The primary statistical models in the outcome evaluation will be linear and non-linear regression models and hierarchical or multilevel models. The purpose of using these models is to relate the observed differences in outcomes to a set of observed characteristics. Of particular interest is how certain organizational features, such as the level of management support for health promotion programs, influence the effectiveness of programs.

For data aggregated at the worksite level, regression models will be the main analysis tool. When the outcome variable is continuous, linear regression models will be used (with transformations for non-normality when needed). When outcomes are discrete or fractional, nonlinear models such as the Logit model will be used. The models will predict which organizational factors increase employee awareness of or participation in health promotion programs. Applied to the baseline to follow-up changes in worksite outcomes, the models will determine which factors are most effective in terms of reaching the desired employee outcomes.

We will use individual-level baseline and follow-up data from the All-Employee Survey and Health Assessment to fit multilevel models. Multilevel analyses have several important advantages, including larger sample sizes and increased statistical power (i.e., the ability of a statistical model to detect the impact of explanatory variables), typically leading to increased precision in estimation. Multilevel models will also explicitly account for the clustering in the data. We will observe individual employees at two time points with employees clustered at worksites, which in turn are clustered by community. In a multilevel model we will analyze the employee-level outcome as a function of individual characteristics (e.g., age, gender) and time (baseline or follow-up). Estimation results from such an analysis will allow us to determine which individual and employer characteristics have a significant impact on health-related and behavioral outcomes such as physical activity and BMI.

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

The OMB expiration date will be displayed on all assessments used for process and outcome evaluation collected from employers, employees, and program providers. The OMB expiration date is not appropriate for programmatic support materials, such as generic Wellness Challenge brochures / tracking logs that are preprinted and not specific to the National Healthy Worksite Program. This information is not collected for program outcome or process evaluation and will supplement health coaching by providing healthy lifestyle self-monitoring tools.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to this certification.

References:

1. Naydeck BL, Pearson JA, Ozminkowski RJ, Day BT, Goetzel RZ. The impact of the Highmark employee wellness programs on 4-year health care costs. J Occup Environ Med. 2008;50(2):146-156.

2. Goetzel RZ, Ozminkowski RJ. The health and cost benefits of work site health-promotion programs. Annu Rev Public Health. 2008;29: 303-323. 

3. Linnan LA, Bowling M, Childress J, Lindsay G, Carter Blakey, S, Wieker, S, and Royall, P. Results of the 2004 national worksite health promotion survey. Am J Pub Health. 2008;98(1): 1-7.

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