Statement B_Fatigue in OGE

Assessing Fatigue and Fatigue Management in U.S. Onshore Oil and Gas Extraction

(Information Collection Request -- OMB # XXXX-XXXX)

Request for Office of Management and Budget Review and

Approval for Federally Sponsored Data Collection

Section B

Project officers:

Alejandra Ramirez-Cardenas and Imelda Wong

Centers for Disease Control and Prevention (CDC)

National Institute for Occupational Safety and Health (NIOSH)

Western States Division

P.O. Box 25226

Denver, CO 80225-0226

Phone: 303-236-5957 and 513-533-6847

E-mail: [email protected] and [email protected]

Table of Contents

B. Collections of Information Employing Statistical Methods 3

B.1 Respondent Universe and Sampling Methods 3

B.2 Procedures for the Collection of Information 4

B.2.a Quantitative Aim (Aim 1) 4

B.2.b Qualitative Aims (Aim 2 and Aim 3) 5

B.3 Methods to Maximize Response Rates and Deal with No Response 5

B.4 Test of Procedures or Methods to be Undertaken 6

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 6

References 8

Attachments

Attachment 3 – Questionnaires

Attachment 3a – Baseline Questionnaire (English)

Attachment 3b – Baseline Questionnaire (Spanish)

Attachment 3c – Pre-shift Questionnaire (English)

Attachment 3d – Pre-shift Questionnaire (Spanish)

Attachment 3e – Post-shift Questionnaire (English)

Attachment 3f – Post-shift Questionnaire (Spanish)

Attachment 4 – Actigraphy

Attachment 4a – Statement of Actigraphy Return (English)

Attachment 4b – Statement of Actigraphy Return (Spanish)

Attachment 5 - Focus Group and Interview Guides

Attachment 5a – Worker Focus group guide (English)

Attachment 5b – Worker Focus group guide (Spanish)

Attachment 5c – Front-line supervisor interview guide

Attachment 5d – Senior Leader interview guide

Attachment 5e – SME interview guide

B. Collections of Information Employing Statistical Methods

B.1 Respondent Universe and Sampling Methods

The respondent universe for this study will be onshore oil and gas extraction (OGE) workers, field-level supervisors, and senior health and safety (H&S) leadership who are employed or contracted by OGE companies operating in the contiguous United States with the North American Industrial Classification System (NAICS) code of 211, 213111, or 213112. Researchers who are subject matter experts (SMEs) in occupational fatigue will also participate in this study. Table 1 identifies the 3 aims of this study and the corresponding study population, sample size, and inclusion and exclusion criteria.

Table 1: Study aims, population description, sample size, inclusion, and exclusion criteria

Aim	Aim 1 – Field study	Aim 2 – Worker focus groups and supervisor interviews	Aim 3 – Leader interviews
Description	To examine occupational and non-occupational determinants of sleep health in U.S. onshore OGE workers	To identify worker and organizational factors critical to fatigue management in the OGE industry	To describe how fatigue mitigation strategies are currently being used in the onshore OGE industry
Sample Population and Size	60 workers and 20 field-level supervisors	30 workers 10 field- level supervisors (All recruited from Aim 1)	7 senior H&S leaders 3 occupational fatigue SMEs
Inclusion Criteria	Can give informed consent Age 18 years or older on the date of consent Employed by a OGE contractor company for at least 3 months Must work at a wellsite at least two days per week Is willing to adhere to the study procedures	Worker focus groups: Same as Aim 1 Field-level supervisor interviews: Same as Aim 1 Employed in a management or supervisory position with a OGE contractor company	Can give informed consent Age 18 years or older on the date of consent Senior H&S Leadership: Employed or contracted by a OGE company in a senior H&S leadership position (i.e., Directors, Vice presidents), or H&S consultants whose business portfolio consist primarily of OGE companies Employed in this position for at least 12 months Scientific researchers: Subject matter expertise in occupational fatigue research
Exclusion Criteria	Self-report they are currently pregnant	N/A	N/A

Power calculations determined the sample size for Aim 1 (field study) would require a total of 80 workers and supervisors, accounting for a 37.5% attrition rate. Participants for Aim 2 (focus groups and interviews) will be recruited from among participants Aim 1 (field study).

Given that study participants are similar in demographic and occupational characteristics, and our research questions are focused, we anticipate we will only need 40 workers and front-line supervisors to participate in Aim 2, and 10 H&S leaders and SMEs for Aim 3 to reach saturation in responses. Studies have shown that qualitative research can reach saturation with sample sizes as small as 9 interviews or 4 focus group discussions when populations are homogenous.[1]

B.2 Procedures for the Collection of Information

All workers employed for at least three months by U.S. OGE companies operating in the contiguous U.S. are considered as potential participants. Study personnel will engage with, and obtain permission from, OGE companies to conduct the study at their sites. Prior to our arrival, a company liaison will inform workers of the study and post the recruitment flyer in common areas. All workers will be informed that participation in the study is voluntary and will not have any impact on their employment. All responses and information gathered will be de-identified and individual results will not be shared with their employer or anyone outside of the NIOSH research team.

Study personnel will arrive at the company field site prior to the start of a shift and work with the company liaison to identify an appropriate location to set up study materials and conduct the study elements. All workers will meet with the study personnel to determine if they are eligible to participate and receive informed consent. Study personnel will be trained on all elements of this study, including conducting informed consent, administering surveys and digital psychomotor vigilance task (PVT) tests, setting up actigraphy watches, and conducting interviews and focus groups.

B.2.a Quantitative Aim (Aim 1)

Upon enrollment into the study, participants will be asked to complete a baseline questionnaire (Attachment 3a or b) with questions related to their current work schedule, sleep, organizational safety and fatigue management, job demands, self-rated health, and demographics. Measures of sleep health will be collected using actigraphy watches (small wristwatch-like devices that are non-intrusive and record limb activity as a measure of sleep-wake movement) for passive, continuous data collection (Attachment 4a or b). At the beginning and end of each shift, participants will also be asked to complete brief daily questionnaires (Attachments 3c-f) and will be asked to complete digital PVT tests (no instrument to attach for the PVT).

Participants will be given the option of completing surveys on paper or electronic tablets. For responses collected on paper copies, one study team member will enter responses into a secured digital data platform. A second study team member will verify responses as an additional quality check.

Digital PVT tests will be administered only on electronic tablets. Actigraphy data will only be collected through the actigraphy watch.

Data from each tablet will be downloaded to a secure CDC owned laptop and data from the actigraphy watches will be downloaded to a secure CDC owned laptop at the end of the complete data collection period. The questionnaires will collect company and worker-level information from each participant. Data collected will be used in descriptive statistic methods such as, means, medians, modes, standard deviations, and multivariable analysis.

B.2.b Qualitative Aims (Aim 2 and Aim 3)

Worker focus groups and front-line supervisor interviews will be conducted in-person in a private location at the worksite by trained moderators using the focus group and interview guides (Attachments 5a-c). Senior H&S leader and occupational fatigue SME interviews (Attachments 5d,e) will be conducted virtually over a secure government virtual platform. Thematic analysis will be used to identify significant topic areas.

B.3 Methods to Maximize Response Rates and Deal with No Response

To maximize response rates and address non-response, we will take the following steps to facilitate respondents’ willingness to participate:

1. NIOSH will work with oil and gas companies to explain the importance of the study, to obtain permission to recruit workers, and administer the study at company sites.

2. Prior to the start of data collection, the study team will meet with on-site management to determine the safest and least intrusive place for study recruitment and administration. Flyers will be placed in common areas notifying the workers of the study and inviting them to participate.

3. Efforts will be made to reach all workers on site to invite them to participate. The study personnel will be available to meet with potential study participants to discuss the study protocol and answer any questions.

4. We will work closely with the on-site management throughout the data collection period to minimize attrition. For example, we may request supervisors remind participants to complete their pre-shift surveys and PVT during the morning check-in.

5. We will maximize response rates among Spanish-speaking workers by making all data collection instruments available in Spanish, as well as English. A Spanish speaking member of the study team will also be available at every visit.

6. Tokens of appreciation, in the form of gift cards, for study participants will only be offered with permission of the participating company. Participants who complete the baseline questionnaire, at least one pre-shift or post-shift questionnaire per day, one PVT test per day, and attest to wearing the actigraphy watch for at least 5 nights will be offered a $50 gift card. Worker and front-line supervisor participants who complete the interview or focus group will be offered a $10 gift card as a token of appreciation.

7. All study team members will be trained to administer surveys, interviews, and focus groups. This will facilitate ease of participation for the participants, increasing the likelihood they will complete all study components in their entirety.

8. Our protocol has been piloted among a small group of OGE workers. Pilot results were used to refine the protocol to ensure that it had enough flexibility to work with various companies’ normal job tasks and workflows and asks only questions that serve the study objectives and analysis purposes.

We will compare the information on respondents who discontinue participation with respondents who complete the data collection to identify potential biases.

B.4 Test of Procedures or Methods to be Undertaken

We have used validated questions in our study surveys. Health and demographic questions were taken from the American Community Survey, HHS Office of Minority Health Standards, National Health Interview Survey, Current Population Survey, and the Behavioral Risk Factor Surveillance Survey. Work schedule information will be collected using questions developed and tested for a previous NIOSH study with OGE workers (OMB No.0920-1195, Exp. Date 07/31/2019). Job stress questions will be ascertained from the Job Content questionnaire. Sleep health will be identified with questions from Jackson Heart Sleep Study. Sleep quality will be assessed with the Pittsburgh Sleep Quality Index. Other validated scales include Organizational Safety Climate (OSC) Scale, Group Safety Climate (GSC) Scale, and the Karolinska Sleepiness Scale (KSS).

All interview and focus group guides were developed in collaboration with NIOSH researchers and academic experts in qualitative research methods in occupational settings, and with knowledge of the OGE industry.

Cognitive testing, as an indicator of fatigue, will be ascertained with NASA PVT+, a validated PVT test for field use.

Objective sleep health measures will be collected using actigraphy watches. These are small wristwatch-like devices that are non-intrusive and passively record limb activity as a measure of sleep-wake movement and are validated against polysomnography, the laboratory-based gold standard for measuring sleep.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

NIOSH employees designed the questionnaires, performed pilot testing of study instruments, and will be responsible for collection and analysis of all data. Key NIOSH contacts are listed below.

Alejandra Ramirez-Cardenas, MPH

Epidemiologist

Western States Division, NIOSH

Phone: 303-236-5957

[email protected]

Imelda Wong, PhD

Program Leader, Center for Work and Fatigue Research

Division of Science Integration, NIOSH

Phone: 513-533-6847

[email protected]

Kenneth Scott, PhD, MPH

Research Epidemiologist

Western States Division, NIOSH

Phone: 303-236-0502

[email protected]

Cooperative Agreement or Contract:

Natalie Schwatka, PhD

Assistant Professor

University of Colorado Denver, Colorado School of Public Health

303-724-4607

[email protected]

Kaitlin Wingate, MPH

Epidemiologist

Synergy America, Inc.

Phone: 303-236-5956

[email protected]

Ms. Wingate will participate in data collection and analysis.

CDC-NIOSH Western States Division employees and members of the CDC-NIOSH Oil and Gas program will assist in data collection and/or analysis. However, the exact persons have yet to be determined. Any new employees brought on board to assist will be trained as described in other portions of the OMB Packet.

References

1. Hennink, M. and B.N. Kaiser, Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Social Science & Medicine, 2022. 292: p. 114523.