Small+Safe+Well: A Longitudinal Study of TWH in Small Business (SSWell)

Workers in small businesses bear a disproportionate burden of occupational fatalities, illnesses, and injuries. The investigators conducted an intervention research project to determine how an intervention at the organizational level modifies business Total Worker Health (TWH) practices, safety climate, and health climate. In turn, the investigators aimed to determine whether organizational TWH adoption impacts individual workers' lifestyle health outcomes. In addition, the investigators also evaluated the use of the RE-AIM public health impact evaluation framework in the small business setting, with the intention of improving generalizability, maintenance, and dissemination of interventions and of guiding future TWH intervention design for both research and practice. The investigators conducted a lagged randomized controlled trial (L-RCT) to determine how different doses of an organizational-level TWH intervention (Health Links vs. Health Links + TWH Leadership Training) resulted in improvement and maintenance of TWH programming and organizational climates for safety and health, in small enterprises, over 36 months. The investigators also evaluated whether it resulted in improvements in workforce lifestyle health risks. In the short and mid-term, the goals and outputs of this project is a greater understanding of the theoretical underpinnings of TWH interventions and a model to test the implementation of the TWH interventions as well as an improvement the ability of TWH researchers and practitioners to apply this knowledge to TWH intervention design, implementation and evaluation to ensure generalizability. The long-term goal of this project is to impact worker safety, health and well-being through the continued use of these principles in small businesses.

Study Overview

• Status: Completed
• Conditions: Life Style
• Intervention / Treatment: Behavioral: Health Links; Behavioral: Health Links + Leadership Training

• Study Type: Interventional
• Enrollment (Actual): 2175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Colorado small business with less than 500 employees

Exclusion Criteria:

• Business does not operate in Colorado or has more than 500 employees

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lagged; Businesses in the lagged arm participated in Health Links for one year from their baseline assessment to their first follow-up assessment one year later. They were eligible to participate in the Leadership Training after both assessments were completed.	Behavioral: Health Links; Health Links is an existing community-based intervention that seeks to help businesses - especially small and medium-sized businesses - create a culture of both safety and health. Health Links does this by helping businesses incorporate Total Worker Health (TWH) programming into their business practices through assessment, advising, and certification. There is evidence that this consultation intervention is effective at helping businesses develop and implement policies and programs.
Experimental: Early; Businesses in this arm participated in Health Links + Leadership Training for one year from their baseline assessment to their first follow-up assessment one year later.	Behavioral: Health Links + Leadership Training; Help businesses undergo transactional (i.e., business management practices) and transformational (i.e., business leadership and culture) change. Transactional change component: Health Links is an existing community-based intervention that seeks to help businesses - especially small and medium-sized businesses - incorporate Total Worker Health (TWH) programming into their business practices through assessment, advising, and certification. There is evidence that this consultation intervention is effective at helping businesses develop and implement policies and programs.Transformational change component: The experimental arm includes TWH leadership training for small business owners and other senior leaders. This is a three-month training that includes assessments, in-person training, and virtual training transfer activities. The goal is to help the leader understand their organization's current approach to TWH, identify areas for improvement, and to take action.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Business Total Worker Health Policies and Programs	Total score, out of 100, on an assessment that measures the quantity of policies and programs that the business develops and implements to protect and promote their employees' health and safety.	up to four years
Health Climate	Health climate (1-5 Likert scale, Strongly disagree to strongly agree) measures employee perceptions of whether their organization is committed to their health and well-being. Zweber, Z. M., Henning, R. A., & Magley, V. J. (2016). A practical scale for Multi-Faceted Organizational Health Climate Assessment. Journal of Occupational Health Psychology, 21(2), 250-259.	up to four years
Safety Climate	Safety climate (1-5 Likert scale, Strongly disagree to strongly agree) measures employee perceptions of whether their organization is committed to their safety. Lee, J., Huang, Y.-H., Robertson, M. M., Murphy, L. A., Garabet, A., & Chang, W.-R. (2014). External validity of a generic safety climate scale for lone workers across different industries and companies. Accident Analysis & Prevention, 63, 138-145.	up to four years
Overall health	A self-reported measure of overall health asks the respondent to rate their overall health (1-5 Likert scale, Poor to excellent). Schwatka, NV, Atherly, A, Dally, MJ, Fang, H, vS Brockbank, C, Tenney, L, Goetzel, RZ, Jinnett, K, Witter, R, Reynolds, S, McMillen, J, Newman, L. (2017). Health risk factors as predictors of workers' compensation claim occurrence and cost. Occupational and Environmental Medicine. 74(1): 14-23.	up to four years
Well-being	A self-reported measure of well-being asks the respondent to rate their well-being related to mood (1-5 Likert scale, Poor to excellent). Staehr Johansen, K. (1998). The use of well-being measures in primary health care - the DepCare project. In World Health Organization, Regional Office for Europe: Well-Being Measures in Primary Health Care - The DepCare Project. Geneva, World Healthcare Organization.	up to four years
Stress	A self-reported measure of stress asks the respondent to rate their level of stress related to work, home, and finances (1-5 Likert scale, Never to always). Schwatka, NV, Atherly, A, Dally, MJ, Fang, H, vS Brockbank, C, Tenney, L, Goetzel, RZ, Jinnett, K, Witter, R, Reynolds, S, McMillen, J, Newman, L. (2017). Health risk factors as predictors of workers' compensation claim occurrence and cost. Occupational and Environmental Medicine. 74(1): 14-23.	up to four years
Sleep	A self-reported measure of sleep asks the respondent about the number of hours of sleep they get in a day (<6 hours, 6-6.9 hours, 7-8 hours, and >8 hours). Schwatka, NV, Atherly, A, Dally, MJ, Fang, H, vS Brockbank, C, Tenney, L, Goetzel, RZ, Jinnett, K, Witter, R, Reynolds, S, McMillen, J, Newman, L. (2017). Health risk factors as predictors of workers' compensation claim occurrence and cost. Occupational and Environmental Medicine. 74(1): 14-23.	up to four years
Exercise	A self-reported measure of exercise asks the respondent about the number of days they get moderate to vigorous physical activity for at least 30 minutes. Schwatka, NV, Atherly, A, Dally, MJ, Fang, H, vS Brockbank, C, Tenney, L, Goetzel, RZ, Jinnett, K, Witter, R, Reynolds, S, McMillen, J, Newman, L. (2017). Health risk factors as predictors of workers' compensation claim occurrence and cost. Occupational and Environmental Medicine. 74(1): 14-23.	up to four years

Collaborators and Investigators

• Sponsor: Colorado School of Public Health
• Collaborators: National Institute for Occupational Safety and Health (NIOSH/CDC)
• Investigators: Principal Investigator: Lee Newman, MA MA, Colorado School of Public Health

Publications and helpful links

General Publications

• Schwatka NV, Tenney L, Dally MJ, Scott J, Brown CE, Weitzenkamp D, Shore E, Newman LS. Small business Total Worker Health: A conceptual and methodological approach to facilitating organizational change. Occup Health Sci. 2018 Mar;2(1):25-41. doi: 10.1007/s41542-018-0013-9.

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: U19OH011227 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All business assessments and employee survey data collected by the researchers will be made available in a timely manner upon written request.
• IPD Sharing Time Frame: The data is currently available and will be stored in the longer term for three years after the study concludes (2023), per federal regulations.
• IPD Sharing Access Criteria: Files with de-identified data will be transferred via electronic format using a secure electronic file transfer along with a statement of data use standards. Documentation of data use standards will be included. To protect our participants we will make the data and its associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. The data will be stored in the longer term for three years after the study concludes, per federal regulations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No