Fulfillment Center Study on Work, Health, and Wellbeing

Psychological Distress Clinical Trial

Official title:

Fulfillment Center Intervention Study as Part of The Harvard T.H. Chan School of Public Health Center for Work, Health and Wellbeing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199415
• Other study ID #: 2008000224
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2023
• Source: Massachusetts Institute of Technology
• Contact: Grace DeHorn, MSW
• Phone: 574-299-6862
• Email: gdehorn[@]mit.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to evaluate how work conditions affect workers' health and well-being, job attitudes and decisions on the job, and key organizational outcomes. This study is being carried out in partnership with a national retailer's e-commerce division. The study centers on a cluster randomized trial evaluation of changes in workplace policies and practices in order to understand their impact on workers, families, and the firm but also utilize multi-method data to gain a better understanding of the stressors and sources of resilience for this growing, but understudied population of low-wage workers.

Description:

The goal of this study is to implement and test the feasibility of a participatory, integrated workplace intervention in fulfillment centers. The focal intervention is the launch of Health and Well-being Committees (HaWCs) in randomized fulfillment centers. The study aims related to the field experiment are to:

Aim #1: Evaluate an innovative participatory intervention aimed at improving health and well-being of non-supervisory workers in fulfillment centers to determine the intervention's efficacy and investigate possible mediation and proximate changes in the conditions of work

Aim #1a: Determine the efficacy of HaWCs in reducing psychological distress, improving key facets of positive psychological well-being and general self-reported health, and lowering levels of reported/unreported injuries.

Aim #1b: Investigate changes in key work conditions including voice, trust, support, safety climate, and workplace policies and practices, including how these proximate changes mediate outcomes

Aim #2: Conduct a process analysis of key contextual factors that support effective and integrated intervention implementation and sustained engagement.

Design and Randomization:

This study is a cluster-randomized trial with a staggered parallel research design. The investigators expect to randomize 21 fulfillment centers (N ≈ 200 workers per site) of a national e-commerce firm, with one additional site designated as a pilot site that will not be included in the randomization. Buildings will be stratified based on the technology used in the main job task of "picking," i.e., retrieving items from different warehouse locations to place into boxes. The firm uses three main picking technologies: conveyor, voice-to-cart, and robotics. Each technology affects the conditions of work and specific safety concerns (e.g., more muscular strain in voice-to-cart sites where workers pull heavy carts, more noise in conveyor sites, and more isolation and small repetitive arm motions in robotics sites).

Data collection involves three waves of survey data (baseline, 6-months, and 12-months). Additional data will be collected from the firm's administrative records and through interviews and focus groups to support the process analysis.

Intervention Delivery (0-12 months):

After randomization, intervention delivery will begin by meeting with management of each fulfillment center to orient them to the study. After the baseline survey, the HaWCs will be announced in treatment sites. HaWCs will involve 10-14 workers and frontline supervisors, with a worker and manager co-chair. The main task of these committees will be to identify challenges to safety, health, and well-being spanning physical hazards, COVID-19 protocols as relevant, other conditions of work (e.g., schedules, pace of work), and policies (e.g., absenteeism, performance management). They will then implement mitigating solutions and track outcomes. HaWCs have a broader scope than traditional safety committees and will actively solicit worker voice regarding policies and practices that are not usually labelled as health and safety policies.

The first four HaWC meetings will be facilitated by the research team. This first set of meetings will also serve as training for the co-chairs who will then take over leading the twice monthly HaWC meetings and coordinating HaWC action plans. The research team will have bi-monthly check-ins with the co-chairs to receive updates on HaWC activities and action plans, gather process data, and provide any needed support.

During this period, the 6-month and 12-month surveys will be administered in all sites.

Maintenance Phase (13-30 months):

Though the official experimental phase concludes at 12 months after baseline (and control sites may adopt the intervention after that), it is expected that HaWC activities will continue as committees implement action plans. During this period there will be less research team support, though technical assistance will be available to HaWCs upon request. The research team will conduct process data using HaWC meeting minutes, visual management tool photos, and periodic check-ins with co-chairs.

Data Analysis Plan:

In the experimental analysis for Aim 1, the investigators will estimate linear mixed-effects regression models for continuous outcomes, including the primary outcome of psychological distress and secondary outcomes such as positive psychological well-being and self-reported health. As a secondary analysis, the investigators will also model the change from baseline in order to directly control for baseline values of the outcomes of interest. However, because this model requires that subjects have baseline data, it will reduce the sample size and be included as a secondary analysis.

In the process analysis for Aim 2,t he investigators will answer research questions using qualitative analysis methods in which the investigators iterate ongoing data collection, analysis of each site as a case as well as comparisons across sites, and writing. The investigators will pursue an abductive analysis oriented to theory construction in which insights from the qualitative data surface in dialogue with existing theories and research as researchers focus on what is surprising, given existing theories, rather than building conclusions in a purely inductive process. Coding will be derived both deductively from themes and questions in the existing literature and inductively from the construction of additional categories as new themes and lines of inquiry emerge. Data analysis will be conducted using the qualitative software program Atlas.ti.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3459
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All individuals, non-supervisory and supervisory, employed at the fulfillment centers, including temporary workers.

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Injuries
• Psychological Distress
• Psychological Well-being
• Subjective Health

Intervention

Behavioral:
• Health and Well-being Committee
Health and Well-being Committees (HaWCs) will be introduced in treatment sites as a means to facilitate on-going problem identification and collaborative processes for developing action plans, implementing small-scale, site-based improvements. HaWCs will involve 10-14 workers and frontline supervisors, with a worker and manager co-chair. HaWCs will identify challenges to safety, health, and well-being spanning physical hazards, COVID-19 protocols as relevant, other conditions of work (e.g., schedules, pace of work), and policies (e.g., absenteeism, performance management). They will then design and implement mitigating solutions and track outcomes. As such, HaWCs have a broader scope than traditional safety committees and will actively solicit worker voice regarding policies and practices that are not labeled as health and safety policies.

Locations

Country	Name	City	State
United States	MIT Sloan School of Management	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts Institute of Technology	Harvard School of Public Health (HSPH)

Country where clinical trial is conducted

United States, 

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* Note: There are 115 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological Distress	The frequency of non-specific psychological distress (e.g., feeling nervous, hopeless, restless or fidgety, depressed, worthless, and everything is an effort) experienced in the last 30 days. This outcome will be measured using the Kessler Distress Scale. Respondents report the frequency from 0 (none of the time) to 4 (all of the time). Items are summed to give a score between 0 and 24, with higher scores indicating higher levels of psychological distress.	12 Months
Secondary	Psychological well-being	Psychological well-being will be measured utilizing vitality items from the General Well-being Schedule. Respondents report the frequency of emotional vitality items in the last month on a scale from 0 (None of the time) to 5 (All of the time). The items are summed, with higher scores indicating greater levels of emotional vitality. The minimum score is 0 and the maximum score is 35. This measure has previously been linked with reduced risk of chronic disease and with better physical health outcomes.	12 Months
Secondary	Self-reported general health	A self-reported rating of general health using a singular item from the Short Form-36. Respondents will assess their own health as poor, fair, good, very good, or excellent.	12 Months
Secondary	Injuries and injuries reported to management	Self-reported injuries will be assessed in the questionnaire. Survey respondents will answer whether they experienced an injury at work in the last 12 months (a dichotomous variable Yes/No) that led to seeking medical advice or losing time from work. They will also be asked whether this injury was reported to management, and the reason for not reporting (if applicable).	12 Months
Secondary	Musculoskeletal pain	This is a self-report of musculoskeletal pain and severity in the last 3 months using a modified question from the Pro-Care Survey (NordicQ). Respondents will be asked whether they experienced pain (a dichotomous Yes/No variable) on 4 different body regions: back, shoulders or neck, hands/wrists/arms, and legs/knees/feet. If they respond yes to a body region, they will then be asked to rate the pain as mild, moderate, or severe.	12 months
Secondary	Sleep duration	Sleep duration (hours and minutes) in the last 30 days using an item from the Pittsburgh Sleep Quality Index.	12 months