Clinical trial NCT05199415: Fulfillment Center Study on Work, Health, and Wellbeing
Official title: Fulfillment Center Intervention Study as Part of The Harvard T.H. Chan School of Public Health Center for Work, Health and Wellbeing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Distress
Psychological Well-being
Subjective Health
Injuries
Lead sponsor: Massachusetts Institute of Technology
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2022-01-20
Enrollment: 3459
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Psychological Distress
timeFrame: 12 Months
Secondary outcomes:
measure: Psychological well-being
timeFrame: 12 Months
measure: Self-reported general health
timeFrame: 12 Months
measure: Injuries and injuries reported to management
timeFrame: 12 Months
measure: Musculoskeletal pain
timeFrame: 12 months
measure: Sleep duration
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: MIT Sloan School of Management
state: Massachusetts
Study officials:
affiliation: MIT Sloan School of Management
name: Erin L Kelly, Phd
role: PRINCIPAL_INVESTIGATOR
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