Effectiveness of the Healthy Workplace Participatory Program With Peer-led Teams in Public Sector Healthcare Facilities (SHIFT)

February 22, 2021 updated by: Alicia Kurowski, University of Massachusetts, Lowell

Safety and Health Through Integrated Facilitated Teams (SHIFT)

Safety & Health through Integrated, Facilitated Teams (SHIFT) is an intervention study to enhance employee health, safety, and well-being in public sector healthcare institutions in New England. The investigators will evaluate the effectiveness of an adapted form of the Center for the Promotion of Health in the New England Workplace (CPH-NEW) Healthy Workplace Participatory Program (HWPP) for strengthening cohesiveness, engagement, and impact of pre-existing joint labor-management health and safety committees.

The sites are enrolled in three pairs, matched by agency and type of services. For each pair of sites, one will be randomly selected for immediate HWPP coaching. The paired organization will serve as a control until the study mid-point, at which time all sites will be coached. Process evaluations will examine barriers to and facilitators of program uptake, reach, and effectiveness. Survey data and injury records will be examined in intervention and control groups to describe the frequencies of workplace and non-occupational exposures of selected health outcomes.

Study Overview

Detailed Description

Safety & Health through Integrated, Facilitated Teams (SHIFT) is a five-year study with etiologic, intervention, and translational research components. Six public sector healthcare institutions are enrolled, in three pairs matched by agency and type of services. The sites are four Massachusetts state healthcare facilities, which have recently been mandated by law to achieve "Occupational Health and Safety Administration (OSHA) equivalent compliance," and two Veterans Administration facilities each of which has multiple nationally mandated programs addressing employee health and safety. Using a "stepped wedge" design, one of each pair will be randomly selected as the immediate intervention site, while the other facility will be the concurrent control or "lagged intervention" site, having access only to technical reports and information until mid-project, when it will also receive the full intervention.

The intervention is the CPH-NEW Healthy Workplace Participatory Program (HWPP), a process for increasing the effectiveness of occupational health and safety committees or peer-led employee teams, through root cause analysis, prioritizing health and safety needs for effective problem-solving, identifying feasible interventions, and presenting these to leadership. Each facility has a pre-existing labor-management health and safety committee (HSC), which is the unit of intervention, so the HWPP will be adapted to joint management-labor teams. The committee is a partner in designing the program to fit the constraints and needs of the specific workplace and workforce. The research team provides training, coaching in the HWPP process, technical information, and practical assistance to committee members, facilitators, champions and leadership.

Etiologic research will entail analysis of baseline data for cross-sectional associations of work organization with worker health indicators. Intervention research will entail effectiveness and cost-outcome analysis of the HWPP. Outcomes will be both generic indicators of employee well-being and specific outcomes appropriate to the topics that the HSC's select for intervention. Translational research (process evaluation) will evaluate the efficacy of the dissemination and training strategy, as well as obstacles to and facilitators of uptake and implementation.

Study Type

Interventional

Enrollment (Anticipated)

3300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Direct employee of the agency (not temporary agency or subcontractor)

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Intervention Group
SHIFT study team provides coaching to Health and Safety Committee to implement a participatory program for increasing committee effectiveness.
A participatory program for increasing effectiveness of occupational health and safety committees or peer-led employee teams through root cause analysis, prioritizing health and safety needs for effective problem-solving, identifying feasible interventions, and presenting these to senior leadership. Interventions are selected and implemented by leadership and evaluated by both teams.
Other: Delayed Intervention Group
Active Comparator for 2 years: status quo program remains in place with new ongoing data collection. Then experimental intervention as above.
A participatory program for increasing effectiveness of occupational health and safety committees or peer-led employee teams through root cause analysis, prioritizing health and safety needs for effective problem-solving, identifying feasible interventions, and presenting these to senior leadership. Interventions are selected and implemented by leadership and evaluated by both teams.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in team-selected health/safety/well-being issue
Time Frame: Through study completion, an average of two years
Targeted pre- and post-intervention surveys will be designed and administered by the Design Team
Through study completion, an average of two years
Change in Team Attendance
Time Frame: Through study completion, an average of three years
Attendance for each Design Team meeting (1-2 times per month)
Through study completion, an average of three years
Change in Team Engagement
Time Frame: Through study completion, an average of three years
Percentage of yes responses for 2 survey items collected following Design Team meetings (1-2 times per month): "I spoke up and gave my opinion at this meeting" and "My opinion was considered seriously by others at this meeting." (Yes, no, somewhat). Items are computed individually.
Through study completion, an average of three years
Change in Level of Committee Activity
Time Frame: Through study completion, an average of three years
A qualitative summary of field notes collected by research personnel following Design Team meetings (1-2 times per month) over the course of the study
Through study completion, an average of three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of content followed according to the HWPP protocol
Time Frame: Through study completion, an average of three years
A process measure that will be determined by adherence to HWPP protocol and pre-designed agendas for Design Team meetings (1-2 times per month)
Through study completion, an average of three years
Change in scope of health/safety/well-being
Time Frame: Through study completion, an average of three years
Periodic interviews, designed by the research team, will be conducted with Design Team co-facilitators and Steering Committee Champions, and compared to results from baseline leadership interviews, designed by the research team, regarding scope of health/safety/well-being
Through study completion, an average of three years
Shared labor-management awareness of job-related health issues
Time Frame: Through study completion, an average of two years
Interim interviews, designed by the research team, will be conducted with Design Team co-facilitators and Steering Committee Champions.
Through study completion, an average of two years
Work Ability of Employees
Time Frame: Prior to random selection of immediate and delayed intervention site, and 3 years later
The "All-Employee Survey" includes items from the Work Ability Index (Ilmarinen, 1991). Scores range from 7-49. Higher scores indicate better work ability.
Prior to random selection of immediate and delayed intervention site, and 3 years later
Quality of Care of Patients/Residents: All-Employee Survey
Time Frame: Prior to random selection of immediate and delayed intervention site, and 3 years later
The "All-Employee Survey" includes three items related to quality of care from Aiken et al., 2002. Items are computed individually.
Prior to random selection of immediate and delayed intervention site, and 3 years later
Organizational Support for Health, Safety, and Wellbeing
Time Frame: Prior to random selection of immediate and delayed intervention site, and 3 years later
The "All-Employee Survey" includes eight selected items from the Nordic Occupational Safety Climate Questionnaire (NOSACQ50). The score is an average of the 8 items. The score ranges from 1-4, where higher scores indicate better support from management for safety.
Prior to random selection of immediate and delayed intervention site, and 3 years later
Employee Burnout: Exhaustion and Disengagement
Time Frame: Prior to random selection of immediate and delayed intervention site, and 3 years later
The "All-Employee Survey" includes 6 questions, 3 related to exhaustion and 3 related to disengagement (Demerouti, 2000; Halbeslebeni 2005). The score is an average of the items. The score ranges from 1-5, where higher scores indicate more exhaustion and more disengagement.
Prior to random selection of immediate and delayed intervention site, and 3 years later
Frequency of Threats, Assault, and Harassment of Employees
Time Frame: Prior to random selection of immediate and delayed intervention site, and 3 years later
The "All-Employee Survey" includes 3 questions designed by the research team, including "In the past 6 months have you experienced someone who threatened to physically hurt or assault you?" "In the past 6 months have you experienced someone who did hurt or assault you?" "In the past 6 months have you experienced someone who sexually harassed you?" (Response categories: none, patient/family member/visitor, supervisor, other employee). Items are computed individually.
Prior to random selection of immediate and delayed intervention site, and 3 years later
Change in Worker Injuries
Time Frame: Through study completion, an average of five years
Annual rates of work-related injuries reported to the Workers' Compensation system - overall and by job type, and selected subgroups such as assault or back injury
Through study completion, an average of five years
Musculoskeletal Pain
Time Frame: Prior to random selection of immediate and delayed intervention site, and 3 years later
The "All-Employee Survey" includes questions related to musculoskeletal pain in various body regions (low back, shoulder/upper arm, forearm/wrist/hand, knee, neck, ankle/foot) in the last three months. Level of discomfort (none, mild, moderate, severe, extreme) and measures of severity (use of pain relievers, surgery/physical therapy) are also included for each body region. Pain in each body region is computed individually.
Prior to random selection of immediate and delayed intervention site, and 3 years later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laura Punnett, ScD, University of Massachusetts, Lowell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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