- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04251429
Effectiveness of the Healthy Workplace Participatory Program With Peer-led Teams in Public Sector Healthcare Facilities (SHIFT)
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
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Direct employee of the agency (not temporary agency or subcontractor)
Exclusion Criteria:
-
Study Plan
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
Investigators
- Principal Investigator: Laura Punnett, ScD, University of Massachusetts, Lowell
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U19OH008857 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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