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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04251429
Other study ID # U19OH008857
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date August 31, 2021

Study information

Verified date February 2021
Source University of Massachusetts, Lowell
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 3300
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Direct employee of the agency (not temporary agency or subcontractor) Exclusion Criteria: -

Study Design


Intervention

Other:
CPH-NEW Healthy Workplace Participatory Program
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Lowell National Institute for Occupational Safety and Health (NIOSH/CDC)

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Team Attendance Attendance for each Design Team meeting (1-2 times per month) Through study completion, an average of three years
Primary Change in Team Engagement 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
Primary Change in Level of Committee Activity 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
Primary Change in team-selected health/safety/well-being issue Targeted pre- and post-intervention surveys will be designed and administered by the Design Team Through study completion, an average of two years
Secondary Proportion of content followed according to the HWPP protocol 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
Secondary Change in scope of health/safety/well-being 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
Secondary Shared labor-management awareness of job-related health issues 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
Secondary Work Ability of Employees 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
Secondary Quality of Care of Patients/Residents: All-Employee Survey 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
Secondary Organizational Support for Health, Safety, and Wellbeing 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
Secondary Employee Burnout: Exhaustion and Disengagement 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
Secondary Frequency of Threats, Assault, and Harassment of Employees 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
Secondary Change in Worker Injuries 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
Secondary Musculoskeletal Pain 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
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