Work-Related ConditionSHIFTNCT04251429
Effectiveness of the Healthy Workplace Participatory Program With Peer-led Teams in Public Sector Healthcare Facilities
A study testing CPH-NEW Healthy Workplace Participatory Program in people with Work-Related Condition and Burnout, Caregiver, run by University of Massachusetts, Lowell.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition, Burnout, Caregiver, Work-related Injury
- What is being tested?
- CPH-NEW Healthy Workplace Participatory Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Direct employee of the agency (not temporary agency or subcontractor)
Who cannot join
- -
About this study
Official title: 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.
Read the 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.
- Being tested
- CPH-NEW Healthy Workplace Participatory Program
- Keywords
- participatory, employee engagement, process evaluation, work ability
- Medical subject headings
- Caregiver Burden, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPH-NEW Healthy Workplace Participatory ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention Group | Experimental | SHIFT study team provides coaching to Health and Safety Committee to implement a participatory program for increasing committee effectiveness. Receives: Other: CPH-NEW Healthy Workplace Participatory Program |
| Delayed Intervention Group | Other | Active Comparator for 2 years: status quo program remains in place with new ongoing data collection. Then experimental intervention as above. Receives: Other: CPH-NEW Healthy Workplace Participatory Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Team Attendance
Attendance for each Design Team meeting (1-2 times per month)
Measured: Through study completion, an average of three years
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.
Measured: Through study completion, an average of three years
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
Measured: Through study completion, an average of three years
Change in team-selected health/safety/well-being issue
Targeted pre- and post-intervention surveys will be designed and administered by the Design Team
Measured: Through study completion, an average of two years
Secondary outcomes (10)
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)
Measured: Through study completion, an average of three years
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
Measured: Through study completion, an average of three years
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.
Measured: Through study completion, an average of two years
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.
Measured: Prior to random selection of immediate and delayed intervention site, and 3 years later
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.
Measured: Prior to random selection of immediate and delayed intervention site, and 3 years later
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.
Measured: Prior to random selection of immediate and delayed intervention site, and 3 years later
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.
Measured: Prior to random selection of immediate and delayed intervention site, and 3 years later
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.
Measured: Prior to random selection of immediate and delayed intervention site, and 3 years later
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
Measured: Through study completion, an average of five years
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.
Measured: Prior to random selection of immediate and delayed intervention site, and 3 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Sep 2016
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work-Related ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Lowell
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Alicia Kurowski, University of Massachusetts, Lowell
- Investigators
- Laura Punnett, ScD, Principal investigator, University of Massachusetts, Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251429
- Sponsor's protocol ID
- U19OH008857
- Acronym
- SHIFT
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2019
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Punnett L, Nobrega S, Zhang Y, Rice S, Gore R, Kurowski A; SHIFT Project Research Team. Safety and Health through Integrated, Facilitated Teams (SHIFT): stepped-wedge protocol for prospective, mixed-methods evaluation of the Healthy Workplace Participatory Program. BMC Public Health. 2020 Sep 29;20(1):1463. doi: 10.1186/s12889-020-09551-2.
PubMed 32993607
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Health Through Integrated Facilitated Teams (SHIFT)
- ClinicalTrials.gov ID
- NCT04251429
- Acronym / sponsor ID
- SHIFT / U19OH008857
- Keywords
- participatory, employee engagement, process evaluation, work ability
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- University of Massachusetts, LowellUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Other: CPH-NEW Healthy Workplace Participatory ProgramSHIFT study team provides coaching to Health and Safety Committee to implement a participatory program for increasing committee effectiveness. |
| Delayed Intervention Group | Other | Other: CPH-NEW Healthy Workplace Participatory ProgramActive Comparator for 2 years: status quo program remains in place with new ongoing data collection. Then experimental intervention as above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Direct employee of the agency (not temporary agency or subcontractor)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPH-NEW Healthy Workplace Participatory ProgramA 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, Immediate Intervention Group |
Primary outcome
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)
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.
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
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
10 secondary outcomes
Proportion of content followed according to the HWPP protocol
Time frame: 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
Shared labor-management awareness of job-related health issues
Time frame: 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
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
Organizational Support for Health, Safety, and Wellbeing
Time frame: 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
Frequency of Threats, Assault, and Harassment of Employees
Time frame: 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
Musculoskeletal Pain
Time frame: Prior to random selection of immediate and delayed intervention site, and 3 years later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 32993607Punnett L, Nobrega S, Zhang Y, Rice S, Gore R, Kurowski A; SHIFT Project Research Team. Safety and Health through Integrated, Facilitated Teams (SHIFT): stepped-wedge protocol for prospective, mixed-methods evaluation of the Healthy Workplace Participatory Program. BMC Public Health. 2020 Sep 29;20(1):1463. doi: 10.1186/s12889-020-09551-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Punnett, ScD principal investigator
University of Massachusetts, Lowell
Questions about this trial
What is this clinical trial studying?
A study testing CPH-NEW Healthy Workplace Participatory Program in people with Work-Related Condition and Burnout, Caregiver, run by University of Massachusetts, Lowell.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Team Attendance (time frame: Through study completion, an average of three years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.