NCT01841983

Brief Summary

While most of the research on integrated approaches of occupational health and safety and worksite health promotion to date has focused on manufacturing settings, employment is shifting to the service sector. Within this sector, health care employs over 12 million workers, and is the second fastest growing industry in the U.S. economy. In contrast to workers in other industries, rates of occupational injuries and illnesses among health care workers have increased over the past decade. The purpose of this study is to lay the foundation for integrated interventions in health care through examination of the associations of worker health outcomes and risks on and off the job with work policies and practices and to address the prevalent issues of musculoskeletal disorders (MSDs), particularly low back pain disability (LBPD), and health promotions through physical activity among patient care workers. The specific aims of this study are:

  1. 1.To estimate the efficacy and determine the feasibility of an integrated intervention, addressing both health protection and health promotion in order to reduce MSD symptoms and improve health behaviors among healthcare workers. We will assess between-group differences in MSD symptoms, health behaviors, including physical activity, and a set of secondary outcomes, including unplanned absence, reported injuries, worker compensation claims and costs, turnover and retention, intention to leave the job, and work-role function. This study will explore the working hypothesis that: Workers employed at baseline in patient-care units receiving the intervention will report greater reductions in their MSD symptoms (primary outcome) and greater improvements in health behaviors, compared with workers employed at baseline in units assigned to the Usual Care control group.
  2. 2.To determine the factors in the work environment which contribute over time to reductions in MSD symptoms and improvements in safe and healthy behaviors. (1) The work environment, work organization, and psychosocial factors, measured in our current study, will be associated with changes in workers' health behaviors and health outcomes between the assessments in the current and proposed studies; (2) Improvements in the work environment over time will be associated with improvements in workers' health behaviors and health outcomes. We will conduct multilevel modeling analysis to evaluate the simultaneous effects of worker-level and unit-level factors on MSD symptoms and safety and health behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

March 19, 2013

Last Update Submit

May 6, 2015

Conditions

Health BehaviorSleepMSDsDietary HabitsPhysical Activity

Keywords

Total worker healthSleepMSDsDietPhysical Activity

Outcome Measures

Primary Outcomes (4)

  • Pain

    * Musculoskeletal disorder pain * Self-report via survey

    Baseline and 1 year

  • Physical Activity

    Self-report via survey

    Baseline and 1 year

  • Diet

    Self-report via survey

    Baseline and 1 year

  • Sleep

    Self-report via survey

    Baseline and 1 year

Secondary Outcomes (3)

  • Safe patient handling

    Baseline and 1 year

  • Work role function/limitations

    Baseline and 1 year

  • BMI/obesity

    Baseline and 1 year

Other Outcomes (1)

  • Economic/systems outcomes

    Baseline and 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Be Well Work Well

Other: Be Well Work Well

Control

NO INTERVENTION

No intervention

Interventions

Be Well Work WellOTHER

The intervention follows principles for integrated approaches to promoting and protecting worker health. It will occur on 4 inpatient units at Massachusetts General Hospital beginning in January 2013, and will continue for 1 year. Overall intervention objectives: 1. Motivate individual staff members to engage in targeted health and safety behavior changes; 2. build awareness of ergonomic and safety hazards and of opportunities for healthy dietary choices and physical activity; 3. facilitate unit-level norms supportive of breaks, safe patient handling, and targeted health and safety behaviors; and 4. promote co-worker and supervisor support for targeted health and safety behaviors.

Also known as: OSH protection and health promotion program
Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult and pediatric in-patient care units at Massachusetts General Hospital that have ceiling lifts in place (n=42 units) are eligible for the intervention.
  • Patient care workers, including registered nurses (RNs), licensed practical nurses (LPNs), patient care assistants (PCAs)/nursing assistants (NAs) and Nurse Leaders working in in-patient units for at least 20 hours per week (n= 9500).
  • Of those patient care workers, those working in adult and pediatric in-patient care units (n=90 units) are eligible to be randomly selected for surveys.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (14)

  • Sembajwe G, Tveito TH, Hopcia K, Kenwood C, O'Day ET, Stoddard AM, Dennerlein JT, Hashimoto D, Sorensen G. Psychosocial stress and multi-site musculoskeletal pain: a cross-sectional survey of patient care workers. Workplace Health Saf. 2013 Mar;61(3):117-25. doi: 10.1177/216507991306100304.

    PMID: 23452130BACKGROUND

  • Kim SS, Okechukwu CA, Dennerlein JT, Boden LI, Hopcia K, Hashimoto DM, Sorensen G. Association between perceived inadequate staffing and musculoskeletal pain among hospital patient care workers. Int Arch Occup Environ Health. 2014 Apr;87(3):323-30. doi: 10.1007/s00420-013-0864-y. Epub 2013 Mar 12.

    PMID: 23475312BACKGROUND

  • Sabbath EL, Hurtado DA, Okechukwu CA, Tamers SL, Nelson C, Kim SS, Wagner G, Sorenson G. Occupational injury among hospital patient-care workers: what is the association with workplace verbal abuse? Am J Ind Med. 2014 Feb;57(2):222-32. doi: 10.1002/ajim.22271. Epub 2013 Oct 22.

    PMID: 24151093BACKGROUND

  • Caspi CE, Dennerlein JT, Kenwood C, Stoddard AM, Hopcia K, Hashimoto D, Sorensen G. Results of a pilot intervention to improve health and safety for health care workers. J Occup Environ Med. 2013 Dec;55(12):1449-55. doi: 10.1097/JOM.0b013e3182a7e65a.

    PMID: 24270297BACKGROUND

  • Sorensen G, McLellan D, Dennerlein JT, Pronk NP, Allen JD, Boden LI, Okechukwu CA, Hashimoto D, Stoddard A, Wagner GR. Integration of health protection and health promotion: rationale, indicators, and metrics. J Occup Environ Med. 2013 Dec;55(12 Suppl):S12-8. doi: 10.1097/JOM.0000000000000032.

    PMID: 24284762BACKGROUND

  • Umukoro PE, Arias OE, Stoffel SD, Hopcia K, Sorensen G, Dennerlein JT. Physical activity at work contributes little to patient care workers' weekly totals. J Occup Environ Med. 2013 Dec;55(12 Suppl):S63-8. doi: 10.1097/JOM.0000000000000046.

    PMID: 24284756BACKGROUND

  • Nelson CC, Wagner GR, Caban-Martinez AJ, Buxton OM, Kenwood CT, Sabbath EL, Hashimoto DM, Hopcia K, Allen J, Sorensen G. Physical activity and body mass index: the contribution of age and workplace characteristics. Am J Prev Med. 2014 Mar;46(3 Suppl 1):S42-51. doi: 10.1016/j.amepre.2013.10.035.

    PMID: 24512930BACKGROUND

  • Kim SS, Okechukwu CA, Buxton OM, Dennerlein JT, Boden LI, Hashimoto DM, Sorensen G. Association between work-family conflict and musculoskeletal pain among hospital patient care workers. Am J Ind Med. 2013 Apr;56(4):488-95. doi: 10.1002/ajim.22120. Epub 2012 Sep 27.

    PMID: 23019044RESULT

  • Hopcia K, Dennerlein JT, Hashimoto D, Orechia T, Sorensen G. Occupational injuries for consecutive and cumulative shifts among hospital registered nurses and patient care associates: a case-control study. Workplace Health Saf. 2012 Oct;60(10):437-44. doi: 10.1177/216507991206001005. Epub 2012 Sep 24.

    PMID: 22998692RESULT

  • Buxton OM, Hopcia K, Sembajwe G, Porter JH, Dennerlein JT, Kenwood C, Stoddard AM, Hashimoto D, Sorensen G. Relationship of sleep deficiency to perceived pain and functional limitations in hospital patient care workers. J Occup Environ Med. 2012 Jul;54(7):851-8. doi: 10.1097/JOM.0b013e31824e6913.

    PMID: 22796931RESULT

  • Reme SE, Dennerlein JT, Hashimoto D, Sorensen G. Musculoskeletal pain and psychological distress in hospital patient care workers. J Occup Rehabil. 2012 Dec;22(4):503-10. doi: 10.1007/s10926-012-9361-5.

    PMID: 22466375RESULT

  • Dennerlein JT, Hopcia K, Sembajwe G, Kenwood C, Stoddard AM, Tveito TH, Hashimoto DM, Sorensen G. Ergonomic practices within patient care units are associated with musculoskeletal pain and limitations. Am J Ind Med. 2012 Feb;55(2):107-16. doi: 10.1002/ajim.21036. Epub 2011 Nov 23.

    PMID: 22113975RESULT

  • Boden LI, Sembajwe G, Tveito TH, Hashimoto D, Hopcia K, Kenwood C, Stoddard AM, Sorensen G. Occupational injuries among nurses and aides in a hospital setting. Am J Ind Med. 2012 Feb;55(2):117-26. doi: 10.1002/ajim.21018. Epub 2011 Oct 24.

    PMID: 22025077RESULT

  • Sorensen G, Stoddard AM, Stoffel S, Buxton O, Sembajwe G, Hashimoto D, Dennerlein JT, Hopcia K. The role of the work context in multiple wellness outcomes for hospital patient care workers. J Occup Environ Med. 2011 Aug;53(8):899-910. doi: 10.1097/JOM.0b013e318226a74a.

    PMID: 21775897RESULT

Related Links

MeSH Terms

Conditions

Health BehaviorFeeding BehaviorMotor Activity

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Glorian Sorensen, PhD, MPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Society, Human Development, and Health

Study Record Dates

First Submitted

March 19, 2013

First Posted

April 29, 2013

Study Start

April 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

US(3)