Project A: Integrated Approaches to Improving the Health and Safety of Health Care Workers

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Harvard School of Public Health
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Partners HealthCare
Brigham and Women's Hospital
Massachusetts General Hospital
Boston University
New England Research Institutes
Information provided by (Responsible Party):
Glorian Sorensen, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01841983
First received: March 19, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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. 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. 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.

Condition Intervention
Health Behavior
Sleep
MSDs
Dietary Habits
Physical Activity
Other: Be Well Work Well

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Project A: Integrated Approaches to Improving the Health and Safety of Health Care Workers

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Pain [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    • Musculoskeletal disorder pain
    • Self-report via survey

  • Physical Activity [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Self-report via survey

  • Diet [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Self-report via survey

  • Sleep [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Self-report via survey


Secondary Outcome Measures:
  • Safe patient handling [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: Yes ]
    Self-report via survey

  • Work role function/limitations [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Self-report via survey

  • BMI/obesity [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Self-report via survey


Other Outcome Measures:
  • Economic/systems outcomes [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    • Unplanned absence
    • Reported injuries
    • Worker compensation
    • Turnover/retention
    • Healthcare utilization/costs

    Self-report via survey



Estimated Enrollment: 9500
Study Start Date: April 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Be Well Work Well
Other: Be Well Work Well

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.
Other Name: OSH protection and health promotion program
No Intervention: Control
No intervention

Detailed Description:

Improving and protecting the health and well-being of healthcare workers requires addressing key risks in the work environment as well as promoting safe and healthy behaviors. Healthcare workers are at elevated risk for musculoskeletal disorders (MSDs) due to a range of job factors, including lifting and transferring patients; working long hours (often at night); and limited control over decisions on the job. Among these, nurses and nurses aides bear the largest burden of injury. Back injuries in particular constitute the greatest source of their disability. These risks are likely to increase in coming years due to the aging nursing workforce, increase in work demands, and labor shortages. Health behaviors, including physical activity, inadequate sleep, and dietary patterns associated with being overweight or obese, are also influenced by the work environment and psychosocial factors on the job, and are also associated with MSD risk. Traditional approaches to redressing these risks have focused separately on health protection, including efforts to reduce MSD risk, and health promotion aimed at improving health behaviors. Little research has systematically examined the dual and potentially synergistic effects of the work environment on risk of MSDs and worker health behaviors, and there is insufficient evidence to determine the most efficacious ways to ameliorate the combined effects of these health risks. Our long-term goal is to improve the overall health and well-being of healthcare workers by making available evidence-based worksite policies, programs, and practices that foster a healthy work environment, reduce potential hazardous job exposures, and promote safe and healthy behaviors. The proposed study is the next logical step in building this evidence base. Factors in the work environment, including high work demands, low social support, and long work hours, have been shown to increase risk of MSDs, as well as risk-related behaviors. Yet little research has systematically explored these cross-cutting pathways and their implications for improving the effectiveness of worksite interventions to address the broad spectrum of worker health outcomes.

The proposed research provides a novel approach to worksite interventions that integrate occupational safety and health and worksite health promotion, taking into account the shared factors in the work environment shaping both MSDs and health behaviors. Standard approaches to occupational health and safety and worksite health promotion are based on a parallel structure of separate silos functioning relatively independently in the worksite, each drawing from their own disciplines and training experiences within public health. Although these parallel efforts share the common mission of improving worker health, their strategies are based on different assumptions about and approaches to improving worker health outcomes. The proposed research integrates these parallel approaches. Although our prior research has rigorously tested the efficacy of this integrated intervention model in changing worker health behaviors, to our knowledge no prior research has examined the impact of this integrated model on health outcomes associated with work exposures - here, notably, on MSD symptoms.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

N/A

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841983

Contacts
Contact: Julie V Theron, RN, MSN, C-PNP 617-582-7912 juliev_theron@dfci.harvard.edu
Contact: Lorraine Wallace, MPH 617-632-5037 lwallace@partners.org

Locations
United States, Massachusetts
Harvard School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: Julie V Theron, MSN, RN, C-PNP    617-582-7912    jtheron@partners.org   
Contact: Lorraine Wallace, MPH    617-632-5037    lwallace@partners.org   
Principal Investigator: Glorian Sorensen, PhD, MPH         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Julie V Theron, MSN, RN, C-PNP    617-582-7912    jtheron@partners.org   
Contact: Lorraine Wallace, MPH    617-632-5037    lwallace@partners.org   
Principal Investigator: Dean Hashimoto, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Julie V Theron, MSN, RN, C-PNP    617-582-7912    jtheron@partners.org   
Contact: Lorraine Wallace, MPH    617-632-5037    lwallace@partners.org   
Principal Investigator: Dean Hashimoto, MD         
Sponsors and Collaborators
Harvard School of Public Health
Dana-Farber Cancer Institute
Partners HealthCare
Brigham and Women's Hospital
Massachusetts General Hospital
Boston University
New England Research Institutes
Investigators
Principal Investigator: Glorian Sorensen, PhD, MPH Harvard School of Public Health
  More Information

Additional Information:
Publications:

Responsible Party: Glorian Sorensen, Professor of Society, Human Development, and Health, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01841983     History of Changes
Other Study ID Numbers: U19-OH-008861
Study First Received: March 19, 2013
Last Updated: June 2, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Harvard School of Public Health:
Total worker health
Sleep
MSDs
Diet
Physical Activity

ClinicalTrials.gov processed this record on September 18, 2014