Professional Quality of Life Clinical Trial
— HSWellnessOfficial title:
Interventions to Promote Well-being of Nightshift Nursing Team Members
Background: Nightshift health care employees can experience greater likelihood of health threats such as weight gain, hypertension, and sleep disturbances. Evidence indicates a willingness of nightshift health care professionals to engage in wellness activities initiated at the work setting and during the assigned nightshift. In this single site study at a freestanding pediatric tertiary care hospital, inpatient units will be randomized to one of two nightshift interventions during an 8-week study period (mindfulness plus sleep hygiene or physical activity plus sleep hygiene). Immediately following the first study period, the randomized units will begin a second study period in which they will continue with the intervention first received but shall add the intervention not initially received. While there are hundreds of studies that describe the adverse health and safety effects of night shift work, there are few studies where interventions are tested for their efficacy to reduce the harm to workers or improve their well-being. Currently the few intervention studies that exist focus on the scheduling, duration and timing of work shifts, the timing of meals, and aspects of lighting in the workplace. Other interventions, such as those proposed in this study, have not been tested systematically using a rigorous design. Purpose and Methods: The purpose of this study, using a cluster cross-over randomized trial design, is to measure the impact on professional quality of life (primary endpoint) and medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention plus sleep hygiene (Arm A) or a physical activity intervention plus sleep hygiene (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.
Status | Recruiting |
Enrollment | 221 |
Est. completion date | June 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Eligible participants will be nurses and members of the nursing care team that work the nightshift fulltime or that rotate from the dayshift to the nightshift on a routine basis. Participants will need to be scheduled to work at least 2 weeks of the nightshift during each study period (Study Period 1, Study Period 2) to be fully eligible to participate in the study. To be fully eligible, participants must be able to complete a consent process and understand the study design and the self-report periods. Exclusion Criteria: - Exclusion criteria would include nurses and nursing care team members who do not rotate regularly to the nightshift or who work only the dayshift. |
Country | Name | City | State |
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United States | Children's National Health System | Washington | District of Columbia |
Lead Sponsor | Collaborator |
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Children's National Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
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Other | Change in the PROMIS Sleep Disturbance Measure | PROMIS Sleep Disturbance Measure: The 8-item short-form for this measure with its 5-point Likert response format will be used in this study; higher scores mean more disturbed sleep. | Baseline or the week before randomization, Week 8 and Week 16 | |
Other | Change in the PROMIS Sleep-Related Impairment Measure (SRI) | PROMIS Sleep-Related Impairment Measure (SRI): This 8-item short-form measure was similarly developed and is similarly formatted and structured as the PROMIS Sleep Disturbance; higher scores mean more impaired sleep. | Baseline or the week before randomization, Week 8 and Week 16 | |
Other | Change in Medication Error Administration | Medication Error Administration: The exploratory outcome variable is Medication Error Administration. According to the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) a "medication error" is defined as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or parent; the higher number means more errors were made. | 60 days before Baseline, Week 8 and Week 16 | |
Primary | Professional Quality of Life Scale, (ProQOL-21). The primary outcome variable will be change in professional quality of life as measured by the Professional Quality of Life Scale, (ProQOL-21). | The ProQOL contains two domains: Compassion Satisfaction and Compassion Fatigue. For this study, we shall administer the ProQOL-21, a revised version of the ProQOL derived from a Rasch analysis (Heritage, et al., 2018) where higher scores mean better professional quality of life. | baseline or the week before randomization, Week 8 and Week 16 | |
Secondary | change in Role-Related Meaning | Role-Related Meaning Scale (RRMS): Role-related meaning is defined as internalized, individualized awareness of personal values, and the extent to which these values are concordant with those of the role, work setting or work culture. In this study, role-related meaning will be measured using the Role-related Meaning Scale for Staff (RRMS) where higher scores mean better role meaning. | Baseline or the week before randomization, Week 8 and Week 16 |
Status | Clinical Trial | Phase | |
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Enrolling by invitation |
NCT04396600 -
The Professional Peer Resilience Initiative
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