Clinical trial NCT05722249: Interventions to Promote Well-being of Nightshift Nursing Team Members
Official title: Interventions to Promote Well-being of Nightshift Nursing Team Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Professional Quality of Life
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The cluster randomized crossover design is selected for logistical and ethical reasons: first, we seek generalizable findings; second, randomizing individual members of the nightshift will inevitably contribute to cross-contamination of the intervention arms; having a control group will similarly be at risk of contamination from peers randomly assigned to intervention arms as nightshift workers are assigned to float to other units when staffing needs merit such assignments; and given the known potential health risks for some nightshift workers, not providing an intervention could be considered unethical. In the cluster cross-over design, the staff in the participating clinical inpatient units will each receive an intervention during each of two time periods.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Study Purpose The purpose of this study, using a cluster cross-over randomized trial design involving inpatient units at a freestanding pediatric hospital, is to measure the impact on professional quality of life (primary endpoint), medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention (Arm A) or a physical activity intervention (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.

Primary Objective

1.The primary objective of this study is to determine and compare the impact on professional quality of life (as measured by the ProQOL scale) of either a mindfulness intervention (Arm A) or a physical activity intervention (Arm B) during an 8-week study period (study period 1).

1h1: ProQOL scale mean scores for compassion satisfaction will increase in both study arms during study period 1 from baseline (the week prior to randomization to the study Arms) to the end of the 8-week study period (Week 8).

1h2: ProQOL scale mean scores for compassion fatigue will decrease in both study arms during study period 1 from baseline (the week prior to randomization to the study Arms) to the end of the 8-week study period (Week 8).

1h3: ProQOL scale mean scores for compassion satisfaction will not differ at baseline (the week prior to randomization to the study Arms) or at the end of the first study period (Week 8) between the two study arms.

1. h4. ProQOL mean scores for compassion fatigue will not differ between the two arms at baseline (the week prior to randomization to the study Arms) or at the end of the first study period (Week 8).

   Secondary Objectives 2. Determine and compare the impact on professional quality of life (as measured by the ProQOL scale) of the combined mindfulness intervention and physical activity intervention (Arms A and B) during a second 8-week study period (study period 2) as compared to the first study period.
2. h1: ProQOL scale mean scores for compassion satisfaction will increase in both study arms during study period 2 from the end of the first 8-week study period (Week 8) to the end of the second study period (Week 16), and from baseline to Week 16.

2h2: ProQOL scale mean scores for compassion fatigue will decrease in both study arms during study period 2 from the end of the first 8-week study period (Week 8) to the end of the second study period (Week 16), and from baseline to Week 16.

2h3: ProQOL scale mean scores for compassion fatigue will not differ between the two arms at Week 8 or at the end of the second study period (Week 16).

2h4. ProQOL scale mean scores for compassion satisfaction will not differ between the two arms at Week 8 or at the end of the second study period (Week 16).

3. Determine and compare the impact of the interventions by study period on role-related meaning as measured by the Role-Related Meaning Scale (RRMS) and sleep quality as measured by the PROMIS Sleep Disturbance measure and the PROMIS Sleep-Related Impairment Measure (SRI).

3h1: the RRMS mean scores will increase and PROMIS Sleep Disturbance and SRI mean scores will decrease in both study arms from baseline to Week 8, from Week 8 to Week 16, and from baseline to Week 16.

3h2: the RRMS mean scores and the PROMIS Sleep Disturbance and SRI mean scores will not differ between the two arms at baseline, Week 8 or at Week 16.

4. Determine the impact of the intervention periods (Week 8, Week 16) on a patient-related indicator, Medication Administration Error as compared to the error rate at baseline.

4h1: Medication Administration Errors will not differ between the two study arms at baseline, Week 8 or at Week 16.

4h2: Medication Administration Errors will decrease within both study arms from baseline to Week8, and from Week 8 to Week 16.

General Design Description The study design is a cluster cross-over randomized trial involving 11 inpatient units at a freestanding pediatric hospital. In the randomization, the 11 units will be randomized to two study arms (Arm A - mindfulness intervention plus sleep hygiene information; Arm B - physical activity plus sleep hygiene information) during the first 8-week study period. Immediately following this study period, the units assigned to each arm will cross and receive the intervention not received in the first study period plus the ongoing access to the previous intervention. Both arms in the first study period will have education content specific to sleep hygiene connected to the existing napping option.

The cluster randomized crossover design is selected for logistical and ethical reasons: first, we seek generalizable findings; second, randomizing individual members of the nightshift will inevitably contribute to cross-contamination of the intervention arms; having a control group will similarly be at risk of contamination from peers randomly assigned to intervention arms as nightshift workers are assigned to float to other units when staffing needs merit such assignments; and given the known potential health risks for some nightshift workers, not providing an intervention could be considered unethical. In the cluster cross-over design, the staff in the participating clinical inpatient units will each receive an intervention during each of two time periods. Interventions, such as physical activity and mindfulness, that can be done at the group level and may be more effective when done with a group, are ideal for this design (Arnup et al., 2014; Arnup et al., 2017; Parienti \& Kuss, 2007; Moerbeek, 2020; Reich et al., 2012). This design is also selected for its efficiency and reduced costs compared with a clinical trial with individuals being randomized (Taljaard et al, 2013).

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: baseline or the week before randomization, Week 8 and Week 16
Secondary outcomes:
measure: change in Role-Related Meaning
timeFrame: Baseline or the week before randomization, Week 8 and Week 16
Other outcomes:
measure: Change in the PROMIS Sleep Disturbance Measure
timeFrame: Baseline or the week before randomization, Week 8 and Week 16
measure: Change in the PROMIS Sleep-Related Impairment Measure (SRI)
timeFrame: Baseline or the week before randomization, Week 8 and Week 16
measure: Change in Medication Error Administration
timeFrame: 60 days before Baseline, Week 8 and Week 16
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National Health System
name: Pamela Hinds, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: