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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06406478
Other study ID # #23-001694
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date June 2025

Study information

Verified date May 2024
Source University of California, Los Angeles
Contact Elizabeth G Keller, PhD
Phone 8593915038
Email kellere4@g.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore how working a 4-day schedule impacts nurse manager wellbeing and job performance. The main questions it aims to answer are: - Do those working 4-days have improved wellbeing with reduced levels of burnout and work/family conflict when compared to those in the control group? - Do levels of sleep, heart rate variability, and physical activity significantly differ between those working the 4-day schedule change and those in the control group? - Are nurse manager satisfaction, patient satisfaction, and patient quality outcomes different among those working the 4-day schedule change and those in the control group? Researchers will compare those working the 4-day schedule change to those working the standard 5-day schedule to determine causality between the intervention and the outcomes. Participants will: - Complete an initial visit to learn about the study. - Begin wearing an OURA ring, which will collect data on physical activity, sleep, and heart rate variability. They will need to download the Oura Ring app on their phone and log in weekly to sync data so that the researchers may access it. - Complete the first survey on the online REDCap platform (baseline). - Begin the work schedule that was assigned to them. - Clock in and out of work each shift. - Take the follow-up survey online (month 3). - Take the final survey online (month 6).


Description:

Researchers are looking to measure the effects of potential worktime schedule changes on a) nurse manager wellbeing (i.e., work/family conflict, burnout) and b) job performance (i.e., nurse manager satisfaction, patient satisfaction, and patient quality outcomes). Informed by the Conservation of Resources (COR) theory, it is hypothesized that working 4 days per week instead of 5 will improve nurse manager wellbeing with reduced burnout and work/family conflict. Using a randomized control trial design, nurse managers working at UCLA Health will be purposively recruited for the study. All participants will begin by taking a baseline online survey at the initial visit. This survey will collect primary data on wellbeing by measuring work/family conflict and burnout using the scales: Work-Family and Family-Work Conflict Scale + Work-Life Balance scale and the Oldenburg Burnout Inventory. The survey will include demographic questions and qualitative questions to elicit responses from nurse managers on how they believe the schedule changes impacts their wellbeing and job performance, providing additional understanding of results from the quantitative part of the survey. All participants will wear a biotracker, called an Oura Ring, for the study duration, uploading their data weekly via an app. The Oura Ring will provide primary data on sleep, heart rate variability, physical activity of nurse managers, which is hypothesized to mediate the relationship between the schedule change and nurse manager wellbeing. Secondary data will be gathered from UCLA MedNet system, including nurse manager TimeClock information, and de-identified aggregate data on job performance (including nurse manager satisfaction, patient satisfaction, and patient quality outcomes) over the duration of the study. Participants will be randomized either into the intervention group or the control group at the initial visit. Those in the intervention group will begin working only four days a week as a schedule change, and those in the control will continue working five days per week. All participants will be taught how to input their time clock information on the UCLA Health System for all working days. Follow-up surveys will be completed remotely, occurring at three months and six months. The participants will receive a reminder email to complete the survey. After six months when the final survey is completed, study participation will conclude. Fifty participants are anticipated.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 2025
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years old or older - Registered nurse - Currently employed as a full-time nurse manager - Having a span of control greater than 40 Full Time Equivalent (FTE) Direct Reports - Currently working at either Ronald Regan UCLA Medical Center or UCLA Medical Center Santa Monica - In the acute care setting Exclusion Criteria: - Those working in ambulatory care settings - Nurse leaders with less than 30 FTE's - Working part time - Working a schedule less than 5 days a week

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Schedule Change
This 4-day workweek is defined by any 4 ten hour shifts between Sunday and Saturday. It will be up to the discretion of participants in the intervention group to coordinate which 4 days they work. The 4 days will most likely be weekdays, but some participants may work weekends. If participants do any work from home, they will clock in remotely to account for the time.
No Schedule Change
The control group will continue to work five days per week, receiving standard practice for the schedule policies at the participating study sites.

Locations

Country Name City State
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States UCLA Health, Santa Monica Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary work family conflict Work family conflict will be measured with the Work-Family and Family-Work Conflict Scale + Work-Life Balance scale with 11 items. Work-Family Conflict is determined with a mean of score of responses for items 1 through 5; higher scores reflect more work-family conflict. Family-Work Conflict is determined with the mean of score of responses for items 6 through 10; higher scores reflect more family-work conflict. Work-Life Balance: Item score. 0, 3, and 6 months
Primary Burnout Burnout will be measured with the Oldenburg Burnout Inventory with 16 items. Disengagement in burnout is the sum of items: 1, 3(Reverse), 6(Reverse), 7, 9(Reverse), 11(Reverse), 13, and 15. Exhaustion is the sum of items: 2(Reverse), 4(Reverse), 5, 8(Reverse), 10, 12(Reverse), 14, and 16. Full Burnout is the sum of the two scales: Disengagement and exhaustion. 0, 3, and 6 months
Secondary Hospital rate of Central Line-associated Bloodstream Infection (CLABSI) This variable is secondary, de-identified aggregate data from the UCLA Tableau server, narrowed down to location, date, and unit, and is a measure of Patient Quality Outcomes. 6 months
Secondary Hospital rate of center-association urinary tract infections (CAUTI) This variable is secondary, de-identified aggregate data from the UCLA Tableau server, narrowed down to location, date, and unit, and is a measure of Patient Quality Outcomes. 6 months
Secondary Hospital rate of falls This variable is secondary, de-identified aggregate data from the UCLA Tableau server, narrowed down to location, date, and unit, and is a measure of Patient Quality Outcomes. 6 months
Secondary Hospital rate of hospital acquired pressure injuries This variable is secondary, de-identified aggregate data from the UCLA Tableau server, narrowed down to location, date, and unit, and is a measure of Patient Quality Outcomes. 6 months
Secondary Nurse manager satisfaction as assessed by the National Database of Nursing Quality Indicators (NDNQI) This variable is secondary, de-identified aggregate data from the Center for Nursing Excellence stored on UCLA Health Box. This is measured by the National Database of Nursing Quality Indicators (NDNQI). NDNQI is the leading nursing-sensitive quality indicators database that contains unit-level information about 600+ measures relevant to nursing performance, patient and workforce experience, and health outcomes. The data is derived from a combination of administrative documentation and medical records. All information reported to NDNQI is available for NDNQI users to review and benchmark performance against other participating NDNQI facilities, to better understand how these findings stack up against competitors-providing valuable insights. 6 months
Secondary Patient satisfaction as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAPHS) This variable is secondary, de-identified aggregate data from the UCLA Tableau server. This is measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAPHS). Individual patient responses are utilized for each of the ten HCAHPS measures for all valid and complete surveys within a discharge quarter. These measures include six composite items, two global items, and two individual items. The composite measures are each comprised of two to three questions from the HCAHPS survey.
Composite Measures
Communication with Nurses (Q1, Q2, Q3)
Communication with Doctors (Q5, Q6, Q7)
Responsiveness of Hospital Staff (Q4, Q11)
Pain Management (Q13, Q14)
Communication about Medicine (Q16, Q17)
Discharge Information (Q19, Q20) Individual Items
1. Cleanliness of Hospital Environment (Q8) 2. Quietness of Hospital Environment (Q9) Global Items
Overall Hospital Rating (Q21)
Recommend the Hospital (Q22)
6 months
Secondary Average weekly working hours Time clock information will provide data for average weekly working hours 3 and 6 months
Secondary Oura Ring sleep score Data will be collected from the Oura Ring. When participants open the Oura Ring app on their phones, their data will be shared with the researchers, providing a 30 day and 60 day summary score of sleep quality and duration. The Sleep Score ranges from 0-100.
85 or higher: sleep is optimal. 70-84: sleep is good. Under 70: sleep is off and there may be lifestyle changes needed to improve it
3 and 6 months
Secondary Oura Ring heart rate variability Data will be collected from the Oura Ring. When participants open the Oura Ring app on their phones, their data will be shared with the researchers, providing a 30 day and 60 day summary score of heart rate variability. 3 and 6 months
Secondary Oura Ring physical activity score Data will be collected from the Oura Ring. When participants open the Oura Ring app on their phones, their data will be shared with the researchers, providing a 30 day and 60 day summary score of physical activity.
The Activity Score ranges from 0-100 and tells participants at a glance, how to adjust their activity-rest balance:
85 or higher: balance is optimal. 70-84: balance is good. Under 70: balance seems off and there may be lifestyle changes needed to improve it.
3 and 6 months
Secondary Write in questions: nurse manager perceptions of their work schedules Nurse manager will have the opportunity to write in how they perceive their work schedules impact their own health and family life, and the outcomes of their patients. These questions are researcher-developed, allowing participants to share additional qualitative data. 3 and 6 months
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