Work-Related ConditionNCT06406478
Work Time Schedule Changes for Nurse Managers
A study testing Schedule Change and No Schedule Change in people with Work-Related Condition, run by University of California, Los Angeles at 2 sites in United States.
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?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition
- What is being tested?
- Schedule Change and No Schedule Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Ida Anderson, DNP, 678-794-7914, IAnderson@mednet.ucla.edu
Ida Anderson
- Recruiting
UCLA Health, Santa Monica
Santa Monica, California, 90404
Ida Anderson, DNP, 6787947914, IAnderson@mednet.ucla.edu
About this study
Official title: Measuring the Effects of Potential Work Time Schedule Changes on Nurse Manager Health and Patient Outcomes
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?
Read more
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).
Read the detailed 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.
- Conditions
- Work-Related Condition
- Being tested
- Schedule Change, No Schedule Change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schedule ChangeBehavioural
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 ChangeBehavioural
The control group will continue to work five days per week, receiving standard practice for the schedule policies at the participating study sites.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will begin working only four days a week as a schedule change. Receives: Behavioral: Schedule Change |
| Control Group | Active comparator | The control group will continue to work five days per week, receiving standard practice for the schedule policies at the participating study sites. Receives: Behavioral: No Schedule Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 3, and 6 months
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.
Measured: 0, 3, and 6 months
Secondary outcomes (11)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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
- Cleanliness of Hospital Environment (Q8) 2. Quietness of Hospital Environment (Q9) Global Items
- Overall Hospital Rating (Q21)
- Recommend the Hospital (Q22)
Measured: 6 months
Average weekly working hours
Time clock information will provide data for average weekly working hours
Measured: 3 and 6 months
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
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study startJan 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related ConditionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified by study site and race, and then randomized into either the control or intervention group. The allocation sequences will be generated by a research team member using a random number table assigning groups 1:1, with equal numbers of participants in each intervention and control group.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Li, MD, PhD, University of California, Los Angeles
- Investigators
- Jian Li, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406478
- Sponsor's protocol ID
- #23-001694
- Status last verified
- May 2024
- First submitted
- 10 Apr 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effects of Potential Work Time Schedule Changes on Nurse Manager Health and Patient Outcomes
- ClinicalTrials.gov ID
- NCT06406478
- Acronym / sponsor ID
- #23-001694
- Conditions
- Work-Related Condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be stratified by study site and race, and then randomized into either the control or intervention group. The allocation sequences will be generated by a research team member using a random number table assigning groups 1:1, with equal numbers of participants in each intervention and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Schedule ChangeThe intervention group will begin working only four days a week as a schedule change. |
| Control Group | Active comparator | Behavioral: No Schedule ChangeThe control group will continue to work five days per week, receiving standard practice for the schedule policies at the participating study sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schedule ChangeThis 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. | Behavioural | Intervention Group |
| No Schedule ChangeThe control group will continue to work five days per week, receiving standard practice for the schedule policies at the participating study sites. | Behavioural | Control Group |
Primary outcome
work family conflict
Time frame: 0, 3, and 6 months
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.
Burnout
Time frame: 0, 3, and 6 months
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.
11 secondary outcomes
Hospital rate of Central Line-associated Bloodstream Infection (CLABSI)
Time frame: 6 months
Hospital rate of center-association urinary tract infections (CAUTI)
Time frame: 6 months
Hospital rate of falls
Time frame: 6 months
Hospital rate of hospital acquired pressure injuries
Time frame: 6 months
Nurse manager satisfaction as assessed by the National Database of Nursing Quality Indicators (NDNQI)
Time frame: 6 months
Patient satisfaction as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAPHS)
Time frame: 6 months
Average weekly working hours
Time frame: 3 and 6 months
Oura Ring sleep score
Time frame: 3 and 6 months
Oura Ring heart rate variability
Time frame: 3 and 6 months
Oura Ring physical activity score
Time frame: 3 and 6 months
Write in questions: nurse manager perceptions of their work schedules
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Li, MD, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schedule Change and No Schedule Change in people with Work-Related Condition, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth G Keller, PhD (8593915038, kellere4@g.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
work family conflict (time frame: 0, 3, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.