NurseNCT07104474
Adaptation and Evaluation of RESTORE
A study testing RESTORE in people with Nurse and Burnout, Healthcare Workers, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this clinical trial is to test whether the RESTORE intervention works to reduce nurse burnout, by engaging nursing staff in system redesign to reduce job demands and increase job resources. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse, Burnout, Healthcare Workers
- What is being tested?
- RESTORE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Nursing staff employed on one of the study units and involved in direct patient care
- Hospital and system leaders from one of the following groups
- leaders from hospitals that participated in Aims 1 and 2, OR
- other leaders from our partner health systems, OR
- leaders from other hospital settings
- leaders from hospital advocacy or quality organizations
Who cannot join
- Nursing staff that are not involved in direct patient care, travel and float nursing staff
- Aim 3:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: REducing Nurse Burnout Through SysTems Analysis and Organizational REdesign (RESTORE)
The purpose of this clinical trial is to test whether the RESTORE intervention works to reduce nurse burnout, by engaging nursing staff in system redesign to reduce job demands and increase job resources.
Participants in the RESTORE intervention process will be interviewed about:
- their experience with RESTORE
- their experiences working on a unit where RESTORE was used
Participants will also complete surveys of the impact of RESTORE on job demands, job resources, burnout, and work engagement.
Read the detailed description
Burnout among nurses occurs when there is an imbalance between job demands and resources in the work system, and is associated with poorer nurse health and well-being, workforce issues, and decreased patient safety. Prior efforts to address burnout among nurses have largely utilized individual-level interventions that fail to address work system drivers of burnout, not engaged nurses in the intervention development and implementation process, and lacked scalability to diverse hospital environments. The overarching goal of this research is to decrease nursing staff burnout, which will improve their health and well-being and the quality of care they provide. Our scientific premise is that hospital nursing staff burnout will be reduced by: 1) identifying and addressing context-specific job demands that act as drivers of burnout, and 2) optimizing job resources for nursing staff through ownership over the design and implementation of unit- level solutions targeting burnout drivers. We propose to address these limitations in previous interventions and test the effectiveness of a nurse-led intervention REducing nurse burnout through SysTems analysis and Organizational REdesign (RESTORE) on reducing job demands, increasing job resources, and reducing burnout among hospital unit nursing staff.
- Conditions
- Nurse, Burnout, Healthcare Workers
- Being tested
- RESTORE
- Keywords
- Burnout, Nurse, Job demands, Work engagement, Hospital nursing units
- Medical subject headings
- Burnout, Psychological, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTOREOther
RESTORE is a process intervention that combines systems analysis and human-centered design (HCD) approaches to directly engage hospital nursing staff in ongoing organizational redesign to address burnout. Specifically, RESTORE is comprised of multiple in-person sessions with hospital unit design teams. In these sessions, hospital nurses are guided through using a well-known systems analysis model to understand their unit, including what factors act as drivers of burnout, what can be modified, and/or what constraints might be in place regarding system changes. Then, using HCD, nursing staff design, develop, and implement a system redesign solution to address the unique drivers of burnout in their unit that works within their constraints.
| Study group | Role | What they receive |
|---|---|---|
| Post-RESTORE Implementation | Experimental | All staff working on the unit will be exposed to the outcomes of the RESTORE intervention and will be included in survey and interview data collection post-implementation. Receives: Other: RESTORE |
| Baseline Pre-Intervention | No intervention | Data will be collected from nursing staff before RESTORE is implemented on each unit. |
| RESTORE Design Team | Experimental | Nursing staff will be identified from each unit to participate on the unit system design team. These staff will be directly exposed to the RESTORE intervention through participation in RESTORE sessions. These staff will participate in interviews about their experiences with the RESTORE intervention. Receives: Other: RESTORE |
| Aim 3 Interview Participants | No intervention | Participants from four groups (listed below) will participate in interviews to identify ongoing barriers and facilitators that impact scalability of RESTORE. These four groups include: 1) leaders from hospitals that participated in the trial of RESTORE, 2) other leaders from our partner health systems, 3) leaders from other hospitals, and 4) leaders from advocacy or quality organizations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maslach Burnout Inventory (MBI)
MBI is comprised of 22 items and will be used to assess three dimensions of burnout: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. It is scored on a 7-point Likert scale, where 0 = Never and 6 = Every day. Scores range from 0 to 132 with higher scores indicating greater levels of burnout.
Measured: Baseline to 30 months (measured quarterly)
Secondary outcomes (2)
Change in Areas of Worklife Scale (AWS)
AWS measures six areas of worklife that characterize the job demands and resources in the organizational context of burnout: Workload, Control, Reward, Community, Fairness, and Values. The AWS is comprised of 28 items and a separate score is calculated for each of the six areas of worklife. Scores are reported on a 5-point Likert scale, where 1 = Strongly Disagree and 5 = Strongly Agree. Aggregate score across the areas will be reported rather than 6 different scores. Aggregate score ranges from 28-140 with higher scores indicating a better match between the individual and their work environment, and lower scores indicating a mismatch.
Measured: Baseline to 30 months (measured quarterly)
Change in Utrecht Work Engagement Scale (UWES)
UWES measures nursing staff work engagement. It is a 9-item survey scored on a 7-point Likert scale. 0 = Never and 6 = Always / Every day. Range of scores is from 0 - 54, with lower scores indicating less engagement.
Measured: Baseline to 30 months (measured quarterly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start2 Dec 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NurseStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- A stepped wedge cluster randomized controlled trial design will be used. We will roll out RESTORE consecutively to the units using a staggered start time, allowing for controlled introduction of the intervention. In this design, units are randomly sequenced into the intervention.
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Linsey Steege, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104474
- Sponsor's protocol ID
- 2025-0039
- Other IDs
- 1R01NR021386-01, A545000, NUR/FACULTY AFFAIRS/ADMIN, Protocol Version 1/14/25
- Status last verified
- Oct 2025
- First submitted
- 29 Jul 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REducing Nurse Burnout Through SysTems Analysis and Organizational REdesign (RESTORE)
- ClinicalTrials.gov ID
- NCT07104474
- Acronym / sponsor ID
- 2025-0039
- Conditions
- Nurse, Burnout, Healthcare Workers
- Keywords
- Burnout, Nurse, Job demands, Work engagement, Hospital nursing units
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 5 Aug 2025 (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 purpose of this clinical trial is to test whether the RESTORE intervention works to reduce nurse burnout, by engaging nursing staff in system redesign to reduce job demands and increase job resources.
Participants in the RESTORE intervention process will be interviewed about:
- their experience with RESTORE
- their experiences working on a unit where RESTORE was used
Participants will also complete surveys of the impact of RESTORE on job demands, job resources, burnout, and work engagement.
Detailed description
Burnout among nurses occurs when there is an imbalance between job demands and resources in the work system, and is associated with poorer nurse health and well-being, workforce issues, and decreased patient safety. Prior efforts to address burnout among nurses have largely utilized individual-level interventions that fail to address work system drivers of burnout, not engaged nurses in the intervention development and implementation process, and lacked scalability to diverse hospital environments. The overarching goal of this research is to decrease nursing staff burnout, which will improve their health and well-being and the quality of care they provide. Our scientific premise is that hospital nursing staff burnout will be reduced by: 1) identifying and addressing context-specific job demands that act as drivers of burnout, and 2) optimizing job resources for nursing staff through ownership over the design and implementation of unit- level solutions targeting burnout drivers. We propose to address these limitations in previous interventions and test the effectiveness of a nurse-led intervention REducing nurse burnout through SysTems analysis and Organizational REdesign (RESTORE) on reducing job demands, increasing job resources, and reducing burnout among hospital unit nursing staff.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A stepped wedge cluster randomized controlled trial design will be used. We will roll out RESTORE consecutively to the units using a staggered start time, allowing for controlled introduction of the intervention. In this design, units are randomly sequenced into the intervention.
| Arm | Type | Receives |
|---|---|---|
| Post-RESTORE Implementation | Experimental | Other: RESTOREAll staff working on the unit will be exposed to the outcomes of the RESTORE intervention and will be included in survey and interview data collection post-implementation. |
| Baseline Pre-Intervention | No intervention | –Data will be collected from nursing staff before RESTORE is implemented on each unit. |
| RESTORE Design Team | Experimental | Other: RESTORENursing staff will be identified from each unit to participate on the unit system design team. These staff will be directly exposed to the RESTORE intervention through participation in RESTORE sessions. These staff will participate in interviews about their experiences with the RESTORE intervention. |
| Aim 3 Interview Participants | No intervention | –Participants from four groups (listed below) will participate in interviews to identify ongoing barriers and facilitators that impact scalability of RESTORE. These four groups include: 1) leaders from hospitals that participated in the trial of RESTORE, 2) other leaders from our partner health systems, 3) leaders from other hospitals, and 4) leaders from advocacy or quality organizations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nursing staff employed on one of the study units and involved in direct patient care
- Hospital and system leaders from one of the following groups
- leaders from hospitals that participated in Aims 1 and 2, OR
- other leaders from our partner health systems, OR
- leaders from other hospital settings
Key exclusion criteria (2 listed)
- Nursing staff that are not involved in direct patient care, travel and float nursing staff
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 |
|---|---|---|
| RESTORERESTORE is a process intervention that combines systems analysis and human-centered design (HCD) approaches to directly engage hospital nursing staff in ongoing organizational redesign to address burnout. Specifically, RESTORE is comprised of multiple in-person sessions with hospital unit design teams. In these sessions, hospital nurses are guided through using a well-known systems analysis model to understand their unit, including what factors act as drivers of burnout, what can be modified, and/or what constraints might be in place regarding system changes. Then, using HCD, nursing staff design, develop, and implement a system redesign solution to address the unique drivers of burnout in their unit that works within their constraints. | Other | Post-RESTORE Implementation, RESTORE Design Team |
Primary outcome
Change in Maslach Burnout Inventory (MBI)
Time frame: Baseline to 30 months (measured quarterly)
MBI is comprised of 22 items and will be used to assess three dimensions of burnout: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. It is scored on a 7-point Likert scale, where 0 = Never and 6 = Every day. Scores range from 0 to 132 with higher scores indicating greater levels of burnout.
2 secondary outcomes
Change in Areas of Worklife Scale (AWS)
Time frame: Baseline to 30 months (measured quarterly)
Change in Utrecht Work Engagement Scale (UWES)
Time frame: Baseline to 30 months (measured quarterly)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
Linsey Steege, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTORE in people with Nurse and Burnout, Healthcare Workers, run by University of Wisconsin, Madison at 1 site 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 2 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: enrolling by invitation, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maslach Burnout Inventory (MBI) (time frame: Baseline to 30 months (measured quarterly)). 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 18 Dec 2025.