[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07104474":3,"trial-entities:NCT07104474":85,"trial-summary:NCT07104474":89},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":45,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":65,"locations":68,"central_contacts":78,"overall_officials":79,"references":83,"see_also_links":84},"NCT07104474","2025-0039","Adaptation and Evaluation of RESTORE","REducing Nurse Burnout Through SysTems Analysis and Organizational REdesign (RESTORE)","ENROLLING_BY_INVITATION","2030-03","2025-10","2025-12-18","2025-12-02","University of Wisconsin, Madison","OTHER",true,"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.\n\nParticipants in the RESTORE intervention process will be interviewed about:\n\n* their experience with RESTORE\n* their experiences working on a unit where RESTORE was used\n\nParticipants will also complete surveys of the impact of RESTORE on job demands, job resources, burnout, and work engagement.","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.",[19,20],"Nurse","Burnout, Healthcare Workers",[22,19,23,24,25],"Burnout","Job demands","Work engagement","Hospital nursing units","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[29],"NA",{"count":31,"type":32},470,"ESTIMATED",[34],{"type":14,"name":35,"description":36,"armGroupLabels":37},"RESTORE","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\u002For 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.",[38,39],"Post-RESTORE Implementation","RESTORE Design Team",[41],{"measure":42,"description":43,"timeFrame":44},"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.","Baseline to 30 months (measured quarterly)",[46,49],{"measure":47,"description":48,"timeFrame":44},"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.",{"measure":50,"description":51,"timeFrame":44},"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 \u002F Every day. Range of scores is from 0 - 54, with lower scores indicating less engagement.","ALL","18 Years",null,{"inclusion":56,"exclusion":62,"raw_text":64},[57,58,59,60,61],"Nursing staff employed on one of the study units and involved in direct patient care","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",[63],"Nursing staff that are not involved in direct patient care, travel and float nursing staff","Aim 1 and Aim 2:\n\nInclusion Criteria:\n\n* Nursing staff employed on one of the study units and involved in direct patient care\n\nExclusion Criteria:\n\n* Nursing staff that are not involved in direct patient care, travel and float nursing staff\n\nAim 3:\n\nInclusion Criteria:\n\n\\- Hospital and system leaders from one of the following groups\n\n* leaders from hospitals that participated in Aims 1 and 2, OR\n* other leaders from our partner health systems, OR\n* leaders from other hospital settings\n* leaders from hospital advocacy or quality organizations",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"University of Wisconsin","Madison","Wisconsin","53705","United States",{"lat":76,"lon":77},43.07305,-89.40123,[],[80],{"name":81,"affiliation":13,"role":82},"Linsey Steege, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":86,"biomarkers":88},[87],"Physical AND emotional exhaustion state",[],{"nct_id":4,"found":90,"summary":54,"prompt_version":54},false]