Adaptation and Evaluation of RESTORE

University of Wisconsin (UW)

Status: Invitation-only

Conditions: Nurse; Burnout, Healthcare Workers

Treatments: Other: RESTORE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07104474

Protocol Version 1/14/25 (Other Identifier)

A545000 (Other Identifier)

2025-0039

1R01NR021386-01 (U.S. NIH Grant/Contract)

NUR/FACULTY AFFAIRS/ADMIN (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Aim 1 and Aim 2:

Inclusion Criteria:

• Nursing staff employed on one of the study units and involved in direct patient care

Exclusion Criteria:

• Nursing staff that are not involved in direct patient care, travel and float nursing staff

Aim 3:

Inclusion Criteria:

- 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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470 participants in 4 patient groups

Post-RESTORE Implementation

Experimental group

Description:

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.

Treatment:

Other: RESTORE

Baseline Pre-Intervention

No Intervention group

Description:

Data will be collected from nursing staff before RESTORE is implemented on each unit.

RESTORE Design Team

Experimental group

Description:

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.

Treatment:

Other: RESTORE

Aim 3 Interview Participants

No Intervention group

Description:

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.