Adaptation and Evaluation of RESTORE

NCT07104474 | Enrolling By Invitation DMC

• 5 other identifiers: 2025-00391R01NR021386-01A545000NUR/FACULTY AFFAIRS/ADMINProtocol Version 1/14/25
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nurse; Burnout, Healthcare Workers

Keywords

Burnout; Nurse; Job demands; Work engagement; Hospital nursing units

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Change in Areas of Worklife Scale (AWS)

  Baseline to 30 months (measured quarterly)

• Change in Utrecht Work Engagement Scale (UWES)

  Baseline to 30 months (measured quarterly)

Other Outcomes (3)

• Aim 3 Qualitative Interviews - Barriers and Facilitators to Scalability and Dissemination of RESTORE

  Up to 3 months

• RESTORE Process Design Team Debrief Interviews

  Up to 3 months

• Post-implementation Qualitative Interviews

  Up to 3 months

Study Arms (4)

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.

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.

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.

Interventions

RESTORE OTHER

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.

Post-RESTORE Implementation; RESTORE Design Team

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Nursing staff that are not involved in direct patient care, travel and float nursing staff
• Aim 3:
• \- 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Burnout, Psychological; Occupational Stress

Interventions

Restore polishing paste

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Occupational Diseases

Study Officials

• Linsey Steege, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)