MedDataX Logo

Adaptation and Evaluation of RESTORE

NCT ID: NCT07104474

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-02

Study Completion Date

2030-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Nurse Burnout, Healthcare Workers

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Burnout Nurse Job demands Work engagement Hospital nursing units

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Post-RESTORE Implementation

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.

Group Type EXPERIMENTAL

RESTORE

Intervention Type 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.

Baseline Pre-Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

RESTORE Design Team

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.

Group Type EXPERIMENTAL

RESTORE

Intervention Type 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.

Aim 3 Interview Participants

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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/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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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

Aim 3:
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Linsey Steege, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01NR021386-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A545000

Identifier Type: OTHER

Identifier Source: secondary_id

NUR/FACULTY AFFAIRS/ADMIN

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 1/14/25

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0039

Identifier Type: -

Identifier Source: org_study_id