NCT06978790

Brief Summary

This study is guided by Maslach's Burnout Theory and with Normalization Process Theory supporting the implementation of the GAINS intervention by facilitating its integration into routine system-level practice. In Year 1, the investigative team will collaborate with hospital-based nursing leadership and key stakeholders to identify staffing-specific factors essential for operationalizing the GAINS AI model/intervention. In Year 1, the investigators will also conduct a survey amongst nursing staff to measure baseline burnout. In Year 2, the AI-staffing intervention will be implemented with the medical-surgical nursing float pool team. In Year 3, the investigators will first repeat the nurse burnout survey and second, expand the intervention to include the nursing assistant float pool team. In Year 4, the investigators will conduct the final burnout survey with nurses, assess feasibility of GAINS (target vs. actual staffing- nurses and nursing assistants), and assess preliminary efficacy of GAINS to reduce costs related to staffing. the investigators will compare outcomes at three time points (pre, mid, and post-intervention). Interviews with nurses, nursing assistants, unit nurse managers, and leadership will further explicate the intervention's acceptability, feasibility, and impact on burnout.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Mar 2029

First Submitted

Initial submission to the registry

May 1, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

May 1, 2025

Last Update Submit

May 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Maslach's Burnout Inventory

    Using Maslach's Burnout Inventory, burnout is the primary outcome measure and will assess burnout (1) at baseline over a time frame of 2 weeks, (2) 12-months after the GAINS intervention is applied to the float pool nurses over a time frame of 2 weeks, and 12-months after the GAINS intervention is applied to the float pool nurses and nursing assistants over a time frame of 2 weeks.

    Up to 2.5 years

  • Qualitative Interviews to Evaluate Feasibility, Normalization, and Acceptability of the GAINS Intervention

    We will interview 10-20 key stakeholders to collect and analyze qualitative data to evaluate the feasibility, normalization, and acceptability of the GAINS intervention. T3here are two phases of the GAINS intervention. 1. Phase I: GAINS study applied to nurses in Year 2 2. Phase 2: GAINS study applied to nurses and nursing assistants in Year These qualitative interviews will be held in Year 3 after Phase 1 over a 1-month time frame and Year 4 after Phase 2 completion of the study over a 1-month time frame. Interviews will be conducted to gather in-depth feedback on the intervention's feasibility, acceptability, and normalized into nursing practice.

    Up to 3 years

Secondary Outcomes (2)

  • Optimization Staffing Rates [Target staffing rate - Actual staffing rate]

    Up to 2 years

  • Total Cost: Travel Nurse and Nurse Overtime

    Up to 2 years

Study Arms (3)

Arm 1: Standard staffing practice for float pool nurse and nursing assistants.

EXPERIMENTAL

This arm represents the control or standard of staffing practice to assign float pool nurse and nursing assistants.

Other: Generative Artificial Intelligence Nurse Staffing (GAINS) Intervention

Arm 2: GAINS intervention applied to float pool nurses

EXPERIMENTAL

Generative Artificial Intelligence Nurse Staffing (GAINS) intervention applied to float pool nurses.

Other: Generative Artificial Intelligence Nurse Staffing (GAINS) Intervention

Arm 3: GAINS intervention applied to float pool nurses and nursing assistants

EXPERIMENTAL

Generative Artificial Intelligence Nurse Staffing (GAINS) intervention applied to float pool nurses and nursing assistants.

Other: Generative Artificial Intelligence Nurse Staffing (GAINS) Intervention

Interventions

The Generative Artificial Intelligence intervention is an industrial engineering and nursing-informed innovation developed to optimize team-based staffing of registered nurses and nursing assistants. We anticipate that the GAINS intervention will enhance staffing efficiency, reduces reliance on travel nurses, minimizes overtime costs, and supports nurse well-being by proactively managing workload distribution and reducing burnout. At the core of GAINS is a generative AI model that predicts future unit-level staffing needs using historical staffing patterns, patient turnover (admissions and discharges), and patient acuity scores (based on ICU versus medical/surgical status, physician orders, charge nurse input, and other clinical factors) reflective of workload. Based on the prediction, the intervention dynamically recommends float pool assignments by evaluating staffing gaps across units and optimally deploying available nurses and nursing assistants to where they are most needed.

Arm 1: Standard staffing practice for float pool nurse and nursing assistants.Arm 2: GAINS intervention applied to float pool nursesArm 3: GAINS intervention applied to float pool nurses and nursing assistants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Registered nurses, nursing assistants, or key stakeholders
  • Employed by The Queen's Medical Center
  • Working at least 24 hours per week
  • Position associated with medical-surgical units where float pool nurses work

You may not qualify if:

  • Employees working less than 24 hours per week at The Queen's Medical Center
  • Employees whose roles are not related to medical-surgical units

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Methods

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Katie A Azama, PhD

    University of Hawaii at Manoa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie A Azama, PhD, APRN

CONTACT

Holly Fontenot, PhD, APRN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 1, 2025

First Posted

May 18, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share