NCT07031245

Brief Summary

Burnout is highly prevalent among VA primary care providers and staff, impairing productivity and retention, as well as safety, quality, and patient experience. In this pilot trial, the investigators will facilitate the development of burnout reduction interventions using an evidence-based quality improvement (EBQI) approach, and then evaluate the feasibility, acceptability and effectiveness of a pilot EBQI-facilitated burnout reduction intervention in a modified stepped wedge design in one VA region.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
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 Progress24%
Oct 2025Sep 2028

First Submitted

Initial submission to the registry

June 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

September 23, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

June 12, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

primary careVAburnoutEBQIevidence-basedquality improvement

Outcome Measures

Primary Outcomes (1)

  • Burnout

    22-item Maslach Burnout Inventory. Minimum score of 0 for all domains. Maximum score of 54 for emotional exhaustion domain. Maximum score of 30 for depersonalization domain. Maximum score of 48 for personal accomplishment domain. Higher scores are worse, except for the personal accomplishment domain where higher scores are better.

    Annually, from enrollment until the end of the study, three years later (4 survey administrations).

Secondary Outcomes (4)

  • Turnover intent

    Annually, from enrollment until the end of the study, three years later (4 survey administrations).

  • Workplace drivers of burnout

    Annually, from enrollment until the end of the study, three years later (4 survey administrations)

  • Depression

    Annually, from enrollment until the end of the study, three years later (4 survey administrations)

  • Anxiety

    Annually, from enrollment until the end of the study, three years later (4 survey administrations)

Study Arms (2)

Evidence-based quality improvement (EBQI)

EXPERIMENTAL

Evidence-based quality improvement (EBQI) to facilitate the development and implementation of one or more burnout reduction interventions. The EBQI-facilitated interventions will be actively managed my the research team for one year, and may be passively continue by clinic leadership, providers, and staff for the following years.

Behavioral: Evidence-based quality improvement (EBQI)

Usual care

NO INTERVENTION

Researchers will have no interaction with the clinics beyond survey administration.

Interventions

Evidence-based quality improvement (EBQI) is a multi-level implementation strategy that aids in the development and implementation of evidence-based interventions to reduce burnout. Preliminary survey, interview, and systematic review data on burnout, turnover intent, burnout drivers, and burnout interventions will be presented to an expert panel for each intervention site. These panels will collectively decide on the top categories of burnout drivers to target and burnout interventions to implement. These top drivers and intervention categories will be presented to site-level providers and staff and proposals will be solicited for quality improvement (QI) interventions to reduce burnout that reflect these categories and address these drivers. The expert panels will then choose one or more of these QI interventions to implement and evaluate at each intervention site.

Evidence-based quality improvement (EBQI)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary care clinics (2 VA Medical Centers \[VAMCs\] and 3 community-based outpatient clinics \[CBOCs\]) in 2 VA healthcare systems in 1 VA Veterans Integrated Service Network
  • Primary care providers, registered nurses, clinical associates (e.g., licensed vocational or practical nurses), or administrative associates (e.g., clerks) on regular Patient-Aligned Care Team (PACT) teamlets at a study site.

You may not qualify if:

  • All other VAMCs and CBOCs.
  • Other primary care professionals at a study site.
  • Members of special types of PACT teamlets at a study site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Bakersfield VA Clinic, VA Greater Los Angeles Healthcare System

Bakersfield, California, 93301, United States

NOT YET RECRUITING

Tibor Rubin VA Medical Center, VA Long Beach Healthcare System

Long Beach, California, 90822, United States

NOT YET RECRUITING

West Los Angeles VA Medical Center, VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

RECRUITING

Sepulveda VA Medical Center, VA Greater Los Angeles Healthcare System

North Hills, California, 91343, United States

NOT YET RECRUITING

Santa Maria VA Clinic, VA Greater Los Angeles Healthcare System

Santa Maria, California, 93454, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Eric A Apaydin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Four-year modified stepped wedge trial with three interventions sites, separated by one year, and two control sites across the four years.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Health Scientist

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 22, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

September 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Study data is confidential and cannot be shared outside of the VA.

Locations