Evidence-Based Quality Improvement to Reduce VA Primary Care Burnout

NCT ID: NCT07031245

Last Updated: 2025-09-23

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Burnout, a long-term psychological response to chronic workplace stress, is highly prevalent among providers and staff in VA primary care. Healthcare worker (HCW) burnout is not only detrimental to affected individuals, but also to the organizations that they work in. High rates of HCW burnout are linked to increased medical errors, worse quality of care, and worse patient experience. Burned out HCWs also work fewer hours and are more likely to leave their organization. Organizational interventions to reduce burnout are more effective than individual interventions, but no single organizational intervention is applicable to all settings. The investigators propose to use evidence-based quality improvement (EBQI) to utilize collaborative leadership and PACT teamlet input to develop and pilot test a burnout reduction intervention, informed by evidence and facilitated by experts, that is tailored to the specific needs of participating primary care clinics. Findings from this work will inform strategies for implementing burnout interventions in other VA facilities, adapted to local organizational contexts.

In VA, 31-55% of providers, nurses, clinical associates, and administrative associates in patient-aligned care team (PACT) teamlets consistently report burnout. Strong primary care models are essential to the VA's integrated delivery system. High burnout, and subsequent turnover, could erode that strength by decreasing primary care staffing, team function and PACT fidelity, thereby impairing Veteran access and shifting more care to the community. Addressing burnout in primary care before it leads to larger downstream effects is essential to preserving Veteran health and the integrity of the VA healthcare system. In addition, addressing burnout in primary care meets the HSR\&D and ORD research priorities of primary care practice and complex chronic disease management, and of increasing substantial real-world impact of VA research. Innovation: EBQI is an effective and well-evaluated strategy that aided in the implementation of PACT, Women's Health PACT, depression collaborative care, and smoking cessation guidelines. The strategy also reduced provider and staff burnout during PACT implementation, but has never been used in tandem with burnout interventions to optimize impacts. This project is the first endeavor to combine EBQI as an implementation strategy with evidence-based burnout interventions, adapted for local organizational contexts. Through EBQI, a multi-level, collaborative approach that empowers frontline HCWs, the investigators may increase the feasibility and impact of burnout reduction interventions.

The investigators will conduct a pilot, modified stepped wedge trial of EBQI for primary care burnout in 5 primary care clinics (based in 2 VA Medical Centers and 3 community-based outpatient clinics) in 2 VA healthcare systems in 1 Veterans Integrated Service Network. Three intervention sites will implement EBQI-facilitated interventions to reduce burnout, while 2 control sites will receive usual care. Survey data on burnout, drivers of burnout, turnover intent, intervention feasibility and acceptability, and other survey respondent individual and workplace characteristics will be collected annually through the trial period.

Conditions

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Burnout Burnout Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Four-year modified stepped wedge trial with three interventions sites, separated by one year, and two control sites across the four years.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Evidence-based quality improvement (EBQI)

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.

Group Type EXPERIMENTAL

Evidence-based quality improvement (EBQI)

Intervention Type BEHAVIORAL

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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Evidence-based quality improvement (EBQI)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 5 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.

Exclusion Criteria

* All other VAMCs and CBOCs.


* Other primary care professionals at a study site.
* Members of special types of PACT teamlets at a study site.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role collaborator

VA Greater Los Angeles Healthcare System

FED

Sponsor Role lead

Responsible Party

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Eric A. Apaydin

Research Health Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bakersfield VA Clinic, VA Greater Los Angeles Healthcare System

Bakersfield, California, United States

Site Status NOT_YET_RECRUITING

Tibor Rubin VA Medical Center, VA Long Beach Healthcare System

Long Beach, California, United States

Site Status NOT_YET_RECRUITING

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

Los Angeles, California, United States

Site Status RECRUITING

Sepulveda VA Medical Center, VA Greater Los Angeles Healthcare System

North Hills, California, United States

Site Status NOT_YET_RECRUITING

Santa Maria VA Clinic, VA Greater Los Angeles Healthcare System

Santa Maria, California, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Eric A Apaydin, PhD

Role: CONTACT

310-478-3711 ext. 44157

Facility Contacts

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Eric A Apaydin, PhD

Role: primary

3104783711 ext. 44157

Eric A Apaydin, PhD

Role: primary

310-478-3711 ext. 44157

Eric A Apaydin, PhD

Role: primary

310-478-3711 ext. 44157

Eric A Apaydin, PhD

Role: primary

310-478-3711 ext. 44157

Eric A Apaydin, PhD

Role: primary

3104783711 ext. 44157

Other Identifiers

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IK2HX003534

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDA 21-158

Identifier Type: -

Identifier Source: org_study_id

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