BurnoutNCT07031245
Evidence-Based Quality Improvement to Reduce VA Primary Care Burnout
A study testing Evidence-based quality improvement (EBQI) in people with Burnout and Burnout Syndrome, run by VA Greater Los Angeles Healthcare System at 5 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Burnout Syndrome
- What is being tested?
- Evidence-based quality improvement (EBQI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Jun 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Site 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
Provider and Staff Inclusion Criteria:
- 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.
Site Exclusion Criteria:
- All other VAMCs and CBOCs.
Provider and Staff Exclusion Criteria:
- Other primary care professionals at a study site.
- Members of special types of PACT teamlets at a study site.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Bakersfield VA Clinic, VA Greater Los Angeles Healthcare System
Bakersfield, California, 93301
Eric A Apaydin, PhD, 3104783711 ext. 44157, eric.apaydin@va.gov
- Not yet recruiting
Tibor Rubin VA Medical Center, VA Long Beach Healthcare System
Long Beach, California, 90822
Eric A Apaydin, PhD, 310-478-3711 ext. 44157, eric.apaydin@va.gov
- Recruiting
West Los Angeles VA Medical Center, VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Eric A Apaydin, PhD, 310-478-3711 ext. 44157, eric.apaydin@va.gov
- Not yet recruiting
Sepulveda VA Medical Center, VA Greater Los Angeles Healthcare System
North Hills, California, 91343
Eric A Apaydin, PhD, 310-478-3711 ext. 44157, eric.apaydin@va.gov
- Not yet recruiting
Santa Maria VA Clinic, VA Greater Los Angeles Healthcare System
Santa Maria, California, 93454
Eric A Apaydin, PhD, 3104783711 ext. 44157, eric.apaydin@va.gov
About this study
Official title: Reducing Burnout Among VA PCPs Using Evidence-Based Quality Improvement
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.
Read the detailed description
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
- Burnout, Burnout Syndrome
- Being tested
- Evidence-based quality improvement (EBQI)
- Keywords
- primary care, VA, burnout, EBQI, evidence-based, quality improvement
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based quality improvement (EBQI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Evidence-based quality improvement (EBQI) |
| Usual care | No intervention | Researchers will have no interaction with the clinics beyond survey administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Annually, from enrollment until the end of the study, three years later (4 survey administrations).
Secondary outcomes (4)
Turnover intent
Turnover intent in the next year, and factors related to turnover intent (questions adapted from the VA All Employee Survey).
Measured: Annually, from enrollment until the end of the study, three years later (4 survey administrations).
Workplace drivers of burnout
28-item Areas of Worklife Survey. Minimum score of 0 for all domains. Maximum score of 25 for workload domain. Maximum score of 20 for control domain. Maximum score of 20 for reward domain. Maximum score of 25 for community domain. Maximum score of 30 for fairness domain. Maximum score of 20 for values domain. Higher scores are better for all domains.
Measured: Annually, from enrollment until the end of the study, three years later (4 survey administrations)
Depression
14-item Hospital Anxiety and Depression Scale. Minimum score of 0 for depression domain. Maximum score of 21 for depression domain. Higher scores are worse.
Measured: Annually, from enrollment until the end of the study, three years later (4 survey administrations)
Anxiety
14-item Hospital Anxiety and Depression Scale. Minimum score of 0 for anxiety domain. Maximum score of 21 for anxiety domain. Higher scores are worse.
Measured: Annually, from enrollment until the end of the study, three years later (4 survey administrations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start18 Jun 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Four-year modified stepped wedge trial with three interventions sites, separated by one year, and two control sites across the four years.
- Masking
- None (open label)
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- VA Office of Research and Development
- Responsible party
- Principal investigator, Eric A. Apaydin, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031245
- Sponsor's protocol ID
- CDA 21-158
- Other IDs
- IK2HX003534
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data is confidential and cannot be shared outside of the VA.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Burnout Among VA PCPs Using Evidence-Based Quality Improvement
- ClinicalTrials.gov ID
- NCT07031245
- Acronym / sponsor ID
- CDA 21-158
- Conditions
- Burnout, Burnout Syndrome
- Keywords
- primary care, VA, burnout, EBQI, evidence-based, quality improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- VA Office of Research and Development
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Four-year modified stepped wedge trial with three interventions sites, separated by one year, and two control sites across the four years.
| Arm | Type | Receives |
|---|---|---|
| Evidence-based quality improvement (EBQI) | Experimental | Behavioral: 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. |
| Usual care | No intervention | –Researchers will have no interaction with the clinics beyond survey administration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Evidence-based quality improvement (EBQI) |
Primary outcome
Burnout
Time frame: Annually, from enrollment until the end of the study, three years later (4 survey administrations).
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.
4 secondary outcomes
Turnover intent
Time frame: Annually, from enrollment until the end of the study, three years later (4 survey administrations).
Workplace drivers of burnout
Time frame: Annually, from enrollment until the end of the study, three years later (4 survey administrations)
Depression
Time frame: Annually, from enrollment until the end of the study, three years later (4 survey administrations)
Anxiety
Time frame: Annually, from enrollment until the end of the study, three years later (4 survey administrations)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Study data is confidential and cannot be shared outside of the VA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based quality improvement (EBQI) in people with Burnout and Burnout Syndrome, run by VA Greater Los Angeles Healthcare System at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric A Apaydin, PhD (310-478-3711 ext. 44157, eric.apaydin@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout (time frame: Annually, from enrollment until the end of the study, three years later (4 survey administrations).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.