BurnoutNCT05436548
The Work-life Check-ins: a Supervisor-driven Intervention to Reduce Burnout in Primary Care
A study testing Supervisor-employee frequent check-ins to identify and address work stressors in people with Burnout, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the effectiveness and process of frequent supervisor-employee check-ins in reducing burnout among employees of primary care clinics in Portland, OR. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout
- What is being tested?
- Supervisor-employee frequent check-ins to identify and address work stressors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Employed at one of the 12 OHSU primary care clinics that weren't involved in the pilot study
- Supervisors (medical director, practice manager, supervisors, leads)
- Employees (patient-facing; back and front of the clinic)
- Patient Access Specialists
- Medical Assistants
- MDs, RNs, NPs
Who cannot join
- Under the age of 18
- Employed at an OHSU primary care clinic that participated in the pilot study
- Non-clinic employees
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
OHSU
Portland, Oregon, 97239
David A Hurtado, ScD, 503-494-3132, hurtadod@ohsu.edu
David A Hurtado, ScD
- Recruiting
OHSU
Portland, Oregon, 97239
David A Hurtado, ScD, 617-510-4114, hurtadod@ohsu.edu
About this study
The objective of this study is to evaluate the effectiveness and process of frequent supervisor-employee check-ins in reducing burnout among employees of primary care clinics in Portland, OR. Healthcare workers are at risk for burnout and associated adverse health and safety outcomes, including chronic diseases and occupational injuries. Not only does burnout affect healthcare workers, but burnout also affects the quality of patient care. The proposed study will create a check-in process between supervisors and healthcare workers, which addresses supervisor support, awareness of services and resources, and work-life balance. The Work-life Check-ins project expects to see reduced burnout among employees participating in the check-ins intervention compared to those in the control group.
Read the detailed description
Burnout is a manifestation of chronic work stress characterized by emotional exhaustion, cynicism, and diminished self-efficacy. The burden of burnout is alarming, especially within healthcare where it affects at least one-third of the workforce, including clinicians and support staff. The causes of healthcare worker burnout are multifactorial, including systemic pressures (e.g., intensification of charting duties, prolonged work hours with circadian and work-life disruptions, exposure to trauma), and unit-level characteristics (e.g., value misalignment and mistrust between team members and leadership, and lack of supportive services or resources). The modification of these systemic factors requires the lengthy action of stakeholders that have competing agendas. In the meantime, the healthcare workforce remains in urgent need of practical, adaptable, and meaningful solutions to start addressing this pervasive problem. In this conundrum, interventions aimed at improving leader-staff relations - a more readily modifiable target than systemic pressures- have reduced the most proximal emotional effects of burnout. However, new approaches are required so that leadership-focused interventions generate and sustain impactful organizational transformations. The need for such interventions is even more significant amid the exploding levels of work stress related to the COVID-19 crisis.
The objective of this five-year proposal is to conduct a cluster randomized controlled trial (CRT) across 10 OHSU primary care clinics to evaluate the effectiveness and process of a supervisor-focused intervention to reduce burnout. The intervention titled "Work-life Check-ins" will create a process designed to reduce burnout by boosting supervisor support, trust, and value alignment, increasing awareness of appropriate services and resources, and addressing workflow or work-life problems. The central hypothesis is that employees at the six clinics randomly assigned to the intervention will have reduced burnout at the 12- month follow-up compared to waitlist-control clinics. The investigators expect that the intervention will reduce burnout based on our preliminary studies and the integration of evidence-based techniques, including supportive supervision training, goal setting, feedback sessions, and quality improvement cycles. This proposal will accomplish the following specific aims.
Aim 1: Determine the Work-life Check-ins' effectiveness on burnout and secondary outcomes.
The investigators will evaluate the effectiveness of the Work-life Check-ins via surveys conducted among eligible employees (N=552 across the 10 clinics). As the primary outcome, it will be surveyed burnout at baseline and after 12 months. As secondary outcomes, we will examine safety and well-being variables (e.g., turnover intentions, values alignment, supervisor support and safety climate,).
Aim 2: Identify organizational changes produced by the Work-life check-ins. The investigators will conduct a multi-method process evaluation, including implementation metrics (e.g., number and frequency of check-ins) and in-depth interviews with supervisors and workers after implementation. The process evaluation will reveal the extent to which the intervention influenced the adoption of environmental, procedural or educational burnout control and prevention measures.
- Conditions
- Burnout
- Being tested
- Supervisor-employee frequent check-ins to identify and address work stressors, Usual practice waitlist controls
- Keywords
- burnout, values alignment, supervisor support
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervisor-employee frequent check-ins to identify and address work stressorsOther
Supervisors will complete three training modules: 1) how and why the check-ins are expected to address burnout; 2) how to demonstrate supportive supervision during the check-ins process, and 3) principle of quality improvement applied to the check-ins
Usual practice waitlist controlsOther
If the check-ins are successful in reducing burnout, supervisors at the control clinics will be offered the training modules
| Study group | Role | What they receive |
|---|---|---|
| Brief and frequent Work-life check-ins between clinic supervisors and each staff member | Experimental | Primary care clinics assigned to the intervention will conduct frequent (every 8 weeks) supervisor-employee brief (30 min) check-ins to identify work stressors. Supervisors at such clinics will complete training on how to use the check-ins to address work stressors. Receives: Other: Supervisor-employee frequent check-ins to identify and address work stressors |
| Usual practice, waitlist controls | Experimental | Primary care clinics randomly assigned to the control condition will continue as usual practice. If the check-is are effective in reducing burnout, then supervisor-level training will become available to supervisors at the end of the study Receives: Other: Usual practice waitlist controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Burnout baseline vs. 12th month follow-up
As a primary outcome, we will use the Maslach Burnout Inventory, which is considered the gold standard in burnout research. The MBI-HSS yields a three-factor score of burnout: emotional exhaustion (9 items; e.g., "I feel burned out from my job"), depersonalization (5 items; e.g., "I've become more callous toward people since I took this job"), and low personal accomplishment (8 items; "I feel I'm positively influencing other people's lives through my job).
Measured: 12 months post supervisor check-ins training
Secondary outcomes (4)
Change in Turnover intentions baseline vs. 12th month follow-up
We will measure turnover intentions as the average of two questions, scored with a 5-point scale (NIOSH Quality of Work Life), about the extent to which participants are considering leaving their current job and organization (higher scores means higher intentions).
Measured: 12 months post supervisor check-ins training
Change in Values alignment with clinic leaders baseline vs. 12th month follow-up
The Mini-Z has 10 questions (continuous variables) for aspects such as value alignment (e.g., "my professional values are well aligned with those of my clinic leader"). Higher scores means higher values alignment.
Measured: 12 months post supervisor check-ins training
Change in Family Supportive Supervisor Behaviors (FSSB) baseline vs. 12th month follow-up
The study will include a modified version of the Family-supportive supervisor behaviors (FSSB) questionnaire, created by Dr. Hammer. The FSSB has 4 questions for emotional support, instrumental support, role modeling and creative conflict management (e.g., "my supervisor works effectively with employees to solve conflicts between work and non-work creatively"). Higher scores means higher FSSB.
Measured: 12 months post supervisor check-ins training
Change in Organizational constraints baseline vs. 12th month follow-up
Organizational constraints is a scale that inquires the extent to which workers perceive that different barriers affect their performance. This scale (title: Organizational Constraints Scale) asks about equipment, supplies, procedures, supervisors, co-workers, insufficient training, and incorrect instructions, among others (11 items; e.g., "how often do you find it difficult or impossible to do your job because of"). Higher scores mean greater constraints.
Measured: 12 months post supervisor check-ins training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start3 Jan 2023
- Primary completion20 Sep 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Primary care clinics randomly assigned to the intervention will conduct frequent supervisor-employee check-ins. Supervisors at those clinics will receive training to conduct such check-ins. Control clinics will continue as usual practice.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hurtado, ScD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436548
- Sponsor's protocol ID
- STUDY00020965
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2022
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hurtado DA, Boyd J, Madjlesi R, Greenspan SA, Ezekiel-Herrera D, Potgieter G, Hammer LB, Everson T, Lenhart A. The Work-life Check-ins randomized controlled trial: A leader-based adaptive, semi-structured burnout intervention in primary care clinics. Contemp Clin Trials. 2024 Aug;143:107609. doi: 10.1016/j.cct.2024.107609. Epub 2024 Jun 13.
PubMed 38878996
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Work-life Check-ins: a Supervisor-driven Intervention to Reduce Burnout in Primary Care
- ClinicalTrials.gov ID
- NCT05436548
- Acronym / sponsor ID
- STUDY00020965
- Conditions
- Burnout
- Keywords
- burnout, values alignment, supervisor support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 29 Jun 2022 (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.
The objective of this study is to evaluate the effectiveness and process of frequent supervisor-employee check-ins in reducing burnout among employees of primary care clinics in Portland, OR. Healthcare workers are at risk for burnout and associated adverse health and safety outcomes, including chronic diseases and occupational injuries. Not only does burnout affect healthcare workers, but burnout also affects the quality of patient care. The proposed study will create a check-in process between supervisors and healthcare workers, which addresses supervisor support, awareness of services and resources, and work-life balance. The Work-life Check-ins project expects to see reduced burnout among employees participating in the check-ins intervention compared to those in the control group.
Detailed description
Burnout is a manifestation of chronic work stress characterized by emotional exhaustion, cynicism, and diminished self-efficacy. The burden of burnout is alarming, especially within healthcare where it affects at least one-third of the workforce, including clinicians and support staff. The causes of healthcare worker burnout are multifactorial, including systemic pressures (e.g., intensification of charting duties, prolonged work hours with circadian and work-life disruptions, exposure to trauma), and unit-level characteristics (e.g., value misalignment and mistrust between team members and leadership, and lack of supportive services or resources). The modification of these systemic factors requires the lengthy action of stakeholders that have competing agendas. In the meantime, the healthcare workforce remains in urgent need of practical, adaptable, and meaningful solutions to start addressing this pervasive problem. In this conundrum, interventions aimed at improving leader-staff relations - a more readily modifiable target than systemic pressures- have reduced the most proximal emotional effects of burnout. However, new approaches are required so that leadership-focused interventions generate and sustain impactful organizational transformations. The need for such interventions is even more significant amid the exploding levels of work stress related to the COVID-19 crisis.
The objective of this five-year proposal is to conduct a cluster randomized controlled trial (CRT) across 10 OHSU primary care clinics to evaluate the effectiveness and process of a supervisor-focused intervention to reduce burnout. The intervention titled "Work-life Check-ins" will create a process designed to reduce burnout by boosting supervisor support, trust, and value alignment, increasing awareness of appropriate services and resources, and addressing workflow or work-life problems. The central hypothesis is that employees at the six clinics randomly assigned to the intervention will have reduced burnout at the 12- month follow-up compared to waitlist-control clinics. The investigators expect that the intervention will reduce burnout based on our preliminary studies and the integration of evidence-based techniques, including supportive supervision training, goal setting, feedback sessions, and quality improvement cycles. This proposal will accomplish the following specific aims.
Aim 1: Determine the Work-life Check-ins' effectiveness on burnout and secondary outcomes.
The investigators will evaluate the effectiveness of the Work-life Check-ins via surveys conducted among eligible employees (N=552 across the 10 clinics). As the primary outcome, it will be surveyed burnout at baseline and after 12 months. As secondary outcomes, we will examine safety and well-being variables (e.g., turnover intentions, values alignment, supervisor support and safety climate,).
Aim 2: Identify organizational changes produced by the Work-life check-ins. The investigators will conduct a multi-method process evaluation, including implementation metrics (e.g., number and frequency of check-ins) and in-depth interviews with supervisors and workers after implementation. The process evaluation will reveal the extent to which the intervention influenced the adoption of environmental, procedural or educational burnout control and prevention measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Primary care clinics randomly assigned to the intervention will conduct frequent supervisor-employee check-ins. Supervisors at those clinics will receive training to conduct such check-ins. Control clinics will continue as usual practice.
| Arm | Type | Receives |
|---|---|---|
| Brief and frequent Work-life check-ins between clinic supervisors and each staff member | Experimental | Other: Supervisor-employee frequent check-ins to identify and address work stressorsPrimary care clinics assigned to the intervention will conduct frequent (every 8 weeks) supervisor-employee brief (30 min) check-ins to identify work stressors. Supervisors at such clinics will complete training on how to use the check-ins to address work stressors. |
| Usual practice, waitlist controls | Experimental | Other: Usual practice waitlist controlsPrimary care clinics randomly assigned to the control condition will continue as usual practice. If the check-is are effective in reducing burnout, then supervisor-level training will become available to supervisors at the end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age
- Employed at one of the 12 OHSU primary care clinics that weren't involved in the pilot study
- Supervisors (medical director, practice manager, supervisors, leads)
- Employees (patient-facing; back and front of the clinic)
Key exclusion criteria (3 listed)
- Under the age of 18
- Employed at an OHSU primary care clinic that participated in the pilot study
- Non-clinic employees
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 |
|---|---|---|
| Supervisor-employee frequent check-ins to identify and address work stressorsSupervisors will complete three training modules: 1) how and why the check-ins are expected to address burnout; 2) how to demonstrate supportive supervision during the check-ins process, and 3) principle of quality improvement applied to the check-ins | Other | Brief and frequent Work-life check-ins between clinic supervisors and each staff member |
| Usual practice waitlist controlsIf the check-ins are successful in reducing burnout, supervisors at the control clinics will be offered the training modules | Other | Usual practice, waitlist controls |
Primary outcome
Change in Burnout baseline vs. 12th month follow-up
Time frame: 12 months post supervisor check-ins training
As a primary outcome, we will use the Maslach Burnout Inventory, which is considered the gold standard in burnout research. The MBI-HSS yields a three-factor score of burnout: emotional exhaustion (9 items; e.g., "I feel burned out from my job"), depersonalization (5 items; e.g., "I've become more callous toward people since I took this job"), and low personal accomplishment (8 items; "I feel I'm positively influencing other people's lives through my job).
4 secondary outcomes
Change in Turnover intentions baseline vs. 12th month follow-up
Time frame: 12 months post supervisor check-ins training
Change in Values alignment with clinic leaders baseline vs. 12th month follow-up
Time frame: 12 months post supervisor check-ins training
Change in Family Supportive Supervisor Behaviors (FSSB) baseline vs. 12th month follow-up
Time frame: 12 months post supervisor check-ins training
Change in Organizational constraints baseline vs. 12th month follow-up
Time frame: 12 months post supervisor check-ins training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 38878996Hurtado DA, Boyd J, Madjlesi R, Greenspan SA, Ezekiel-Herrera D, Potgieter G, Hammer LB, Everson T, Lenhart A. The Work-life Check-ins randomized controlled trial: A leader-based adaptive, semi-structured burnout intervention in primary care clinics. Contemp Clin Trials. 2024 Aug;143:107609. doi: 10.1016/j.cct.2024.107609. Epub 2024 Jun 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervisor-employee frequent check-ins to identify and address work stressors in people with Burnout, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Burnout baseline vs. 12th month follow-up (time frame: 12 months post supervisor check-ins training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436548, which also lists 1 linked publication.
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 29 Jun 2023.