- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436548
The Work-life Check-ins: a Supervisor-driven Intervention to Reduce Burnout in Primary Care
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- OHSU
-
Contact:
- David A Hurtado, ScD
- Phone Number: 617-510-4114
- Email: hurtadod@ohsu.edu
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Portland, Oregon, United States, 97239
- Not yet recruiting
- OHSU
-
Contact:
- David A Hurtado, ScD
- Phone Number: 503-494-3132
- Email: hurtadod@ohsu.edu
-
Principal Investigator:
- David A Hurtado, ScD
-
Principal Investigator:
- Abigail Lenhart, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under the age of 18
- Employed at an OHSU primary care clinic that participated in the pilot study
- Non-clinic employees
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief and frequent Work-life check-ins between clinic supervisors and each staff member
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.
|
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
|
|
Experimental: Usual practice, waitlist controls
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
|
If the check-ins are successful in reducing burnout, supervisors at the control clinics will be offered the training modules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
12 months post supervisor check-ins training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Turnover intentions baseline vs. 12th month follow-up
Time Frame: 12 months post supervisor check-ins training
|
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).
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
12 months post supervisor check-ins training
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00020965
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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