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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05436548
Other study ID # STUDY00020965
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date August 31, 2026

Study information

Verified date June 2023
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date August 31, 2026
Est. primary completion date September 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Supervisor-employee frequent check-ins to identify and 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
Usual practice waitlist controls
If the check-ins are successful in reducing burnout, supervisors at the control clinics will be offered the training modules

Locations

Country Name City State
United States OHSU Portland Oregon
United States OHSU Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 12 months post supervisor check-ins training
Secondary 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). 12 months post supervisor check-ins training
Secondary 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. 12 months post supervisor check-ins training
Secondary 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. 12 months post supervisor check-ins training
Secondary 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. 12 months post supervisor check-ins training
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