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Recruiting NCT05436548

The Work-life Check-ins: a Supervisor-driven Intervention to Reduce Burnout in Primary Care

No phase Interventional Burnout

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supervisor-employee frequent check-ins to identify and address work stressors, Usual practice waitlist controls.
Who it may be relevant to
Registry conditions: Burnout. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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
  • Other Usual practice waitlist controls
    If the check-ins are successful in reducing burnout, supervisors at the control clinics will be offered the training modules

Primary outcome measures

  • Change in Burnout baseline vs. 12th month follow-up [Time frame: 12 months post supervisor check-ins training]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • OHSU — Portland
  • OHSU — Portland

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. PMID 38878996

Identifiers

NCT: NCT05436548 · STUDY00020965

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗