Keck Medicine of University of Southern California Thrive Study

Burnout Clinical Trial

Official title:

A Randomized-Controlled Trial to Reduce Clinician Burnout

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780892
• Other study ID #: UniHealth Foundation 5125
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: Steven J. Siegel, MD, PhD
• Phone: (323) 422-4000
• Email: steven.siegel[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Burnout and job dissatisfaction among clinicians are one of the greatest challenges facing healthcare today. Clinicians report feeling less engaged in their work and are leaving their fields in large numbers which reflects increasing stress from the pandemic coupled with increased administrative and regulatory demands and a decreased sense of autonomy. To attenuate these factors the current study will enact a series of interventions that would decrease mental distress, increase self-efficacy, and attenuate inefficiencies in their work environment to achieve sustainable improvement. The investigators will offer psychological training using techniques that have been shown to impact individual's mental health that target feelings of demoralization, depression and anxiety that result from chronic stress. Additionally, the investigators will offer individualized training on optimization of the Electronic Health Record (EHR) to help clinicians from different fields and settings reduce their time and effort needed for documentation. The investigators will also engage clinicians in systemic redesign to empower clinician-directed changes to the health system environment. The investigators anticipate that each intervention will positively affect emotional wellbeing, skills mastery of the Electronic Health Record (EHR), and environmental dissatisfaction to reduce overall burnout.

Description:

This study is a randomized controlled trial to reduce burnout that is frequently experienced among clinicians. Personal burnout can be defined as a state of emotional, physical, and mental exhaustion created by excessive and prolonged stress occurring when one feels overwhelmed, emotionally drained, and unable to meet constant demands. The need to improve clinician burnout is higher than ever before due to increased intensity and duration of chronic stress resulting from the COVID-19 pandemic. However, there are significant barriers to attenuating burnout experienced by clinicians, some of which are extrinsic such as the severe nature of the COVID-19 pandemic, and some are intrinsic such as pressure of increased productivity. Previous research has focused on increasing clinician wellness through improving their toleration of difficulties in the work environment and has concluded that no single intervention is effective in promoting and maintaining wellbeing but utilizing multiple interventions could have an additive effect. The goal of the current study is to determine the extent to which different interventions impact clinician burnout. Each intervention in this study targets a unique aspect of burnout including emotional wellbeing, skill using the Electronic Health Record (EHR), and factors that contribute to dissatisfaction in the workplace. The results from this study will guide future programs to reduce burnout at Keck Medicine and the broader health environment.

Clinicians cannot effectively function in their jobs if they feel overwhelmed, depressed, or anxious, so the investigators will address the emotional state of clinicians using Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) to reduce measures of depression and anxiety while increasing measures of resilience. The investigators anticipate that learning how to employ the principles of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) will result in improvements in clinicians' emotional wellbeing. This intervention will consist of training sessions led by licensed therapist and will utilize Cognitive Behavioral Therapy-based skills, such as cognitive restructuring to identify unhelpful behaviors and thought patterns, relaxation strategies such as deep breathing, and acceptance and commitment therapy-based skills such as increasing psychological flexibility. Participants in this intervention group will complete the Patient General Health Questionnaire (PHQ-9) and Brief Resilience Scale (BRS) prior to the intervention, immediately following the intervention, and 6 months after completion of the intervention. These scores will be compared to the scores of the control group to determine the impact of this intervention.

Additionally, if clinicians lack mastery of key skills needed to do their jobs quickly and efficiently they are likely to feel overwhelmed and overworked. Self-efficacy beliefs will be addressed by teaching clinicians how to better use the Electronic Health Record (EHR) to reduce frustrations at work and time spent in the EHR, increase percentage of clinical notes completed on time, and decrease the need to revise clinical records. Augmented specialty and site-specific training will be provided to improve current capabilities in the EHR and identify areas for improvement in EHR configuration. Preintervention data will also be collected and shared with study participants which includes but is not limited to actual EHR per patient, time spent in EHR after hours, and chart review time per patient. The investigators anticipate that learning how to better use the EHR for one's field and setting will increase scores for self-efficacy and reduced frustrations at work. To assess the immediate and long-term impact of the intervention, participants in this intervention will complete a newly developed survey by the study team pertaining to participant's skills and satisfaction with the EHR system prior to the intervention, immediately following the intervention and 6 months after the intervention.

Perceptions of a poor work environment such as too much workload, low control or being treated unfairly will negatively impact clinicians' ability to do their job and remain engaged in their field. This dissatisfaction will be addressed by providing participants with basic performance improvement knowledge and skills through didactic training, group discussions, and hands on practice leading a performance improvement project. The performance improvement concepts are Lean, systems thinking, change management and sustainability. To assess the immediate and long-term impact of this intervention, participants will complete a modified version of the Beliefs, Attitudes, Skills and Confidence in Quality Improvement (BASiC-QI) scale prior to the intervention, immediately following the intervention, and 6 months after the intervention. The investigators anticipate that participating in systemic redesign will increase participants perception of Keck Medicine as a positive work environment and this environmental improvement will have collateral benefit for a reduction in clinician departures.

In addition to the 3 interventions, there will also be a control condition in which the participants do not complete any intervention to control for impact of changes in their lives, subsequent pandemic variants, or other world stressors on evaluations of mental state. The control participants will complete the same assessments at the same time points as the intervention participants. The assessment scores of the participants in each intervention condition will be compared to the scores of participants in the control condition allowing the investigators to study the impact of the different interventions.

Statistical analyses will focus on examining whether participation in the interventions leads to reductions in burnout, improvement in wellbeing, and greater work efficiency and job satisfaction immediately after treatment and at 6-month follow-up. Data will be assessed in accordance with the intent to treat (ITT) principle for all primary analyses on treatment effects. The investigators will use repeated measure analyses of covariance models. The investigators will first conduct an omnibus test for both post treatment assessment periods to examine the overall effect of each intervention followed by separate tests for each posttreatment assessment period of the study. Estimated intervention effects will be derived as the group difference in change from baseline to a specific assessment period. Intervention effect sizes will be calculated with Cohen's d and standardized response mean as the group difference in change relative to the SD of change scores. Additionally, the Wellbeing Index will be evaluated across all active arms compared to a control using an ANOVA with study arms as the independent variables such that the investigators can then look for an interaction between active arms and outcomes enabling the investigators to look at each arm individually.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Credentialed providers (e.g., MD/PA/NP across all specialties or clinical Ph.D./MS) or direct care providers/clinicians (e.g., RN, LVN, OT, PT, SLP, RT) within the Keck Medical System.

Exclusion Criteria:

a. Non-faculty or non-clinical staff (e.g., residents, administrators, etc.) at Keck Medicine

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological

Intervention

Behavioral:
• Emotional Wellbeing
Participants in this intervention will learn cognitive behavioral therapy tools to identify unhelpful beliefs and thought patterns, increase motivation through SMART goal making, and increase relaxation and stress management techniques through deep breathing, progressive muscle relaxation and pleasant activity scheduling. Additionally, participants will learn acceptance and commitment therapy tools to increase cognitive flexibility and resilience through acceptance and diffusion work, being present through contact with present moment and self as context and doing what matters through committed actions and value identification.
• EHR Skills Optimization
Participants in this intervention will learn how to better utilize the EHR by gaining knowledge and skills in the EHR. Session topics include, but are not limited to, understanding current usage patterns and behaviors in the EHR, optimization of the table of contents for easier chart navigation, integration of specialty-focused workflows with current EHR documentation and chart review tools, and recommendations to be more efficient and reduce amount of time spent in the EHR.
• Performance Improvement
This intervention focuses on improving participants perception of Keck Medicine as a positive workplace environment by supporting participants in gaining basic performance improvement knowledge and skills through didactic training, group discussions based on sociocultural learning theory, and hands on practice leading a performance improvement project. Sessions will review performance improvement concepts such as Lean wastes, systems thinking, change management and sustainability. Participants in this intervention will then identify a project area of focus that they want to improve and develop a project charter. Once a project area has been identified, participants will be put into breakout rooms to discuss successes and challenges as well as receive feedback on their project from peers.
• control
Participants randomly assigned to the control condition will continue as usual care and will not complete any intervention during the duration of the study.

Locations

Country	Name	City	State
United States	Keck School of Medicine, University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in emotional well-being	Emotional wellbeing will be assessed by a change in baseline on the Patient Health Questionnaire (PHQ-9) which is a 9-item validated survey designed to measure symptoms of depression. This scale incorporates the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria into self-reported scores of wellbeing. Responses are on a 0-3 scale based on frequency of symptoms. A score of 0 corresponds to "not at all" and a score of 3 corresponds to "nearly every day."	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
Primary	Change in Resilience	Resilience will be assessed by a change in baseline on the Brief Resilience Scale (BRS) which is a 6-item validated scale measuring a participant's perception of their ability to bounce back from stressful events. The responses are on a 5-point Likert scale based on extent of agreement with the statements on the scale. Statements 1,3, and 5 are positively worded and statements 2,4, and 6 are negatively worded, so responses are scored by reverse coding statements 2,4, and 6. A score of 1 corresponds to "Strongly Disagree" and a score of 5 corresponds to "Strongly Agree".	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
Primary	Change in EHR Skills and Optimization	EHR Skills and optimization will be assessed using a newly developed 7-item survey by the study team that pertain to an individual's skills and satisfaction with the EHR. Responses are on a 5-point Likert scale based on extent of agreement with the statements on the scale. A score of 1 corresponds to "Strongly Disagree" and a score of 5 corresponds to "Strongly Agree."	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
Primary	Change in Electronic Health Record (EHR) Proficiency	Objective measures of EHR proficiency will include percentage of clinical notes completed on time, reduction in time spent using the EHR and reduction in need to revise clinical records among study participants in the EMR skills acquisition group. These will be compared to the same measures among study participants in other arms of this study, as well as system wide trends for all measures over the study interval.	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
Primary	Change in perceptions of Quality Improvement	Perceptions of Quality/Performance Improvement will be assessed by a change in baseline scores on the Beliefs, Attitudes, Skills, and Confidence in Quality Improvement (BASiC-QI) Scale. The BASiC-QI Scale is 31-item multidimensional self-assessment to assess knowledge, skills, and attitudes about Quality Improvement. The statements in the survey are in sequential order by which one would design a QI project. The responses for the beliefs and attitudes subscale and the knowledge subscale are on a 7-point Likert scale based on extent of agreement with the statements. A score of 1 corresponds to "Strongly Disagree" and a score of 7 corresponds to "Strongly Agree". The QI Skills subscale responses are a continuum of confidence level about the statements, with a score of 1 corresponding to "Not confident whatsoever" and a score of 4 corresponds to "Extremely Confident."	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
Primary	Change in score of Proficiency improvement	NIH Proficiency Scale assesses, "How would you rate your level of expertise?" using the following options: Fundamental Awareness (basic knowledge); Novice (limited experience); Intermediate (practical application); Advanced (applied theory); Expert (recognized authority)	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
Primary	Change in Environmental Satisfaction	Environmental satisfaction will be assessed using the Safety, Culture, Operational Risk, Resilience/Burnout and Engagement (SCORE) survey. The SCORE survey is an outcomes-predictive and proprietary established scale designed to measure satisfaction in the workplace. The responses are based on extent of agreement with the statements. A score of 1 corresponds to "Strongly Disagree", a score of 5 corresponds to "Strongly Agree", and a score of 6 corresponds to "not applicable."	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
Primary	Change in Burnout	Burnout levels will be assessed using the 7- item Personal Burnout subscale of the SCORE survey. The responses are based on extent of agreement with the statements. A score of 1 corresponds to "Strongly Disagree", a score of 5 corresponds to "Strongly Agree", and a score of 6 corresponds to "not applicable."	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
Primary	Change in Overall Well-being	Overall well-being will be assessed using the 7-item Wellbeing Index. The Well-being Index identifies distress in a variety of dimensions such as anxiety and fatigue. The response choices are either "yes" or "no" based on whether the participant has experienced the symptoms described in the scale.	Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
Secondary	Change in Emotional Thriving	Emotional Thriving will be assessed using the 5-item Emotional Thriving Subscale of the SCORE Survey. The responses are based on extent of agreement with the statements. A score of 1 corresponds to "Strongly Disagree", a score of 5 corresponds to "Strongly Agree", and a score of 6 corresponds to "not applicable."	: participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
Secondary	Change in Emotional Recovery	Emotional Recovery will be assessed using the 4-item Emotional Recovery subscale of the SCORE Survey. The responses are based on extent of agreement with the statements. A score of 1 corresponds to "Strongly Disagree", a score of 5 corresponds to "Strongly Agree", and a score of 6 corresponds to "not applicable."	participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
Secondary	Change in Workload	Perceptions of workload will be assessed using the 7-item Workload Subscale of the SCORE Survey which identifies the demands that contribute ti a workload that is increasingly demanding and stressful to manage. The responses are based on extent of agreement with the statements. A score of 1 corresponds to "Strongly Disagree", a score of 5 corresponds to "Strongly Agree", and a score of 6 corresponds to "not applicable."	participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
Secondary	Change in Intent to Leave	Participant's intent to leave will be assessed using the 3-item Intent to Leave subscale of the SCORE Survey. The responses are based on extent of agreement with the statements. A score of 1 corresponds to "Strongly Disagree", a score of 5 corresponds to "Strongly Agree", and a score of 6 corresponds to "not applicable."	participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
Secondary	Change in Participation in Decision Making	The Participation in Decision-Making will be assessed using the 6-item Participation in Decision-Making subscale of the SCORE survey which evaluates the current state of the decision-making process and participant's perception of their level of participation in the decision-making process. The responses are based on extent of agreement with the statements. A score of 1 corresponds to "Strongly Disagree", a score of 5 corresponds to "Strongly Agree", and a score of 6 corresponds to "not applicable."	participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention