Clinical trial NCT05780892: Keck Medicine of University of Southern California Thrive Study
Official title: A Randomized-Controlled Trial to Reduce Clinician Burnout
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burnout
Keywords: healthcare worker
clinician
wellness
process improvement
electronic health record
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial of 3 interventions for clinician well-being as compared to controls.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in emotional well-being
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
measure: Change in Resilience
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
measure: Change in EHR Skills and Optimization
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
measure: Change in Electronic Health Record (EHR) Proficiency
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
measure: Change in perceptions of Quality Improvement
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
measure: Change in score of Proficiency improvement
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
measure: Change in Environmental Satisfaction
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
measure: Change in Burnout
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
measure: Change in Overall Well-being
timeFrame: Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention.
Secondary outcomes:
measure: Change in Emotional Thriving
timeFrame: : participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
measure: Change in Emotional Recovery
timeFrame: participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
measure: Change in Workload
timeFrame: participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
measure: Change in Intent to Leave
timeFrame: participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
measure: Change in Participation in Decision Making
timeFrame: participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine, University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Steven Siegel, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: