Keck Medicine of University of Southern California Thrive Study

NCT05780892 | Recruiting

• 1 other identifier: UniHealth Foundation 5125
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Burnout

Keywords

healthcare worker; clinician; wellness; process improvement; electronic health record

Outcome Measures

Primary Outcomes (9)

• 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.

• 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

• 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.

• 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.

• 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

• Change in score of Proficiency improvement

  NIH Proficiency Scale assesses, "How would you rate your level of expertise?" using the following options: 1. Fundamental Awareness (basic knowledge) 2. Novice (limited experience) 3. Intermediate (practical application) 4. Advanced (applied theory) 5. Expert (recognized authority)

  Participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention

• 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.

• 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.

• 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 Outcomes (5)

• Change in Emotional Thriving

  : participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention

• Change in Emotional Recovery

  participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention

• Change in Workload

  participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention

• Change in Intent to Leave

  participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention

• Change in Participation in Decision Making

  participants will complete this survey at baseline, immediately following the intervention, and 6 months after completion of the intervention

Study Arms (4)

Emotional Wellbeing

EXPERIMENTAL

This arm consists of 6 30-minute group sessions taking place every 2 weeks for a total of 12 weeks. The sessions will be led by licensed therapists based on cognitive behavioral therapy and acceptance and commitment therapy. Session topics are sequential in nature such that each session builds on the previous session. Between sessions, participants will complete worksheets based on the material covered in the previous session. If a participant misses a session, they will be provided with a pre-recording with the content they missed.

Behavioral: Emotional Wellbeing

EHR Skills Optimization

EXPERIMENTAL

This arm consists of 6 individual educational sessions taking place every 2 weeks for a total of 12 weeks which will be scheduled to accommodate clinicians schedule and preferences. These sessions will be led by a member of the clinical informatics team and target optimization of the EHR. The sessions will be conducted on site, virtually, or a combination of both onsite and virtual. Between sessions participants are to note any challenges, questions, or recommendations related to the EHR. If participant misses 2 sessions, they will be asked to reschedule, but if they miss 3 sessions they may be asked to withdraw from the intervention.

Behavioral: EHR Skills Optimization

Performance Improvement

EXPERIMENTAL

This arm consists of 6 virtual group sessions taking place over every 2 weeks for a total of 12 weeks. The sessions target improving perceptions of the work environment through foundational performance improvement knowledge and skills, and they will be led by a member of the systems-reengineering team. Between sessions, participants will be asked to follow through on tasks outlined in the learning sessions and share in the next session. If a session is missed, they will be provided with a prerecording of the didactic material presented in the learning sessions.

Behavioral: Performance Improvement

Control

ACTIVE COMPARATOR

Participants randomly assigned to the control condition will continue as usual care and will not complete any intervention during the duration of the study.

Behavioral: control

Interventions

Emotional Wellbeing BEHAVIORAL

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.

Emotional Wellbeing

EHR Skills Optimization BEHAVIORAL

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.

EHR Skills Optimization

Performance Improvement BEHAVIORAL

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.

Performance Improvement

control BEHAVIORAL

Participants randomly assigned to the control condition will continue as usual care and will not complete any intervention during the duration of the study.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck School of Medicine, University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (1)

• Ruple C, Brodhead J, Rabinovich L, Junghaenel DU, Nakamura T, Wong J, De-Oliveira S, Brown J, Nguyen P, Horn J, Middleton R, Brahe M, Wen C, Rao S, Nguyen C, Shlamovitz G, Marino D, Osorno F, Siegel S. Protocol of randomized-controlled trial to examine the effectiveness of three different interventions to reduce healthcare provider burnout. BMC Health Serv Res. 2024 Dec 23;24(1):1643. doi: 10.1186/s12913-024-12131-4.

  PMID: 39716202 DERIVED

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Steven Siegel, MDPhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven J. Siegel, MD, PhD

CONTACT

(323) 422-4000; steven.siegel@med.usc.edu

John Brodhead, MD

CONTACT

(626) 375-0942; John.Brodhead@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: Randomized controlled trial of 3 interventions for clinician well-being as compared to controls.

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: April 12, 2023
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)