Identifying Mental Health Distress in EM Physicians

Burnout, Professional Clinical Trial

Official title:

Investigating Proactive, Digital Methods to Identify Signs and Symptoms of Mental Health Distress in Emergency Medicine Physicians

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05606887
• Other study ID #: 0852220
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. This will be done by investigating the feasibility and acceptability of wearable device and EMA feedback with personalized linkage to an evidence-based mental health platform at the University of Pennsylvania Health System.

Description:

This proposal aims to conduct a 3-month pilot randomized control trial (n=60) testing feasibility, acceptability, and the exploratory effectiveness of digital data feedback (wearables and EMA) with tailored, symptom-specific linkage to mental health and resilience resources versus control on mental health symptoms (depression, anxiety, PTSD) and burnout in EM clinicians. The study will recruit and enroll 60 emergency medicine physicians, residents, and advanced practice providers via email and inperson outreach. Once enrolled, both arms be asked to take a baseline survey which will measure their level of well-being, burnout, depression, and anxiety.

Study participants will be randomized following consent and completion of baseline surveys. Participants will be randomly assigned to usual care or intervention. We will use 2:1 randomization. We will randomize in block sizes of 3 and 6.

Intervention: The intervention arm will then be given a wearable device and will be asked to wear it for 3 months. The device will collect biometric data on stress levels, sleep patterns, and other physiological measures of well-being. The intervention group will receive biweekly EMA short surveys, personalized bi-weekly reports from their EMA data, biometric feedback from wearable devices (sleep, heart rate variability, physical activity), and linkage to tailored and symptom-specific Cobalt resources on health and resilience. After 3 months, we will survey providers to complete a post-survey followed by a survey at 6-months following a 3-month washout period.

Control: The control arm will be asked to complete a baseline survey as well as one assessment at the end of the three-month study period. They will receive usual care, or clinician-initiated use of Penn Cobalt. They will then complete additional surveys at 3-months and 6-months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Emergency Medicine (EM) physician or advanced practice provider

• Daily access to smart phone

• Ability to use a wrist-worn wearable device

• Has or is willing to create a Gmail / Google account

• Provides at least 20 hours per week of clinical care.

Exclusion Criteria:

• Under 18

• Not a Penn EM physician or advanced practice provider

• Does not have daily access to a smart phone

• Unwilling or unable to wear a wearable device

• Does not have or is unwilling to create a Gmail / Google account

• Does not provide at least 20 hours per week of clinical care

Related Conditions & MeSH terms

• Burnout, Professional

Intervention

Other:
• Wearable Device and Ecological Momentary Assessments
The intervention will consist of three components: Completion of brief text-message based surveys 2-3 times per week Wearing a wrist-based wearable device to generate individual data insights on physiological data related to stress and well-being, including heart rate variability, stress scores, and sleep quality Individual biweekly reports of survey response trends and curated resources intended to support participant well-being

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Emergency Medicine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention (FIM)	Feasibility will be measured by the Feasibility of Intervention Measure (FIM)	Through study completion, on average 6 months
Primary	Feasibility of Intervention (Study Retention)	Feasibility will be measured by study retention	Through study completion, on average 6 months
Primary	Acceptability of Intervention (AIM)	Acceptability will be measured by the validated Acceptability of Intervention Measure.	Through study completion, on average 6 months
Primary	Acceptability of Intervention (EMA Completion Rates)	Acceptability will be measured by the open/completion rates of ecological momentary assessment.	Through study completion, on average 6 months
Secondary	Anxiety	While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The GAD-7 will be used to measure anxiety.	Through study completion, on average 6 months
Secondary	Depression	While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The PHQ-8 will be used to measure depression.	Through study completion, on average 6 months
Secondary	Professional Burnout	While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The Stanford Professional Fulfillment Index will be used to measure burnout.	Through study completion, on average 6 months
Secondary	Post-Traumatic Stress Disorder	While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The PC-PTSD-5 will be used to measure PTSD.	Through study completion, on average 6 months