Clinical trial NCT05606887: Identifying Mental Health Distress in EM Physicians
Official title: Investigating Proactive, Digital Methods to Identify Signs and Symptoms of Mental Health Distress in Emergency Medicine Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Emergency Medicine Foundation
First posted: 2022-11-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to the intervention arm (with wearable devices or EMAs) or control (survey-only) in parallel and will remain in their assigned arm throughout their participation in the survey.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Intervention (FIM)
timeFrame: Through study completion, on average 6 months
measure: Feasibility of Intervention (Study Retention)
timeFrame: Through study completion, on average 6 months
measure: Acceptability of Intervention (AIM)
timeFrame: Through study completion, on average 6 months
measure: Acceptability of Intervention (EMA Completion Rates)
timeFrame: Through study completion, on average 6 months
Secondary outcomes:
measure: Anxiety
timeFrame: Through study completion, on average 6 months
measure: Depression
timeFrame: Through study completion, on average 6 months
measure: Professional Burnout
timeFrame: Through study completion, on average 6 months
measure: Post-Traumatic Stress Disorder
timeFrame: Through study completion, on average 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: