Identifying Mental Health Distress in EM Physicians

NCT ID: NCT05606887

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2024-06-10

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.

Conditions

Burnout, Professional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

In addition to completing 3 surveys over the course of 6 months, participants in the intervention arm will be asked to wear a wearable device (FitBit Charge 5), complete texting-based ecological momentary assessments to gauge real-time feelings of stress, and receive bi-weekly personalized data dashboards to report back their data.

Group Type: EXPERIMENTAL

Wearable Device and Ecological Momentary Assessments

Intervention Type: OTHER

The intervention will consist of three components:

1. Completion of brief text-message based surveys 2-3 times per week

2. 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

3. Individual biweekly reports of survey response trends and curated resources intended to support participant well-being

Control

Participants randomized to this arm will receive digital surveys over the course of 6 months (one at baseline, one at 3 months, and one at 6 months). These surveys will be the same as the intervention arm and will ask questions related to burnout, anxiety, depression, PTSD, and stress.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wearable Device and Ecological Momentary Assessments

The intervention will consist of three components:

1. Completion of brief text-message based surveys 2-3 times per week

2. 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

3. Individual biweekly reports of survey response trends and curated resources intended to support participant well-being

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emergency Medicine Foundation

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

0852220

Identifier Type: -

Identifier Source: org_study_id