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Identifying Mental Health Distress in EM Physicians

Primary Purpose

Burnout, Professional

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable Device and Ecological Momentary Assessments
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Burnout, Professional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of Intervention (FIM)
Feasibility will be measured by the Feasibility of Intervention Measure (FIM)
Feasibility of Intervention (Study Retention)
Feasibility will be measured by study retention
Acceptability of Intervention (AIM)
Acceptability will be measured by the validated Acceptability of Intervention Measure.
Acceptability of Intervention (EMA Completion Rates)
Acceptability will be measured by the open/completion rates of ecological momentary assessment.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 26, 2022
Last Updated
October 9, 2023
Sponsor
University of Pennsylvania
Collaborators
Emergency Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05606887
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Emergency Medicine Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Given the nature of the intervention (i.e., participants in the intervention arm receiving a wearable device and investigators and analysts reviewing biometric data for this group), the study will not be masked.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Wearable Device and Ecological Momentary Assessments
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of Intervention (FIM)
Description
Feasibility will be measured by the Feasibility of Intervention Measure (FIM)
Time Frame
Through study completion, on average 6 months
Title
Feasibility of Intervention (Study Retention)
Description
Feasibility will be measured by study retention
Time Frame
Through study completion, on average 6 months
Title
Acceptability of Intervention (AIM)
Description
Acceptability will be measured by the validated Acceptability of Intervention Measure.
Time Frame
Through study completion, on average 6 months
Title
Acceptability of Intervention (EMA Completion Rates)
Description
Acceptability will be measured by the open/completion rates of ecological momentary assessment.
Time Frame
Through study completion, on average 6 months
Secondary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
Through study completion, on average 6 months
Title
Depression
Description
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.
Time Frame
Through study completion, on average 6 months
Title
Professional Burnout
Description
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.
Time Frame
Through study completion, on average 6 months
Title
Post-Traumatic Stress Disorder
Description
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.
Time Frame
Through study completion, on average 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anish K Agarwal, MD, MS, MPH
Phone
215-573-9359
Email
anish.agarwal@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel E Gonzales, MPH
Phone
2155739359
Email
rachel.gonzales@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Gonzales, MPH
Email
rachel.gonzales@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Identifying Mental Health Distress in EM Physicians

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