Identifying Mental Health Distress in EM Physicians

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05606887
Collaborator
Emergency Medicine Foundation (Other)
60
2
24

Study Details

Study Description

Brief Summary

This project seeks to develop and test physician-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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Wearable Device and Ecological Momentary Assessments
N/A

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 and residents 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 wil lbe randomly assigned to usual care or intervention. We will use 1:1 randomization stratified by sex and race. We will randomize in block sizes of 2 and 4.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Primary Purpose:
Health Services Research
Official Title:
Investigating Proactive, Digital Methods to Identify Signs and Symptoms of Mental Health Distress in Emergency Medicine Physicians
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 (Garmin VivoSmart) and complete texting-based ecological momentary assessments to gauge real-time feelings of stress.

Behavioral: Wearable Device and Ecological Momentary Assessments
The intervention will ask participants to wear a wrist-based wearable device that will collect real-time biometric data related to stress and well-being, including heart rate variability, stress scores, and sleep quality. Based on these values as well as ecological momentary assessment results, participants will receive curated resources intended to support their well-being.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of Intervention (FIM) [Through study completion, on average 6 months]

    Feasibility will be measured by the Feasibility of Intervention Measure (FIM)

  2. Feasibility of Intervention (Study Retention) [Through study completion, on average 6 months]

    Feasibility will be measured by study retention

  3. Acceptability of Intervention (AIM) [Through study completion, on average 6 months]

    Acceptability will be measured by the validated Acceptability of Intervention Measure.

  4. Acceptability of Intervention (EMA Completion Rates) [Through study completion, on average 6 months]

    Acceptability will be measured by the open/completion rates of ecological momentary assessment.

Secondary Outcome Measures

  1. Anxiety [Through study completion, on average 6 months]

    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.

  2. Depression [Through study completion, on average 6 months]

    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.

  3. Professional Burnout [Through study completion, on average 6 months]

    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.

  4. Post-Traumatic Stress Disorder [Through study completion, on average 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Emergency Medicine (EM) physician, daily access to smart phone, ability to use a wrist-worn wearable device, and provides at least 20 hours per week of clinical care.
Exclusion Criteria:
  • Under 18, not a Penn EM physician, does not have daily access to a smart phone, unwilling or unable to wear a wearable device, does not provide at least 20 hours per week of clinical care

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pennsylvania
  • Emergency Medicine Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05606887
Other Study ID Numbers:
  • 0852220
First Posted:
Nov 7, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2022