A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID

Study Overview
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Brief Summary
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For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic. The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems. Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources. Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.

Official Title
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A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID

Conditions
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Depression, Anxiety, Satisfaction, Well-being

Intervention / Treatment
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* Other: Comprehensive Well-Being Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age; Interest in participating in an 18 month study and willing to complete regular surveys; Regular, daily access to a phone with texting capabilities Identify as a Physician at Penn Medicine; Exclusion Criteria: Under 18 years of age; Not willing to sign informed consent document for an 18 month study; No access to a phone with texting capabilities; Not a Physician at Penn Medicine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants will be asked to complete an ICF and baseline survey at enrollment. They will be given survey assessments at 0, 18 and 30 months. Survey assessments will include validated measures on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The control group will have access to usual care well-being resources at Penn Medicine. These include links, classes, groups, social media sites such as Penn Cobalt which require self-awareness to find the resources and access them. In this context, the individual has to pull the resources they need and there may be several barriers to completing each step | |
| Experimental: Comprehensive Well-Being Intervention<br>Participants will be asked to complete an ICF and baseline survey at enrollment. Participants will complete a full assessment using validated instruments at enrollment, 18 months and 30 months (depression, anxiety, stress, resilience, and job satisfaction). Participants will also complete the brief well-being index (WBI, nine questions) every 3 months over 30 months. The primary endpoint is assessed at 18 months. A secondary endpoint of persistence of effect is measured at 30 months. The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. | Other: Comprehensive Well-Being Intervention<br>* The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. The content of monthly text messaging resources and discussion topics for the peer-support groups will be informed by the Aim 1 qualitative findings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-Being Index (WBI) | The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey | at month 0 | 
| Well-Being Index (WBI) | The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey | at month 3 | 
| Well-Being Index (WBI) | The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey | at month 6 | 
| Well-Being Index (WBI) | The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey | at month 9 | 
| Well-Being Index (WBI) | The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey | at month 12 | 
| Well-Being Index (WBI) | The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey | at month 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-2) | PHQ-2 and GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. | at month 0 | 
| Patient Health Questionnaire (PHQ-2) | PHQ-2 and GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. | at month 18 | 
| General Anxiety Disorder (GAD-2) | GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. | at month 0 | 
| General Anxiety Disorder (GAD-2) | GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. | at month 18 | 
| Perceived Stress Scale (PSS-10) | The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress | at month 0 | 
| Perceived Stress Scale (PSS-10) | The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress | at month 18 | 
| Connor-Davidson Resilience Scale (CDRS) | The Connor-Davidson Resilience Scale (CDRS) is a 2-item standardized and validated instrument in physician populations and measures bounce back and adaptability aspects of resilience | at month 0 | 
| Connor-Davidson Resilience Scale (CDRS) | The Connor-Davidson Resilience Scale (CDRS) is a 2-item standardized and validated instrument in physician populations and measures bounce back and adaptability aspects of resilience | at month 18 | 
| Physician Job Satisfaction Scale (JSS-10) | The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure | at month 0 | 
| Physician Job Satisfaction Scale (JSS-10) | The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure | at month 18 | 
| Professional Fulfillment Index | • The Professional Fulfillment Index (PFI) was developed to capture both burnout and professional fulfillment in the evaluation and assessment of professional wellbeing [18]. The PFI is a 16-item index that measures burnout and professional fulfillment. | at month 0 | 
| Professional Fulfillment Index | • The Professional Fulfillment Index (PFI) was developed to capture both burnout and professional fulfillment in the evaluation and assessment of professional wellbeing [18]. The PFI is a 16-item index that measures burnout and professional fulfillment. | at month 18 |