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

Not Applicable

Active, not recruiting

• Conditions: Satisfaction; Depression, Anxiety; Well-being
• Interventions: Other: Comprehensive Well-Being Intervention

• Registration Number: NCT05931432
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-05
• Study Start: 2023-10-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-07-27
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 293

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive Well-Being Intervention	Comprehensive Well-Being Intervention	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.

Primary Outcome Measures

Name	Time	Method
Well-Being Index (WBI)	at month 15	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

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-2)	at month 18	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.
General Anxiety Disorder (GAD-2)	at month 18	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.
Perceived Stress Scale (PSS-10)	at month 18	The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress
Connor-Davidson Resilience Scale (CDRS)	at month 18	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
Physician Job Satisfaction Scale (JSS-10)	at month 18	The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure
Professional Fulfillment Index	at month 18	• 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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States