- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05931432
A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID (Thrive)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
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
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-Being Index (WBI)
Time Frame: at month 0
|
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)
Time Frame: at month 3
|
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)
Time Frame: at month 6
|
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)
Time Frame: at month 9
|
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)
Time Frame: at month 12
|
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)
Time Frame: 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
|
at month 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire (PHQ-2)
Time Frame: at month 0
|
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)
Time Frame: 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.
|
at month 18
|
|
General Anxiety Disorder (GAD-2)
Time Frame: at month 0
|
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)
Time Frame: 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.
|
at month 18
|
|
Perceived Stress Scale (PSS-10)
Time Frame: at month 0
|
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)
Time Frame: at month 18
|
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)
Time Frame: at month 0
|
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)
Time Frame: 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
|
at month 18
|
|
Physician Job Satisfaction Scale (JSS-10)
Time Frame: at month 0
|
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)
Time Frame: at month 18
|
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
Time Frame: at month 0
|
• 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
Time Frame: 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.
|
at month 18
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 852022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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