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

Primary Purpose

Depression, Anxiety, Satisfaction, Well-being

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Well-Being Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Comprehensive Well-Being Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

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.
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.
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.
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.
Perceived Stress Scale (PSS-10)
The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress
Perceived Stress Scale (PSS-10)
The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress
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
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
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
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
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.
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.

Full Information

First Posted
May 16, 2023
Last Updated
October 17, 2023
Sponsor
University of Pennsylvania
Collaborators
Pennsylvania Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT05931432
Brief Title
A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID
Acronym
Thrive
Official Title
A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Pennsylvania Department of Health

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Satisfaction, Well-being

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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
Arm Title
Comprehensive Well-Being Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Well-Being Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Well-Being Index (WBI)
Description
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
Time Frame
at month 0
Title
Well-Being Index (WBI)
Description
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
Time Frame
at month 3
Title
Well-Being Index (WBI)
Description
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
Time Frame
at month 6
Title
Well-Being Index (WBI)
Description
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
Time Frame
at month 9
Title
Well-Being Index (WBI)
Description
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
Time Frame
at month 12
Title
Well-Being Index (WBI)
Description
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
Time Frame
at month 15
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-2)
Description
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.
Time Frame
at month 0
Title
Patient Health Questionnaire (PHQ-2)
Description
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.
Time Frame
at month 18
Title
General Anxiety Disorder (GAD-2)
Description
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.
Time Frame
at month 0
Title
General Anxiety Disorder (GAD-2)
Description
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.
Time Frame
at month 18
Title
Perceived Stress Scale (PSS-10)
Description
The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress
Time Frame
at month 0
Title
Perceived Stress Scale (PSS-10)
Description
The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress
Time Frame
at month 18
Title
Connor-Davidson Resilience Scale (CDRS)
Description
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
Time Frame
at month 0
Title
Connor-Davidson Resilience Scale (CDRS)
Description
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
Time Frame
at month 18
Title
Physician Job Satisfaction Scale (JSS-10)
Description
The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure
Time Frame
at month 0
Title
Physician Job Satisfaction Scale (JSS-10)
Description
The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure
Time Frame
at month 18
Title
Professional Fulfillment Index
Description
• 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.
Time Frame
at month 0
Title
Professional Fulfillment Index
Description
• 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.
Time Frame
at month 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Gonzales, MPH
Phone
6304846834
Email
Rachel.Gonzales@Pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Southwick, MPH
Email
Lauren.Southwick@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

Learn more about this trial

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

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