Clinical trial NCT05931432: A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Satisfaction
Well-being
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2023-07-05
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Well-Being Index (WBI)
timeFrame: at month 0
measure: Well-Being Index (WBI)
timeFrame: at month 3
measure: Well-Being Index (WBI)
timeFrame: at month 6
measure: Well-Being Index (WBI)
timeFrame: at month 9
measure: Well-Being Index (WBI)
timeFrame: at month 12
measure: Well-Being Index (WBI)
timeFrame: at month 15
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: at month 0
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: at month 18
measure: General Anxiety Disorder (GAD-2)
timeFrame: at month 0
measure: General Anxiety Disorder (GAD-2)
timeFrame: at month 18
measure: Perceived Stress Scale (PSS-10)
timeFrame: at month 0
measure: Perceived Stress Scale (PSS-10)
timeFrame: at month 18
measure: Connor-Davidson Resilience Scale (CDRS)
timeFrame: at month 0
measure: Connor-Davidson Resilience Scale (CDRS)
timeFrame: at month 18
measure: Physician Job Satisfaction Scale (JSS-10)
timeFrame: at month 0
measure: Physician Job Satisfaction Scale (JSS-10)
timeFrame: at month 18
measure: Professional Fulfillment Index
timeFrame: at month 0
measure: Professional Fulfillment Index
timeFrame: at month 18
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: