Clinical trial NCT05321381: Thriving Together: Supporting Resilience in the Healthcare Workforce
Official title: Thriving Together: Supporting Resilience in the Healthcare Workforce
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Distress
Burn Out
Anxiety
Keywords: Resilience
Well-being
Burnout
Health Care Worker
Peer Support
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2022-04-11
Enrollment: 1362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Complete stepped-wedge cluster randomized design
Primary purpose: OTHER

Brief summary: Health care workers (HCW) face distressing work related situations that pose a threat to the HCW's resilience and well-being. Hospital-based peer support programs can improve HCW well-being, but there are few programs and little data for settings outside of hospitals. The program would adapt, implement, and evaluate an evidence-informed peer support program (RISE) in ambulatory practices, rural hospitals, Federally Qualified Health Centers (FQHC), and community based organizations (CBOs). The hypothesis is that the availability of peer support will improve the culture of well-being, and the resilience and well-being of HCW in participating organizations. The research has the potential to improve the quality of life of HCW and the quality of care available to diverse organizations and the populations the HCW serve.

Detailed description: Health care workers (HCW) face distressing work related situations that pose a threat to the HCW's resilience and well-being. Hospital-based peer support programs can improve HCW well-being, but there are few programs and little data for settings outside of hospitals. The program would adapt and implement an evidence-informed peer support program ((Resilience in Stressful Events = RISE) in ambulatory practices, rural hospitals, Federally Qualified Health Centers (FQHC), and community based organizations (CBOs). The hypothesis is that the availability of peer support will improve the culture of well-being, and the resilience and well-being of HCW in participating organizations.

The objectives are to:

1. Adapt and implement the RISE hospital peer support model in other health care contexts where HCW experience distressing events in the HCW's work.
2. Adapt and implement the Mental Emotional and Spiritual Help (MESH) collaborative model to provide a coordinated continuum of HCW support programs.
3. Adapt and implement a curriculum targeted at supporting organizational leaders during times of crisis which focuses on communication skills and understanding of fundamental psychological responses to stress.
4. Evaluate the program's effect on the culture of wellbeing, and the resilience and well-being of HCW in participating organizations.

The design of the study is a mixed-methods evaluation of the implementation of training and organizational structures to support HCW at different types of healthcare organizations (45 John Hopkins Community Physicians (JHCP) outpatient primary care clinics, 3 rural hospitals, 3 Federally Qualified Health Centers, and 3 community-based social service organizations - for a total 54 practice sites).

Based on the training, participating organizations will develop the organizations' own volunteer-based team to provide confidential, timely, peer support for HCW who encounter stressful, patient-related events. The RISE team is available on-call 24/7 to respond to calls and provide in person or virtual psychological first aid sessions.

The primary evaluation will be based on the differences between anonymous pre and post implementation surveys of random samples of HCW across sites. In the cluster randomized design, each of the 54 practice sites is considered a cluster. Half of the sites will be randomized to receive a team of trained RISE peer supporters launching in Year1Quarter3. The other half will receive this services launching Year2Quarter3.

The baseline survey will be in Year1Quarter2, the step 1 survey will be in Year2Qquarter2, and the step 2 survey will be Year3Quarter2. A random sample of 352 HCW will be surveyed at each time point. Focus groups will be conducted during the intervention with 120 HCW to inform quality improvement, and with 160 HCW across types of organization to coincide with the step 1 and step 2 surveys, to ask about the uptake of peer support services.

Survey data collection will be anonymous via a secure online platform. Focus groups will be conducted virtually using Zoom. HCWs will be compensated to complete surveys and participate in focus groups.

Analysis: The investigators will aim to detect a change of 0.2-0.3 standard deviation (SD) units on a given scale score, from before until after implementation, between the different steps. The investigators assume an intra-cluster (within site) correlation (ICC) of 0.3 SD. To detect an effect size of 0.3 on a measure of anxiety (GAD-7) for independent survey samples pre- and post-intervention step, with a two-tailed alpha=0.05 and power=80%, the investigators would need a total of 1056 HCW responses (352 at each of 3 survey timepoints) using a two-sided Wald Z-Test.

Eligibility criteria: Inclusion Criteria:

* Health care worker employed at participating implementation health care site/organization

Exclusion Criteria:

* Age less than 18 years

Primary outcomes:
measure: Change in Generalized Anxiety Disorder-7 scale (GAD-7) score
timeFrame: Baseline, 1 and 2 years
Secondary outcomes:
measure: Change in Adult PROMIS Short Form v.1.0 Sleep Disturbance 4a score
timeFrame: Baseline, 1 and 2 years
measure: Change in Impact of Event Scale-Revised (IES-R) score
timeFrame: Baseline, 1 and 2 years
measure: Change in Maslach Burnout Inventory 2-item (MBI-2) scale score
timeFrame: Baseline, 1 and 2 years
measure: Change in Connor-Davidson Resilience Scale 2-item score
timeFrame: Baseline, 1 and 2 years
measure: Change in Patient Health Questionnaire-2 (PHQ-2) score
timeFrame: Baseline, 1 and 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Community Physicians
state: Maryland
city: Chestertown
country: United States
facility: UM Shore Regional Health
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Albert W Wu
role: PRINCIPAL_INVESTIGATOR
References: