Thriving Together: Supporting Resilience in the Healthcare Workforce

February 25, 2025 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Johns Hopkins Community Physicians
      • Chestertown, Maryland, United States, 21620
        • UM Shore Regional Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age less than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RISE Early
RISE peer support program available early, launched study year 1
Other: Resilience In Stressful Events (RISE) peer support team
Availability of peer support team to health care workers who experience stressful work-related events or situations
Active Comparator: RISE Late
RISE peer support program available later, launched study year 2
Other: Resilience In Stressful Events (RISE) peer support team
Availability of peer support team to health care workers who experience stressful work-related events or situations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Generalized Anxiety Disorder-7 scale (GAD-7) score
Time Frame: Baseline, 1 and 2 years
Score on 7-item scale to measure anxiety
Baseline, 1 and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adult PROMIS Short Form v.1.0 Sleep Disturbance 4a score
Time Frame: Baseline, 1 and 2 years
Score on single item to measure sleep disturbance : Adult Patient Reported Outcome Measurement Information System (PROMIS) Short Form v.1.0 Sleep Disturbance 4a.
Baseline, 1 and 2 years
Change in Impact of Event Scale-Revised (IES-R) score
Time Frame: Baseline, 1 and 2 years
Score on scale to measure post traumatic stress.
Baseline, 1 and 2 years
Change in Maslach Burnout Inventory 2-item (MBI-2) scale score
Time Frame: Baseline, 1 and 2 years
Score on 2-item scale to measure worker burnout.
Baseline, 1 and 2 years
Change in Connor-Davidson Resilience Scale 2-item score
Time Frame: Baseline, 1 and 2 years
Score on 2-item scale to measure resilience.
Baseline, 1 and 2 years
Change in Patient Health Questionnaire-2 (PHQ-2) score
Time Frame: Baseline, 1 and 2 years
Score on 2-item scale to measure depressive symptoms.
Baseline, 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Albert W Wu, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00319396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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