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Emotional DistressNCT05321381

Thriving Together: Supporting Resilience in the Healthcare Workforce

A study testing Resilience In Stressful Events (RISE) peer support team in people with Emotional Distress and Burn Out, run by Johns Hopkins University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Emotional Distress, Burn Out, Anxiety
What is being tested?
Resilience In Stressful Events (RISE) peer support team
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,362 participants
Where
2 sitesUnited States
Study dates
1 Aug 2022to 31 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Age less than 18 years

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Johns Hopkins Community Physicians

    Baltimore, Maryland, 21209

  • UM Shore Regional Health

    Chestertown, Maryland, 21620

Other trials in United States

About this study

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.

Read the 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.

Being tested
Resilience In Stressful Events (RISE) peer support team
Keywords
Resilience, Well-being, Burnout, Health Care Worker, Peer Support
Medical subject headings
Burnout, Psychological, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resilience In Stressful Events (RISE) peer support teamOther

    Availability of peer support team to health care workers who experience stressful work-related events or situations

Study groups in NCT05321381
Study groupRoleWhat they receive
RISE EarlyActive comparatorRISE peer support program available early, launched study year 1
Receives: Other: Resilience In Stressful Events (RISE) peer support team
RISE LateActive comparatorRISE peer support program available later, launched study year 2
Receives: Other: Resilience In Stressful Events (RISE) peer support team

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Generalized Anxiety Disorder-7 scale (GAD-7) score

    Score on 7-item scale to measure anxiety

    Measured: Baseline, 1 and 2 years

Secondary outcomes (5)
  1. Change in Adult PROMIS Short Form v.1.0 Sleep Disturbance 4a score

    Score on single item to measure sleep disturbance : Adult Patient Reported Outcome Measurement Information System (PROMIS) Short Form v.1.0 Sleep Disturbance 4a.

    Measured: Baseline, 1 and 2 years

  2. Change in Impact of Event Scale-Revised (IES-R) score

    Score on scale to measure post traumatic stress.

    Measured: Baseline, 1 and 2 years

  3. Change in Maslach Burnout Inventory 2-item (MBI-2) scale score

    Score on 2-item scale to measure worker burnout.

    Measured: Baseline, 1 and 2 years

  4. Change in Connor-Davidson Resilience Scale 2-item score

    Score on 2-item scale to measure resilience.

    Measured: Baseline, 1 and 2 years

  5. Change in Patient Health Questionnaire-2 (PHQ-2) score

    Score on 2-item scale to measure depressive symptoms.

    Measured: Baseline, 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Model description
Complete stepped-wedge cluster randomized design
Masking
None (open label)
Enrolment
1,362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321381
Sponsor's protocol ID
IRB00319396
Status last verified
Feb 2025
First submitted
4 Apr 2022
Last updated
26 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Resilience In Stressful Events (RISE) peer support team in people with Emotional Distress and Burn Out, run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Generalized Anxiety Disorder-7 scale (GAD-7) score (time frame: Baseline, 1 and 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.

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