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.
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
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:
- Adapt and implement the RISE hospital peer support model in other health care contexts where HCW experience distressing events in the HCW's work.
- Adapt and implement the Mental Emotional and Spiritual Help (MESH) collaborative model to provide a coordinated continuum of HCW support programs.
- 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.
- 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.
- Conditions
- Emotional Distress, Burn Out, Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| RISE Early | Active comparator | RISE peer support program available early, launched study year 1 Receives: Other: Resilience In Stressful Events (RISE) peer support team |
| RISE Late | Active comparator | RISE 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.
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)
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
Change in Impact of Event Scale-Revised (IES-R) score
Score on scale to measure post traumatic stress.
Measured: Baseline, 1 and 2 years
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
Change in Connor-Davidson Resilience Scale 2-item score
Score on 2-item scale to measure resilience.
Measured: Baseline, 1 and 2 years
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.
- First posted11 Apr 2022
- Study start1 Aug 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Albert W Wu, Principal investigator, Johns Hopkins University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thriving Together: Supporting Resilience in the Healthcare Workforce
- ClinicalTrials.gov ID
- NCT05321381
- Acronym / sponsor ID
- IRB00319396
- Conditions
- Emotional Distress, Burn Out, Anxiety
- Keywords
- Resilience, Well-being, Burnout, Health Care Worker, Peer Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,362 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Adapt and implement the RISE hospital peer support model in other health care contexts where HCW experience distressing events in the HCW's work.
- Adapt and implement the Mental Emotional and Spiritual Help (MESH) collaborative model to provide a coordinated continuum of HCW support programs.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Complete stepped-wedge cluster randomized design
| Arm | Type | Receives |
|---|---|---|
| RISE Early | Active comparator | Other: Resilience In Stressful Events (RISE) peer support teamRISE peer support program available early, launched study year 1 |
| RISE Late | Active comparator | Other: Resilience In Stressful Events (RISE) peer support teamRISE peer support program available later, launched study year 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health care worker employed at participating implementation health care site/organization
Key exclusion criteria (1 listed)
- Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience In Stressful Events (RISE) peer support teamAvailability of peer support team to health care workers who experience stressful work-related events or situations | Other | RISE Early, RISE Late |
Primary outcome
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
5 secondary outcomes
Change in Adult PROMIS Short Form v.1.0 Sleep Disturbance 4a score
Time frame: Baseline, 1 and 2 years
Change in Impact of Event Scale-Revised (IES-R) score
Time frame: Baseline, 1 and 2 years
Change in Maslach Burnout Inventory 2-item (MBI-2) scale score
Time frame: Baseline, 1 and 2 years
Change in Connor-Davidson Resilience Scale 2-item score
Time frame: Baseline, 1 and 2 years
Change in Patient Health Questionnaire-2 (PHQ-2) score
Time frame: Baseline, 1 and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert W Wu principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
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.