NCT05321381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

April 4, 2022

Last Update Submit

February 25, 2025

Conditions

Keywords

ResilienceWell-beingBurnoutHealth Care WorkerPeer Support

Outcome Measures

Primary Outcomes (1)

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

    Score on 7-item scale to measure anxiety

    Baseline, 1 and 2 years

Secondary Outcomes (5)

  • Change in Adult PROMIS Short Form v.1.0 Sleep Disturbance 4a score

    Baseline, 1 and 2 years

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

    Baseline, 1 and 2 years

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

    Baseline, 1 and 2 years

  • Change in Connor-Davidson Resilience Scale 2-item score

    Baseline, 1 and 2 years

  • Change in Patient Health Questionnaire-2 (PHQ-2) score

    Baseline, 1 and 2 years

Study Arms (2)

RISE Early

ACTIVE COMPARATOR

RISE peer support program available early, launched study year 1

Other: Resilience In Stressful Events (RISE) peer support team

RISE Late

ACTIVE COMPARATOR

RISE peer support program available later, launched study year 2

Other: Resilience In Stressful Events (RISE) peer support team

Interventions

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

RISE EarlyRISE Late

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Community Physicians

Baltimore, Maryland, 21209, United States

Location

UM Shore Regional Health

Chestertown, Maryland, 21620, United States

Location

MeSH Terms

Conditions

Burnout, PsychologicalAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Albert W Wu

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Complete stepped-wedge cluster randomized design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 11, 2022

Study Start

August 1, 2022

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations