Thriving Together: Supporting Resilience in the Healthcare Workforce
Primary Purpose
Emotional Distress, Burn Out, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resilience In Stressful Events (RISE) peer support team
Sponsored by
About this trial
This is an interventional other trial for Emotional Distress focused on measuring Resilience, Well-being, Burnout, Health Care Worker, Peer Support
Eligibility Criteria
Inclusion Criteria:
- Health care worker employed at participating implementation health care site/organization
Exclusion Criteria:
- Age less than 18 years
Sites / Locations
- Johns Hopkins Community PhysiciansRecruiting
- UM Shore Regional HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
RISE Early
RISE Late
Arm Description
RISE peer support program available early, launched study year 1
RISE peer support program available later, launched study year 2
Outcomes
Primary Outcome Measures
Change in Generalized Anxiety Disorder-7 scale (GAD-7) score
Score on 7-item scale to measure anxiety
Secondary Outcome Measures
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.
Change in Impact of Event Scale-Revised (IES-R) score
Score on scale to measure post traumatic stress.
Change in Maslach Burnout Inventory 2-item (MBI-2) scale score
Score on 2-item scale to measure worker burnout.
Change in Connor-Davidson Resilience Scale 2-item score
Score on 2-item scale to measure resilience.
Change in Patient Health Questionnaire-2 (PHQ-2) score
Score on 2-item scale to measure depressive symptoms.
Full Information
NCT ID
NCT05321381
First Posted
April 4, 2022
Last Updated
August 21, 2023
Sponsor
Johns Hopkins University
Collaborators
Health Resources and Services Administration (HRSA)
1. Study Identification
Unique Protocol Identification Number
NCT05321381
Brief Title
Thriving Together: Supporting Resilience in the Healthcare Workforce
Official Title
Thriving Together: Supporting Resilience in the Healthcare Workforce
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Health Resources and Services Administration (HRSA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Distress, Burn Out, Anxiety
Keywords
Resilience, Well-being, Burnout, Health Care Worker, Peer Support
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Complete stepped-wedge cluster randomized design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1396 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RISE Early
Arm Type
Active Comparator
Arm Description
RISE peer support program available early, launched study year 1
Arm Title
RISE Late
Arm Type
Active Comparator
Arm Description
RISE peer support program available later, launched study year 2
Intervention Type
Other
Intervention Name(s)
Resilience In Stressful Events (RISE) peer support team
Intervention Description
Availability of peer support team to health care workers who experience stressful work-related events or situations
Primary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder-7 scale (GAD-7) score
Description
Score on 7-item scale to measure anxiety
Time Frame
Baseline, 1 and 2 years
Secondary Outcome Measure Information:
Title
Change in Adult PROMIS Short Form v.1.0 Sleep Disturbance 4a score
Description
Score on single item to measure sleep disturbance : Adult Patient Reported Outcome Measurement Information System (PROMIS) Short Form v.1.0 Sleep Disturbance 4a.
Time Frame
Baseline, 1 and 2 years
Title
Change in Impact of Event Scale-Revised (IES-R) score
Description
Score on scale to measure post traumatic stress.
Time Frame
Baseline, 1 and 2 years
Title
Change in Maslach Burnout Inventory 2-item (MBI-2) scale score
Description
Score on 2-item scale to measure worker burnout.
Time Frame
Baseline, 1 and 2 years
Title
Change in Connor-Davidson Resilience Scale 2-item score
Description
Score on 2-item scale to measure resilience.
Time Frame
Baseline, 1 and 2 years
Title
Change in Patient Health Questionnaire-2 (PHQ-2) score
Description
Score on 2-item scale to measure depressive symptoms.
Time Frame
Baseline, 1 and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Health care worker employed at participating implementation health care site/organization
Exclusion Criteria:
Age less than 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albert W Wu, MD
Phone
4109781539
Email
awu@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl Connors, DNP
Phone
3016391934
Email
ccicio1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert W Wu
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Community Physicians
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Moore, MS, RN, CNS
Email
pmoore23@jhmi.edu
Facility Name
UM Shore Regional Health
City
Chestertown
State/Province
Maryland
ZIP/Postal Code
21620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherri Hobbs, MSM, MSN, RN
Phone
410-822-1000
Ext
5298
Email
sherri.hobbs@umm.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thriving Together: Supporting Resilience in the Healthcare Workforce
We'll reach out to this number within 24 hrs