Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05321381 |
| Other study ID # |
IRB00319396 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Johns Hopkins University |
| Contact |
Albert W Wu, MD |
| Phone |
4109781539 |
| Email |
awu[@]jhu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
