Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peer Champion Support for Hospital Staff During and After the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373382
Recruitment Status : Active, not recruiting
First Posted : May 4, 2020
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Robert Maunder, Mount Sinai Hospital, Canada

Brief Summary:
Experience from the 2003 Severe Acute Respiratory Syndrome (SARS) outbreak taught that healthcare workers (HCWs) often experience chronic stress effects for months or years after such an event, and that supporting HCWs requires attention to the marathon of occupational stress, not just the sprint of dramatic stressors that occur while infections are dominating the news. This study will test if the well-being of hospital workers facing a novel coronavirus outbreak is improved by adding either of two interventions: (1) Peer Resilience Champions (PRC): an interdisciplinary team of professionals who actively monitor for early signs of heightened stress within clinical teams, liaise between staff and senior management to improve organizational responsiveness, and provide direct support and teaching (under the supervision of experts in resilience, infection control, and professional education). Investigators will test the effectiveness of this PRC Intervention by rolling it out to different parts of the hospital in stages and comparing levels of burnout before and after the intervention reaches particular teams and units (a stepped wedge design). By the end of the study, PRC Support will have been provided to all clinical and research staff and many learners (> 6,000 people). Note that the provision of PRC support will be directed to the entire organization. The research portion of the study is the evaluation of PRC support through a repeated survey completed by consenting staff. Investigators will test the effectiveness of the PRC by measuring trends in burnout and other effects of stress over the course of the study in a subgroup of hospital workers (as many as consent, target ~1000 people) through an online questionnaire (called "How Are You?"). (2) The second intervention is an enriched version of the "How Are You?" Survey, which provides personalized feedback about coping, interpersonal interactions and moral distress. Participants will be randomized (1:1) to receive the shorter Express Survey (identifying data and outcome measures only), or the Enriched survey (all of the Express measures plus additional measures with feedback based on responses). It is hypothesized that both the PRC intervention and the Enriched Survey intervention will help prevent or reduce instances of burnout in HCWs.

Condition or disease Intervention/treatment Phase
Burnout Behavioral: Peer Resilience Champion Behavioral: Enriched Survey Feedback Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 882 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Hospital staff will receive support from Peer Resilience Champions, whose activities will, in part, be modelled on the role that psychiatrists acting as support coaches have played in during the acute phase of the pandemic. These include support, identification of needs, education, advocacy and resource navigation. In doing so, they follow evidence-based principles and guidelines.

A randomized cluster stepped wedge design will be used, with five clusters of clinical units and departments constructed in order to approximate the following goals: similar number of staff, comparable COVID-19 exposure, similar mix of staff by discipline and gender, number of clusters small enough to allow for the PRC intervention to be provided with at least six months of implementation within the two-year study after cross-over occurs. (Two arms).

The Enriched survey intervention will be a randomized controlled trial design with equal allocation (1:1) to both the express and enriched surveys. (Two arms).

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Peer Champion Support for Hospital Staff During and After the COVID-19 Pandemic
Actual Study Start Date : July 27, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peer Resilience Champion Support
The clusters that receive this intervention will receive support from a Peer Resilience Champion.
Behavioral: Peer Resilience Champion
PRC is supplied to everyone and provides support to hospital staff during the COVID-19 pandemic in a stepped-wedge design.

No Intervention: No Peer Resilience Champion Support
The clusters in this arm of the study will not receive the Peer Resilience Champion support until they cross-over into the Peer Resilience Champion support arm.
Experimental: Enriched Feedback
This arm of the study encompasses individuals who will receive feedback from the survey that will hopefully help provoke self-reflection.
Behavioral: Enriched Survey Feedback
This intervention provides feedback based on answers to questionnaires to those in the Enriched Feedback arm of the study.

No Intervention: Express Feedback
This arm of the study encompasses individuals who will not receive feedback from the survey.



Primary Outcome Measures :
  1. Change in instances of burnout for hospital staff due to the Peer Resilience Champion intervention [ Time Frame: 21 months ]
    Impact of the Peer Resilience Champion intervention as determined by a high outcome (defined as a cutoff of ≥27 on the Maslach Burnout Inventory: Emotional Exhaustion subscale)

  2. Change in instances of burnout for hospital staff due to the Enriched Feedback Survey intervention [ Time Frame: 21 months ]
    Impact of the Enriched survey feedback intervention as determined by a high outcome (defined as a cutoff of ≥27 on the Maslach Burnout Inventory: Emotional Exhaustion subscale)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • An employee, physician, scientist, employee of a contractor or retail business, learning, or volunteer of Sinai Health at time of recruitment. Must be able to read and respond to a survey in English. Need to have access to a computer or device connected to the internet and be able to use said device.

Exclusion Criteria:

  • Failure to meet inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373382


Locations
Layout table for location information
Canada, Ontario
Sinai Health System
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Robert G Maunder Sinai Health
Publications:
Edmondson AC, Higgins M, Singer S & Weiner J. Understanding Psychological Safety in Health Care and Education Organizations: A Comparative Perspective. Research in Human Development. 2016; 13(1): 65-83.

Layout table for additonal information
Responsible Party: Robert Maunder, Professor, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT04373382    
Other Study ID Numbers: 20-0084-E
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Maunder, Mount Sinai Hospital, Canada:
healthcare workers
resilience
infectious disease
COVID-19
burnout
Additional relevant MeSH terms:
Layout table for MeSH terms
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms