NCT04373382

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
882

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

April 30, 2020

Last Update Submit

March 16, 2023

Conditions

Keywords

healthcare workersresilienceinfectious diseaseCOVID-19burnout

Outcome Measures

Primary Outcomes (2)

  • Change in instances of burnout for hospital staff due to the Peer Resilience Champion intervention

    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)

    21 months

  • Change in instances of burnout for hospital staff due to the Enriched Feedback Survey intervention

    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)

    21 months

Study Arms (4)

Peer Resilience Champion Support

EXPERIMENTAL

The clusters that receive this intervention will receive support from a Peer Resilience Champion.

Behavioral: Peer Resilience Champion

No Peer Resilience Champion Support

NO INTERVENTION

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.

Enriched Feedback

EXPERIMENTAL

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

Express Feedback

NO INTERVENTION

This arm of the study encompasses individuals who will not receive feedback from the survey.

Interventions

PRC is supplied to everyone and provides support to hospital staff during the COVID-19 pandemic in a stepped-wedge design.

Peer Resilience Champion Support

This intervention provides feedback based on answers to questionnaires to those in the Enriched Feedback arm of the study.

Enriched Feedback

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai Health System

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (6)

  • Maunder RG, Lancee WJ, Balderson KE, Bennett JP, Borgundvaag B, Evans S, Fernandes CM, Goldbloom DS, Gupta M, Hunter JJ, McGillis Hall L, Nagle LM, Pain C, Peczeniuk SS, Raymond G, Read N, Rourke SB, Steinberg RJ, Stewart TE, VanDeVelde-Coke S, Veldhorst GG, Wasylenki DA. Long-term psychological and occupational effects of providing hospital healthcare during SARS outbreak. Emerg Infect Dis. 2006 Dec;12(12):1924-32. doi: 10.3201/eid1212.060584.

    PMID: 17326946BACKGROUND
  • Maunder R. The experience of the 2003 SARS outbreak as a traumatic stress among frontline healthcare workers in Toronto: lessons learned. Philos Trans R Soc Lond B Biol Sci. 2004 Jul 29;359(1447):1117-25. doi: 10.1098/rstb.2004.1483.

    PMID: 15306398BACKGROUND
  • Salyers MP, Bonfils KA, Luther L, Firmin RL, White DA, Adams EL, Rollins AL. The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis. J Gen Intern Med. 2017 Apr;32(4):475-482. doi: 10.1007/s11606-016-3886-9. Epub 2016 Oct 26.

    PMID: 27785668BACKGROUND
  • 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.

    BACKGROUND
  • Maunder RG, Lancee WJ, Mae R, Vincent L, Peladeau N, Beduz MA, Hunter JJ, Leszcz M. Computer-assisted resilience training to prepare healthcare workers for pandemic influenza: a randomized trial of the optimal dose of training. BMC Health Serv Res. 2010 Mar 22;10:72. doi: 10.1186/1472-6963-10-72.

    PMID: 20307302BACKGROUND
  • Aiello A, Khayeri MY, Raja S, Peladeau N, Romano D, Leszcz M, Maunder RG, Rose M, Adam MA, Pain C, Moore A, Savage D, Schulman RB. Resilience training for hospital workers in anticipation of an influenza pandemic. J Contin Educ Health Prof. 2011 Winter;31(1):15-20. doi: 10.1002/chp.20096.

    PMID: 21425355BACKGROUND

MeSH Terms

Conditions

Burnout, PsychologicalCommunicable DiseasesCOVID-19

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Robert G Maunder

    Sinai Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 4, 2020

Study Start

July 27, 2020

Primary Completion

May 16, 2022

Study Completion

July 27, 2023

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations