- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373382
Peer Champion Support for Hospital Staff During and After the COVID-19 Pandemic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project studies the impact of two interventions, the addition of Peer Resilience Champions to other hospital supports and an interactive computer-based learning intervention that provides personalized feedback about relevant interpersonal and psychological characteristics of participants.
The Peer Resilience Champion (PRC) Intervention Investigators will second or hire an interdisciplinary team of healthcare professionals (e.g. nurses, social worker, or infection control professional, total of 1 FTE) to serve as Peer Resilience Champions. These Champions will receive coaching and then ongoing supervision in the relevant aspects of stress management, peer support, and resource navigation by expert members of the research team based on existing evidence. Peer Resilience Champions will act predominantly at the level of clinical units and departments.
The activities of Peer Resilience Champions 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, the Champions follow evidence-based principles and guidelines. The model is to provide quickly responsive, adaptive, peer support because it is expected that the needs of staff will change over the course of a pandemic and in its aftermath.
Peer Resilience Champions will work in an expanding selection of hospital locations, following a randomized cluster (stepped wedge) design until the resource is available to the entire organization. People who work and learn at Sinai Health do not need to participate in this study in order to receive the potential benefits provided by Peer Resilience Champions, which will be provided irrespective of study participation. The effectiveness of Peer Resilience Champions in reducing burnout and other outcomes will be tested using outcome measures included in the feedback staff survey (see below), which is completed by consenting participants in this study.
Interactive Computer-based Learning Intervention A staff survey which includes all primary and secondary outcomes measures will be completed by consenting participants at intervals of approximately 3 months seven times (over approximately 21 months). Participating staff will be randomized 1:1 to receive only these measures with no feedback (the Express Survey) or these measures plus additional measures of interpersonal and psychological characteristics, with personalized feedback (the Enriched Survey). Feedback is based on previous experience from the investigators in providing feedback from validated measures completed online to both healthcare workers and the general public. The purpose of feedback is to encourage self-reflection, especially with respect to coping and interpersonal interactions. The core measures that are common to both the Express and Enriched surveys serve to tests the effectiveness of the Peer Resilience Champions Intervention. The effectiveness of the Interactive Computer-based learning intervention will be tested by comparing the core measures between those receiving the Express Survey and those receiving the Enriched Survey.
Peer Resilience Champion Support The study design provides a controlled comparison of support as usual to PRC support. Using a randomized cluster (stepped wedged) design, usual staff support will be compared to that of PRC. PRC operates largely at the level of the clinical units and groups, and so a randomized cluster design is preferable to a randomized controlled trial. The stepped wedge design allows clusters of hospital staff/volunteers to receive the PRC intervention in a random sequence until the resource is available to all areas of the hospital.
This intervention will take place at Sinai Health System, including the Mount Sinai (approximately 4500 employees), Bridgepoint (approximately 1200 staff), and Lunenfeld-Tanenbaum Research Institute (LTRI) (approximately 1200 staff).
Five clusters of clinical units and departments will be constructed that are approximately balanced between hospital units and staff groups with (i) high COVID patient acuity (ICU, Emergency, medical units with negative pressure rooms) or high exposure to patients from community with unknown COVID status (Family Medicine, Labour and Delivery), (ii) all other clinical patient care areas, (iii) non-patient care areas, and (iv) areas in which most or all staff are/were temporarily restricted from attending the hospital (e.g. LTRI, volunteers).
After survey participants (and their disciplines and clinical units) are identified (T0 survey), their corresponding units, will be grouped into one of the five clusters in order to meet the above goals. These clusters will then be randomized in order to determine the order of intervention implementation. Each cluster will either receive support as usual or PRC for a period of three months, followed by the completion of a survey questionnaire given at seven different time points (T1-T7) spaced by three months.
NOTE - justification for choosing a non-blind comparison: Since the Express Survey is shorter than the Enriched Survey, participants are not blind to survey cohort assignment. Nor does the design control for time spent on an online activity. It would be possible to control for the duration of the survey by expanding the length of the control condition and this would also allow for the possibility of a blind comparison. However, a longer control survey would increase the risk of drop-out among participants in the control condition because completing surveys without interaction or feedback is not interesting. Since maximizing continued participation in serial surveys is critical to testing the PRC intervention hypothesis, a non-blind test of the Enriched Survey intervention hypothesis is preferable to increasing the risk of being underpowered to test the PRC hypothesis.
Feedback Surveys Immediately after consenting, participants will be asked to complete the T0 survey that asks about identifying information, and the characteristics of the participant's work at Sinai Health. The T0 survey also collects an email address, to which all subsequent surveys (T1 to T7) are sent. Following receipt of the T0 survey, participants are randomized to receive either the Express Survey (T1 to T7) or the Enriched survey (T1 to T7). In either case, T1 is sent soon (~1-2 weeks) after T0. All subsequent surveys are sent at approximately 3-month intervals.
T0 survey - The initial survey collects identifying data (non-binary gender, discipline, department, age, marital status), years of experience, SARS experience, number of people in household and information about COVID-19 experience to date (exposure to patients, experience with isolation of self or family members, testing etc.). Two free optional text write-in questions provide allow participants to describe more about themselves or their experience (past experience surveying healthcare workers post-SARS was that many were keen to write at length about their experience, beyond data collected more formally, and that insights from this open-ended reporting were valuable for placing quantitative results in experiential context during analysis and knowledge dissemination phases). The T0 survey takes about 10 minutes to complete plus whatever time is spent providing optional free-text answers.
Express Survey: The express survey includes validated measures of the primary outcome, the emotional exhaustion scale of the Maslach Burnout Inventory. The Express Survey also includes measures of secondary outcomes: sleep, post-traumatic stress disorder symptoms, psychological distress, occupational resilience, and COVID-19 prevention and control self-efficacy (using an instrument revised from a measure of self-efficacy used in preparation for an expected pandemic. The survey is the same each time it is completed (T1 to T7) at 3-month intervals. The Express Survey takes about 10 minutes to complete.
Enriched Survey: The Enriched Survey contains all of the measures included in the Express survey. No feedback is provided from any of these measures (i.e. this portion of the Enriched survey is identical to the Express Survey). In addition to these core outcome measures, the Enriched Survey includes measures of personality, interpersonal style and coping and provides personalized feedback based on scores at time points T1 to T6. The interactive measures included vary from one survey time point to the next in order to provide variety, and to cover a larger number of participant characteristics within the limits of reasonable survey time burden. State-dependent characteristics which may change over time (coping, interpersonal problems) are measured twice. A measure of lifetime experience with moral distress and a measurement of attachment, a stable trait, occur only once. The Enriched T1 to T6 surveys take about 10-20 minutes.
Sample size This study is powered to test hypothesis 1, which is expected to require a larger sample size than testing hypothesis 2. There are over 6000 staff at Sinai Health. Assuming a starting proportion of 30.4% of staff with high burnout (based on previous studies), an 80% power, and an alpha level of 0.05, five clusters of 200 staff providing measures per cluster is sufficient to detect a drop of ≥ 9.4% (with an intracluster correlation coefficient [ICC] of 0.01), ≥10.7% (ICC of 0.015), or ≥ 11.9% (ICC of 0.2). These ICC estimates are congruent with previous studies. These differences are consistent with a post-SARS study that found high burnout in 30.4% of exposed and 19.2% of unexposed HCWs. Five clusters of 200 staff (n=1000) would require <17% of staff to consent to participate and complete the measures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X5
- Sinai Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peer Resilience Champion Support
The clusters that receive this intervention will receive support from a 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
21 months
|
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)
|
21 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert G Maunder, Sinai Health
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-0084-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Burnout
-
Shengjing HospitalActive, not recruitingCareer Burnout | Student BurnoutChina
-
Region SkaneLund University; Swedish Council for Working Life and Social Research; County...CompletedProfessional BurnoutSweden
-
University of PadovaUniversity of ChileCompleted
-
University Diego PortalesInstituto de Seguridad del Trabajo, ChileRecruitingBurnout | Burnout, Caregiver | Parental BurnoutChile
-
Colleen J KleinRecruitingJob Stress | Professional BurnoutUnited States
-
Mayo ClinicNational Institute of Nursing Research (NINR)Enrolling by invitation
-
Duke UniversityCompleted
-
Fondazione Don Carlo Gnocchi OnlusCompleted
-
Wroclaw University of Health and Sport SciencesUniversity of Silesia in Katowice; Jan Dlugosz University in CzestochowaCompleted
-
Harvard Medical School (HMS and HSDM)Massachusetts General HospitalActive, not recruitingBurnout, Professional | Burnout, Student | Exercise | Community Building | MentorshipUnited States
Clinical Trials on Peer Resilience Champion
-
Johns Hopkins UniversityHealth Resources and Services Administration (HRSA)RecruitingAnxiety | Burn Out | Emotional DistressUnited States
-
University of VirginiaJohns Hopkins University; Virginia Commonwealth UniversityUnknownDecision Support TechniquesUnited States
-
Memorial University of NewfoundlandCompleted
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI); University of South CarolinaCompleted
-
Brigham and Women's HospitalEnrolling by invitationMild Cognitive Impairment | Subjective Cognitive Decline | Dementia, Mild | At Risk for Cognitive DeclineUnited States
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern... and other collaboratorsActive, not recruitingKidney Diseases | Kidney FailureUnited States
-
Institute of Human Virology, NigeriaUniversity of Maryland, Baltimore; University of Pittsburgh; University of Georgia and other collaboratorsRecruiting
-
Lydia FurmanUniversity Hospitals Cleveland Medical Center; Mt. Sinai Health Care FoundationCompletedHealth Behavior | Breastfeeding | IntentionUnited States
-
Johns Hopkins UniversityActive, not recruiting
-
Kaiser PermanenteBrown University; National Institute on Aging (NIA)CompletedDementia | Med: DementiaUnited States