Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04373382
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-17
First Post:
2020-04-30
Brief Title:
Peer Champion Support for Hospital Staff During and After the COVID-19 Pandemic
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
Peer Champion Support for Hospital Staff During and After the COVID-19 Pandemic
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 6000 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 11 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
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 eg 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 11 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 staffvolunteers 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 arewere temporarily restricted from attending the hospital eg 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 participants 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 ie 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 304 of staff with high burnout based on previous studies an 80 power and an alpha level of 005 five clusters of 200 staff providing measures per cluster is sufficient to detect a drop of 94 with an intracluster correlation coefficient ICC of 001 107 ICC of 0015 or 119 ICC of 02 These ICC estimates are congruent with previous studies These differences are consistent with a post-SARS study that found high burnout in 304 of exposed and 192 of unexposed HCWs Five clusters of 200 staff n1000 would require 17 of staff to consent to participate and complete the measures
The Peer Resilience Champion PRC Intervention Investigators will second or hire an interdisciplinary team of healthcare professionals eg 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 11 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 staffvolunteers 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 arewere temporarily restricted from attending the hospital eg 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 participants 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 ie 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 304 of staff with high burnout based on previous studies an 80 power and an alpha level of 005 five clusters of 200 staff providing measures per cluster is sufficient to detect a drop of 94 with an intracluster correlation coefficient ICC of 001 107 ICC of 0015 or 119 ICC of 02 These ICC estimates are congruent with previous studies These differences are consistent with a post-SARS study that found high burnout in 304 of exposed and 192 of unexposed HCWs Five clusters of 200 staff n1000 would require 17 of staff to consent to participate and complete the measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None