Physician Stress LevelsNCT04614844
COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS)
A study testing Simulation Intervention in people with Physician Stress Levels, run by Yale University at 1 site in United States.
Trial summary
This will be a randomized control trial assessing the impact of CRI:SIS as a simulation-based preparedness intervention on physician stress levels through changes to heart rate variability (HRV) on shift while caring for COVID-19 patients and post-shift anxiety as measured by the State-Trait Anxiety Inventory (STAI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physician Stress Levels
- What is being tested?
- Simulation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2021to 2 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resident or Attending Physician working at Yale New Haven Hospital York Street or Saint Raphael Emergency Departments
- Currently treating patients with COVID-19 or suspected COVID-19
Who cannot join
- Currently taking a beta-blocker and/or anti-arrhythmic medication
- Active (uncontrolled) thyroid dysfunction
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06512
About this study
Official title: COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS) Randomized Control Trial
This will be a randomized control trial assessing the impact of CRI:SIS as a simulation-based preparedness intervention on physician stress levels through changes to heart rate variability (HRV) on shift while caring for COVID-19 patients and post-shift anxiety as measured by the State-Trait Anxiety Inventory (STAI). The aim is to test CRI:SIS to determine its effect on mitigating physician stress on shift and anxiety post-shift related to provision of COVID-19 care
Read the detailed description
The overall goal of this study is to develop and test the COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS), a simulation-based training and quality improvement intervention that will minimize physician stress and improve system responsiveness. To accomplish this goal, the investigators will conduct a two-site randomized clinical trial to test the efficacy of CRI:SIS as a simulation-based preparedness intervention on decreasing emergency physician stress and anxiety during the care of COVID-19 patients in the ED through on-shift measurements of heart rate variability as a physiologic marker of stress and responses to the State-Trait Anxiety Inventory post-shift. The investigators will rapidly disseminate CRI:SIS as two simulation interventions, one on clinician preparedness and the other on system improvement, through interactive virtual tele-simulations, webinars, and virtual workshops providing mentorship and shared learning for other institutions facing similar challenges. If proven successful, the simulation-based CRI:SIS intervention to rapidly prepare clinicians and improve system responsiveness can be widely disseminated to other institutions to combat the anticipated lengthy response to COVID-19 safety challenges.
Participants randomized to the intervention arm will receive CRI:SIS as a three-hour simulation session. This session will include three scenarios focused on three critical areas of COVID-19 patient care:
- airway management procedures in patients with COVID-19 given increased risk of viral transmission to personnel and rapid respiratory deterioration in infected patients
- new presenting symptoms and associated complications of COVID-19 (e.g., hypercoagulability, cardiovascular morbidity), making accurate diagnosis and treatment of patients with suspected infection difficult
- caring for patients presenting with severe illness and poor prognosis adding emotional and cognitive strain to physicians as they initiate palliative care, discuss goals of care, or withdraw care in the ED.
In addition, all three scenarios will address negative effects on team performance during COVID-19 care from social distancing and personal protective equipment (PPE) requirements through interactions with nursing and ancillary staff confederates during each scenario. Each participant will complete all three scenarios within a three-hour block between one to five days prior to a clinical shift.
Participants randomized to the control arm will participate in four shift data collections, with no additional intervention. These participants will have access to the routinely distributed COVID-19 Task Force updates, guidelines, weekly town hall meetings, and any in-service support that would routinely be available to all clinical staff as per standard operational practice in our local departments. Once enrollment for Aim 2 is complete, all participants randomized to the control arm will be offered the opportunity to complete the simulation intervention.
- Conditions
- Physician Stress Levels
- Being tested
- Simulation Intervention, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation InterventionBehavioural
Participants randomized to the intervention arm will receive CRI:SIS as a three-hour simulation session.
ControlBehavioural
Participants randomized to the control arm will participate in four shift data collections, with no additional intervention.
| Study group | Role | What they receive |
|---|---|---|
| Simulation Intervention | Experimental | Participants randomized to the intervention arm will receive CRI:SIS as a three-hour simulation session. Receives: Behavioral: Simulation Intervention |
| Control | Active comparator | Participants randomized to the control arm will participate in four shift data collections, with no additional intervention. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in end-of-shift heart rate variability
The change in physician end-of-shift heart rate variability will be measured using the Hexoskin Smart Shirt.
Changes in HRV will be averaged over the two post-intervention shift data collections to control for an anticipated shift-to-shift and patient-to-patient variability in stress response due to patient acuity and workload
Measured: Baseline, 5 minutes post-intervention shift
Change in STAI S-Anxiety
The change in physician end-of-shift anxiety measured by the State-Trait Anxiety Inventory (STAI) for physicians exposed to the simulation based training preparation compared to standard guideline update delivery. Each STAI item is given a weighted score of 1 to 4. A rating of 4 indicates the presence of a high level of anxiety for items (e.g., "I feel frightened," "I feel upset"). To obtain scores for the S-Anxiety, simply add the weighted scores for the twenty items that make up the scale, taking into account the fact that the scores are reversed for specific items. Scores for the S-Anxiety scale can vary from a minimum of 20 to a maximum of 80.
Measured: Baseline, 5 minutes post-intervention shift
Change in STAI T-Anxiety
The secondary outcome of interest is change in anxiety between the intervention and control conditions as measured by the State-Trait Anxiety Inventory (STAI). The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how people generally feel. The scoring weights for the anxiety-present items are the same as the chosen numbers on the print inventory form. To obtain scores for the T-Anxiety scale, simply add the weighted scores for the twenty items that make up the scale, taking into account the fact that the scores are reversed for specific items. Scores for the T- Anxiety scales can vary from a minimum of 20 to a maximum of 80.
Measured: Baseline, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start6 Jan 2021
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physician Stress LevelsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Leigh Evans, MD, Principal investigator, Associate Professor of Emergency Medicine; Executive Director, Yale Center for Medical Simulation; Director, Resident Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614844
- Sponsor's protocol ID
- 2000029372
- Other IDs
- 1R01HS028340-01
- Status last verified
- Oct 2022
- First submitted
- 2 Nov 2020
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Evans LV, Ray JM, Bonz JW, Joseph M, Gerwin JN, Dziura JD, Venkatesh AK, Wong AH. Improving patient and clinician safety during COVID-19 through rapidly adaptive simulation and a randomised controlled trial: a study protocol. BMJ Open. 2022 May 19;12(5):e058980. doi: 10.1136/bmjopen-2021-058980.
PubMed 35589358
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS) Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04614844
- Acronym / sponsor ID
- 2000029372
- Conditions
- Physician Stress Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized control trial assessing the impact of CRI:SIS as a simulation-based preparedness intervention on physician stress levels through changes to heart rate variability (HRV) on shift while caring for COVID-19 patients and post-shift anxiety as measured by the State-Trait Anxiety Inventory (STAI). The aim is to test CRI:SIS to determine its effect on mitigating physician stress on shift and anxiety post-shift related to provision of COVID-19 care
Detailed description
The overall goal of this study is to develop and test the COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS), a simulation-based training and quality improvement intervention that will minimize physician stress and improve system responsiveness. To accomplish this goal, the investigators will conduct a two-site randomized clinical trial to test the efficacy of CRI:SIS as a simulation-based preparedness intervention on decreasing emergency physician stress and anxiety during the care of COVID-19 patients in the ED through on-shift measurements of heart rate variability as a physiologic marker of stress and responses to the State-Trait Anxiety Inventory post-shift. The investigators will rapidly disseminate CRI:SIS as two simulation interventions, one on clinician preparedness and the other on system improvement, through interactive virtual tele-simulations, webinars, and virtual workshops providing mentorship and shared learning for other institutions facing similar challenges. If proven successful, the simulation-based CRI:SIS intervention to rapidly prepare clinicians and improve system responsiveness can be widely disseminated to other institutions to combat the anticipated lengthy response to COVID-19 safety challenges.
Participants randomized to the intervention arm will receive CRI:SIS as a three-hour simulation session. This session will include three scenarios focused on three critical areas of COVID-19 patient care:
- airway management procedures in patients with COVID-19 given increased risk of viral transmission to personnel and rapid respiratory deterioration in infected patients
- new presenting symptoms and associated complications of COVID-19 (e.g., hypercoagulability, cardiovascular morbidity), making accurate diagnosis and treatment of patients with suspected infection difficult
- caring for patients presenting with severe illness and poor prognosis adding emotional and cognitive strain to physicians as they initiate palliative care, discuss goals of care, or withdraw care in the ED.
In addition, all three scenarios will address negative effects on team performance during COVID-19 care from social distancing and personal protective equipment (PPE) requirements through interactions with nursing and ancillary staff confederates during each scenario. Each participant will complete all three scenarios within a three-hour block between one to five days prior to a clinical shift.
Participants randomized to the control arm will participate in four shift data collections, with no additional intervention. These participants will have access to the routinely distributed COVID-19 Task Force updates, guidelines, weekly town hall meetings, and any in-service support that would routinely be available to all clinical staff as per standard operational practice in our local departments. Once enrollment for Aim 2 is complete, all participants randomized to the control arm will be offered the opportunity to complete the simulation intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation Intervention | Experimental | Behavioral: Simulation InterventionParticipants randomized to the intervention arm will receive CRI:SIS as a three-hour simulation session. |
| Control | Active comparator | Behavioral: ControlParticipants randomized to the control arm will participate in four shift data collections, with no additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resident or Attending Physician working at Yale New Haven Hospital York Street or Saint Raphael Emergency Departments
- Currently treating patients with COVID-19 or suspected COVID-19
Key exclusion criteria (3 listed)
- Currently taking a beta-blocker and/or anti-arrhythmic medication
- Active (uncontrolled) thyroid dysfunction
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation InterventionParticipants randomized to the intervention arm will receive CRI:SIS as a three-hour simulation session. | Behavioural | Simulation Intervention |
| ControlParticipants randomized to the control arm will participate in four shift data collections, with no additional intervention. | Behavioural | Control |
Primary outcome
Change in end-of-shift heart rate variability
Time frame: Baseline, 5 minutes post-intervention shift
The change in physician end-of-shift heart rate variability will be measured using the Hexoskin Smart Shirt. Changes in HRV will be averaged over the two post-intervention shift data collections to control for an anticipated shift-to-shift and patient-to-patient variability in stress response due to patient acuity and workload
Change in STAI S-Anxiety
Time frame: Baseline, 5 minutes post-intervention shift
The change in physician end-of-shift anxiety measured by the State-Trait Anxiety Inventory (STAI) for physicians exposed to the simulation based training preparation compared to standard guideline update delivery. Each STAI item is given a weighted score of 1 to 4. A rating of 4 indicates the presence of a high level of anxiety for items (e.g., "I feel frightened," "I feel upset"). To obtain scores for the S-Anxiety, simply add the weighted scores for the twenty items that make up the scale, taking into account the fact that the scores are reversed for specific items. Scores for the S-Anxiety scale can vary from a minimum of 20 to a maximum of 80.
Change in STAI T-Anxiety
Time frame: Baseline, 1 week
The secondary outcome of interest is change in anxiety between the intervention and control conditions as measured by the State-Trait Anxiety Inventory (STAI). The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how people generally feel. The scoring weights for the anxiety-present items are the same as the chosen numbers on the print inventory form. To obtain scores for the T-Anxiety scale, simply add the weighted scores for the twenty items that make up the scale, taking into account the fact that the scores are reversed for specific items. Scores for the T- Anxiety scales can vary from a minimum of 20 to a maximum of 80.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Derived from this study: PubMed 35589358Evans LV, Ray JM, Bonz JW, Joseph M, Gerwin JN, Dziura JD, Venkatesh AK, Wong AH. Improving patient and clinician safety during COVID-19 through rapidly adaptive simulation and a randomised controlled trial: a study protocol. BMJ Open. 2022 May 19;12(5):e058980. doi: 10.1136/bmjopen-2021-058980.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Evans, MD principal investigator
Associate Professor of Emergency Medicine; Executive Director, Yale Center for Medical Simulation; Director, Resident Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation Intervention in people with Physician Stress Levels, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in end-of-shift heart rate variability (time frame: Baseline, 5 minutes post-intervention shift). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.