About the Study: The objective of this study is to design, implement and evaluate a cognition-based guidance system (CGS) during complex, team-based cardiac surgery, using clinical simulation. This study will be conducted by the Human Factors & Cognitive Engineering lab, STRATUS Center for Medical Simulation at the Brigham and Women’s Hospital (BWH), under the supervision of Dr. Roger D. Dias, MD, PhD, MBA, who is the BWH Principal Investigator (PI). This study is part of a research grant sponsored by the National Institute of Health (NIH/NHLBI-R01HL126896-04A1 – PI/PD: Dr. Marco Zenati).
Why is this research study being done?
Medical errors causing preventable adverse events are the third leading cause of death in the U.S. The role of human cognition in contributing to errors in complex healthcare environments is increasingly being recognized. The cardiac operating room (OR) is a high-risk high-stakes setting, in which many opportunities to improve patient safety exist. We believe that human errors in the cardiac OR can be reduced by supporting individual and team interactions via dynamically-updated computer-based guidance that is responsive to the details of the ongoing process (i.e., context-aware), the patient’s current medical condition (i.e., patient-aware), and cognitive workload demands from clinicians (i.e., workload-aware). The proposed Cognition-based Guidance System (CGS) will be evaluated in a simulated environment and the findings from this study have the potential to substantially contribute to improvements in patient safety in the cardiac OR.
How long will I take part in this research study?
You will be given the option to participate in any of the 4 phases of this study.
In Phase 1, subjects will participate in a 1-hour focus group via videoconferencing (Zoom).
In Phase 2, subjects will participate in a 1-hour focus group via videoconferencing (Zoom).
In Phase 3, subjects will participate in a 3-hour in-person simulation session at the STRATUS Center for Medical Simulation at the Brigham and Women’s Hospital in Boston, MA.
In Phase 4, subjects will participate in a 3-hour in-person simulation session at the STRATUS Center for Medical Simulation at the Brigham and Women’s Hospital in Boston, MA.
What will happen in this research study?
Based on which phases you decide to participate in, the following procedures will be utilized:
In Phase 1, subjects will participate in a 1-hour focus group via videoconferencing (Zoom) to provide their feedback on the CGS, presented through screenshots. At the end of the session, participants will complete online surveys. Audio and video will be recorded for analysis and stored in secure servers behind the MassGeneral Brigham (MGB) firewall.
In Phase 2, subjects will participate in a 1-hour focus group via videoconferencing (Zoom) to provide their feedback on the CGS, presented through video scenarios. At the end of the session, participants will complete online surveys. Audio and video will be recorded for analysis and stored in secure servers behind the MassGeneral Brigham (MGB) firewall.
In Phase 3, subjects will participate in a 3-hour in-person simulation session at the STRATUS Center for Medical Simulation at the Brigham and Women’s Hospital in Boston, MA. Participants will take part in a series of simulations in a high-fidelity simulated operating room and will provide feedback on the CGS. During the simulations, participants will wear a series of unobtrusive wearable devices (heart rate sensor, brain activity sensor, eye-tracking glasses, and a smartwatch). At the end of the session, participants will complete online surveys. Audio and video will be recorded for analysis and stored in secure servers behind the MassGeneral Brigham (MGB) firewall.
In Phase 4, subjects will be randomized into two groups (with vs without CGS) and will participate in a 3-hour in-person simulation session at the STRATUS Center for Medical Simulation at the Brigham and Women’s Hospital in Boston, MA. Participants will take part in a series of simulations in a high-fidelity simulated operating room. During the simulations, participants will wear a series of unobtrusive wearable devices (heart rate sensor, brain activity sensor, eye-tracking glasses, and a smartwatch). At the end of the session, participants will complete online surveys. Audio and video will be recorded for analysis and stored in secure servers behind the MassGeneral Brigham (MGB) firewall.
These are the wearable devices that you will use during the simulation sessions in Phase 3 and Phase 4:
What are the risks and possible discomforts from being in this research study?
There are no risks from participating in this research, other than taking the time to complete surveys, meeting with researchers via videoconferencing, participating in simulations and wearing the physiological sensors. Wearable devices are not expected to cause any harm or discomfort to participants. To mitigate the risk of potential loss of privacy and confidentiality, we will use confidential codes and all research data, including audio and video, will be stored in secure servers behind the MassGeneral Brigham (MGB) firewall
What are the possible benefits from being in this research study?
You will not directly benefit from participating in this study. The knowledge generated by this study will advance the field of cardiac surgery and patient safety.
What should I do if I want to stop taking part in the study?
At any moment, if you want to stop participating in this study and/or have all your data removed from the study database, you can contact the study PI.
Will I be paid to take part in this research study?
As an appreciation for your participation in this study, you may be eligible to receive a gift card, according to the study phase you opt to participate in:
All Phase 1 and Phase 2 participants will receive a $25 gift card as an appreciation for their participation.
All Phase 3 and Phase 4 participants will receive a $50 gift card as an appreciation for their participation. Parking vouchers will be provided for these participants, since it requires a visit to our simulation center in Boston, MA. No travel or accommodation costs will be covered.
If I have questions or concerns about this research study, whom can I call?
Dr. Roger D. Dias MD, PhD, MBA at Brigham & Women’s Hospital/Harvard Medical School is the Principal Investigator for this study. He can answer any questions. You can contact him at rdias@bwh.harvard.edu or (617) 525-7627.
If I take part in this research study, how will you protect my privacy?
Your confidentiality will be secured and your survey responses will be kept in MGB REDCap, which is a secure application supported by Partners Research Computing, Enterprise Research Infrastructure & Services (ERIS). ERIS has all the necessary physical and operational securities in place to meet or exceed Federal and State security and privacy regulations for data transmission and storage using REDCap. Audio, video and physiological data will also be stored in secure servers behind the MassGeneral Brigham (MGB) firewall.
Are you interested in participating in this study?
Please click on the link below to access a registration survey and indicate in which phases (s) you want to participate.
Registration Survey: https://redcap.partners.org/redcap/surveys/?s=3L8DKCE7WT