Eligibility: Perfusionists who work in a cardiac operating room in the United Sates.
About the Study: Our goal is to develop and gather initial validity evidence of a proof-of-concept for a Robot-Assisted Perfusion System (RAPS) that can be integrated into the cardiac surgery workflow as a non-human teammate. The RAPS will support the perfusion team in a way that perfusionists will still keep control of the perfusion system (i.e. human-in-the-loop approach), but cognitively supported by the RAPS. 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- 1R56HL157457-01). Your participation is voluntary.
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, the patient’s current medical condition, and cognitive workload demands from perfusionists. The development and validation of human-machine intelligent systems that have the potential to enhance patient safety and improve surgical outcomes in the OR.
How long will I take part in this research study?
Subjects will participate in a 90-minute interview via videoconferencing (Zoom) and will respond to two 15-minute online surveys after the interview.
What will happen in this research study?
Subjects will participate in an interview via videoconferencing (Zoom) to provide their expertise on cardiac surgery process models. After the sessions, participants will complete two online surveys (15-minute duration each) with questions about the usability of a visual analytics platform. Audio and video will be recorded for analysis and stored in secure servers behind the MassGeneral Brigham (MGB) firewall.
Study staff will launch the videoconferencing in a private and secure application. We will obtain your verbal consent before beginning the recording. To protect your privacy, we ask that you do not take screenshots, photographs, or recordings of any kind with any electronic equipment. Sensitive information can be revealed during group discussion. All information discussed during the interviews needs to remain confidential.
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, and meeting with researchers via videoconferencing. The only identifiable data are audio and video which contain identifiers because it will not be possible to de-identify audio and video data. There is a minimum risk of data breach, however, it would not be damaging to your employability, advancement, or reputation. 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 applications approved by the MassGeneral Brigham (MGB).
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, perfusion 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, participants will receive a $50 gift card as an appreciation for their participation. If you decide to participate in more than one session or the total amount is greater than $50, the payment will be made by check.
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 firstname.lastname@example.org 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. Identifiable data, such as audio and video will be sent to research collaborators at the Veterans Affairs (VA) Boston Healthcare System via encrypted drive. Your de-identified information may be used or shared with other researchers without your additional informed consent.
Are you interested in participating in this study?
Please click on the link below to access a registration survey and indicate that you want to participate in this study.
Registration Survey: REDCap LINK