Table 4.

How Our Case Had Applied the Strategies

Strategy 1: Assemble project team with necessary expertise	The project recruited team members who were knowledgeable experts, self-driven and proactive in defining and executing tasks. Experts were brought in to assist certain aspects of the project when needed. The expertise applied included but was not limited to health care systems engineering research, Institutional Review Board (IRB) approval process, information technology (IT), legal, contracts and data sharing, patient electronic health record and database management, specialized project management in health care technology management, third-party risk management, surgical systems operations, and supply chain management. The project enlisted a project manager (PM) with inter-institutional data sharing expertise ensured the task completion timeliness and reported project statuses periodically to governing bodies. Relevant contracts were created and updated with intention for re-use in future contract negotiations or expansion to more operating rooms (OR). Another PM with successful prior experience with health care technology implementation led the CM.34 The PM accomplished many formal, informal and behind-the-scenes effective communications with the OR staff, unions, and managers of nursing and anesthesia to ensure that they were informed of and were engaged in the project progress to create advocates for the project. This PM and the researchers also actively engaged the institution’s legal department, IRB, and media relations in preparation for the event if the project was publicized.
Strategy 2: Anticipate potential institutional cultural and regulatory hurdles	The project team anticipated and addressed various privacy and data integrity concerns from the approval committees by collaborating with in-house risk management; IT and infrastructure proponents to create data safety protocols to satisfy international agreements; and legal, employer, staff, and patient confidentiality requirements. A surgeon core team proponent delivered numerous presentations to committees clarifying the capability and safeguards of the system. The team’s use of briefing documents and preliminary discussions with committees facilitated the familiarization of the transformational and innovative nature of the technology. These efforts allowed the project team to address the questions that the committees posed and to minimize misperceptions and misinterpretations. The team minimized potential OR staff resistance by working with surgical leadership to reinforce the consistent message that data collected from this system would not be used for individual performance assessment, adherence, or disciplinary purposes, but rather for OR safety, quality, efficiency, and teamwork enhancement. They also verified that under state law the videos were not discoverable for legal purposes.35
Strategy 3: Add agility to project planning and execution	The project team deliberated a strategy and executed a CM plan that were both predictive and agile. The plan’s predictability took inspiration from existing CM models (Table 1) with added experience from a recent successful internal CM project.34 The team maintained an agile mindset to accommodate for an unconventional hybrid (research and practice) approval process. To satisfy committee inquires of data ownership and governance, the team allowed ample time to work closely with approval committees, legal, contracting, and the internal IT teams to establish that the surgeon whose case was recorded as well as the institution would own the data.
Strategy 4: Accommodate institutional culture and regulations	A vital component of this project’s strategy was customizing to the culture and complexity of our institution. For example, the project team aligned the hybrid project approval pathway with greater affinity toward research to leverage existing data security approval pathways that existed within the research enterprise. It was also important that the team allocated appropriate time, resources and expertise to follow the appropriate committee approval sequence without “shortcuts,” which largely facilitated the timeliness of project delivery. These efforts were convincing to leadership that this project was well aligned with the institution’s primary value “the needs of the patients come first,” which facilitated the project’s navigation through the institution’s intricate and unique committee approval process. Different institutions may experience different levels of hesitation and trust toward new technology and toward change, depending on its prior new technology implementation and CM experiences. Lessons learned from recent internal CM projects involving updated technology albeit of different scale and nature of the technology34,36 contributed tremendously to this implementation, especially the CM process. It is worth noting that the salary structure and level of employee unionization involved in the CM may matter in implementation. All physicians in our institution are salaried as are many of the allied health groups. However, select OR staff groups are unionized, which prompted the project team’s early engagement and communication with unions for their buy-in.
Strategy 5. Early clinical partner buy-in and stakeholder engagement	It was decided at the beginning of the project that an important aspect to facilitate CM was early stakeholder engagement and buy-in.34 Effective leadership was recognized as a central element and necessary resource during change particularly to address employee resistance. Thus, the team included committed leaders from surgical leadership, in which the change was to take place, to actively support the project activities. These leaders provided generous and sustained support within the scope of their normal day-to-day leadership roles and in project-required activities (eg, committee approval process, CM, and system installation). The senior leaders’ involvement, visibility, and commitment from the project’s beginning sent a strong message across the enterprise that they would actively support this change with employees. Besides surgical leadership support and endorsement, 2 surgeons became core project team members and advocated for the implementation of the project among their colleagues and institutional leadership. This physician–research–administrator partnership led the core team and lent a respected and credible voice to CM activities among project stakeholders. Additionally, to de-freeze the existing OR culture,10,11 the project team invited key stakeholders (ie, nursing leadership) to attend the annual Surgical Safety Network Conference, 2021. Gaining deeper understanding of the OR Blackbox technology, hearing experiences shared by experienced institutions, and networking with institutions with similar interests via the conference were essential in boosting stakeholder buy-in and engagement. The conference addressed potentially negative preconceptions of the technology; and the multi-institutional collaborations developed among surgeons, anesthetists, and OR nurses. Shortly after the conference, these key stakeholders identified “influencers” and “resisters” in their department and the team worked closely to create advocates for the project and to minimize resistance.
Strategy 6: Consistent Communication	Communication to approval committees and OR staff regarding the project implementation was a concerted and controlled effort throughout the project. This information was only circulated among project team members during Phase 1 (Project team assembly), and among approval committees during Phase 2 (Committee approvals) before finally being communicated as uniformly and consistently as possible to OR staff members and other employees of the institution in Phase 3 (CM). Surgeon team members conducted presentations to and led discussions among approval committees regarding the project goals and plans. The nonpunitive nature of the technology and data security and patient privacy assurance were presented by a surgeon working in one of the 3 ORs in which the system was to be installed. The ease of peer-to-peer conversation among clinicians facilitated the approval process. OR staff were encouraged, but not forced, to learn about or to adopt the AI technology. Two important documents were created to socialize the project before it went live: the frequently asked questions (FAQ), and the “key message.” Staff were provided with resources to the technology and this project from, eg, the key message and frequently asked questions (FAQ). The FAQ contained 53 questions that were categorized to “why,” “what,” “who,” “where,” “when,” and “how” groups. It was published on the institution’s intranet and served as a resource for all employees who had questions about the project. It was inspired by FAQs published by other institutions using the system and was based on a successful internal example.33 It incorporated numerous rounds of feedback from the project team, surgery, nursing, and anesthesia leadership. It remains an active document with ongoing edits based on new information, comments, and concerns that arise. By creating and sharing this repertoire of resources to OR and all other hospital staff, the investigators hoped to encourage organization-wide awareness, as well as open and continuous conversations regarding AI technologies and their application. A quick response (QR) code is installed on the doors of the ORs where the system was installed that links to the FAQ. The key message is a one-page “elevator speech” for the project, sent by managers to relevant OR staff. It was intended to be the one and only message to be disseminated to all relevant OR staff at the same time regarding the launch of the project. The message was intended to be concise but contain the core information of the purpose and goals of the project, and the resources to obtain more information (eg, web link to the FAQ). Besides the FAQ and the Key Message, a patient-oriented standard script was created. It was intended to be used by OR staff to provide patients with adequate information and consistent answers if they noticed door signage about the presence of the system required by the IRB when being wheeled into the OR. To date, this patient script has not been needed. Additionally, a dedicated email address to which staff could send concerns was created. A shared document repository site was set up early in the process to facilitate communication within the project team. Additionally, the core team discussed project progress weekly at hour-long meetings; leads of expert teams hosted regular summaries meetings per their particular goals with their stakeholders. Weekly email updates were sent by the PM to core team and stakeholders highlighting key items: high-level milestones, contracts, committees, facilities, infrastructure and hardware, operational activities, and CM. The authors intended to empower broader artificial intelligence (AI) application in the organization by setting a positive and leading example of AI technology implementation in the highly confidential and private OR. The positive outcomes of the implementation in enhancing surgical practice, efficiency, and teamwork, enabling interdisciplinary research, and strengthening intraoperative and postoperative learning contributed to sustaining the acceleration of AI technology implementation within the organization. In addition, core project team members have shared our implementation and CM experiences, success stories, and lessons learned internally and externally via educational seminars to inspire relevant education and collaborative research. The team has also kept a continuous conversation with the AI technology company regarding questions that emerged from system usage and suggestions for system and technology improvement.