Using Flow Disruptions to Examine System Safety in Robotic-Assisted Surgery: Protocol for a Stepped Wedge Crossover Design.

BACKGROUND: The integration of high technology into health care systems is intended to provide new treatment options and improve the quality, safety, and efficiency of care. Robotic-assisted surgery is an example of high technology integration in health care, which has become ubiquitous in many surgical disciplines. OBJECTIVE: This study aims to understand and measure current robotic-assisted surgery processes in a systematic, quantitative, and replicable manner to identify latent systemic threats and opportunities for improvement based on our observations and to implement and evaluate interventions. This 5-year study will follow a human factors engineering approach to improve the safety and efficiency of robotic-assisted surgery across 4 US hospitals. METHODS: The study uses a stepped wedge crossover design with 3 interventions, introduced in different sequences at each of the hospitals over four 8-month phases. Robotic-assisted surgery procedures will be observed in the following specialties: urogynecology, gynecology, urology, bariatrics, general, and colorectal. We will use the data collected from observations, surveys, and interviews to inform interventions focused on teamwork, task design, and workplace design. We intend to evaluate attitudes toward each intervention, safety culture, subjective workload for each case, effectiveness of each intervention (including through direct observation of a sample of surgeries in each observational phase), operating room duration, length of stay, and patient safety incident reports. Analytic methods will include statistical data analysis, point process analysis, and thematic content analysis. RESULTS: The study was funded in September 2018 and approved by the institutional review board of each institution in May and June of 2019 (CSMC and MDRH: Pro00056245; VCMC: STUDY 270; MUSC: Pro00088741). After refining the 3 interventions in phase 1, data collection for phase 2 (baseline data) began in November 2019 and was scheduled to continue through June 2020. However, data collection was suspended in March 2020 due to the COVID-19 pandemic. We collected a total of 65 observations across the 4 sites before the pandemic. Data collection for phase 2 was resumed in October 2020 at 2 of the 4 sites. CONCLUSIONS: This will be the largest direct observational study of surgery ever conducted with data collected on 680 robotic surgery procedures at 4 different institutions. The proposed interventions will be evaluated using individual-level (workload and attitude), process-level (perioperative duration and flow disruption), and organizational-level (safety culture and complications) measures. An implementation science framework is also used to investigate the causes of success or failure of each intervention at each site and understand the potential spread of the interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25284.

Identifying Opportunities to Improve Patient Experience With Sacral Neuromodulation: A Human Factors Approach.

OBJECTIVES: To use a human factors approach to conduct a needs assessment of patient preparedness, education, device usability, and satisfaction regarding all stages of sacral neuromodulation therapy and identify opportunities for improvement. Sacral neuromodulation, though minimally invasive, involves an initial testing phase that requires active patient participation. This process is relatively complex and, if a patient does not receive adequate preprocedure education, can be difficult to conceptualize. MATERIALS AND METHODS: Candidates were recruited to participate before undergoing staged sacral neuromodulation. Ten patients were observed, and their experiences were evaluated at 4 phases: (1) date of test implant (Stage I), (2) 5 days following Stage I, (3) date of permanent implant (Stage II), and (4) 3 months following Stage II. Administered questionnaires focused on preoperative preparedness, postoperative satisfaction, and usability. RESULTS: While every patient reported that their symptoms were at least "a little better" postoperatively, they generally had difficulty understanding the risks of the planned procedure, did not know what to expect postoperatively and were unsatisfied with the preoperative materials. Patients struggled with adjusting the settings for their implant devices and usability was considered "below average." Despite overall objective success, 30% of patients indicated that they would not recommend this treatment to friends/family. CONCLUSION: This pilot needs analysis demonstrates several opportunities for improvement in the experience of patients undergoing sacral neuromodulation. These findings highlight the opportunities for a multifaceted intervention to improve patient understanding through the testing phase.

Discovering the barriers to efficient robotic operating room turnover time: perceptions vs. reality.

Turnover time (TOT) has remained the subject of numerous research articles and operating room (OR) committee discussions. Inefficiencies associated with TOT are multiplied when complex technology, such as surgical robots, is involved. Using a human factors approach, this study investigated impediments to efficient robotic TOT and team members' perceptions surrounding this topic. Researchers observed 20 robotic turnovers over 2 months at a tertiary hospital. TOT, cleaning time, number of staff present, bed set-up time, instrument set-up time and any major delays were recorded. Additionally, 79 OR team members completed a questionnaire regarding perceptions of OR turnover. Average TOT was 72 min (s, 24 min). Overall, cleaning required the most time (average of 27.4 min, 37.96% of TOT), followed by instrument set-up (15.4 min, 21.34% of TOT) and RN retrieval of the patient from pre-op (12 min, 17.72% of TOT). OR team members estimated that turnovers require 60.36 min. Physicians believed the greatest contributor to TOT was "time to set up the OR", while OR staff rated "instrument availability" as the greatest issue, both of which were inaccurate. OR team members' perceptions of robotic TOT and contributing factors were different from reality based on observed contributors. Data demonstrated several areas of opportunity for process improvement. These data can be used to guide the implementation of targeted interventions to improve TOT efficiency.