A qualitative design using a validated assessment tool was chosen in order to better understand the factors that influenced implementation of a novel workflow. The study was approved by our Institutional Review Board (IRB) at the Beth Israel Deaconess Medical Center. As this was a qualitative study identifying the factors that influenced implementation, and did not constitute human subject research, the requirement for written informed consent was waived. This manuscript conforms to the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines and the Template for Intervention Description and Replication (TIDieR) checklist (15,16).
ii. Description of Workflow Checklist Implementation (obstetric workflow redesign)
Initial reviews of COVID-19 pandemic preparedness in our hospital identified the need for the redesign of a L&D site-specific perioperative workflow for managing a COVID-19 parturient. Our L&D unit serves as a regional referral center serving an urban, metropolitan area of approximately 4.6 million people, and is the academic teaching hospital for Beth Israel Lahey Health, a state-wide hospital network representing more than 15,000 births annually. As a center for high-risk patients, we anticipated a higher traffic of both diagnosed and suspected COVID-19 patients, in common with earlier experiences at similar units in New York State.
We reviewed the available literature on both SARS-CoV-2 and other related viruses (17), including recommendations on the standards of care from government and professional bodies such as the American College of Obstetrics and Gynecology (ACOG), the Society for Obstetric Anesthesia and Perinatology (SOAP) and the Anesthesia Patient Safety Foundation (APSF) (18–20). We combined these recommendations with our own organization’s newly designed perioperative workflows for COVID-19 patients to create the L&D workflow for the COVID-19 parturient requiring perioperative care. It was produced as a single page document, formatted as a sequential checklist with the intention to be used in real time as a cognitive aid (2). The checklist was an intentional design decision, documented as an effective means of detailing sequential steps in care (21); it also fit in with existing local practice of checklist use for pre-operative briefings for all patients going to the operating room on L&D. The intended users of the checklist were staff from nursing, maternal-fetal-medicine, obstetrics, anesthesia and neonatology.
Implementation of workflow change:
Implementation of this innovation took place through a process of rapid cycling over a period of 2 weeks (22–24), described in detail by Li et al, 2020 (2). The initial workflow draft was disseminated among clinical leaders and stakeholders and underwent one cycle of cognitive redesign. Prior to further refinement, planned testing or wide-scale dissemination amongst providers, its use was urgently requested by clinical leaders to assist in the management of our first live COVID-19 obstetric case. At this time, staff members involved in the case had no formal input into the design of the checklist or training in its use but were coached in real-time to work through the checklist elements. By following the sequence of the checklist, staff were able to safely perform the standard operating procedures, as indicated. Following our first live case, a formal debriefing with all members of the obstetric, anesthesia and perinatal team was conducted using video-conferencing, and specific steps were identified for checklist optimization. Subsequent inter-professional input from the departments of obstetrics, nursing and anesthesia, virtual event debriefings and on-site walkthroughs, several iterations of workflow re-design resulted in our final refined product (Figure 1). Post-case debriefings were performed routinely after-hours and led by the division chiefs of obstetrics, and included staff from nursing, maternal-fetal-medicine, obstetrics, anesthesia, neonatology, and quality and safety. Details on the individual cycles for change are listed (Supplemental Table 1). Our finalized workflow materials are freely available to access online. (2,25).
Outcome of implementation:
Adoption of this new workflow was quantitatively defined by documentation of its use during the care of successive COVID-19 parturients over the subsequent weeks, in the medical record. We modified the anesthesia information management system to capture three elements of workflow utilization in a binary (yes/no) fashion: a) patient transport per COVID checklist protocol, b) the intraoperative use of COVID checklist protocol, and c) early postoperative recovery per COVID checklist protocol. Following implementation, we report consistent use of this new workflow for all obstetric COVID-19 perioperative cases; 100% workflow utilization was observed and documented for a total of 23 cases (10 patients who required perioperative care, 13 who required labor analgesia), between March and August 2020. Repeated verbal feedback from frontline clinicians was that the checklist helped with ensuring proper use of PPE, created an environment of safety, and improved coordination and communication among the teams.
iii. Identification of Factors Influencing Implementation
To identify factors influencing implementation of the redesigned perioperative workflow checklist on L&D, we conducted a detailed retrospective analysis using the CFIR (8,26,27). CFIR classifies operationally defined domains that have been shown to influence implementation success (8), namely, intervention characteristics (e.g.; adaptability, design quality and cost), the outer setting (e.g., external policy, peer pressure), the inner setting (e.g., culture, climate and readiness for implementation), the characteristics of individuals (e.g., knowledge and beliefs about the intervention) and the process of implementation (e.g., planning, engaging, executing and reflecting).
Our assessment of the implementation experience was mapped against the CFIR constructs and ranked by a panel of 6 experts within our organization. The panel included members of the multidisciplinary team; obstetricians, anesthesiologists and our quality and safety faculty, who are included authors in this study. The first and last authors of this study (LZ and SKR) are not members of the L&D unit.
We opted to use a group deliberation approach because of the extensive history of collaborative work that existed in the L&D unit. Given this previous shared knowledge of local context, each construct was evaluated by the group with respect to its likely influence on implementation, and ranked as a facilitator or barrier, having no effect or not applicable to implementation. Virtual group deliberations took place over several days, initially each member of the panel of experts independently reviewed each construct, then as a collaborative discussion facilitated by the senior author and chair of quality and safety division. Disagreements were discussed in two settings, initially through email and then again in person, facilitated by the lead author.
In order to compare the relative contribution of each equally weighted construct within each domain at baseline, we transformed these results into a quantitative assessment by allocating a numerical score of 1 to a construct if it acted as a facilitator and 0 if it was considered a barrier or not influencing implementation success. The denominator included all constructs within each domain, apart from those deemed not applicable to the study.