i. Outcome of implementation
Over two weeks, a redesigned perioperative workflow for the obstetric COVID-19 patient was successfully implemented within our L&D unit. 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 checklist use, post-case debriefing and workflow redesign continued through a process of rapid cycling as described above. Following implementation, we report successful and consistent use of this new workflow for all obstetric COVID-19 perioperative cases (100% compliance) over the subsequent weeks to date. 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.
ii. Evaluation Of Checklist Implementation
Evaluation of the implementation experience using CFIR demonstrated the significance of the following domains, when ranked in order of influence as facilitators of implementation success (expressed as a percentage of constructs within each domain): process (89%), innovation characteristics (88%,) inner setting (64%,) characteristic of individuals (40%) and the outer setting (0%). Constructs not applicable to this study included cosmopolitanism, organizational incentives and rewards, and external change agents.
Facilitators of implementation:
Constructs which positively influenced the implementation of this workflow redesign spanned all domains, except the outer setting. The domains of implementation process (Table 1) and innovation characteristics (Table 2) demonstrated the greatest proportion of facilitating constructs. Constructs within the inner setting which had a strong influence in facilitating implementation included the structural characteristics of the unit, the implementation climate (tension for change, compatibility, relative priority, goals and feedback) and the readiness for implementation (leadership engagement, available resources) (Table 3).
Table 1
CFIR Constructs and Definitions
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Ranking
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Reason for Assigned Ranking
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Score
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Planning: The degree to which a scheme or method of behaviour and tasks for implementing an innovation are developed in advance, and the quality of those schemes or methods.
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F
|
The innovation was tested in real-time within the organization, assessed and modified, prior to implementation in L&D. There was a role for all stakeholders in the planning process, tracked the implementation process.
|
1
|
Engaging: Attracting and involving appropriate individuals in the implementation and use of the innovation through a combined strategy of social marketing, education, role modelling, training, and other similar activities.
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F
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Staff members were engaged with the innovation, invited to use the checklist during live cases, participated in debriefings and did not require repeated attempts to engage. This engagement encouraged feedback and enabled the rapid improvement of steps within the checklist.
|
1
|
Opinion Leaders: Individuals in an organization that have formal or informal influence on the attitudes and beliefs of their colleagues with respect to implementing the innovation.
|
F
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Clinical leaders within L&D were engaged with the innovation and were actively involved in each step of implementation, assessment and improvement.
|
1
|
Formally Appointed Internal Implementation Leaders: Individuals from within the organization who have been formally appointed with responsibility for implementing an innovation as coordinator, project manager, team leader or another similar role
|
F
|
A formally appointed quality and safety lead (SKR) supported and enabled implementation of this innovation. Clinical leads and local stakeholder buy-in was present.
|
1
|
Champions: Individuals who dedicate themselves to supporting, marketing, and ‘driving through’ an [implementation]”, overcoming indifference or resistance that the innovation may provoke in an organization.
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F
|
The innovation was informally championed by our surgical obstetric divisional lead.
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1
|
External Change Agents: Individuals who are affiliated with an outside entity who formally influence or facilitate innovation decisions in a desirable direction.
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NA
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We did not have an outside organization assisting with implementation, this was internally driven and tested.
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NA
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Key Stakeholders: Individuals from within the organization that are directly impacted by the innovation, e.g., staff responsible for making referrals to a new program or using a new work process.
|
F
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Key stakeholders, including a designated quality and safety team, were engaged with the innovation and assisted in the development, implementation, assessment and improvement of the innovation.
|
1
|
Innovation Participants: Individuals served by the organization that participate in the innovation, e.g., patients in a prevention program in a hospital.
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NI
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The ‘participants’ in this study were considered the patients with confirmed or under investigation for COVID-19. These participants did not impact implementation.
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0
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Executing: Carrying out or accomplishing the implementation according to plan.
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F
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The redesigned workflow was implemented rapidly, in a concise manner, according to plan.
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1
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Reflecting & Evaluating: Quantitative and qualitative feedback about the progress and quality of implementation accompanied with regular personal and team debriefing about progress and experience.
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F
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The implementation team consistently assessed the progress of implementation and the quality of the innovation in order to promote continuous quality improvement.
|
1
|
B: barrier, CFIR: Consolidated Framework for Implementation Research, F: facilitator, NA: not applicable, NI: no impact. |
Table 2
CFIR Domain - Innovation Characteristics
CFIR Constructs and Definitions
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Ranking
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Reason for Assigned Ranking
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Score
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Intervention source: Perception of key stakeholders about whether the innovation is externally or internally developed.
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F
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The intervention came from within the organization, it was an internally developed workflow checklist, not from outside policy makers or regulatory bodies.
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1
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Evidence, strength & quality: Stakeholders’ perceptions of the quality and validity of evidence supporting the belief that the innovation will have desired outcomes.
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F
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The intervention came from a trusted internal source and from an expert group with awareness of local needs. Though guided by literature from previous epidemics, there was little peer-reviewed evidence of what exactly was needed to promote effectiveness.
|
1
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Relative advantage: Stakeholders’ perception of the advantage of implementing the innovation versus an alternative solution.
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F
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National guidelines and recommendations for managing obstetric COVID-19 patients were collected, synthesised, and disseminated among the stakeholders; however, there was wide variety of interpretation as to the implementation of these in practice. Implementing a sequential checklist was perceived to be faster at producing alignment.
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1
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Adaptability: The degree to which an innovation can be adapted, tailored, refined, or reinvented to meet local needs
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F
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The ability to adapt the innovation to the local obstetric context was clear. Input from multiple disciplines (OB, anesthesia, nursing, NICU) were involved in deciding whether changes were needed to the intervention.
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1
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Trialability: The ability to test the innovation on a small scale in the organization, and to be able to reverse course (undo implementation) if warranted.
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F
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Immediate testing was possible. The intervention was used during real cases with the ability to reverse the implementation if required.
|
1
|
Complexity: Perceived difficulty of the innovation, reflected by duration, scope, radicalness, disruptiveness, centrality, and intricacy and number of steps required to implement.
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B
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The workflow was felt to be very complex, involved several aspects of care that were not intuitive and required several iterations to improve performance. It required extra staff members for implementation compared to routine care, which was perceived as a further complication that may have hindered adoption, in particular if staffing levels were low..
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0
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Design Quality & Packaging: Perceived excellence in how the innovation is bundled, presented, and assembled.
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F
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The initial reception of the innovation was positive and the quality perceived to be high.
|
1
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Cost: Costs of the innovation and costs associated with implementing the innovation including investment, supply, and opportunity costs.
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F
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The cost of implementation was the additional manpower needed to ensure the checklist was being followed as the many steps would be impossible to memorise in a short period of time.
|
1
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B: barrier, CFIR: Consolidated Framework for Implementation Research, F: facilitator, NA: not applicable, NI: no impact. |
Table 3
CFIR Domain - Inner Setting
CFIR Constructs & their definitions
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Ranking
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Reason for Assigned Ranking
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Score
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Structural Characteristics: The social architecture, age, maturity, and sise of an organization.
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F
|
The intervention took place within the L&D unit, which is a world-leading center of excellence in obstetrics and in anesthesia, and well-established division within the medical center. They have clear processes in place to facilitate quality improvement.
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1
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Networks & Communications: The nature and quality of webs of social networks, and the nature and quality of formal and informal communications within an organization.
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Change over time
B to F
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Clear lines of communication were not initially evident within the organization regarding this innovation; it was an initial source of frustration for where to locate the most up to date resource. This was rectified over the course of implementation and communicated through the hospital’s COVID intranet. Further communication improvements at the local departmental levels, via intranet, email and teleconferencing permitted inter-professional collaborative work.
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0
|
Culture: Norms, values, and basic assumptions of a given organization.
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Change over time
B to F
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While the culture within the L&D unit was accustomed to the use of checklists, standard operating procedures, and iterative cycle improvement. Additional internal forces along with external pressures of fears and anxiety, were present that affected the cohesion of the unit. Pre-existing egotism and individuality initially impacted implementation negatively. In view of the urgency of COVID-19, recognition that assistance outside of the L&D unit was required, sought and later welcomed over the course of the implementation.
|
0
|
Implementation Climate: The absorptive capacity for change, shared receptivity of involved individuals to an innovation, and the extent to which use of that innovation will be rewarded, supported, and expected within their organization.
|
F
|
Within the organization and within the L&D unit, there was clear receptivity to implementing the innovation. It aligned with existing frameworks already in place, including the use of cognitive aids, checklists, team training and iterative process improvement. Although the checklist and processes were developed quickly, limiting stakeholder buy-in, the implementation climate supported the innovation and valued its use.
|
1
|
Tension for Change: The degree to which stakeholders perceive the current situation as intolerable or needing change.
|
F
|
The innovation was absolutely necessary, as the outbreak revealed gaps in our workflow for the COVID-19 parturient.
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1
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Compatibility: The degree of tangible fit between meaning and values attached to the innovation by involved individuals, how those align with individuals’ own norms, values, and perceived risks and needs, and how the innovation fits with existing workflows and systems.
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F
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The innovation was based upon frameworks already used within the organization (e.g.: cognitive aids, checklists) and therefore demonstrated compatibility with organizational values and work processes
|
1
|
Relative Priority: Individuals’ shared perception of the importance of the implementation within the organization.
|
F
|
There was clarity in the priority and urgency of this innovation. Given the anticipated surge of potential COVID-19 patients on L&D, implementing this workflow was a priority for all staff.
|
1
|
Organizational Incentives & Rewards: Extrinsic incentives such as goal-sharing, awards, performance reviews, promotions, and raises in salary, and less tangible incentives such as increased stature or respect.
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NA
|
This innovation was not associated with an external policy or incentive, financial or otherwise.
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NA
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Goals and Feedback: The degree to which goals are clearly communicated, acted upon, and fed back to staff, and alignment of that feedback with goals.
|
F
|
This innovation was aligned with organizational and departmental goals, and feedback was obtained to help understand if any gaps existed between the current organizational status and the perceived goal.
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1
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Learning Climate: A climate in which: 1. Leaders express their own fallibility and need for team members’ assistance and input; 2. Team members feel that they are essential, valued, and knowledgeable partners in the change process; 3. Individuals feel psychologically safe to try new methods; and 4. There is sufficient time and space for reflective thinking and evaluation.
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Change over time
B to F
|
The time pressure resulted, initially, in insufficient time to for reflective thinking and evaluation.
Leaders within L&D valued the input of all inter-professional team members and, over time, staff members involved in the implementation felt like a valued partner in the change process.
|
0
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Readiness for Implementation: Tangible and immediate indicators of organizational commitment to its decision to implement an intervention.
|
F
|
The L&D leadership demonstrated a readiness to change; they sought out assistance and innovation.
|
1
|
Leadership Engagement: Commitment, involvement, and accountability of leaders and managers with the implementation of the innovation
|
F
|
Organizational leaders demonstrated a dedicated level of engagement and invested adequate time and resource to the innovation. This included the Director of L&D, division director of maternal-fetal-medicine, division direction of OB anesthesia, Anesthesia Executive Vice Chair, and the Vice Chair for quality and safety
|
1
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Available Resources: The level of resources dedicated for implementation and on-going operations including physical space and time.
|
F
|
Resources, including time, were allocated specifically to the innovation being implemented.
Resources in particular: implementation team released from clinical duties to develop and implement this innovation
|
1
|
Access to Knowledge & Information: Ease of access to digestible information and knowledge about the innovation and how to incorporate it into work tasks.
|
B
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Access to information regarding the innovation was difficult initially, due to version updates. All information was eventually made readily available throughout the organization through the intranet
|
0
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B: barrier, CFIR: Consolidated Framework for Implementation Research, F: facilitator, NA: not applicable, NI: no impact. |
Barriers to implementation:
Several constructs were felt to negatively influence implementation in this study, in particular those from within the outer setting (Table 4). Additional barriers to implementation included the complexity of the innovation (innovation characteristics, Table 2), baseline culture, climate and communication (inner setting, Table 3) and personal attributes (characteristics of individuals, Table 5).
Table 4
CFIR Domain - Outer Setting
CFIR Constructs & Definitions
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Ranking
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Reason for Assigned Ranking
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Score
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Patient Needs & Resources: The extent to which the needs of those served by the organization (e.g., patients), as well as barriers and facilitators to meet those needs, are accurately known and prioritised by the organization.
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Change over time
B to F
|
Despite the purpose of the intervention being focused on managing the patient, it was designed for use amongst the healthcare force.
Initially the perceived purpose of the checklist and usefulness for care of the COVID-19 patient was not clear to some staff, creating a barrier for implementation. After the experience gained from a real case and spread of knowledge from the debriefing process after the case, the perceived benefit of the checklist then acted as a facilitator.
|
0
|
Cosmopolitanism: The degree to which an organization is networked with other external organizations.
|
NA
|
Networking with external organizations did not apply in this circumstance.
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NA
|
Peer Pressure: Mimetic or competitive pressure to implement an innovation, typically because most or other key peer or competing organizations have already implemented or are in a bid for a competitive edge.
|
B
|
Differences in international and regional guidelines for preparedness and practice for the clinical care of patients with COVID-19 on the L&D Unit resulted in interdepartmental conflicts that impacted behaviours and impacted the readiness for alignment.
|
0
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External Policy & Incentives: A broad construct that includes external strategies to spread innovations including policy and regulations (governmental or other central entity), external mandates, recommendations and guidelines, pay-for-performance, collaboratives, and public or benchmark reporting.
|
B
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The leadership was in communication colleagues in China, Italy and other centers in the United States. In the early stages the practices and societal recommendations varied considerably, and this affected expectations and prevented shared mental models. This impacted the readiness for alignment.
|
0
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B: barrier, CFIR: Consolidated Framework for Implementation Research, F: facilitator, NA: not applicable, NI: no impact. |
Table 5
CFIR Domain - Characteristics of Individuals
CFIR Constructs and Definitions
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Ranking
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Reason for Assigned Ranking
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Score
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Knowledge & Beliefs about the Intervention:
Individuals’ attitudes toward and value placed on the innovation, as well as familiarity with facts, truths, and principles related to the innovation.
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NI
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Individual stakeholders shared a belief that the intervention was necessary and were seeking an innovation. Obtaining the checklists and processes was challenging initially due to a lack of coordinated communication.
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0
|
Self-efficacy: Individual belief in their own capabilities to execute courses of action to achieve implementation goals.
|
F
|
There was confidence in the ability to implement the intervention and that staff members would be able to use the intervention.
|
1
|
Individual Stage of Change:
Characterization of the phase an individual is in, as s/he progresses toward skilled, enthusiastic, and sustained use of the innovation.
|
NI
|
Various roles and responsibilities within the organization of staff members affected how they readiness for adoption in the initial stages of implementation.
|
0
|
Individual Identification with Organization: A broad construct related to how individuals perceive the organization, and their relationship and degree of commitment with that organization.
|
F
|
There was broad consensus that all staff members were working toward a common organizational goal.
|
1
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Other Personal Attributes: A broad construct to include other personal traits such as tolerance of ambiguity, intellectual ability, motivation, values, competence, capacity, and learning style.
|
B
|
Despite several positive traits among stakeholders in terms of willingness to implement changes, expectations toward standard operating procedures and innovation. We identified negative traits such as tribalism, egotism and individualism which affected implementation.
|
0
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B: barrier, CFIR: Consolidated Framework for Implementation Research, F: facilitator, NA: not applicable, NI: no impact. |
External pressures created by peer pressure, both locally and internationally, were evident as an early barrier to implementation. Local peer pressure created by a departmental policy within anesthesia on the appropriate personal protective equipment (PPE) resulted in general anxiety, disagreement and inconsistencies in inter-departmental guidance that impacted behaviors within the L&D unit and overall readiness for alignment. Furthermore, external influences from international peer groups, in particular communications from colleagues in China, Italy and other centers across the USA including the Center for Disease Control (CDC), demonstrated a considerable disconnect between the recommendations for care and clinical practice. This affected expectations and resulted in a delay of the shared mental model.
Constructs which demonstrated a change over time:
Evaluation of our implementation revealed some constructs which demonstrated a temporal change over time, the majority of which were within the inner setting (Table 3). At baseline, constructs such as communication, culture and learning climate initially acted as a barrier to implementation, but then progressed to become facilitators within the space of a few weeks.
With respect to this innovation, clear lines of communication and knowledge of where to access the most up to date information were not evident initially within the organization, which resulted in frustration. This was rectified over the course of implementation and communicated through the hospital’s COVID intranet. Further communication improvements at the local departmental levels, via intranet, email and teleconferencing permitted inter-professional collaborative work.
While the culture within the L&D unit was accustomed to the use of checklists, standard operating procedures, and iterative cycle improvement, additional internal forces such as recent staffing changes along with external pressures, fears and anxiety, were present that may have influenced the cohesion of the unit. Pre-existing egotism and individualism may have impacted the learning climate and further impacted implementation negatively. However, in view of the urgency of COVID-19, assistance outside of the L&D unit was sought and welcomed over the course of the implementation. Leaders within L&D valued the input of all inter-professional team members during the implementation period. Additionally, through the debrief mechanism, involved staff members felt like a valued partner in the change process.
Finally, within the outer setting, the patient’s needs and resources also shifted in influence over time (Table 4).