The know-do gap is a well-recognized phenomenon in healthcare and represents the difference between what healthcare workers know should be done based on evidence and what takes place in practice.1 When organizations fail to implement known best practices in patient safety, these gaps can lead to poor patient outcomes and even unnecessary harm and death. Despite the successful wide-scale adoption of patient safety initiatives such as the central line–associated bloodstream infection checklist2 and the Surgical Safety Checklist,3 many effective patient safety practices exhibit a large know-do gap, and medication errors, falls, and pressure ulcers persist.4 Patient safety initiatives that have proven successful at one facility frequently fail to be adopted by other facilities.
Adoption is the uptake of the initiative, defined by Proctor et al5 as “the intention, initial decision, or action to try or employ an innovation or evidence-based practice.” There are many barriers to the adoption of patient safety initiatives, most rooted in the effort and resources required for change management within an organization when transitioning from an old system to a new system or process.6 This is compounded by the sheer complexity of healthcare, with many micro and meso systems containing unique relationships and interactions.7
Although adoption is the catalyst for implementation, the implementation process must be effective to create the desired change and improve patient safety. Other indicators of implementation success include acceptability, appropriateness, costs, feasibility, fidelity, penetration, and sustainability.5 Along with adoption, these serve as intermediate outcomes for patient-level outcomes. The implementation science literature has identified determinants that influence these intermediate outcomes and are the basis for several frameworks.8 Although these frameworks can assist in planning, implementing, and evaluating an initiative, they have limited value in practice because they are often applied conceptually and not operationalized during the implementation process.9
A simpler, more practical framework focused on adopting and implementing patient safety initiatives is needed to guide organizations in closing the know-do gap. Focusing on adoption is more crucial now than ever, with healthcare leaders facing numerous competing priorities during the recovery from the COVID-19 pandemic with constrained resources and staffing challenges.10 Leaders may be hesitant to adopt patient safety initiatives and use their scarce resources toward implementation.
Here we describe the Patient Safety Adoption Framework, which we developed as a practical solution to address the know-do gap through the successful adoption and implementation of patient safety initiatives. It was created in close collaboration with experts in quality improvement, risk management, implementation science, and patient and family advisors and is grounded in human-centered design principles. The framework and its accompanying guidance tool can benefit healthcare leaders and implementers by identifying the essential elements of the successful adoption and implementation of patient safety initiatives.
METHODS
Setting
CRICO, an insurance program for all of the Harvard medical institutions and their affiliates, led the development of the framework as part of a strategic goal to promote the successful adoption and implementation of patient safety initiatives by their member organizations. CRICO provides coverage to 35 hospitals, 16,000 physicians, more than 325 other healthcare organizations, and more than 140,000 other clinicians and employees.
Framework Design Team
The core design team was composed of executive leadership and subject-matter experts in implementation and patient safety from CRICO and Ariadne Labs, a joint innovation center with Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health. The framework was co-created with an Ad Hoc Steering Committee comprising 26 leaders and stakeholders representing the CRICO member organizations. In addition, we regularly met with non–CRICO-affiliated implementation and patient safety subject-matter experts and patient and family advisors for input during the design process.
Literature Review
We reviewed the literature to provide background on existing patient safety and implementation frameworks and best practices related to patient safety initiatives. We searched PubMed, targeted healthcare organizations, and the Google search engine looking for gray and academic literature. We chose to focus the search on practical frameworks and excluded frameworks that were purely theoretical. We found 91 resources, which included 21 frameworks. The domains from each framework were compiled on a spreadsheet and reviewed for commonalities.
Formative Qualitative Interviews and Analysis
We conducted qualitative interviews to explore the contexts of the member organizations and their experiences with previous implementation efforts. We recruited participants using purposive sampling through contacts from the members of the Ad Hoc Committee. There were 33 participants, 21 individual interviews, and 6 focus groups representing various roles (Table 1). Focus groups were composed of 2 to 3 individuals grouped by similar roles, expertise, or organization.
TABLE 1 -
Participant Characteristics
| Variable |
Formative (n = 33) |
Evaluation (n = 11) |
| Gender identity |
|
|
| Female |
15 |
3 |
| Male |
18 |
8 |
| Role |
|
|
| C-level executive |
11 |
3 |
| President, vice president |
8 |
1 |
| Director |
11 |
5 |
| Program manager |
2 |
1 |
| Other |
1 |
1 |
| Clinical background |
|
|
| Physician |
24 |
8 |
| Nurse |
5 |
2 |
| None |
4 |
1 |
| Usual practice setting |
|
|
| Academic health system |
22 |
7 |
| Community hospital |
5 |
1 |
| Specialty hospital |
4 |
0 |
| Other |
2 |
2 |
Interviews and focus groups were facilitated by Ariadne Labs staff (R.M.-S., J.M., F.L.M.) over a video conferencing platform using a semistructured guide that included questions and probes on areas identified a priori on experience with adopting and implementing patient safety initiatives. Interviewers used an iterative approach and adjusted the guide for topics that emerged during the interviews. A notetaker was present in each session to document the conversations; these notes were the primary reference for subsequent analyses. For reference, we recorded the interviews via the video conferencing platform. A qualitative researcher (J.M.) on the design team conducted a thematic analysis using both a priori and emerging themes and subthemes.
Framework Design Process
We reviewed findings from the literature review and the qualitative themes and grouped commonalities into draft domains. The draft domains underwent several iterations with feedback from stakeholders, subject-matter experts, patient and family advisors, and the Ad Hoc Committee until we reached a consensus among stakeholders on 5 domains and 6 subdomains. The final 5 domains were grouped into multiple draft configurations to represent relationships between the domains visually.
The design team created a guidance tool to accompany the framework, providing practical information on how to use the framework effectively. The guidance tool also underwent evaluation by implementation and patient safety subject-matter experts, patient and family advisors, and the Ad Hoc Committee stakeholders.
Framework Evaluation
We used purposive sampling to identify 11 leaders in quality and safety at CRICO member organizations who had recently used the framework in a working group to inform their design of implementation guidance for a colorectal cancer ambulatory safety net. Participants represented several roles and practice sites and included 4 of the same individuals from the formative interviews (Table 1). Participants were sent the framework and guidance tool before the interview, and the framework domains were reviewed at the beginning of the interview. Similar to the formative qualitative work, interviews were conducted by a qualitative researcher (J.M., R.M.-S.) and a notetaker over a video conferencing platform using a semistructured interview guide, with thematic analysis based on detailed notes. The interview guide included questions about the framework and guidance tool’s acceptability, feasibility, completeness, and perceived utility.
RESULTS
Final Framework and Guidance
The Patient Safety Adoption Framework (Fig. 1) identifies and provides guidance for achieving the critical elements of adoption and implementation. Each triangle represents a specific domain (or element) with the smaller, nested triangles representing subdomains. The framework is not meant to be followed in a particular order but rather provides a scaffolding for adoption and implementation.
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FIGURE 1: Patient Safety Adoption Framework.
The framework guidance tool (Supplementary Material, https://links.lww.com/JPS/A549) describes the domains in a general format, leaving room to supplement the framework with details specific to the patient safety initiative. The guidance tool includes a checklist for teams to assess their readiness in each domain, which we adapted from a context assessment survey developed by Ariadne Labs.11 The questions are mapped to each framework domain to provide teams with actionable guidance on where to focus their efforts based on the assessment. Teams can use the checklist before implementation to reflect on organizational readiness and prompt conversations on strengths and potential opportunities for improvement.
Framework Domains
Domain: Leadership
The leadership, governance structure, and prioritization of the initiative occur early in the process; thus, it is at the top of the pyramid. Leadership plays a key role in promoting patient safety and quality care, prioritizing initiatives, and gaining support from leadership at multiple levels of the organization. Leaders are the keepers of the learning and improvement system of the organization. An effective leadership system will succeed in its subdomains with a strong governance structure, clear priorities, and accountability for achieving organizational goals.
Leadership Subdomain: Governance
The primary function of governance is to establish the organizational and system-level structures and networks, including decision making, communication, and flow of information. Effective governance will prepare leaders to make sound decisions through prioritization and establish accountability with a shared understanding of goals and behaviors.
Leadership Subdomain: Accountability
Leaders at every level are accountable for achieving results; however, everyone shares the responsibility for patient safety. Regardless of role, each individual is accountable to others for acting in ways that reflect organizational values and are committed, responsible, competent, and ethical. Accountability can be built into an initiative through performance goal setting, transparent measurement, and oversight (such as an executive review).
Leadership Subdomain: Prioritization
Prioritization requires all stakeholders to collaborate toward a shared patient safety goal. Adopting and prioritizing a patient safety initiative can be achieved by evaluating the current state, including a review of past patient safety events, speaking to frontline staff and patients, and assessing organization-specific data for the intervention.
Domain: Culture and Context
Culture and context are at the center of the framework because they profoundly affect the other domains throughout the implementation process.
A strong safety culture can promote transparency, reduce adverse events,12,13 reduce mortality,14 improve error reporting,15 and provide a firm foundation for implementing patient safety initiatives. Healthcare organizations must embrace and exemplify a safety culture in their work. Leadership can facilitate this by setting norms and expectations that create an atmosphere in which everyone feels responsible for safety. The ideal culture for implementation extends beyond safety culture and includes a just culture, transparency, psychological safety, organizational learning, knowledge sharing, and continuous improvement. Organizations with strong cultures of safety will have more success implementing safety initiatives.
Context is one of the strongest influences on implementation. Context is often interchanged with the terms “setting” and “environment,” including the physical environment and the environment of relationships and networks. Context includes how hierarchical an organization is, how amenable leaders are in deferring decisions to staff, and how the external context directly impacts the healthcare system (e.g., COVID-19, payment structures). Patient safety initiatives need to be flexible and adaptable to account for organizational differences, with each organization adjusting implementation to fit their local context.
Domain: Process
Process includes the components of implementation that happen on the ground, including the practices and workflows that existed before that change. These interrelated actions are vital to transforming ideas into tangible solutions. This domain spans each implementation stage and is very specific to the chosen initiative.
Process Subdomain: Co-Creation
Co-creation centers on partnering with patients, families, and frontline staff throughout the improvement process, including prioritization of issues, face validity testing, implementation, and sustainment of solutions. Co-creation exemplifies deference to all forms of expertise as it is a bottom-up approach involving those directly impacted by the initiative from the start of its development. Successful initiatives that use co-creation models promote widespread acceptance.16
Co-creation with staff can provide valuable input on the current workflow to facilitate embedding the initiative in ways that make the work easier, automated, and intuitive. Partnering with patients and families brings a unique perspective that can lead to more innovative solutions.17 In addition, patient and family advisors provide cultural context and identify potential barriers during the development phase.
Process Subdomain: High-Reliability
Healthcare environments are complex, and integrating high-reliability principles into improvement efforts can lead to the development of new processes that reduce system failures and effectively respond when failures occur.18 The principles of high-reliability are described in depth elsewhere and include sensitivity to operations, reluctance to simplify, preoccupation with failure, deference to expertise, and resilience.19 Integrating these principles into patient safety initiatives ensures that staff can implement safety initiatives that drive reliable processes and are integrated with human factors to assure success.
Process Subdomain: Engagement
It is important to engage stakeholders throughout the implementation process, with everyone aligned in working toward a single goal. Collaboration, negotiation, and cohesion among the implementation team and other stakeholders promote co-creation and keep people engaged. Key drivers to building awareness and engaging everyone about the patient safety initiative include building consensus around decision points, sharing patient stories, clear and consistent messaging, and maintaining transparency about patient safety events.
Domain: Meaningful Measurement
Meaningful measures are parsimonious and embody the Quadruple Aim20 of improving the health of a population, improving patient experience, improving clinician work life, and lowering per-capita cost. These measures are actionable, feasible, streamlined, and focused on improving the most crucial aspects of healthcare. They are centered around what is meaningful to the patient and clinician and incorporate patient-reported outcome measures when possible. Measures can identify areas for improvement, demonstrate change, and are a mechanism for accountability.
Domain: Person-Centered
Person-centered care is when individuals’ preferences and values are central to their healthcare.21 Person-centered is at the framework’s base to serve as a reminder to be the foundation in all patient safety initiatives. Integrating person-centered principles into patient safety initiatives benefits clinicians, the healthcare system, and everyone interacting with the system. It requires collaboration among patients, healthcare organizations, and the local community. Partnering with patients in co-creation is one method to enhance the person-centeredness of care.
Framework Evaluation
Testing confirmed the framework and guidance tool’s overall acceptability, feasibility, and utility. Participants expressed that the framework and its domains were complete, and no changes were necessary. Participants reinforced the importance of some domains and subdomains, emphasizing leadership, prioritization, culture, co-creation, and person-centeredness. There were suggestions for changes to the guidance tool, including a statement in the prioritization section warning about starting underfunded work and a statement about the importance of transparency in leadership and culture. Participants also pointed out that the guidance tool would benefit from being more explicit about the structural threats to equity and access to healthcare services. Based on this feedback, an expert in health equity reviewed the guidance tool and provided revisions. A few participants expressed that directions on using the tool were not apparent, so we added simplified instructions to the executive summary. Most of the feedback was related to the usability of the readiness checklist in the guidance tool. Participants understood the importance of the questions but were unsure how to use them. Based on this feedback, we streamlined the readiness checklist and included additional instructions.
DISCUSSION
The Patient Safety Adoption Framework offers a structure with practical guidance for promoting the adoption and implementation of patient safety initiatives. The framework emphasizes the importance of the local culture, capabilities, and context. Our testing with stakeholders and subject-matter experts identified that the framework is feasible, is acceptable to implementers, and has a high perception of utility.
The framework is a determinant framework,8 meaning that each domain is crucial to implementing patient safety initiatives effectively. Although designed with patient safety initiatives in mind, the domains include many core principles in quality improvement and can likely benefit other improvement efforts. The framework provides a pragmatic foundation for leaders and implementers while planning an implementation effort. To demonstrate how to apply the framework, we provided examples of each domain applied to the case of a patient safety initiative addressing diagnostic errors through a closed-loop communication process in which “all patient data and information that require action are communicated to the right individuals at the right time through the right mode of communication to allow for review, action, acknowledgment, and documentation” (Table 2).22
TABLE 2 -
Application of the Patient Safety Adoption Framework to a “Closing the Loop” Intervention
| Domain |
Applied Example |
| Governance |
Evaluate existing governance structures for areas of improvement |
| Develop an interorganizational collaborative |
| Hold convenings to reach a consensus on defining problems and processes |
| Accountability |
Schedule regular meetings with an executive review |
| Create or join a collaborative with monthly check-in’s and submission of measures |
| Assign an owner to every step of the referral process |
| Prioritization |
Review safety reports and share patient stories |
| Present data of other successful programs to motivate prioritization |
| Provide resources, such as a project manager, and incentives |
| Raise awareness of vulnerabilities in the diagnostic and referral process |
| Culture |
Conduct team training session between clinical units |
| Include patients in the diagnostic process |
| Demonstrate transparency around diagnostic errors |
| Context |
Assess local context with the readiness checklist in the guide or another context assessment tool |
| Adapt the initiative based on local contextual factors |
| Co-creation |
Partner with patients, families, and caregivers by inviting evaluation of the patient portal, display, and methods of communication |
| Train patient family advisors in quality improvement and embed them on the implementation team |
| Create small multidisciplinary working groups to develop new processes around workflow, patient outreach, and patient tracking |
| High reliability |
Use tools, such as detailed process mapping and driver diagrams, to assess failure points and prioritize areas for improvement |
| Embed referral systems, clinical decision support tools, and results notifications into existing workflows and EHR systems |
| Link EHRs to patient reports and registries to track patients that needed follow-up for an abnormal result |
| Engagement |
Share real patient stories from closed medical malpractice cases, along with data on patient harm from missed and delayed diagnoses |
| Identify champions and build on their enthusiasm |
| Propose critical parts of the project to primary care providers and other relevant stakeholders before moving forward with implementation |
| Meaningful measurement |
Develop run charts, dashboards, and other visualizations, and share them with clinical staff |
| Stratify measures through risk adjustment for complexity and by race, ethnicity, primary language, payer type, and zip code to monitor for disparities in care |
| Person-centered |
Ensure that people are aware of the patient portal and are able to access it, and that results are presented in a format appropriate to health literacy levels |
| Utilize referral coordinators, patient navigators, and multiple modes of communication to contact patients |
| Provide support to patients so they have the confidence, knowledge, and skills needed to understand the information they are given about their health and to navigate healthcare system |
EHR, electronic health record.
The Patient Safety Adoption Framework is novel for several reasons. It differs from other implementation determinant frameworks, such as the Consolidated Framework for Implementation Research23 and Promoting Action on Research Implementation in Health Services,24 in that the primary user is not researchers or implementation scientists. We designed the framework for healthcare leaders and implementers through a user-centered consensus-building approach with hospital executives, patient safety leaders, implementers, and patient and family advisors. It is not theoretical but practical and can be used by implementers with the guidance tool to systematically review each domain, ensuring that they have accounted for its content. In addition, it is meant to be applied to a specific patient safety initiative, not the entire system, which sets it apart from the Institute for Healthcare Improvement’s Framework for Safe, Reliable, and Effective Care.25 Finally, context is included in many determinant frameworks, but none of these have a context assessment woven into the domains.26 We mapped questions from a context assessment survey to each domain, which makes up the readiness checklist. The checklist provides a method for teams to reflect on the organization’s readiness to implement in each domain and direction on which areas of the framework may need additional focus.
A limitation of the framework is that we created it with local stakeholders in an urban setting in the United States. Stakeholder institutions included community and specialty hospitals and academic medical centers. Still, the local geographic context and phenomena specific to the area may have influenced the framework, and it may not apply as readily in rural areas or outside of the United States. In addition, although we evaluated this framework for acceptability, feasibility, and utility, we did not evaluate it against existing frameworks. Finally, although we tried to include a wide range of stakeholders and multiple perspectives, the co-creation process lacked diversity in stakeholder roles. Participants were heavily weighted toward administrators and physicians, most of whom were leaders in quality and patient safety within academic medical centers. There was little representation from nurses and no representation from advanced practice providers or other allied health professionals, such as patient care technicians. Also, although we had one patient family advisor on the Ad Hoc Committee and 3 in our stakeholder group, we could have had more representation from patient family advisors.
CONCLUSIONS
Leadership, implementation teams, and others can use the Patient Safety Adoption Framework to guide adoption and implementation by ensuring that key elements are addressed and have a shared language for communicating and planning. It provides practical guidance and tools, such as the readiness checklist, to support teams with varying levels of experience in implementation. Implementation can make or break a patient safety initiative, and this framework provides a strategy for success. The Patient Safety Adoption Framework offers a way forward for organizations to adopt and implement patient safety initiatives and bridge the know-do gap.
ACKNOWLEDGMENTS
The authors gratefully acknowledge members of the Patient Safety Adoption Framework Ad Hoc Committee and the CRICO/Risk Management Foundation of the Harvard Medical Institutions leadership for their help and guidance. The also acknowledge Grace Galvin, Sue Gullo, Ami Karlage, and Courtney Staples from Ariadne Labs for their critical role in the development of the Patient Safety Adoption Framework and guide.
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