The community-based framework, which is customizable, measurable, adaptable, sustainable, and scalable, will grow as users provide curated content.
Framework Pillars
Six pillars guide a quality improvement initiative: prepare, engage, design, implement, report, sustain/scale. Each pillar is expanded by specific action steps. The steps are fluid: steps may occur simultaneously or in a different order throughout the pillars.
Prepare
The Prepare Pillar comprises steps and key considerations to begin a QI initiative in atrial fibrillation care. These foundational steps include gathering the personnel and data that are essential to engage a healthcare system in the initiative.
While AF is the most common arrhythmia, it continues to be undiagnosed, untreated, and undertreated. The consequence for untreated patients can be high, especially for stroke prevention, as AF is associated with a five-fold increased risk of stroke, and strokes resulting from AF are more severe and disabling.
A supportive network of QI champions often emerges during a QI initiative, which could include primary care, cardiology, electrophysiology, pharmacy, IT, administrators, or other representatives.
Some champions may become part of the QI initiative implementation team, others may not. All should remain regularly informed of status and progress as the initiative progresses.
An important first step is to identify one champion to act as the primary lead. This lead champion does not have to be a physician but it is recommended that a physician be included in the champion network to facilitate initiative success.
A strong lead champion should embody specific criteria.
- is passionate about, and ideally has experience in, leading quality QI initiatives
- has available time to devote to the initiative
- has the authority to advocate effectively for the QI initiative and gain executive sponsorship from system leaders
- understands the overall system and systemic changes that might result from initiative outcomes
- has a comprehensive understanding of, and ability to, field questions regarding the gap in AF care that is being addressed in the QI initiative
1.3.a Obtain Data Analytics Support
IT staff support is essential throughout a QI initiative, since many subsequent steps entail securing, reviewing, comparing, and interpreting health system data. Data analytics support is necessary to secure AF baseline data when considering the initiative.
1.3.b Collect and Analyze Baseline Data
Data may be acquired from an electronic health record, survey tools, chart review, and other sources to establish a baseline of both clinical and financial data. An analytics team member(s) may be necessary to interpret and depict the baseline data.
1.3.c Perform Gap Analysis
A gap is broadly defined as the difference between the current state and the desired state. Determining where the healthcare system has gaps in care and outcomes for patients is critical for discovering how a QI initiative can deliver the most value. If it is determined through system baseline data and analytics that a significant percentage of patients with AF are not receiving guideline-concordant care, then this gap represents an opportunity to improve both care and outcomes through a QI initiative.
1.3.c.1 Clinical: Estimate Stroke Burden/Potential Stroke Avoidance
Clinical practice guidelines define the standard of care for patients with AF.
When the QI initiative is intended to address stroke prevention, it is important to note that AF causes approximately 1 in 7 strokes, and lack of guideline- concordant care for patients with AF increases the likelihood of strokes. Strokes caused by complications from AF tend to be more severe and debilitating than strokes from other underlying causes. Most importantly, suffering a stroke has a profound impact on the quality of life for the patients with AF and those who love them.
The current level of anticoagulation for patients with AF (males with a CHA₂DS₂-VASc score ≥ 2 and females with a score ≥ 3) provides the baseline for improvement and specifically for AF treatment. These data are vital when making the case to executives because the non-treatment or undertreatment of AFib carries the risk of stroke which may translate to a cost burden on the system.
Note that a frequent challenge relating to data acquired through system IT is lack of validity of data reports. This issue may result from errors in data entry, errors when pulling data from the system, lack of standardization, and other system and process problems. Preliminary checks on data validity (by chart review) may prevent later data integrity and analysis problems.
Conducting a preliminary investigation of the contributors and root causes for a gap in AF care will help you prepare the business case and determine interventions for improvement. For example, the gap may be due to poor communication in care transitions, lack of clinician knowledge, lack of resources, lack of patient compliance, or lack of meaningful alerts in the workflow process—to name just a few of the potential contributors.
Related Resources
2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation
(American Heart Association)
1.3.c.2 Financial: Estimate Current Cost Burden/Potential Cost Savings
The financial gap compares the anticipated costs of conducting the QI initiative and deploying resulting interventions to reduce stroke costs resulting from lack of AF guideline-concordant care, with the current costs and financial burden associated with AF treatment and resulting AF patient strokes. A variety of financial costs should be considered in this analysis: direct, charged, reimbursed, indirect costs, avoidable. Your system may have the capability of estimating or knowing these costs, but there are tools that can also be employed to assess the cost of stroke and the savings of avoiding stroke in patients with AF. Healthcare system leadership and insurers are aligned with the financial outcomes associated with improved care: hospitals are incentivized to achieve reduced readmissions and consequent costs.
Related Resources
Building the Business Case for Quality Improvement
(Health Quality Innovation Network)
1.3.d Establish Benchmarks
Gap analysis reveals the percentage of patients with AF who are not receiving guideline-concordant care. Establishing the benchmark percentage of patients receiving guideline-concordant care that is intended to be achieved through the QI initiative is an initial goal, although it may be modified as the initiative is designed.
1.3.e Identify Key Opportunities for Improvement
Analysis of benchmark data will highlight contributors to care gaps that can be improvement targets. Each potential improvement intervention has associated costs and benefits. Answers to specific questions will assist in determining which intervention(s) to pursue.
- Which is most likely to achieve the initial goal?
- What personnel and/or other system resources will need to be acquired or re-deployed to accomplish the intervention?
- Which is most likely to be supported by system leadership?
- What barriers might stand in the way of accomplishing the intervention and what is the likelihood these barriers can be overcome?
- How likely is it that this intervention can be sustained and scalable at its conclusion?
The initiative should focus on only a small number of potential barriers. The champion network should come to consensus on the specific interventions that will serve as the subject of the QI initiative.
1.3.f Identify Potential Barriers
Common barriers that might impede a successful initiative include competing priorities for IT support, lack of time by key initiative personnel, lack of acceptance by healthcare system clinicians, no support from system leadership. Barriers to the potential intervention(s) should be identified and the likelihood of overcoming these barriers should be considered.
1.3.g Identify Needed Resources
QI initiatives require several types of resources that should be identified when making preparatory plans. The network of champions typically includes decision-makers with multiple responsibilities. The project team that will be implementing the initiative will include representatives from each of the touchpoint areas, e.g., primary care, cardiology, pharmacy, but will be personnel with more time to devote to executing the project. As with the champion network, one individual should be identified to lead the initiative. This should be someone with available time and interest in QI, a role in the system that relates to the identified intervention and demonstrated leadership and commitment to overseeing projects from outset to conclusion. Pharmacists are often well-suited to serve in this role.
IT support tools, such as a best practice alert, may need to be created and launched. Data report templates and analytics will need to be developed and IT personnel to assist in these activities will need to be represented on the initiative project team. Financial grant or contract support may be necessary to underwrite initiative costs and sources for such funding will need to be secured. Educational interventions with related materials may need to be developed and pilot-tested and supportive tools and checklists created. The champions should carefully consider and identify these additional needs.
Engage
The focus of the Engage Pillar is forming, motivating, and activating the project team that will design and implement the QI initiative, as well as the expanded network of key clinical and system champions and stakeholders who will support and advocate for the initiative.
Whenever possible, it is helpful to seek the support of an executive sponsor. The executive sponsor should be a top-level administrator who shares the QI vision and has authority to influence, prioritize, and advocate for the initiative with healthcare system leadership. The executive sponsor is an ongoing link to senior leadership to assure continued alignment of the QI initiative with the healthcare system’s strategic aims. This person will not be a member of the initiative implementation team but must receive regular team progress reports.
The executive sponsor should embody these criteria:
- has the clinical expertise to answer questions regarding the gap in care and intended outcomes for patients with AF
- supports the importance of AF guideline-concordant care
- knows and supports the healthcare system’s strategic aims
- able to address and eliminate system barriers that may occur throughout the duration of the initiative
The healthcare system leadership must agree that the QI initiative addresses a significant clinical gap for which patient and business outcomes warrant the use of resources necessary for implementation. These leaders will consider the clinical/business case that presents the opportunity for improvement in care and outcomes when making the decision to approve the initiative. The Executive Sponsor presents these data to the system leadership and advocates for reducing the clinical gap in guideline-concordant care of patients with AF.
Tracing the patient’s pathway through the healthcare system and identifying the specialty and therapeutic settings along this pathway will determine the composition of the core team. Personnel in these settings will need to be informed as the initiative progresses.
Three categories of members should be engaged to drive successful initiative outcomes:
- Those who will directly oversee the day-to-day implementation (the “core team”),
- Those who provide expertise either as regular or ad hoc team members, and
- Extended team members who serve as links to the healthcare system clinical and administrative leadership.
- Ideally all stakeholders who influence patient care decisions will be represented on the core team.
Activating especially committed and invested team members as a network that regularly meets to review progress and barriers may contribute greatly to the QI initiative success.
Effective team members should embody several characteristics:
- Ability to learn from other team members
- Ability to maintain open communication with staff, leadership, and patients
- Will assume individual responsibility that contributes to the team’s success
- Will commit to the success of the initiative
2.4.a Develop Charter with Team Purpose, Roles, and Responsibilities
A charter is a document that defines a team's purpose, deliverables, and resources. A charter helps ensure that each team member understands the overall objective of the initiative, what their role is and how the team contributes to the initiative's success. A team charter provides direction and boundaries that support focus and minimizes the risk of confusion and repetition. The following information is typically included in a team charter: team name, team leader, project name, project duration, purpose, objective, deliverables, team members and responsibilities, budget, resources, and communication plans. Each team member will sign the charter.
Related Resources
CardiQ Sample Charter Template
ProjectManager: How to Create a Team Charter (Example & Template Included)
(Project Manager)
2.4.b Engage Project Champion(s) for all Project Touchpoints
Transition issues or barriers may impede implementation of the QI initiative. Engaging a champion for all project touchpoints will assist in resolving issues and eliminating barriers as they arise. These champions may or may not be on the core team but must receive regular team progress reports.
Design
The Design Pillar defines the steps to develop the QI design and scope for the QI initiative implementation and results in a documented plan.
The initiative plan builds on the clinical and financial gaps identified in the Prepare and Design Framework stages. The plan delineates the initiative protocol prior to implementation for healthcare system leadership and all stakeholders, assures that team members share a common understanding of what the initiative entails and the role of each member, and can be used to secure external financial grant or contract support, if necessary. The plan is often necessarily revised as the initiative progresses and new factors become apparent.
3.1.a Background
The background provides sufficient information to justify the QI initiative. This may include data collected during the Prepare stage showing the clinical gap in the healthcare system’s care of patients with AF when compared to current practice guidelines, the consequences of this gap such as stroke incidence and the financial cost to the system, and the potential financial benefit if this gap is reduced or eliminated. The healthcare system current outcomes data could be compared to broader state or national data, if the latter are available.
3.1.b Purpose / Goal / Objectives
The purpose of this QI initiative to improve the care of patients with AF is specified, the intended goal(s) and outcomes are identified, and the objectives to achieve these goals and outcomes are delineated. The purpose is broadly stated, the goal and outcomes become more specific, and the objectives are SMART: specific, measurable, achievable, relevant, and time-bound. This process is often referenced as backwards planning or starting with the end in mind.
Goal: to create awareness of current evidenced-based anticoagulation guidelines and improve anticoagulation prescribing rates among system practices for patients with atrial fibrillation.
Objectives:
- Review patients who have been identified to have a CHA₂DS₂-VASc score of 2 or greater in males or 3 or greater in females that are not on anticoagulation
- Identify why anticoagulation is not currently prescribed and determine if the patient should be on an anticoagulant based on the guidelines that were reviewed
- Identify the need for further evaluation by the AF Center for intervention such as LAAO
Related Resources
Writing SMART Objectives
(Centers for Disease Control and Prevention (CDC), Division for Heart Disease and Stroke Prevention)
3.1.c Scope
Scope defines the initiative size and boundaries, including sources of patient data and start/end dates of data acquisition. If the initiative goal and related objectives are to improve a narrow clinical gap, then scope is limited, and the stakeholder group may be small. If the goal is to address and sustain an improvement of a major clinical gap in care, then scope is broad and will require support from many relevant stakeholders. Consider attaining a broader scope through the completion of smaller QI initiatives with limited scope that require fewer resources and are more likely to succeed.
3.1.d Metrics / Outcomes / Benchmarks
Preliminary metrics and related analytics were identified during the Prepare stage, but now methods to measure success must be specifically defined. The most often cited struggle with QI initiatives is determining the analytics: it is difficult to determine how the healthcare system is measuring up. Methods to measure success are critical to sustain the outcomes. Baseline data metrics may need to be refined to reflect an accurate and valid numerator/denominator. Below are some sample benchmarks for data acquisition:
- number of patients diagnosed with AF and with a CHA₂DS₂-VASc score ≥2 for men or ≥3 for women (“qualifying AF patients”)
- number of qualifying AF patients (1) with and (without) an active Rx
When the measures are identified, baseline data for each measure should be acquired and tracked throughout the duration of the initiative. It will be necessary to work with the IT department to determine any necessary EHR adaptations to acquire and routinely report the data being tracked in the QI initiative.
Sample outcome measures might include the following:
- % change in untreated and treated patients
- % change in medication adherence
- Projected stroke prevention rate
- # of strokes in AF diagnosed patients without anticoagulant medication
3.1.e Interventions Focused on Processes, Patients, Providers
Many variables may contribute to the identified clinical gap in AF care. Clinicians may not be aware of the clinical practice guidelines or may not recall the criteria that suggest the need to discuss the use of an anticoagulant with the patient. Data may not be entered accurately in the EHR and thus inaccurately overstates or understates a problem. Patients may resist the need for medication due to fears of side effects and fail to appreciate the link between atrial fibrillation and stroke. As you choose the interventions for your initiative, consider where you can have the most success or impact for your organization. The team should identify the most likely contributing variable(s) and design an intervention(s) that addresses and is designed to reduce the effect of this variable. If the initiative design includes more than one intervention, these should be staged over time so that the effect of each can be identified in the ongoing data collection.
Patient education might include the following:
- Stroke risk awareness
- Understanding treatment options
- Medication adherence
- Health literacy and health numeracy
Provider education might include the following:
- Guidelines from recognized expert organizations
- Principles of shared decision-making
- Relevant publications
- Principles of motivational interviewing
System issues might be identified by reviewing the patient journey with specific attention to the following:
- Data regarding drop off points
- Transitions of care
- Social determinants of health
3.1.f Timeline / Milestones
A specific timeline should be developed for the QI initiative, from beginning to conclusion. The timeline should include milestones to be met throughout the initiative duration, including when interventions will occur and data will be reviewed. The data may reveal the need to redesign certain initiative interventions or activities: the QI plan exemplifies a Plan-Do-Study-Act (PDSA) cycle.
3.1.g Communications Plan
Ongoing communication with all initiative stakeholders is critical. This communication may be in the form of routine meetings, documentation of initiative activities, or other formal methods. Equally effective are informal discussions with key stakeholders by the team members. Establish set check-in points for the initiative team to update one another on the status of initiative activities.
Develop specific communication plans to engage the health system stakeholders and leadership. Incorporate messages and presentations from local AF champions across all system therapeutic areas.
3.1.h Roles and Responsibilities
The core team should come to a mutual understanding of and respect for the role and responsibility of each team member.
Related Resources
Project Champions
3.1.i Resources
The specific resources to accomplish the initiative must be identified and the activities necessary to create and/or locate these resources should be incorporated in the overall initiative timeline with associated milestones. These resources may include IT support tools, data report templates, and physician and/or patient educational materials.
3.1.j Budget
The initiative budget should be prepared that includes all sources of income and all estimated initiative expenses: direct and indirect costs as may be required by the healthcare system. If grant or contract support is necessary, the sources of such support and the requirements necessary to secure the support should be ascertained. The initiative plan will undergird the request for external financial support.
3.1.k Pilot Site(s)
If the healthcare system comprises multiple sites, consider using a subset as pilot sites for the QI initiative. This would allow for varied and/or comparative interventions. Communicating the need for the QI initiative and sharing and securing feedback regarding the initiative plan will be essential to enlist pilot site support. If pilot sites are used during the initiative, an implementation team should be formed at each site and regularly scheduled meetings with each site should be included in the initiative timeline. Defined benchmarks may be necessary to compare metrics between the sites and with the overall healthcare system.
Your plan is prepared and ready to be shared and discussed with all project stakeholders and participants. Answer any questions they have, secure feedback and their insight as to revisions that might be necessary. When all understand and are committed to their participation, you are ready to implement the plan.
If there is no research plan included in the QI initiative, then IRB approval may not be necessary. Many healthcare systems permit a QI exemption to such formal review.
Implement
The QI initiative is launched with the Implementation Pillar. The plan is tested and refined as barriers and issues are encountered. Ongoing reporting to the project team and stakeholders occurs during this pillar.
The QI initiative is ready to be tested, launched, tracked, revised as might be necessary, and reported. Many systems have found it helpful to assign oversight of initiative details to smaller core team subsets or individual team members who report status of their area of responsibility to the entire core team as part of meeting agendas. This reduces the work required of every team member.
The QI initiative is launched during the Implement pillar. The plan is tested and refined as barriers and issues are encountered. Ongoing reporting to the project team and stakeholders occurs during this pillar.
4.1.a Build, Test, and Refine IT Infrastructure and Reports
It is important to test the data collection process before launching the QI initiative to identify and resolve any issues associated with data collection and reporting. Engaged stakeholders can be asked to navigate through the system to assure that it functions and performs as expected. A cumulative list of changes can be maintained before requesting EHR modifications, as there will often be only one opportunity to request these changes from an IT department with many competing priorities. Note that if changes appear too complex, those who “build” the changes may set them aside. Remain persistent to see that the IT department makes these changes.
It may be necessary to educate and orient healthcare providers along the QI care continuum about the plans and how these plans might affect their role when the initiative is launched. A training plan and materials can be developed for this purpose to be used prior to the launch and during the implementation stage for new providers. Maintaining a list of persons who have received this training will be helpful in identifying new providers.
Communication with and among the core team members, stakeholders, and engaged healthcare personnel is essential. Formal meetings and informal contacts will flag barriers and issues that should be addressed and eliminated in the data and reporting processes. These contacts will also provide the core team with valuable information about the interventions and suggestions for improvement or modifications.
4.1.b Obtain Baseline Data
The baseline data are the comparative foundation for all subsequent data runs and will depict the outcomes as the initiative continues to its conclusion. A preliminary data run is likely to have occurred as an initial step when preparing for the QI initiative. The baseline data will now be collected for the initiative.
4.1.c Implement Interventions
Intervention plans and materials are ready and the initiative is launched. Interventions will be implemented in accord with the design timeline. Note the start and end date for each intervention so that the effect of each may be tracked in comparison to baseline data.
4.1.d Measure, Analyze, and Report Changes Compared to Benchmarks
Track the progress through the initiative through data runs and corresponding reports that occur on a regular schedule throughout the initiative and are tracked against the baseline data.
4.1.e Discuss Findings and Challenges with Core Team
Initiative findings and barriers will emerge as the QI initiative continues. Experience suggests that some or all of the following barriers are among those that may be encountered:
- Fractured healthcare system, where groups in different geographic areas have their own business units, processes, and leadership teams. It can be difficult to implement a QI initiative across an entire healthcare system.
- Receiving management support to complete the necessary work.
- Initiatives that span multiple stakeholders are difficult to initiate and are often delayed due to lack of internal coordination.
- Lack of specific examples of pathways, dashboards, EHR tools, and other resources.
- Resource allocation from the IT department.
- Clinicians don’t like to exit from their own EHR system to access external resources.
The identification and resolution of barriers is an important role for the core team throughout the entire QI initiative.
4.1.f Optimize Intervention(s): Make Incremental Changes as Needed
The need to redesign certain project interventions or activities may be revealed as the QI initiative progresses, exemplifying a Plan-Do-Study-Act (PDSA) cycle. Please see section 3.1.f Timeline/Milestones for more information and resources on the PDSA cycle.
Report
Reports play an essential role in the quality improvement process. Many options exist depending upon the healthcare system, the audience, and the purpose of the report.
Reports play an essential role in the quality improvement process. Many options exist depending upon the healthcare system, the audience, and the purpose of the report.
5.1.a Project Updates
Update reports throughout the QI journey serve several purposes. They inform the initiative core team about the impact of intervention(s) on the metrics being measured, they serve as a continuing source of information to the stakeholders, and they remind system leadership of the initiative and its progression. These reports can be shared and discussed with initiative stakeholders.
5.1.b Collate Insights (subjective)
Subjective insights are a valuable source of information. Informal visits by core team members to stakeholders often identify issues that would otherwise not be known to the core team. Experience suggests that interventions may need to be modified to be more closely integrated with the patient care pathway, and stakeholders along that pathway are those who are most aware of these issues. The core team members also are a source of subjective insights, particularly when unexpected findings require interpretation.
5.1.c Analyze Results (objective)
Maintaining data from the beginning of the QI initiative to the endpoint, as well as interim data reports, provides an objective source of information regarding the impact of the QI initiative. Interim and final data reports to stakeholders continue to keep them informed and provide an opportunity for their feedback.
5.1.d Record Changes
Intervention(s) changes and modifications should be recorded and tracked on the reporting updates. The type of change and the rationale for making the change provides helpful feedback for the stakeholders and system leadership.
A summary report prepared at the conclusion of the defined initiative endpoint could include at least the following sections:
- the clinical gap being investigated
- the purpose of the QI initiative
- the stakeholders and core team members
- the planned interventions
- the metrics used to measure data
- barriers encountered during the initiative and how these barriers were resolved
- summary data from interim reports
- changes and modifications to interventions throughout the initiative and the rationale for these changes
- objective and subjective reported outcomes
- insights gained through the initiative
- plans for sustaining the outcomes, and, where warranted, how the initiative results will be expanded to other parts of the healthcare system or to other external systems.
It will be important to disseminate the summary report to all the stakeholders and the system leadership. This report validates the work of the core team as well as the impact of the QI initiative on patient care in the healthcare system.
A plan to communicate the initiative findings should indicate who will need to be informed, how the findings will be presented, and who will represent the team in the communication process. The plan may include dissemination of the final report, meetings with healthcare system departments who have been engaged in the initiative, formal presentations and informal discussions. The plan may include presentations at annual meetings and submission of journal articles. The plan then will be instituted. Be sure to celebrate with the team the success of the QI endeavor.
Sustain/Scale
A plan to review regularly atrial fibrillation data resulting from the completion of a quality improvement initiative is essential to sustain the results. If the initiative has resulted in improved outcomes, healthcare system leaders may broaden the plan to other sites or to other systems.
A plan to review regularly atrial fibrillation data resulting from the completion of a quality improvement initiative is essential to sustain the results. If the initiative has resulted in improved outcomes, healthcare system leaders may broaden the plan to other sites or to other systems. A plan to regularly review the data resulting from the completion of the QI initiative assures that the positive outcomes will be sustained.
6.1.a Upkeep/Maintenance
A challenge often observed in QI initiatives is that upon conclusion the team disbands. It is important to identify who on the team or in the healthcare system will be responsible for continued review and maintenance of AF outcomes and communicating these with stakeholders and system leadership.
6.1.b Transitions of care
Transition points often give rise to discontinuity in patient care. The sustainability plan should include a regular review of transition points to identify issues that may contribute to a continuing or new gap in the care of patients with atrial fibrillation.
6.1.c Update benchmarks
Identified benchmarks may need to be updated to reflect continuing improvement. A review of benchmarks can be included in the sustainability plan.
6.1.d Ongoing Quality Achievement Feedback Reports to Providers, Clinics, Stakeholders
Continuing to provide reports to individual clinicians who are caring for patients with AF and comparing their performance with peer group performance drives change and such reports are often used to judge performance. Ongoing AF data reports to system leaders increases the likelihood that the improvement will be sustained.
6.1.e Reinforcement/Education
Reinforcing the importance of quality patient care assists in sustaining the positive outcomes from a QI initiative. Education is a continuing intervention as guidelines and standards change and refreshes the knowledge base of healthcare providers.
6.1.f Concordance with Culture
Cultures can vary from system to system: some insist on standardization, while others support flexibility. To sustain QI results, the sustainability plan must be in concordance with the system culture.
6.1.g Fit into Workflow
Maintaining quality improvement results is most easily accomplished if interventions are included in the clinical workflow and require no extra work by healthcare providers.
6.1.h HCP Performance/Incentive Goals
Providing incentives for quality performance is a key factor in sustaining outcomes.
Scalability depends upon the availability of an eRecord to identify patients and calculate the CHA₂DS₂-VASc score. Scalability depends upon accurate data that is trusted by healthcare providers. A plan will be necessary to scale the initiative to other locations and launch further QI initiatives.