1. The Innovation Process
1.1. Brainstorming and Ideation
1.1.1. Initial steps of the innovative process; framework, issue redefinition and idea generation (Weiss & LeGrand, 2011)
1.1.1.1. A Technical Expert Panel met in July and brainstormed ideas for capturing a med rec measure as well as a scale up plan to medication management
1.1.2. 4 steps for Brainstorming: Lay out the problem you want to solve, Identify the objectives of a possible solution,Try to generate solutions individually, Once you have gotten clear on your problems, your objectives and your personal solutions to the problems, work as a group. (Adams, 2013)
1.1.3. "Ideation is the process where you generate ideas and solutions through sessions"
1.2. Rapid Prototyping
1.2.1. Rapid prototyping allows for end-user testing before moving on to develop and implement the innovation
1.2.1.1. We are currently piloting a medication reconciliation process using process mapping (Holbrook, 2016)
1.3. Considerations for course correction
1.3.1. Because we are alpha and beta testing the medication reconciliation measure, we can incrementally course correct
1.4. The Case for Innovation
2. Leadership structure
2.1. Dynamic Cybernetic Leadership Team Model
2.1.1. The DCT model is an innovative model that supports systematizing the achievement of outcomes and integrates continuous review of five process factors
2.1.1.1. Team Performance and Organizational Alignment
2.1.1.1.1. Member roles: Private and Federal Partnerships will advance innovation
2.1.2. Leadership Core Values
2.1.2.1. Innovation is a process of learning and creation from which new problems are defined and new knowledge is developed to solve them (Porter-O'Grady & Malloch, 2015, p.177)
2.1.2.2. Value for disruptive innovation (Porter-O'Grady & Malloch, 2015, p.182)
2.1.2.3. Understands the dynamic (cybernetic) nature of innovation (Porter-O'Grady & Malloch, 2015, p.177)
2.1.3. Emergent Leadership
2.1.3.1. ..."evolution of new behaviors, relationships, processes and ways of being." (Porter-O'Grady & Malloch, 2015, p.107)
2.1.3.1.1. Collective wisdom and creativity
2.1.3.1.2. Metrics are not considered in isolation
2.1.4. Systems thinking
2.1.4.1. Understand intersection of the elements of the system, work through nose when creating a good fit ((Porter-O'Grady & Malloch, 2015, p.32)
2.1.4.2. Understand how medication reconciliation at point of service affects the larger complex dialysis delivery system
2.1.5. Sustainability plan
2.1.5.1. Leverage dialysis growth and increasing costs
2.1.5.2. Continued alignment with stakeholder engagement (Porter-O'Grady & Malloch, 2015, p.32)
2.1.6. User ownership and input
2.1.6.1. Need to engage end-users: staff, clinicians and patients
2.1.6.2. This will drive management, education, research and change practice
2.1.7. Facilitation mindset
2.1.7.1. Leader must define and direct work that needs to be done driven by bottom up strategies (Porter-O'Grady & Malloch, 2015, p.393)
2.1.7.2. Use environmental scanning techniques (Porter-O'Grady & Malloch, 2015, p.288)
2.2. Key roles
2.2.1. organizing
2.2.1.1. alpha testing, engage dialysis unit leadership
2.2.2. role modeling
2.2.2.1. build student-led/ancillary staff medication reconciliation for alpha testing
2.2.3. mentoring
2.2.3.1. mentor pharmacists who will work in dialysis med rec
2.2.4. facilitating
2.2.4.1. liaise between CMS, LDO and Surescripts
2.2.5. coordinating
2.2.5.1. Coordinate initiatives from stakeholders and circumvent barriers to moving innovation forward
2.2.6. integrating
2.2.6.1. Integrating communication between stakeholders
2.3. Change Theory and Management
2.3.1. Lipitt's change theory framework
2.3.1.1. Phase 1: Diagnose/Identify the problem
2.3.1.1.1. Medication reconciliation and management are not performed accurately or systematically in dialysis units
2.3.1.2. Phase 2: Assess motivation and capacity for change
2.3.1.2.1. CMS desires a new measure which moves beyond attestation to quality
2.3.1.2.2. Surescripts would like their platform used widely to support medication reconciliation
2.3.1.2.3. Patient's providers and staff agree medication reconciliation and management is important
2.3.1.3. Phase 3: Assess change agents motivation and resources
2.3.1.4. Phase 4: Selective progressive change objective
2.3.1.4.1. To create a quality measure and IT infrastructures that facilitates accurate and efficient medication reconciliation
2.3.1.5. Phase 5: Choose appropriate role of the change agent
2.3.1.6. Phase 6: Maintain change
2.3.1.6.1. alpha and beta testing will facilitate scale up and maintenance
2.3.1.7. Phase 7: Terminate helping relationship
2.3.1.7.1. Once solid policies and procedures are developed, measure is implemented and short-term outcomes are documented (medication list concordance, medication record discrepancies)
2.3.2. Systems Theory Application: ..."skill of translating understanding of human dynamics and social enterprise" (Porter-O'Grady & Malloch, 2015, p.260)
2.3.2.1. Dynamic Cybernetic Team Model
3. Evidence (Pai et al., 2009, Pai et al 2013)
3.1. Medication record discrepancies have been shown to occur in 60% of dialysis patients who had their medication lists reconciled by a pharmacist. (Manley HJ et al., 2003)
3.1.1. Improved Patient Safety and Outcomes
3.2. Dialysis patients are at high risk for medication related problems: more than five medications, multiple doses per day, multiple comorbidities (Pai et al, 2013)
3.2.1. Improved Patient Safety and Outcomes
3.3. Medication Therapy Management provided by pharmacists in dialysis facilities was associated with a 48% reduction in re-hospitalization (Manley HJ et al., 2018)
3.3.1. ROI Cost Avoidance
3.4. User input: A study evaluating dialysis staff views toward pharmacist-led MTM in dialysis patients revealed the following themes (Parker WM et al, 2015)
3.4.1. the need for access to MTM services in dialysis facilities
3.4.2. services should include medication reconciliation and patient education
3.4.3. services should be proactive, consistent, individualized, and covered by insurance;
3.4.4. pharmacists are uniquely suited to provide MTM services.
3.5. A cluster-randomized controlled clinical trial showed that dialysis patients receiving medication management by a pharmacist reduced hospitalizations and length of stay as well as reducing the number and cost of medications (Pai et al., 2009)
3.5.1. ROI Cost Avoidance and Improved Patient Safety and Outcomes
4. References
5. Finance
5.1. Budget
5.1.1. Based on 1 year project development and roll out for alpha testing
5.1.1.1. Physician, Pharmacist, Nurse salary 25% FTE
5.1.1.2. CMS representative 25% FTE
5.1.1.3. Surescripts representative 25% FTE
5.1.1.4. Interoperability specialist 50% FTE
5.2. Return on Investment and Financial Impact on Medicare
5.2.1. Improving medication reconciliation and resolving discrepancies will reduce hospitalizations and medication costs in dialysis patients
5.2.1.1. ROI Model
5.2.1.1.1. The total cost of inpatient ESRD care was $29,436 per beneficiary per year (PBPY) (approximately $2,453 per day) in 2016. Based on an anticipated annual reduction in length of stay by 3.15 days (Pai et al, 2009), a cost savings of $7,727 PBPY reduction in total cost of care (USRDS, 2017)
6. Information Technology
6.1. Use of Technology in Dialysis Medication Reconciliation
6.1.1. The main issue in doing medication reconciliation efficiently is system interoperability (Rose et al, 2017)
6.1.1.1. The major technology element used in my innovation is interfacing web-based data capture. Crownweb is the Web-based data-collection system that enables Medicare-certified dialysis facilities to securely submit administrative and clinical data to the Centers for Medicare & Medicaid Services (CMS) in real time.
6.2. IT Governance Model: 4 Plan Hierarchies across Corporate Business, Functional and Operation Management (Mintzberg, Ahlstrand & Lempel, 1998, p.56).
6.2.1. Budget
6.2.1.1. Costs of interoperability investment, integration of data, staff for 3-5 years to iterate and adjust. Balanced with proposed reduced total cost of care.
6.2.2. Objectives
6.2.2.1. Intervention is complex, must stay focused on patient-centered objective
6.2.3. Strategies
6.2.3.1. Proactive timelines and adequate resource allocation as well as flexibility to adjust based on both outcomes and the patient experience will be required.
6.2.4. Programs
6.2.4.1. Need to consider intervention outside of capital budgeting as this will impede the IT strategy implementation (Mintzberg, Ahlstrand & Lempel, 1998, p.76).
6.3. Technology Assets
6.3.1. Architecture
6.3.1.1. A web-based application that integrates data from Surescripts with the quality measure capture platform Crownweb. The focus of this architecture approach is on integratability (Glaser & Salzberg, 2011, p.57) Adaptive artificial intelligence (Panetta, 2017). This will ensure that the components will be fitted to achieve desired characteristics and capabilities (Glaser & Salzberg, 2011, p.64).
6.3.2. IT staff
6.3.2.1. Needs to be Multidisciplinary Team!
6.3.2.1.1. Data science researchers, healthcare professionals and technical staff to integrate data sources into an artificial intelligence-based advanced analytics adaptive algorithm (Kerby, J., 2018).
6.3.3. Data
6.3.3.1. Data will be imported from Surescripts into Crownweb producing an an up to date list that can highlight potential discrepancies and be confirmed by the patient. A separate software application can convert the reconciled med list into a patient friendly version.
6.3.4. Applications
6.3.4.1. A software application that integrates data sources can be further developed using AI to highlight the most frequent medication record discrepancies.
6.4. Influencing IT Strategy
6.4.1. Design Thinking
6.4.1.1. Personas for end-users
6.4.1.2. Prototyping
6.4.1.3. End-user testing
7. Policy
7.1. Medicare
7.1.1. Current Inhibitory Policies
7.1.1.1. Medication Therapy Management (MTM is billable under Medicare Part D. Dialysis is billed under Medicare Part B. Moving MTM for dialysis patients under Part B would allow MTM to be provided efficiently at the dialysis unit
7.1.2. Long-term Goal: Restructure of Medicare Payment
7.1.2.1. Prescription Drug Plans that bill for MTM under Part D can pay an opt out fee to CMS so that MTM can be performed at the dialysis center
7.1.3. Plan to Change Policies with Evidence of Research- This was already discussed with CMS at a Technical Expert Panel held in July 2017
7.1.3.1. Cost savings from reduction of hospitalizations
7.1.3.2. Cost savings from reduced medication costs (deprescribing)
7.1.3.3. Opt out fees from PDPs further support MTM in dialysis units
7.2. Organizational
7.2.1. Different Large dialysis organizations have different policies on medication reconciliation: Need to be unified (via new CMS measure)
7.2.1.1. DaVita
7.2.1.2. Fresenius Medical Care
7.2.1.3. Dialysis Clinic, Inc
8. Outcomes
8.1. Quantitative
8.1.1. Medication list concordance
8.1.1.1. Manley et al 2003
8.1.2. Number of interventions made with MTM
8.1.2.1. Pai et al, 2009
8.1.3. Proportion of patients achieving phosphorus < 5.5 mg/dL
8.1.4. Reducing proportion of patients with pre-dialysis systolic blood pressure > 150 or < 120 mmHg
8.1.5. Mortality rate
8.1.6. Dialysis treatment adherence
8.1.7. Hospitalization rate
8.1.7.1. Pai et al 2009
8.1.8. Hospital length of stay
8.1.8.1. Pai et al, 2009
8.1.9. Rate of 30 day readmission
8.1.9.1. Manley HJ et al, 2018
8.1.10. Hospitalization costs
8.1.11. Part D medication costs
8.1.12. Part B medication costs
8.1.13. Total costs of care
8.2. Qualitative
8.2.1. Patient health literacy
8.2.2. Patient satisfaction
8.2.3. Provider satisfaction
8.3. Better health delivery
8.3.1. By systematizing medication reconciliation and management, staff can perform these activities more efficiently and consistently
8.4. Evolution of innovation over time
8.4.1. Because of the complexity of implementing a medication reconciliation quality measure, alpha and beta testing will be necessary