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Neuromodulation and Private Practice: not an oxymoron

Neuromodulation and Private Practice: not an oxymoron. Mark Gudesblatt MD South Shore Neurologic Associates Suffolk County, Long Island, New York. Know your diseases Know your options both as a clinician and as a patient Know your therapies Be the best you can, always give your best effort

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Neuromodulation and Private Practice: not an oxymoron

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  1. Neuromodulation and Private Practice: not an oxymoron Mark Gudesblatt MD South Shore Neurologic Associates Suffolk County, Long Island, New York

  2. Know your diseases Know your options both as a clinician and as a patient Know your therapies Be the best you can, always give your best effort An uninformed advocate is not an effective advocate Neuromodulation: The best therapies that no one has ever heard of Lack of awareness of treatment options is not the same as lack of efficacy A treatment not utilized is a treatment not effective Not all treatments are appropriate for all patients Not all treatments produce desired outcomes Summary for those who are hungry, like to read the end of the story first or leave early …

  3. “It’s hard to make predictions, especially about the future.” Yogi Berra The Challenge of Predicting Prognosis, Treatment needs and response, and Disease Progression

  4. Classic Education, Traditional Care Who are you as a clinician? Who do you want to be as a clinician? How do you get from where you are to where you might want to be? “The times they are a changing…” Concurrent & simultaneous evolution and revolution

  5. Neurology, Therapeutics, & The Concept of Actually Offering Treatment: Oxymoron? Appreciation that the disease or symptoms are truly a problem for the patient Accurate and comprehensive analysis of the problem or problems reported Diagnosis of the disease problem followed by an actual interest and intent to treat Identification of the issues that have a potential treatment and need to treat Intention to treat followed by action and actual treatment Treatment & Intervention followed by ongoing care, monitoring and management Not diagnose and adios

  6. What Neuromodulation therapies are available? Are Neuromodulation therapies effective? No therapy is effective for all patients Goal setting: appropriate, realistic, mutually agreed upon Inappropriate or unrealistic goals can lead to dissatisfaction and apparent therapy failure Why offer Neuromodulation in general or private practice? Why not? Which Neuromodulation Therapy to offer in practice? Neuro What?

  7. The first Neuromodulation clinical trial

  8. Why should these therapies be utilized? Why should I do this? Why shouldn't i do this? How can I offer these treatments? Why don’t others offer these treatments? Which one(s) should I be involved with? The Problem

  9. The North American Neuromodulation Society

  10. Why is it a problem? Lack of awareness at multiple levels Patient, family, caregiver, and staff fear Lack of knowledgeable advocacy of available effective treatment Lack of comfort for patient, caregiver, and clinician in utilizing “novel therapies” ITB therapy gained U.S. Food and Drug Administration (FDA) approval for managing severe spasticity of spinal origin in 1992 ITB therapy gained U.S. Food and Drug Administration (FDA) approval for managing severe spasticity of cerebral origin in 1996 The (FDA) approved DBS as a treatment for Essential Tremor in 1997, for Parkinson’s Disease in 2002, and Dystonia in 2003 Physician fear and limited training in these therapies Medical School, Residency, Fellowship, Post-graduate CME Lack of exposure

  11. Making the jump from diagnosing and implementation of standard neurological care models to awareness, offering and implementing available and effective or evolving therapies that have developed in the past 25 years can be a difficult transition. • Hakuna Matata – “change can be difficult” - Rafiki

  12. The Challenge of Fear Address issues of fear Address issues of uncertainty Address issues of concern Address issues that arise Address lack of awareness Address misconceptions Address lack of exposure With apologies to the movie

  13. Offering effective therapies often times requires more than just treatments administered orally. • To adequately and effectively address symptoms and to treat disease progression from some neurological disorders treatment requirements might include: • Parenteral or intravenous treatments • Intrathecal delivery of medication • Neuromodulation interventions.

  14. Offering Hope can be contagious Is an effective clinician something more than just a diagnostician? Are you just a diagnostician or a clinician who will not only diagnose but manage the neurological disorder? Are you a clinician that will only go so far in the care of your patients? What is the role of advocacy in neurological care? What is the role of objective analysis?

  15. Effective disease management might require more than just standard traditional evaluations, treatments and interventions. A comprehensive armamentarium of treatment opportunities offer more hope and options for effective and satisfying care than does limited choices or options. As diseases evolve or progress treatment decisions and treatment requirement may become more complex. Are you interested and ready to offer treatments that can be effective, dramatic and satisfying if they require more time, effort, and involvement beyond a prescription or a brief discussion? What is comprehensive care?

  16. Flexibility is the name of the game

  17. What is in a name, anyway? Evaluating care needs goes beyond a diagnosis or a disease name. Disease management requires addressing not only the underlying disorder but as many of the concurrent associated symptoms or problems as possible. These symptoms or problems may evolve or appear over time despite adequate use or adjustment of first line standard or conventional treatments.

  18. Psychiatric Anxiety-depression OCD-gambling Panic Cognition Memory Executive Function Information Processing Attention Apathy Sleep Disorders Apnea RLS/PLMS REM Sleep Behavioral Disorder Parkinson’s Disease: What is in a name? Treatment Plan Co-morbidities or …Spectrum of disease Tremor vs. Akinetic Rigid Fatigue Dystonia Dyskinesia Autonomic BP lability Freezing of Gait Autonomic GI Motility Balance Vestibular Fall Risk

  19. As diseases evolve or progress treatment decisions and treatment requirement may become more complex. • Patient needs may change over time. • What is a significant change or threshold of change that needs to be addressed? • Are you interested and ready to offer treatments that can be effective, dramatic and satisfying if they require more time, effort, and involvement beyond a prescription or a brief discussion?

  20. Challenging Neurological Disorders may require adjunct use of novel technology or treatment Identifying Appropriate Candidates or people in need who can benefit from neuromodulation They are really just all around …. Open your eyes Look, listen, question Just ask – be proactive Educate others Don’t be afraid to advocate or discuss options

  21. Effective disease management might require more than just standard traditional evaluations, treatments and interventions or oral medications. • Effective evaluations and treatments of complex and evolving or progressing neurological disorders might require an arsenal of analysis, documentation, and treatment methods and tools. • Objective documentation of change is better than a subjective report • A comprehensive armamentarium of treatment opportunities offer more hope and options for effective and satisfying care than does limited choices or options.

  22. The Challenge of Patient Selection Successful patient selection simply starts with awareness of therapeutic options Awareness starts with education, hope, proactive concern and communication as well as elimination of the concept of therapeutic nihilism. Demystification of “Neuro-mythology” lack of effective and available treatment options. Be proactive, be involved ITB

  23. No matter what the therapy is…. “The more convincing you have to do to get a patient to undergo a screening test, the less likely the patient is to be satisfied with the outcome.” Janet Gianino, R.N., M.S.N. Rush-Presbyterian-St. Luke’s Medical Center, Chicago

  24. Treatment team must continuously work closely with patients, families/caregivers to establish functional goals tailored to the patients level of disability and reinforce them post-implant Goals should be realistic, reasonable, explicit, mutually agreed upon, collective, and established prior to intervention Patience is needed to achieve goals Unstated and/or unrealistic expectations and impatience can lead to disappointment and perceptions of treatment failure Communication is key It is not the speed of adjustment or reprogramming but achieving the goals desired The Challenge of Effective Communication

  25. Communication is a 2 way street

  26. Patience, Patient, Patients • The challenge of being a patient, encouraging, proactive advocate, communicator and clinician • The challenge of being a reasonable, reliable, responsible, and patient patient • The challenge of being a reasonable, reliable, responsible, and patient caregiver • Put yourself in someone else’s shoes • Let the patient and family/care-giver be your guide • Let the clinician be your guide • Opportunities for trust and cooperation are all around • Make allies not enemies

  27. Program development is a process Evolution takes time (just ask Darwin) The “what is needed or not” changes with time, clinical experience, and patient needs Treatment or therapeutic interventions require modification over time to address patient needs that "appear" or develop Experience and awareness of what is needed for effective & satisfying implementation develops over time A vision for a Neuromodulation center or team is modified and achieved over time

  28. One practice practical approach Pre-implant testing Specialty Consult regarding candidacy agree Clinic SSNA identify appropriate candidate referral Surgical implant disagree Ongoing local Care reprogamming establish plan of care, communicate post-implant Initial Programming Rehab

  29. Teamwork and Communication are key Can comprehensive care be delivered in isolation by one clinician? Experienced Implanter and Team Deciding on roles for MD, NP, PA and RN partners in care: what are the personalities and work relationship of team members ... Effective ongoing communication In-Network insurance coverage Follow plan of care Co-management with seamless cooperation and communication offers better care opportunities and all providers have improved satisfaction and likely improved outcomes What can you do to improve care efficacy & efficiency? Trouble shooting

  30. One Example: The Challenge of An Effective ITB Trial • Goal setting prior to ITB trial • Mutually agreed upon, appropriate, collective, realistically obtainable goals • Choosing dose to administer • Outcome goals to be measured at ITB trial • Allaying patient & care-giver fear of test dose • Educating regarding effective spasticity management

  31. Predictable Reduce tone in extremities Reduce spasms in extremities or trunk Control clonus in extremities Reduce spasticity-related pain Improve sleep Reduce side effects of oral antispasmodic medications Improve quality of life Ease care giving tasks, performance of hygiene, dressing, bathing Ease positioning in wheelchair Unpredictable Improve quality of gait Reduce spasticity-related pain with ambulation Increase independence in transfers Increase upper extremity control and function Improve bladder and bowel function Reduce incidence of skin breakdown Improve oral motor control and vocal cord dysfunction Goals of ITB Therapy Barbara Ridley, Patrice Korth Rawlins, Intrathecal Baclofen Therapy: Ten Steps Toward Best Practice. Journal of Neuroscience Nursing, April 2006 Volume 38, Number 2

  32. Potential Goals: keep it simple ITB ITB goals

  33. Goals must be: Reasonable, realistic, mutually agreed upon • Not all goals identified and planned for might be achieved • Goal setting can be modified ongoing or after implementation of neuromodulation • Feedback from patient, care-giver, staff, therapist is important • Communication to set or change goals • Clinician: Let the patient, family, caregiver be your guide • Patient/Family: Let the clinician be your guide • Put yourself in someone else’s shoes • Opportunities for trust, communication and cooperation are everywhere, and must be identified and pursued

  34. Experience does count: if I can do this so can you. Learning from each exposure leads to experience

  35. Practice Does Improve Clinician Confidence & Performance DBS Implant Neuromodulation

  36. Roles constantly change and evolve MD ITB involvement >15 years, >250 active ITB pumps, >350 ITB trials MD initially - initial evaluation, trial, post trial review, post implant adjust, refills & adjustment, house calls NP involvement – teamwork and close involvement >10 years with ongoing collective discussions and co-management MD or NP currently does initial spasticity evaluation; trial done together (MD does LP and injection), post ITB trial review and initiation of plan of care (NP), post implant adjustment & refills (NP), trouble shooting with catheter line check (NP)

  37. “We need a plan.”

  38. Effective treatment is often not accomplished in a single office visit. • Not all issues can be addressed in one visit • Effective treatments require consideration, communication, thought, comprehensive care, ongoing care, feedback and concerned proactive management. • Did it work out for you or not? • What is comprehensive care? • What is the standard of care? • Are all current care guidelines appropriate and up to date?

  39. Therapy availability, access, implementation and ongoing management and adjustment should be seamless. • Know your resources • Teamwork • Promote ease of access and community awareness • Continuity of providers and communication offers an effective avenue and opportunity for satisfying care delivery and collaboration

  40. Post-implant Plan of Care Review outcomes: Were functional objectives met? Yes No • Reassess adjunctive therapies • Modify procedure/dose • Reevaluate patient selection/goals • Continuous reevaluation at follow-up to review • treatment strategy • Reassessment of adjunctive therapies Brin MF et al. Muscle Nerve. 1997;20(suppl 6):S208-S220. Physician extenders can help coordinate and effectively implement the plan of care

  41. The Challenge of Individualization of any Neuromodulation Therapy Post implant management is not just about dose adjustments, refills, or change in stimulator settings Individualized dosing patterns and speed of titration or adjustment that enhance patient satisfaction and outcomes should be used Neuromodulation is a program, not simply just a procedure

  42. The Challenge of Setting Appropriate & Effective Goals Post Implant • Improve ease of care & comfort • Improve function and or independence • Prevent deformity or contracture • Pick another goal • Clarify expectations • Realistic and individualized for each patient • Commitment, understanding, motivation • Document Change and response

  43. Establishing liaisons and relationships with company representatives and academic centers • Education if exposure did not occur during training • Expand and increase awareness of options for effective therapy utilization • Help identifying candidates for appropriate effective treatment • Advocacy • Developing awareness of availability of an effective therapy and awareness of local expertise. • Not all centers do all aspects of treatment from implementation, evaluation, goal setting, screening for candidacy, trial or implant, post implant management (early vs. late) • Co-management can be effective for not only refining care needs but transitioning and optimizing patient care from tertiary centers back to the community for local care.

  44. ITB • Initial spasticity evaluation and determining plan of care • ITB trial- goal setting, education, evaluation of response • Post trial review, education, and confirming plan of care • Coordinating plan of care • Post implant adjustment, monitoring and management • Refills • Trouble shooting • Office issues & catheter dye studies

  45. DBS - VNS • Co-management of care • When to be seen in the office again • Establish a plan of care • Flexibility is important • Identification of candidates • DBS:ET, PD vs atypical PD, Dystonia, ? Other • VNS: refractory, not surgical candidate, organic epilepsy • Inclusion vs exclusion • Goal setting must be appropriate • Education • Post-implant programming or ramp-up and review of clinical response or therapeutic gains

  46. Neuromodulation Reprogramming & Fear: Error messages you will not see.. • Adjustable, Reversible, not permanent or destructive • There is no Geek Squad to call but technical services can be helpful • Before any change the message will remind you .. Are you certain you want to do that? .. Stop and think …

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