Increasing Uptake of Non-Pharmacologic Approaches to Assess and Manage the Neuropsychiatric Symptoms of Dementia

1. Increasing Uptake of Non-Pharmacologic Approaches to Assess and Manage the Neuropsychiatric Symptoms of Dementia Helen C. Kales MD Professor of Psychiatry Director, Section of Geriatric Psychiatry and Program for Positive Aging University of Michigan Research Investigator VA GRECC, CCMR and SMITREC

2. Acknowledgements • H. Myra Kim, PhD • Claire Chiang, PhD • Janet Kavanagh, MS • Kara Zivin, PhD • Marcia Valenstein, MD • Francesca Cunningham, PharmD • Lon S. Schneider, MD • Frederic C. Blow, PhD • NIMH: R01MH081070 • There are no conflicts to disclose • Laura Gitlin, PhD • Kostas Lyketsos, MD • NINR: R01NR014200 • Discussion of off-label uses of antipsychotics

3. Overview • Neuropsychiatric symptoms of dementia (NPS) symptom description matters • NPS etiology matters • Non-pharmacologic management • The DICE approach to assessment and management

4. The Case of Elizabeth • 81 year old with dementia • Daughter called by in-home caregiver about “agitation”

5. Neuropsychiatric Symptoms of Dementia (NPS) • Also known as behavioral and psychiatric symptoms of dementia (BPSD) • Cognitive impairment is the clinical hallmark of dementia, but it is NPS that often dominate both presentation and course • Present in >90% of patients with dementia at some point in illness course Sources: Lyketsos et al, Am J Psychiatry, 2000; Sink et al, J Am Geriatrics Soc, 2004; Steffens et al, Am J Alzheimers Dis Other Dementias, 2005

6. Source: Rabheru (2004)

7. Miscellaneous but problematic behaviors • unfriendliness • poor self-care • not paying attention or caring about what is going on • repetitive verbalizations/questioning • wandering • “inappropriate” behaviors (screaming, spitting, sexual behaviors) • sleep problems (day-night reversal)

8. Elizabeth’s “agitation”: further description would help • Could be: • Grumpiness • Aggression • Resistance • Restlessness • Anxiety • Psychosis

9. Etiology • Not well understood • Likely heterogeneous • Cognitive loss • Preexisting psychiatric illness • Environmental factors • Comorbid medical conditions • Medications • Pain • Delirium • Consequence of multiple concurrent factors

10. Elizabeth’s “agitation”: understanding possible etiology would help • Could be: • Overstimulating environment • Poor caregiver communication • Pain • Delirium • Psychosis

11. How should we manage Elizabeth? • Pharmacologic treatment: • In real-world settings, a patient NPS will often receive an antipsychotic

12. Real-World Management • There is no FDA-approved pharmacotherapy for NPS • Therefore, all use is off-label • Antipsychotics • Benzodiazepines • Mood stabilizers • Antidepressants • Cholinesterase inhibitors and Table 3. Adjusted¶ absolute risk differences between study medication users relative to antidepressant users (N=45,669) **p<0.01 Sources: Kales et al, Am J Psychiatry 2007; Maust et al, Under review

13. The Role ofNon-pharmacologic Management • Recommended by multiple medical organizations and expert groups as first-line for NPS • *except in emergency situations when behaviors could lead to imminent danger or compromise safety

14. Non-pharmacologic Management • These interventions have not yet received widespread uptake • Study of new nursing home admissions • Only 12% received a non-pharmacologic intervention • >70% received >1 psychotropic • 15% received >4 psychotropics Source: Molinari et al, J Gerontol B PsycholSciSocSci, 2010

15. Why are Non-pharmacologic Management Strategies Underutilized? • Time • Training • Funding/reimbursement in current care systems • Lack of guidelines • Symptoms are a moving target

16. Why are Non-pharmacologic Management Strategies Underutilized? • ?Perception that they are unproven and/or unlikely to work, especially as compared to medications

17. Non-pharmacologic Management • What is it?: • Behavioral, environmental and caregiver interventions • Examples: • Caregiver education and support • Activity • Communication strategies • Modifying the environment • Acupuncture • Aromatherapy • Light therapy • Massage Source: Gitlin, Kales, Lyketsos et al, JAMA2012

18. Non-pharmacologic Management • Inconsistent to no evidence for: • Reminiscence • Aromatherapy • Light Therapy • Validation Therapy • Simulated Presence Therapy Source: Gitlin, Kales, Lyketsos et al, JAMA 2012

19. Non-pharmacologic Management • Brodatymeta-analysis of 23 RCTs with family caregivers; outcomes related to frequency/severity of NPS and caregiver well-being • Significant treatment effect, overall effect size=0.34 • Variation among trials in dose, intensity and delivery mode • Key features of successful trials=9-12 sessions; tailoring to patient and caregiver; delivered in the home; multiple components • No adverse effects for any of the trials • REACH II (generalized approach with targeted behavioral strategy) • Problem solving behavioral approach with significant reductions in frequency of behavioral symptoms • REACH VA (generalized approach with targeted behavioral strategy) • Significant reduction in problem behaviors (p=0.04) and improvement in caregiver burden (p=0.001) and depression (p=0.009) Source: Brodaty et al Am J Psychiatry 2012; Belle et al Ann Int Med 2006; Nichols et al Arch Int Med 2011

20. Non-pharmacologic Management • Tailored Activity Program (TAP): • 8-12 home/telephone sessions by occupational therapists; caregiver training including customized activity • significant reductions in problem behaviors (p=0.004) including agitation (p=0.14) and decrease in caregiver “hours on duty” (p=0.001) • COPE • Up to 12 home/telephone contacts by health professionals; assessment for underlying medical issues; caregiver training, significant reduction in problem behaviors (p=0.01) and improvement in caregiver well-being (p=0.002) Source: Gitlin et al , Am J Geriatr Psychiatry 2008; Gitlin et al, ,JAMA, 2010

21. Project ACT • N=272 patients • 11 home/telephone sessions over 4-months by health professionals • Identification of potential triggers of problem behaviors • Communication • Environment • Patient undiagnosed medical condition • Caregiver training to modify triggers and reduce caregiver upset • 3 booster contacts between 16-24 weeks Source: Gitlin, et al, JAGS, 2010

22. Project ACT • Medical test results: • Undiagnosed illnesses detected in 34% of subjects • Most prevalent conditions: • UTI 14.5% • Hyperglycemia 5.9% • Anemia 5.1% Source: Gitlin, et al, JAGS, 2010

23. Project ACT Source: Gitlin, et al, JAGS, 2010 Source: Gitlin, et al, JAGS, 2010

24. Project ACT • At 16 weeks: • Patient improvement in 67.5% of intervention dyads vs. 45.8% of control dyads (p=0.002) • Reduced caregiver upset (p=0.028) • Enhanced confidence in managing behaviors (p=0.011) • Reduction in caregiver upset (p=0.001) • Reduction in negative communication (p=0.17) • Improved caregiver well-being (p=0.001) • Improvement in ability to keep patient at home (p=0.001) • Similar outcomes at 24 weeks Source: Gitlin, et al, JAGS, 2010

25. Non-pharmacologic Management • “If these interventions were drugs, it is hard to believe that they would not be on the fast track to approval. The magnitude of benefit and quality of evidence supporting these interventions exceed those of pharmacologic therapies…” • Covinsky , Annals of Internal Medicine 2006

26. Expert Consensus Panel • Convened in Detroit Michigan, September 7, 2011 Faculty: • Mary G. Austrom, PhD Indiana University • Frederic C. Blow, PhD VA Ann Arbor/University of Michigan • Kathleen C. Buckwalter, PhD University of Iowa • Christopher M. Callahan, MD Indiana University • Ryan Carnahan Pharm.D., M.S. University of Iowa • Laura N. Gitlin, PhD Johns Hopkins University • Helen C. Kales, MD VA Ann Arbor/University of Michigan • Dimitris N. Kiosses, PhD Weill Cornell Medical College • Mark E. Kunik, MD VA Houston/Baylor College of Medicine • Constantine G. Lyketsos, MD Johns Hopkins University • Linda O. Nichols, PhD VA Memphis / University of Tennessee • Daniel Weintraub, MD VA Philadelphia/University of Pennsylvania

27. Panel Results • 1) Create an evidence-informed approach representing best practice known to date • 2) Construct an approach that can guide the use of both pharmacologic and non-pharmacologic approaches (roadmap) • Knee-jerk prescribing of meds is not optimal • Going through the decision-making steps to derive the treatments tailored to the patient, caregiver, environment is key

28. Panel Results • 3) We need better and more systematic ways to differentiate symptoms by phenomena and putative causes. • This may improve uptake of behavioral and environmental modification approaches • This may better direct/target medication use • This will be of critical assistance to future medication trials

29. Panel Results • 4) Behavioral and environmental modifications should be tried first-line with three major exceptions: • Major depression with or without suicidal ideation • Psychosis causing harm or creating potential for harm • Aggression causing risk Emphasis on SAFETY and ACUITY

30. Etiology matters! • We don’t know what is prompting Elizabeth’s symptoms • Knowing the underlying cause will direct the treatment: • Urinary tract infection • Pain • Issues with caregiver • Psychosis ? ? ? ?

31. Panel Results • 5) Definition of the key elements of care for NPS: • Need accurate characterization and contextualization • Examine underlying causes of NPS • Devise treatment plan • Assess intervention effectiveness

32. Kales et al, JAGS, 2014

33. The DICE Approach • Describe:Caregiver details the problematic behavior

34. The DICE Approach • InvestigateExamine possible underlying causes of the problematic behavior

35. The DICE Approach • Create:Provider, caregiver and team collaborate to create and implement treatment plan

36. Kales et al, JAGS, 2014

37. Kales et al, JAGS, 2014

38. The DICE Approach • Evaluate:Provider assesses whether “Create” interventions have been implemented by the caregiver and are safe and effective

39. Using the DICE Approach with Elizabeth • Primary symptom is aggression with a particular caregiver around ADLs like bathing; patient expresses that baths “hurt”; caregiver is not afraid for her safety but feels that the patient is “doing this on purpose”; there is no psychosis. • Patient does have an underlying diagnosis of arthritis; she is currently not taking any medications for pain. She is unable to follow multi-step commands due to level of cognitive impairment. Caregiver has a lack of understanding of dementia and tone with patient when frustrated is somewhat harsh and confrontational. • Consider starting standing pain medication, consider physical therapy. Educate caregiver about the “broken brain” and behavior. Address communication. Enhance bathing environment so that it is soothing and calm. • Was pain medication effective? How has it impacted aggression around bathing? What of the caregiver/environmental interventions were tried?

40. The Place for Psychotropics in the DICE Approach • Three first-line scenarios (major depression; psychosis or aggression with potential for harm) • Medications as a temporizing measure for harmful behaviors while working up and treating the underlying causes • Continued use may depend on symptom persistence and non-responsiveness to other treatment strategies • Psychotropics are unlikely to impact: unfriendliness, poor self-care, memory problems, not paying attention or caring about what is going on, repetitive verbalizations/questioning, wandering

41. Testing and Implementing DICE • NINR R01NR014200 • Co-PI Gitlin • Co-I Lyketsos • 3.5 year grant to incorporate approach into a tool using technology • NIA Submission • Testing of DICE approach in primary care with team social workers as interventionists

42. Summary • NPS are ubiquitous but remain often under- or mistreated with an • Overreliance on medications • Underuse of non-pharmacologic strategies with a substantial evidence base • Symptom description and underlying etiology matter • The DICE approach offers an evidence-informed structured method that is tailored, patient- and caregiver-centered and enables clinicians to conjointly consider pharmacologic, non-pharmacologic and medical treatments

43. kales@umich.edu http://www.programforpositiveaging.org/ www.facebook.com/ProgramforPositiveAging