Increasing Uptake of - PowerPoint Presentation

Slide1

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 Slide2

AcknowledgementsH. Myra Kim, PhDClaire

Chiang, PhD

Janet Kavanagh, MS

Kara Zivin, PhD Marcia Valenstein, MDFrancesca Cunningham, PharmDLon S. Schneider, MDFrederic 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 antipsychoticsSlide3

OverviewNeuropsychiatric symptoms of dementia (NPS) symptom description matters

NPS

etiology

mattersNon-pharmacologic managementThe DICE approach to assessment and managementSlide4

The Case of Elizabeth

81 year old with dementia

Daughter called by in-home caregiver about “agitation”Slide5

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, 2005Slide6

Source:

Rabheru

(2004

)Slide7

Miscellaneous but problematic behaviorsunfriendlinesspoor self-carenot paying attention or caring about what is going on

repetitive verbalizations/questioning

wandering

“inappropriate” behaviors (screaming, spitting, sexual behaviors)sleep problems (day-night reversal)Slide8

Elizabeth’s “agitation”: further description would helpCould be:GrumpinessAggressionResistance

Restlessness

Anxiety

PsychosisSlide9

EtiologyNot well understoodLikely heterogeneousCognitive lossPreexisting psychiatric illness

Environmental factors

Comorbid medical conditions

MedicationsPainDeliriumConsequence of multiple concurrent factorsSlide10

Elizabeth’s “agitation”: understanding possible etiology would helpCould be:Overstimulating environmentPoor caregiver communication

Pain

Delirium

PsychosisSlide11

How should we manage Elizabeth?Pharmacologic treatment:In real-world settings, a patient NPS will often receive an antipsychoticSlide12

Real-World ManagementThere is no FDA-approved pharmacotherapy for NPSTherefore, all use is off-labelAntipsychoticsBenzodiazepines

Mood stabilizers

Antidepressants

Cholinesterase inhibitors and Sources: Kales et al, Am J Psychiatry 2007; Maust et al, Under review % risk difference (CI)NNH(CI)

Antidepressant

Ref

Ref

Haloperidol

9.4 (7.3 - 11.5)**

11 (9 -14)

Olanzapine

5.2 (3.4 - 7.0)**

19 (14 - 29)

Quetiapine

2.3 (1.3 - 3.4)**

43 (29 -77)

Risperidone

4.5 (3.4 - 5.6)**

22 (18 - 29)

Valproic acid

3.8 (1.5 - 6.2)**

26 (16 - 67)

Table 3. Adjusted

¶

absolute risk differences between study medication users relative to antidepressant users (N=45,669)

**p<0.01Slide13

The Role ofNon-pharmacologic ManagementRecommended 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 safetySlide14

Non-pharmacologic ManagementThese interventions have not yet received widespread uptakeStudy of new nursing home admissionsOnly 12% received a non-pharmacologic intervention

>70% received

>

1 psychotropic15% received >4 psychotropicsSource: Molinari et al, J Gerontol B Psychol Sci Soc Sci, 2010Slide15

Why are Non-pharmacologic Management Strategies Underutilized?TimeTrainingFunding/reimbursement in current care systemsLack

of

guidelines

Symptoms are a moving targetSlide16

Why are Non-pharmacologic Management Strategies Underutilized??Perception that they are unproven and/or unlikely to work, especially as compared to medicationsSlide17

Non-pharmacologic ManagementWhat is it?:Behavioral, environmental and caregiver interventionsExamples:Caregiver education and support

Activity

Communication strategies

Modifying the environmentAcupunctureAromatherapyLight therapyMassageSource: Gitlin, Kales, Lyketsos et al, JAMA2012Slide18

Non-pharmacologic ManagementInconsistent to no evidence for:ReminiscenceAromatherapyLight TherapyValidation Therapy

Simulated Presence Therapy

Source:

Gitlin, Kales, Lyketsos et al, JAMA 2012Slide19

Non-pharmacologic ManagementBrodaty meta-analysis of 23 RCTs with family caregivers; outcomes related to frequency/severity of NPS and caregiver well-beingSignificant 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 trialsREACH II (generalized approach with targeted behavioral strategy)Problem solving behavioral approach with significant reductions in frequency of behavioral symptomsREACH 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 2011Slide20

Non-pharmacologic ManagementTailored Activity Program (TAP): 8-12 home/telephone sessions by occupational therapists; caregiver training including customized activitysignificant

reductions in problem

behaviors (p=0.004)

including agitation (p=0.14) and decrease in caregiver “hours on duty” (p=0.001)COPEUp 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 Slide21

Project ACTN=272 patients11 home/telephone sessions over 4-months by health professionalsIdentification

of

potential triggers

of problem behaviorsCommunicationEnvironmentPatient undiagnosed medical condition Caregiver training to modify triggers and reduce caregiver upset3 booster contacts between 16-24 weeksSource: Gitlin, et al, JAGS, 2010Slide22

Project ACTMedical test results:Undiagnosed illnesses detected in 34% of subjectsMost prevalent conditions:UTI 14.5%

Hyperglycemia 5.9%

Anemia 5.1%

Source: Gitlin, et al, JAGS, 2010Slide23

Project ACTSource: Gitlin, et al, JAGS, 2010

Source:

Gitlin

, et al, JAGS, 2010Slide24

Project ACTSource: Gitlin, et al, JAGS, 2010

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 weeksSlide25

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 2006Slide26

Expert Consensus PanelConvened in Detroit Michigan, September 7, 2011Faculty:

Mary G.

Austrom

, PhD Indiana UniversityFrederic C. Blow, PhD VA Ann Arbor/University of MichiganKathleen C. Buckwalter, PhD University of IowaChristopher M. Callahan, MD Indiana UniversityRyan Carnahan Pharm.D., M.S. University of Iowa Laura N. Gitlin, PhD Johns Hopkins University Helen C. Kales, MD VA Ann Arbor/University of MichiganDimitris N. Kiosses, PhD Weill Cornell Medical CollegeMark E. Kunik, MD VA Houston/Baylor College of MedicineConstantine G. Lyketsos, MD Johns Hopkins University Linda O. Nichols, PhD VA Memphis / University of Tennessee Daniel Weintraub, MD VA Philadelphia/University of PennsylvaniaSlide27

Panel Results1) Create an evidence-informed approach representing best practice known to date2) 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 keySlide28

Panel Results3) 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 trialsSlide29

Panel Results4) 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 riskEmphasis on SAFETY and ACUITYSlide30

Etiology matters!

We don’t know what is prompting Elizabeth’s symptoms

Knowing the underlying cause will direct the treatment:

Urinary tract infectionPainIssues with caregiverPsychosis

?

?

?

?Slide31

Panel Results5) Definition of the key elements of care for NPS:

Need accurate characterization and contextualization

Examine underlying causes of NPS

Devise treatment planAssess intervention effectivenessSlide32

Kales et al, JAGS, 2014Slide33

The DICE ApproachDescribe: Caregiver details the problematic behavior

Linkage of

Describe Step with Patient/Caregiver/Environmental ConsiderationsPatientWhat behavior did the patient exhibit (e.g. movie in my head)?How did the patient perceive what occurred?How did the patient feel about it?Is the patient’s safety at risk?CaregiverHow much distress did the behavior generate for the caregiver?Does the caregiver feel their safety is threatened by the behavior?What about the behavior is distressing to the caregiver?What did the caregiver do during and after the behavior occurred?Environment

Who was there when the behavior

occurred (e.g. family members, unfamiliar people, etc.)?

When did the behavior occur (time of day) and what relationship did this have to other events (e.g. occurring while bathing or at dinner)?

Where did the behavior occur (e.g. home, daycare, restaurant, etc.)?

What happened before and after the behavior occurred in the environment?Slide34

The DICE ApproachInvestigateExamine possible underlying causes of the problematic behavior

Linkage of

Investigate Step with Patient/Caregiver/Environmental ConsiderationsPatientRecent changes in medicationsUntreated or undertreated painLimitations in functional abilitiesMedical conditions (e.g. urinary tract infection)Underlying psychiatric comorbiditySeverity of cognitive impairment, executive impairmentPoor sleep hygieneSensory changes (vision, hearing)

Fear, sense of loss of control, boredom

Caregiver

Caregiver’s lack of understanding of dementia (e.g. patient is “doing this to” them “on purpose”)

Caregiver’s negative communication style (e.g. overly critical or harsh, use of complex questions, too many choices)

Caregiver’s expectations not aligned with dementia stage (under/over

estimation of capability)

Caregiver’s own stress/depression

Family/Cultural context (e.g. not wanting to involve “outsiders” or “air dirty laundry”, promise to keep patient at home,

etc

)

Environment

Over- (e.g. clutter, noise, people) or under- (e.g. lack of visual cues, poor lighting) stimulating environment

Difficulty navigating

or finding way in environment

Lack of predictable

routines that are comforting to patient

Lack of pleasurable activities tapping into preserved capabilities and previous interestsSlide35

The DICE ApproachCreate: Provider, caregiver and team collaborate to create and implement treatment plan

Linkage of

Create Step with Patient/Caregiver/Environmental ConsiderationsPatientRespond to physical problemsDiscontinue medications causing behavioral side effects if possibleManage painTreat infections, dehydration, constipation, etc.Optimize regimen for underlying psychiatric conditionsSleep hygiene measuresDeal with sensory impairments

Prescribe

psychotropics

if judged necessary

Caregiver

Work collaboratively with caregiver/other team members to institute

nonpharmacologic

interventions including:

Providing caregiver education and support

Enhancing communication with patient

Creating meaningful activities for patient

Simplifying tasks

Environment

Work collaboratively with caregiver/other team members to institute

nonpharmacologic

interventions including:

Ensuring the environment is safe

Simplifying/enhancing the environmentSlide36

Kales et al, JAGS, 2014Slide37

Kales et al, JAGS, 2014Slide38

The DICE ApproachEvaluate: Provider assesses whether “Create” interventions have been implemented by the caregiver and are safe and effective

Linkage of

Evaluate Step with Patient/Caregiver/Environmental ConsiderationsPatientHas the intervention(s) been effective for the problem behavior? Have there been any unintended consequences or “side effects” from the intervention(s)?CaregiverWhich interventions has the caregiver implemented?If the caregiver did not implement the interventions, why?EnvironmentWhat changes in the environment were made?Slide39

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?Slide40

The Place for Psychotropics in the DICE ApproachThree 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, wanderingSlide41

Testing and Implementing DICENINR R01NR014200Co-PI GitlinCo-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 interventionistsSlide42

SummaryNPS are ubiquitous but remain often under- or mistreated with anOverreliance 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 treatmentsSlide43

kales@umich.eduhttp://www.programforpositiveaging.org/

www.facebook.com/ProgramforPositiveAging