Improving Dementia Care in Maryland Nursing Homes: A Patient Safety Initiative

Transcription

1 Improving Dementia Care in Maryland Nursing Homes: A Patient Safety Initiative March 14, 2014 Susan M. Levy, MD, CMD VPMA Levindale

2 2 Susan M. Levy, MD-Disclosures VPMA Levindale Physician consultant for CMS LTC Division Advisor to MMDA board AMDA committee member: Governance, Public Policy, Transitions of Care Legal consultant No drug company or DME company affiliations

3 Susan M. Levy, MD - Off Label Use of Medications Discussion That is part of the issue with antipsychotic drugs in patients with dementia, use is all off-label.

4 Learning Objectives Understand the goals of the CMS Partnership to Improve Dementia Care. Understand strategies to achieve these goals on a national, state, and facility level.

5 CMS INITIATIVE Partnership to Improve Dementia Care in Nursing Homes launched March 29, 2012 (Has anyone not heard?)

6 Partnership Goals Provide the best care and quality of life Reduce unnecessary antipsychotic drug use Utilize non-pharmacologic alternatives

7 National Partnership First Year Goal Reduce national prevalence rate of antipsychotic medication use in long-stay nursing home residents by 15% by end of 2012 Baseline: national rate based on MDS data (Nursing Home Compare takes an average of previous three quarters) in December 2011 National rate in long-stay residents was 23.9% with goal 20.3% Denominator includes all residents except those with schizophrenia, Tourette s or Huntington s disease

8 Partnership Methods Collaboration among government, providers, caregivers, residents, all stakeholders at federal and state level Enhanced training Staff (Hand in Hand training series) Federal and state surveyors Increased transparency - new indicators on Nursing Home Compare

9 Hand-in-Hand Training The Hand in Hand training materials consist of six one-hour video-based modules, each of which has a DVD, an accompanying instructor guide, and orientation guide. Module 1: Understanding the World of Dementia: The Person and the Disease Module 2: What Is Abuse? Module 3: Being with a Person with Dementia: Listening and Speaking Module 4: Being with a Person with Dementia: Actions and Reactions Module 5: Preventing Abuse Module 6: Being with a Person with Dementia: Making a Difference

10 Advanced Training Interdisciplinary case-based webinar released in March 2012 Available free online Expert panel includes perspectives from medicine, nursing, pharmacy, surveyors, and advocates Enhanced Training: Hand-in-Hand training series Emphasizes person-centered care Provide to all nursing facilities (9/12) Surveyor Training Series

11 TO DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C Baltimore, Maryland DATE: May 24, 2013 Center for Clinical Standards and Quality /Survey & Certification Group Ref: S&C: NH TO: FROM: SUBJECT: State Survey Agency Directors Director Survey and Certification Group Advanced Copy: Dementia Care in Nursing Homes: Clarification to Appendix P State Operations Manual (SOM) and Appendix PP in the SOM for F309 Quality of Care and F329 Unnecessary Drugs Memorandum Summary Guidance This memo conveys clarification to Appendices P and PP related to nursing home residents with dementia and unnecessary drug use. Training - Mandatory surveyor trainings are available online at

12 Public Reporting: Nursing Home Compare Reports Quality Measures for each nursing home including Short-stay residents given antipsychotic medications Long-stay residents given antipsychotic medications Information on Quality Measures is collected on each resident and is reported using the Minimum Data Set Compared to national and state averages

13 13 Partnership Process Technical Expert panel convened in April 2012 Conference calls with stakeholders Material review by stakeholders at multiple levels Engage professional organizations - especially the provider groups - to educate and lead their members in this initiative

14 Why Now? General Aging Demographics Baby Boomers They re here 13% population over age 65-now 20% population over age Over 85 fastest going segment of the population

15 Why Now? Dementia Prevalence with Aging Risk for developing dementia increases with aging 5%-8% over 65 and 50% over 85 5% of the over 65 reside in a nursing home and 20% or more of those over that age will spend some time there for at least a short stay 60-80% of those living in a nursing home have some evidence of dementia/cognitive disorder

16 Where did this concern start? Institute Of Medicine Report: 1986 Quality of care and quality of life in many nursing homes not satisfactory Inadequate assessments Scarcity of applying geriatrics Psychotropic drugs Overused, and for unclear indications Used for too long and in too high doses Inadequate monitoring of use Many side effects, often not identified

17 Why Now? Government OBRA 87 and subsequent updates (F 329, F 309)-in response to IOM report OIG reports Congressional hearings Focus on cost-effectiveness Shift in risk : benefit for use of antipsychotics Demographics

18 Atypical APs: FDA s Boxed Warning FDA requires that drug manufacturers include a boxed warning (black-box warning) on the product s labeling to warn prescribers and consumers of these risks Physicians are not prohibited from prescribing a drug in the presence of the condition(s) specified in the boxed warning. In April 2005, FDA required manufacturers of these drugs to include a boxed warning regarding the increased risk of mortality in elderly patients with dementia

19 Available Atypical Antipsychotics Aripiprazole (Abilify, Bristol-Myers Squibb) Clozapine (Clozaril, Novartis) Olanzapine* (Zyprexa, Eli Lilly), Olanzapine/fluoxetine (Symbyax, Eli Lilly) Paliperidone (Invega, Janssen) Quetiapine* (Seroquel, AstraZeneca) Risperidone* (Risperdal, Janssen) Ziprasidone* HCl (Geodon, Pfizer) Iloperidone (Fanapt, Novartis) Latuda (Lurasidone, Sunovion) Asenapine (Saphris, Merck) * Generic available

20 20 FDA Black Box Warning WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (model duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to come characteristic(s) of the patients is not clear.

21 Background- How did we get here? Senator Charles Grassley requested that the Office of Inspector General (OIG) evaluate the extent to which elderly nursing home residents receive atypical antipsychotic drugs and the associated cost to Medicare. Concern about atypical antipsychotic drugs prescribed for elderly nursing home residents for: Off-label conditions (i.e., conditions other than schizophrenia and/or bipolar disorder) For residents with the condition specified in the FDA boxed warning (i.e., dementia).

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23 23 OIG report May 2011 January-June 2007 claims 14% of nursing home residents had a claim for atypical antipsychotic 83% were off-label and 88% of those for indications on the FDA boxed warning 51% of claims erroneous 22% not given in accordance with CMS standards regarding unnecessary drugs

24 24 OIG: Unnecessary Use Excessive dose 10.4% Excessive duration 9.4% Without indication 8.0% Without monitoring 7.7% Presence of adverse effect 4.7% Total 40.2% Overlap 18.3% TOTAL(net) 22.1%

25 25 OIG: Top Four Atypical Antipsychotics Risperidone Olanzapine Quetiapine Aripiprazole

26 26 OIG : Atypical Antipsychotics Cost 1.7 million claims $309 million Average $7.26/day (range $4.53-$13.28) 17% received more than one of the drugs

27 U.S Senate Special Committee on Aging November 30, 2011 Overprescribed: The Human and Taxpayer s Costs of Antipsychotics in Nursing Homes

28 OIG Report July, 2012 Lack of one or more components of care planning in 99% of cases of nursing home residents with orders for antipsychotics.

29 29 Off-Label Use of Drugs 2006 Archives of Internal Medicine: 21% drugs prescribed for off-label use 2007 AHRQ identified the common off-label uses for atypical antipsychotics 2009 VAH: 60.2% received AP with no record of a diagnosis for which drugs FDA approved

30 FDA: Off Label Prescribing Prohibits manufacturers from advertising or promoting the use of pharmaceuticals for indications that have not been approved by the FDA. To do so is illegal. Off label prescribing by physicians is permitted.

31 31 United States Settlements for Atypical Antipsychotics Manufacturer settlements Nursing Home Pharmacy

32 Antipsychotic Usage in Nursing Homes Between 1:3 or 1:4 nursing home residents receive these medications Regional variance Facility variance Use increased when the atypical believed safer agents available Since 2008 black box warning by FDA on typical and atypical APs

33 AP Drug Usage Varies by State

34 BPSD Term coined by the International Psychogeriatric Association in 1996 to describe the Behavioral and Psychological Symptoms of Dementia (BPSD)

35 BPSD Behavioral symptoms: Physical aggression, screaming, restlessness, agitation, wandering, culturally inappropriate behaviors, sexual disinhibition, hoarding, cursing, shadowing Psychological symptoms: Anxiety, depressive mood, hallucinations, and delusions

36 Progression of Alzheimer s Disease Early diagnosis Mild-Mod Severe Cognitive symptoms MMSE score Loss of IADLs Behavioral problems Nursing home placement Death Years RFeldman H, Gracon S. In: Clinical Diagnosis and Management of Alzheimer s Disease. 1996:

37 Prevalence of BPSD-90% Perceptual (delusions, misperceptions, hallucinations) 15-73% Affective Depression up to 80% Mania 3-15% Personality Personality change up to 90% Behavioral Symptoms up to 50% Aggression/hostility up to 20%

38 38 What Causes BPSD? Biologic Neurotransmitters Anatomy Comorbid conditions/treatment Environmental changes Social interactions WE NEED MORE RESEARCH!!!!!!!!

39 Antecedent events that trigger BPSD Communication Emotional Environmental Physical Task

40 40 BPSD Environmental/Social Theories Unmet needs - If we could only figure out what the person wants? Environmental vulnerability/reduced stress threshold Behavioral/learning model - ABC model

41 41 Course of BPSD Increases as disease progresses May tend to occur during different periods of the disorder Wandering and agitation seem to be the most enduring

42 42 Impact of BPSD Premature institutional care Caregiver burnout Staff turnover and burnout (consistent assignment?) Worse prognosis and more rapid decline Adds to direct and indirect costs of care

43 43 Approach to Residents with Recognition of BPSD Assessment for cause(s) of the symptoms including scope and severity of the symptoms Treatment Nonpharmacologic interventions Pharmacologic interventions (acute vs. chronic) Monitoring BPSD Response to therapies Adjust care plan/management

44 44 Non-pharmacologic Interventions for BPSD Standard therapies Behavioral therapy Reality orientation Validation therapy Reminiscence therapy Brief psychotherapies Cognitive-behavioral therapy Interpersonal therapy

45 45 Non-pharmacologic Interventions for BPSD (cont.) Other therapies Art therapy Music therapy Activity therapy Aromatherapy Bright-light therapy Multi-sensory approaches

46 46 Medications in the Management of BPSD Psychoactive medications of which Antipsychotic (AP) medications are one class Medications directed at the treatment of dementia-studies variable on impact

47 Medications Used For Behavioral and Psychological Symptoms of Dementia Antipsychotics Cholinesterase inhibitors N-methyl-D-aspartate receptor modulators Anticonvulsants Antidepressants Anxiolytics 47

48 Medications for Specific Target Clusters Aggression Psychomotor agitation Apathy AChE inhibitors Antidepressants Depression Antipsychotics Anticonvulsants Antidepressants Antidepressants Antipsychotics AChE inhibitors Antipsychotics Anticonvulsants Benzodiazepines Antidepressants Psychosis McShane R. Int Psychogeriat. 2000;12(suppl 1):147.

49 Unresponsive Behavior Symptoms Wandering Annoying repetitive activities, including exit seeking Disrobing Persistent disruptive vocalization (swearing, offensive comments, yelling/screaming) Restlessness/ repeated attempts to unsafely arise from chair or climb out of bed Hiding/hoarding Eating inedibles Climbing into bed with other residents Sleep disturbance, diurnal reversal Pushing wheelchair-bound residents

50 Behavior Symptoms That May Respond to Medication Persistent and distressing delusions or hallucinations Manic-like symptoms Anxiety Depressive symptoms Persistent physical aggression Sleep disturbance, insomnia

51 51 Principles of Treatment with APs Start low and go slow for chronic (enduring) symptoms Treat aggressively if acute Less EPS effects with the atypical antipsychotics Monitor and document response to therapy and for adverse drug effects Taper when symptoms have stabilized

52 52 Summary of Benefits: Dementia AHRQ 2011 Atypical antipsychotics, as a class, improve behavioral symptoms of dementia, although effect sizes are small. Strength of Evidence = High Maglione M, Ruelaz Maher A, Hu J, et al. Comparative Effectiveness Review No. 43. Available at

53 AHRQ 2011 Adverse effect of antipsychotics are summarized as follows:

54 54 Antipsychotics increase the risk of death in elderly patients (65 and older) with dementia. For atypical antipsychotics, the death of 1 in 100 patients can be attributed to the antipsychotic drug. Strength of Evidence = High Risperidone is associated with an increased risk of cerebrovascular accidents. One in 34 patients will experience a cerebrovascular accident attributable to risperidone. Strength of Evidence = Moderate Both risperidone and olanzapine are associated with increased risk of cardiovascular adverse events. For every 53 patients treated, 1 cardiovascular adverse event will occur due to risperidone. For every 48 patients treated, 1 cardiovascular adverse event will occur due to olanzapine. Strength of Evidence = Moderate Maglione M, Ruelaz Maher A, Hu J, et al. Comparative Effectiveness Review No. 43. Available at.

55 In elderly adults (65 and older), extrapyramidal symptoms are most common with risperidone and olanzapine. Strength of Evidence = Moderate Atypical antipsychotics are associated with sedative effects and fatigue. Strength of Evidence = Moderate Atypical antipsychotics elevate the risk of urinary adverse effects (infections, incontinence) in elderly patients, but the evidence is too limited to permit conclusions about the degree of risk. Strength of Evidence = Low 55

56 56 What are the risks of APs? Death Stroke/TIAs Metabolic syndrome Cognitive decline Identified largely in pooled studies as well as unpublished data

57 57 Potential benefits May stabilize behavior May correct symptoms bothersome to the resident May avoid harm to self or others Most effective with agitation, aggression, psychotic features

58 What to Discuss with Patients and Caregivers Potential benefit for non-psychotic behaviors Risks of adverse effects Tradeoff of risk for behavior changes Non-pharmacologic interventions Need for monitoring for metabolic syndrome Consider formal informed consent

59 59 THE REGULATIONS State Operations Manual F329 - Unnecessary Drugs F309 - Quality of Care F428 - Drug Medication Review Regimen READ THEM!!!!!

60 F329: Unnecessary Drugs 1. General Each resident s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used (i) In excessive dose (including duplicate therapy); or (ii) For excessive duration; or (iii) Without adequate monitoring; or (iv) Without adequate indications for its use; or (v) In the presence of adverse consequences, which indicate the dose should be reduced or discontinued; or (vi) Any combinations of the reasons above. 60

61 F329: Unnecessary Drugs 2. Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that: (i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. 61

62 F329: Medication Management Gradual Dose Reduction (GDR) Tapering may be indicated when the resident s clinical condition has improved or stabilized, the underlying causes of the original target symptoms have resolved, and/or non-pharmacological interventions, including behavioral interventions, have been effective in reducing the symptoms. 62

63 63 APs: The Rules GDR Frequency of attempts Twice in the first year Annually thereafter Clinical contraindications Failed GDR with clinical documentation

64 F329: Medication Management Gradual Dose Reduction (GDR) The requirements underlying this guidance emphasize the importance of seeking an appropriate dose and duration for each medication and minimizing the risk of adverse consequences. The purpose of tapering a medication is to find an optimal dose or to determine whether continued use of the medication is benefiting the resident. 64

65 65 Antipsychotics: The Rules Surveyor Guidance on Antipsychotic Use in Long Term Care Facilities: F-Tag 329 The behavioral symptoms present a danger to the resident or others AND one or both: A. The symptoms are identified as being due to mania or psychosis OR B. Behavioral interventions have been attempted and included in the POC, except in an emergency.

66 66 Antipsychotics: The Rules Additional criteria for acute situations/emergencies The acute treatment period is limited to 7 days or less; AND A clinician in conjunction with the IDT must evaluate and document the situation within 7 days to identify and address any contributing and underlying causes of the acute psychiatric condition and verify the continuing need for antipsychotic medication; AND Pertinent non-pharmacologic interventions must be attempted, unless contraindicated, and documented following the resolution of the acute psychiatric situation

67 Antipsychotics: The Rules-Enduring Conditions Meet the criteria and target behaviors must be clearly/specifically identified and documented. Monitoring must ensure the symptoms are not due to a : medical condition environmental stressor psychological stressor And are persistent

68 Antipsychotics : The Rules- Admission Use must be evaluated at the time of admission and/or within two weeks to consider whether it can be reduces or discontinued.

69 69 What Nursing Homes Should be Doing at a Minimum Make sure that all antipsychotic medication orders are in compliance with F-329 and that your documentation supports use, that you are monitoring for effect and adverse events and that gradual dosage reductions occur Review routine medication reviews by your consultant pharmacist and review with your medical director Be prepared for public reporting (it is here) and probably consent requirement (likely to follow) Start the dialogue with staff and families.

70 70 Behavior Management Program for Long-term Care IDT members Nurse/GNA Social workers Consultant pharmacist Providers(NPs/attending/medical director/mental health provider) Resident/responsible party Do not need to have them all but may need to keep them all informed. What works for your facility!

71 71 Principles of Resident Centered Personhood Knowing the person Maximizing choice and autonomy Quality care Care Nurturing relationships A supportive physical and organizational environment

72 72 Behavior Management Program for Nursing Homes Frequency-start monthly(weekly) Have a process for provider review within 7 days of initial order and within two weeks for residents admitted on an AP Documentation(keep attendance) Response to non pharmacologic interventions Who is on psychoactive medication and target behaviors Who is on a taper and their response Resident/responsible party communication Update care plan if needed (document provider involvement in the care plan!!!!!)

73 73 Behavior Management Program for Nursing Homes Quality indicators % long term residents on antipsychotics % short term residents started on antipsychotics Other indicators (process/outcome) Other psychoactive medication use % residents on GDR/success rate of GDRs Non-pharmacologic interventions/programs Documentation audits Impact on other quality indicators Falls ADL decline Weight loss

74 Behavior Management Program for Nursing Homes Other measures to track Resident to resident altercations Resident to staff altercations Transfers out for behavioral issues # doses and cost (impacts facility)

75 75 Behavior Management Program for Nursing Homes Letters to providers about initiative Letters to families about initiative Consent process Staff education-all Leadership buy in a MUST HAVE

76 76 Role of the Medical Director Educational resource Quality oversight Communicate with providers Clinical champion THEY SHOULD NOT BE PART OF THE PROBLEM

77 77 Transitions of Care and Antipsychotic Use Delirium common in hospitalized elderly Antipsychotics effective in treatment of delirium Patients discharged to nursing homes from hospitals where antipsychotics started? Need for clear discharge plan regarding new antipsychotic treatment

78 78 Transitions of Care and Antipsychotic Use Clear diagnosis (delirium, dementia, psychosis, other) Was there a psychiatric assessment and if so the results Use should be revisited upon transfer to a post acute setting Discontinue or initiate taper if no clear indication

79 AMDA (4) Don t prescribe antipsychotic medications for behavioral and psychological symptoms of dementia (BPSD) individuals with dementia without an assessment for an underlying cause of the behavior.

80 APA (3) Don t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia.

81 State Coalitions CMS has been conducting state calls to form coalitions of various stakeholders to increase awareness and develop approaches to meeting the goal 81

82 National Results 2011Q1-2013Q3 23.9% down to 20.8% Overall 13.1% reduction Three CMS regions at greater than 15% Many states greater than 15%

83 CMS Partnership-Has it worked? 30,000 less long term care residents on antipsychotic drugs (even greater now) 30,000 X $7.26/day = $217,800 $217,800 X 365 = $79,497,000 saved per year

84 CMS Efforts National Calls Regional Calls Individual Facility/Chain calls

85 CMS Lessons Provider buy in (primary and mental health) Provider availability Returns from acute psych stays Reluctant families- buddy system creep of other psychoactive medicationsanecdotal Letters from states to high utilizing facilities

86 Region III-Results 2011Q1-2013Q3 STATE % Rank % change MD DC DE WV PA VA

87 Partnership to Improve Dementia Care: MD Data Q Q # facilities # long stay % or less

88 Maryland State Coalition 60 Members (at last count)-bimonthly call Consumers/Ombudsman Industry - Lifespan/HFAM/Pharmacy providers Professional Organizations MMDA, GAPNA, MD NADONA, MD ASCP Provider Groups Delmarva QIO OHCQ

89 Maryland State Coalition Activities Ombudsman education and training Lifespan/HFAM LANE agenda OHCQ letters QIO Nursing home provider outreach Mental health provider group Other professional state organizations

90 Delmarva QIO Nursing Home Collaborative Q through Q homes participating in the Maryland National Nursing Home Collaborative all working on reduction in AP usage 61 (79.25) have had some reduction in the long stay measure Participating homes have had a 32% greater reduction than overall Maryland homes

91 Delmarva QIO Success Factors Stable leadership and stable staff Using interdisciplinary team approach fosters ownership by staff at all levels Using data to drive clinical decisions and prioritize quality improvement efforts Embracing quality improvement methodologies such as PDSA, RCA to make lasting improvements

92 Maryland Stories Clinton nursing facility shared their story with CMS Feb use 25% (state 175) 2 nd quarter fiscal 2013 decreased to 16% They received deficiency in Feb which triggered the efforts Worked with their psych provider, put systems in place, biweekly meetings Recognized by the Delmarva QIO for their work

93 Levindale and Courtland Gardens Q Q1-Q Courtland 14.2% 10.0%(4.2) Levindale 18.8% 8.0%(10.8) Courtland Levindale 29.0% reduction 57.4% reduction

94 LEVINDALE STRATEGIES Oversight team met monthly-medical director, DON, QA nurse, psychiatrist, unit managers, consultant pharmacist (now quarterly) Monthly behavioral rounds Letter to families about dementia care and antipsychotics Consent form Neighborhood model/culture change

95 Courtland Gardens Strategies Work with Psychogeriatric services NP and CP working on GDR collaboratively Track results through QA process

96 Attendee Challenge Review your data-by close of the next working day Talk with your staff-when you are back at work Pick one thing to do by the end of next week Set a goal and track through your QA process Share your successes

97 Resources

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104 Morris J. Kaplan, ESQ, NHA President, Kaplan Health Management LLC Operating Partner, Geynedd Square Nursing Center Improving Dementia Care in Nursing Homes: Best Care Practices

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107 Delmarva Foundation for Medical Care National Nursing Home Quality Care Collaborative Collaborative Resources

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109 VA Review of Non-Pharmacological Interventions

110 TO DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C Baltimore, Maryland DATE: May 24, 2013 Center for Clinical Standards and Quality /Survey & Certification Group Ref: S&C: NH TO: FROM: SUBJECT: State Survey Agency Directors Director Survey and Certification Group Advanced Copy: Dementia Care in Nursing Homes: Clarification to Appendix P State Operations Manual (SOM) and Appendix PP in the SOM for F309 Quality of Care and F329 Unnecessary Drugs Memorandum Summary Guidance This memo conveys clarification to Appendices P and PP related to nursing home residents with dementia and unnecessary drug use. Training - Mandatory surveyor trainings are available online at

111 Morris J. Kaplan, ESQ, NHA President, Kaplan Health Management LLC Operating Partner, Geynedd Square Nursing Center Improving Dementia Care in Nursing Homes: Best Care Practices