QUM-D (QUALITY USE OF MEDICATION IN DEMENTIA) AN AUSTRALIAN TOOL FOR SYSTEMIC CHANGE

1. QUM-D (QUALITY USE OF MEDICATION IN DEMENTIA) AN AUSTRALIAN TOOL FOR SYSTEMIC CHANGE Conjoint Assoc/Prof CarmellePeisah, University of NSW, Sydney University, Northern Sydney Local Health District, CAPACITY AUSTRALIA

2. CONFLICT OF INTERESTS The author has been a past recipient of honoraria, research funding & travel grants from Eli Lily; Lundbeck, Pfizer and Janssen L.P. Janssen.

3. Outline • Background: • THE PROBLEM - dementia + BPSD • OUR RESPONSE • Method: • Literature Review & Delphi Consensus: what constitute medication burden in BPSD? • Testing • Results • Conclusions: implementation and resistance

4. Dementia and BPSD • Behavioural & psychological symptoms of dementia (BPSD) • Eg agitation, aggression, calling out/ screaming, disinhibition (sexual), wandering, night time disturbance, shadowing, swearing, depression, anxiety, apathy, delusions, hallucinations, irritability, elation/euphoria. • up to 97% of people experience BPSD of variable severity during course of their illness

5. 4 days in the life of p with dementia • Calling out throughout the day “help me, help me, get me out of here” • Constantly calling out this morning • resident extremely noisy yelling out continuously causing the residents much anxiety • calling out “help me” constantly • verbally and physically aggressive during personal care hitting nurses, calling them “bastards”

6. Our response to this • prn5mg haloperidol was given at 1000hrs “for calling out continuously “ • 5mg haloperidol prn to settle with effect • haloperidol 5mg given with nil effect. Resident awake all night and calling out

8. Our response to BPSD • High rates of psychotropic use • Polypharmacy • Inappropriate dosages • Side effects/toxicity of psychotropic use • Underuse of alternatives with >ES • Without proper consent

9. HIGH LEVELS OF PRESCRIBING • 47-75% of NH residents with dementia are prescribed psychotrpics(Pitkala et al, 2004; Selbaek et al, 2007; Eggermont et al, 2009; Snowdon et al., 2011) • Very variable • It is getting worse – cf 2003, regular use of antipsychotic medication ↑by about 19%, although at ↓ mean dosage (Snowdonet al , 2011)

10. Side effects/toxicity • Serious • DEATH - 1.5- to 1.8-fold increase in mortality risk • risk of thrombo-embollic and cerebrovascular event • Pneumonia • Arrhythmia & QT prolongation • neuroleptic hypersensitivity a/wDementia with Lewy bodies (DLB) • Aspirational pneumonia • Sedation falls fractures • DVT • NMS • Serotonin syndrome (SSRIs; SNRI’s) • Other • Cognitive worsening • EPSE • Akathisia (restlesness) • Tardive dyskinesia

11. Failure to use alternatives despite limited proven efficacy of psychotropics • Drug efficacy limited • 20 PBCT + several MA • ES 0.13-0.20 of antipsychotics (Schneider, Dagerman & Insel, 2006; Ballard et al., 2009a)

12. Non-pharm alternatives • Psychosocial & environmental interventions: • light massage & aromatherapy (particularly Lavender Oil, Melissa Oil & Lemon Balm); • individualised music; • animal assisted therapy; • individual behaviourtherapy; • bright light therapy; • Montessori activities; • humourtherapy • family caregiver interventions, • PCC & PEC

13. Brodaty & Arasaratnam (2012) Meta-analysis of nonpharmacological interventions for neuropsychiatric symptoms of dementia. Am J Psych; 169(9):946-53.. OBJECTIVE: • Behavioral and psychological symptoms are common in dementia, and they are especially stressful for family caregivers. Nonpharmacological (or psychosocial) interventions have been shown to be effective in managing behavioral and psychological symptoms, but mainly in institutional settings. The authors reviewed the effectiveness of community-based nonpharmacological interventions delivered through family caregivers. METHOD: • Of 1,665 articles identified in a literature search, 23 included unique randomized or pseudorandomizednonpharmacological interventions with family caregivers and outcomes related to the frequency or severity of behavioral and psychological symptoms of dementia, caregiver reactions to these symptoms, or caregiver distress attributed to these symptoms. Studies were rated according to an evidence hierarchy for intervention research. RESULTS: • Nonpharmacological interventions were effective in reducing behavioral and psychological symptoms, with an overall ES 0.34 (95% CI=0.20-0.48; z=4.87; p<0.01), as well as in ameliorating caregiver reactions to these behaviors, with overall ES 0.15 (95% CI=0.04-0.26; z=2.76; p=0.006). CONCLUSIONS: • Nonpharmacological interventions delivered by family caregivers have the potential to reduce the frequency and severity of behavioral and psychological symptoms of dementia, with effect sizes at least equaling those of pharmacotherapy, as well as to reduce caregivers' adverse reactions. The successful interventions identified included approximately nine to 12 sessions tailored to the needs of the person with dementia and the caregiver and were delivered individually in the home using multiple components over 3-6 months with periodic follow-up

15. Chenoweth et al (2009).Caring for Aged Dementia Care Resident Study (CADRES) of person-centred care, dementia-care mapping, and usual care in dementia: a cluster-randomised trial; Lancet Neurology; 8(4):317-25 BACKGROUND: • Evidence for improved outcomes for people with dementia through provision of person-centred care and dementia-care mapping is largely observational. We aimed to do a large, randomised comparison of person-centred care, dementia-care mapping, and usual care. METHODS: • In a cluster randomised controlled trial, urban residential sites were randomly assigned to person-centred care, dementia-care mapping, or usual care. Carers received training and support in either intervention or continued usual care. Treatment allocation was masked to assessors. The primary outcome was agitation measured with the Cohen-Mansfield agitation inventory (CMAI). Secondary outcomes included psychiatric symptoms including hallucinations, neuropsychological status, quality of life, falls, and cost of treatment. Outcome measures were assessed before and directly after 4 months of intervention, and at 4 months of follow-up. FINDINGS: • 15 care sites with 289 residents were randomly assigned. Pairwise contrasts revealed that at follow-up, and relative to usual care, CMAI score was lower in sites providing mapping (mean difference 10.9, 95% CI 0.7-21.1; p=0.04) and person-centred care (13.6, 3.3-23.9; p=0.01). Compared with usual care, fewer falls were recorded in sites that used mapping (0.24, 0.08-0.40; p=0.02) but there were more falls with person-centred care (0.15, 0.02-0.28; p=0.03). There were no other significant effects. INTERPRETATION: • Person-centred care and dementia-care mapping both seem to reduce agitation in people with dementia in residential care

17. PerCEN: a cluster randomized controlled trial ofperson-centered residential care and environmentfor people with dementia; Chenoweth et al (2014) IntPsychogeriatrics Background: There is good evidence of the positive effects of person-centered care (PCC) on agitation in dementia. We hypothesized that a person-centered environment (PCE) would achieve similar outcomes by focusing on positive environmental stimuli, and that there would be enhanced outcomes by combining PCC and PCE. Methods: 38 Australian residential aged care homes with scope for improvement in both PCC and PCE were stratified, then randomized to 1 of 4 intervention groups: (1) PCC; (2) PCE; (3) PCC +PCE; (4) no intervention. People with dementia, >over 60 years of age and consented were eligible. Co-outcomes assessed pre & 4mths post-intervention & at 8 mhsfollow-up were resident agitation, emotional responses in care, quality of life and depression, and care interaction quality. Results: From 38 homes randomized, 601 people with dementia were recruited. At follow-up the mean change for quality of life and agitation was significantly different for PCE (p = 0.02, p = 0.05, respectively) and PCC (p = 0.0003, p = 0.002 respectively), compared with the non-intervention group (p = 0.48, p = 0.93 respectively). Quality of life improved non-significantly for PCC+PCE (p = 0.08), but not for agitation (p = 0.37). Improvements in care interaction quality (p = 0.006) and in emotional responses to care (p =0.01) in PCC+PCE were not observed in the other groups. Depression scores did not change in any of the groups. Conclusion: The hypothesis that PCC+PCE would improve quality of life and agitation even further was not supported, even though there were improvements in the quality of care interactions and resident emotional responses to care for some of this group.

18. Use of psychotropics without obtaining proper consent Some of the laws in Australia…

19. Guardianship Regulation 2000 under the NSW Guardianship Act 1987 Consent guidelines

23. This is all very well but…….

24. Substitute consent for nursing home residents prescribed psychotropic medication.Rendina et al (2009) Int J GeriatrPsychiatr 24(3):226-31. • BACKGROUND: Prescribing psychotropic medications for persons with dementia who lack capacity to give informed consent requires proxy consent under NSW Guardianship legislation. • OBJECTIVE: To survey current practice in complying with legislation and regulations in prescribing psychotropic medications for nursing home residents. • METHOD: In three Sydney nursing homes, the files of 77 residents identified as having dementia, being on a psychotropic medication and not having capacity to give informed consent, were audited. • RESULTS: In only 6.5% of cases were all regulations adhered to; a further 6.5% attempted and partially completed substitute consent requirements. The problem and the nature of the treatment were documented in 70.1% of cases. In 16.9% of files the only documentation of the prescribed medication was in the medication chart. Doses of medications prescribed were within accepted guidelines. • CONCLUSION: Current regulations and legislation are not being observed. Recommendations are made as to how to make them more practicable

25. Gurian, Baker, Jacobson, Lagerbom and Watts (1990)JAGS 38(1): 37-44 • 4 studies • use of neuroleptics in an aging population • both in nursing homes and in a psychiatric teaching hospital. • Aim to determine if prescribing practices in compliance with recent court rulings respecting the right of patients to informed consent to "exceptional" medication. • Results: physicians in nursing homes do not inform their patients of the risks of neuroleptics, do not seek consent, and do not consider competency to be even an issue. • Elderly patients in the acute academic setting were informed of risks and benefits. However, both consent to medication and the competency to give this consent were presumed until or unless the patient failed to acquiesce.

26. Guardianship Act 1987 No 257Division 2: Section 35 Offences • (1) A person must not carry out medical or dental treatment on a patient to whom this Part applies unless: (a) consent for the treatment has been given in accordance with this Part, or (b) the carrying out of the treatment is authorised by this Part without any such consent, or (c) the treatment is carried out in accordance with an order made by the Supreme Court in the exercise of its jurisdiction with respect to the guardianship of persons.

27. Maximum penalty: • in the case of special treatment or treatment in the course of a clinical trial (on conviction on indictment)—imprisonment for 7 years, or • in the case of minor or major treatment (on summary conviction)—imprisonment for 1 year or 10 penalty units, or both.

28. “Global” solutions Europe Australia Govt initiatives: Ministerial roundtable Aug/Oct 2012 Senate enquiry: March 14 Deprescribingstudies Brodaty- (HALT) which aims to reduce the inappropriate use of antipsychotic medication in 12-18 high level RACF Westbury funding $3 million from DoHA to deliver a multifaceted program involving 150 aged care facilities across Australia which involves collaboration among nurses, carers, pharmacists, GP’s General deprescribing NHMRC • ALCOVE • PROPER (PRescription Optimization of Psychotropic drugs in Elderly nuRsing home patients with dementia) II study conducted by pharmacists, physicians, & nurses; 3 components: 1) preparation & education, 2) conduct, and 3) evaluation/guidance. 1o outcome: % of p with appropriate psychotropic drug use. 2o outcomes: overall frequency of psychotropic drug use, NPI syx, QOL, ADL, S/E (including cognition, comorbidity, mortality (Smeets et al, 2013)

29. METHOD 1 : Tool development What constitutes drug burden in this setting? • Literature Review to develop the research question: What is burden? • Delphi method: an iterative multistage group facilitation process, designed to transform opinion into group consensus achieved through a series of rounds where information is fed back to panel members • Sample: Psychogeriatricians, geriatricians, pharmacists, pharmacologists

30. METHOD 1. Tool development WHAT CONSTITUTES DRUG BURDEN IN BPSD? • Failure to use safer more efficacious alternatives as first line Rx • Use of drugs for inappropriate target syx • Use of drugs not indicated in this setting • Polypharmacy • High doses • Rapid titration (NOT START SLOW GO SLOW!!!!!) • Use of depot antipsychotics • Lack of review

32. Frail elderly specifier* (from one of the final Delphi rounds) In frail elderly, with several co-morbid medical conditions, lower cap doses may be required & lower doses may be considered “burdensome”. For these patients, consider rating “2” for: haloperidol >1mg; risperidone >1mg, olanzapine >5mg, quetiapine >50mg

33. METHOD 11. Testing the tool • 41 patients • nursing or medical professionals: psychogeriatricians, registrars in training, general practitioners, clinical nurse consultants • Settings: nursing home; home; acute inpatient setting

35. Results • Mean baseline QUM-D = 9.4 (SD=4.5) Mean post QUM-D = 4.6 (SD = 3.5) • Sig ↓ in QUM-D using paired samples: • t = 9.24, df = 40, p < 0.001 • 2 raters’ QUM-D scores had high inter-raterreliability: Intraclasscorrelation coefficient = 0.98, 95% confidence interval 0.87 to 0.996). • Sample: 100% power

36. Results: feasibility • Takes 5 mins • Fits on one page; can be emailed • Can be used to: empower nurse intervention; to educate the user eg registrar in training, GP • What is enough ↓ burden? (QUM-D as a verb)

37. Conclusion: Implementation • Implementation at systemic level: • Education: eg executive of organisational risk; specialist clinicians; GP’s; • Inflitration practice: medication committee; electronic medical records • Use for audit (what?) e.g. consent, dosage, polypharmacy • Use to identify clinical risk/red flags

38. Resistance • Psychiatrists, GP’s who are not engaged already: “you don’t understand… • RACF :Antipsychotic drug not only predicted by the type of dementia & p behaviour, but independently associated with the dementia SCU at which the patient resides. • “antipsychotic drugs are not only prescribed for their clinical indications (agitation/aggression) but are associated with environmental factors that may reflect a specific nursing home prescribing culture” (Van der Puttenet al, 2014; Ageing Mental Health)

40. Peak body MEDIA RELEASE 26 March 2014 Use of Psychotropic Drugs in Dementia a Doctor/Patient Issue Alzheimer’s Australia’s report released today regarding use of Restraints and Psychotropic Medication in residential aged care largely ignores the key relationship between a resident and their doctor. “The key relationship is between a doctor and their patient and the family or carer. In some instances the provider will also give information regarding daily activities and capacity.” said Patrick Reid CEO of age services peak body Leading Age Services Australia (LASA). LASA believes there is a place for sedative medications in the treatment of dementia sufferers, but also contends that providers are not central decision makers in this process. There is however a greater role for allied health practitioners and bodies such as the national Prescribing Service or Medicare in appropriate and timely use of sedative medications.

41. United we stand……