NFR: Forskning for et bedre helsevesen 2011, Oslo The Impact of Pain on Behavioural Disturbances in Patients with Moderate and Severe Dementia. A Cluster Randomized Trial Norwegian Research Council (Sponsor s Protocol Code: 189439) Bettina Sandgathe Husebø, MD, PhD University of Bergen Bergen Red Cross Nursing Home Kavli Research Centre for Aging and Dementia COST-Action EU 7th FP
Temaoversikt Hva vet vi om smerte og BPSD hos pasienter med demens? MOBID-2 Smerteskala Review av RCT studier om smertebehandling og BPSD NFR RCT studien: Smerte-BPSD studie Forutsetninger, utfordringer og muligheter, ansvar
What do we know? Prevalens >80% sykehjemspasienter har demens (Selbaek 2007) 43-83% har smerte/smertefulle diagnoser (Husebo 2008) >70% har signifikante atferdsproblemer (75% 1xuken, 65% flere ganger i uken) (Testad 2007) Hyppighet av atferdsproblemer og smerte øker ved tiltagende demens (Selbaek 2007)
What do we know? Behandlung 20-55% av sykehjemspasienter med demens får psychotropic drugs (Selbaek 2009) Med delvis svært alvorlige bivirkninger (Ballard 2009) <25% får adaekvat smertebehandling (Cohen-Mansfield 2006) Ubehandlet smerte kan være ko-faktor for økning av atferdsproblemer (Husebo 2011)
ETIKK Informert samtykke Formodet samtykke
PLEIEPERSONALE- PROXY RATER Kompetens Oppmerksomhet Mobilisering Interpretasjon ETIKK Informert samtykke Formodet samtykke
SMERTE Diagnose Lokalisasjon Intensitet Varighet PLEIEPERSONALE- PROXY RATER Kompetens Oppmerksomhet Mobilisering Interpretasjon ETIKK Informert samtykke Formodet samtykke
SMERTE Diagnose Lokalisasjon Intensitet Varighet PLEIEPERSONALE- PROXY RATER Kompetens Oppmerksomhet Mobilisering Interpretasjon ETIKK Informert samtykke Formodet samtykke SMERTEATFERD Smertelyder Ansiktsuttrykk Avvergereaksjoner
SMERTE Diagnose Lokalisasjon Intensitet Varighet PLEIEPERSONALE- PROXY RATER Kompetens Oppmerksomhet Mobilisering Interpretasjon ETIKK Informert samtykke Formodet samtykke SMERTEATFERD Smertelyder Ansiktsuttrykk Avvergereaksjoner MOBID-2 Pain Scale Del 1: Smerte fra muskel, ledd, skjelett Del 2: Smerte fra indre organer, hud, hode
SMERTE Diagnose Lokalisasjon Intensitet Varighet PLEIEPERSONALE- PROXY RATER Kompetens Oppmerksomhet Mobilisering Interpretasjon ETIKK Informert samtykke Formodet samtykke SMERTEATFERD Smertelyder Ansiktsuttrykk Avvergereaksjoner PSYCHOMETRIC PROPERTIES Intern konsistens Reliabilitet Validitet Responsiveness MOBID-2 Pain Scale Del 1: Smerte fra muskel, ledd, skjelett Del 2: Smerte fra indre organer, hud, hode
SMERTE Diagnose Lokalisasjon Intensitet Varighet PLEIEPERSONALE- PROXY RATER Kompetens Oppmerksomhet Mobilisering Interpretasjon ETIKK Informert samtykke Formodet samtykke DEMENS Alvorlighetsgrad av demens Demenstyper Atferdsproblemer SMERTEATFERD Smertelyder Ansiktsuttrykk Avvergereaksjoner PSYCHOMETRIC PROPERTIES Intern konsistens Reliabilitet Validitet Responsiveness MOBID-2 Pain Scale Del 1: Smerte fra muskel, ledd, skjelett Del 2: Smerte fra indre organer, hud, hode
SMERTE Diagnose Lokalisasjon Intensitet Varighet SMERTEATFERD Smertelyder Ansiktsuttrykk Avvergereaksjoner PLEIEPERSONALE- PROXY RATER Kompetens Oppmerksomhet Mobilisering Interpretasjon SMERTE-ELLER DEMENSATFERD? Impact of treatment DEMENS Alvorlighetsgrad av demens Demenstyper Atferdsproblemer MOBID-2 Pain Scale Del 1: Smerte fra muskel, ledd, skjelett Del 2: Smerte fra indre organer, hud, hode ETIKK Informert samtykke Formodet samtykke PSYCHOMETRIC PROPERTIES Intern konsistens Reliabilitet Validitet Responsiveness
MOBID-2 smerteskala Mobilization Observation Behaviour Intensity Dementia Husebo et al. Pain Sympt Manage 2007; JAMDA 2008; SJCS 2009; SJCS 2010
Objectives Explore relationship between NH patients with different stages and diagnoses of dementia, and use of medication according to pain intensity Results Patients with severe dementia and mixed dementia are at high risk to suffer from severe pain.
Smerteatferd eller demensatferd?
Pain Treatment of Agitation in Patients with Dementia: A Systematic Review. Relevant RCT studies N MMSE Months, Design Results Limitations Manfredi 2003 47 6 2 Double-blind 1 placebo 1 opioid Low dose, long-acting opioids can lessen agitation in very old (>84 years) patients Large placebo effect (47%); Oxycontin 20mg/day may be twice than morphine 20mg/day Chibnall 2005 25 NA 2 Double-blind Placebo-control Randomized Cross-over More activities, media and social interaction; No effect on agitation, emotional well being Low frequency of behavioral disturbances at baseline Kovach 2006 147 (26) 7.8 1 Double-blind Control group Randomized Analgesics reduce discomfort, no effect of analgesics on BEHAVE-AD no information regarding the effect of this intervention Husebo BS, Ballard C, Aarsland D. Int J Geriatr Psychiatry 2011; DOI: 10.1002/gps.2649.
Reduction of behavioural disturbances by pain treatment in nursing home patients with dementia: A cluster randomized clinical trial of efficacy Bettina S. Husebo,1 Clive Ballard,2 Dag Aarsland3,4 Objective To test the hypothesis that individual pain treatment can reduce agitation in nursing home patients with moderate and severe dementia. Design Cluster randomized 8-week double-blind controlled trial with followup assessment four weeks after end of intervention. Setting 18 nursing homes (60 clusters) in 5 municipalities in Western Norway. Participants 352 patients with moderate or severe dementia and significant BPSD were included and were randomized to control (27 clusters; N=177) or individual pain treatment (33 clusters; N=175). Participants, primary caregivers and research assistant were blinded to group assignment. bettina.husebo@isf.uib.no
Fig 1 CONSORT Chart Enrollment Assessed for eligibility (n=420) Excluded (n= 68) Not meeting inclusion criteria (n=47) Declined to participate (n=4) Others (n=17) Randomized (n=352) clusters, n=352) Allocation Allocated to intervention (n=177) Received treatment as usual (n=175) Did not participate in control (moved to an other nursing home or hospital) (n=2) Allocated to intervention (n=175) Randomization to Stepwise Protocol for the Treatment of Pain (n=169) Did not receive allocated intervention (moved to psychiatry, moved to hospital, relatives, lost of data) (n=6) Follow-Up Lost to follow-up (lost of data) (n=4) Discontinued intervention (reduced condition, reduced compliance, drowsiness, nausea, acute psychiatry, skin allergic reaction, acute back prolapse) (n=9); withdrawal of consent (n=3); death by pneumonia, renal failure, heart failure, cerebral apoplexies, and cancer) (n=6) Lost to follow up (lost of data) (n=7) Discontinued participation (reduced condition) (n=3) and death by pneumonia, heart failure, renal failure or aorta aneurism) (n=8) Analysis Analysed (n=157) Excluded from analysis (lost of data, reduced condition, moved, death) (n=20) Analysed (n=147) Excluded from analysis (lost of data, reduced condition, moved, death) (n=28)
Intervention Group Individual Pain Treatment Patients with BPSD Basis treatment Study treatment Doses and titration With/ without pain Without analgesics Paracetamol Max. dose: 3g/d With pain Paracetamol and/or NSAIDs Morphine Dolcontin ret. Tab. 5mgx2/d; max. dose:10mgx2/d With pain, unable to swallow Paracetamol and/or NSAIDs Buprenorphin plaster 5ųg/h, change each 7.day; max. dose: 10ųg/h Neuropathic pain Paracetamol and/or Morphine Pregabalin Lyrica 75 mgx1/d; max. dose: 300mg/d
Assessment of BPSD, dementia, pain and outcome measures Primary outcome measures Cohen-Mansfield Agitation Inventory long form (CMAI) Secondary outcome measures Mini-Mental State Examination (MMSE) Functional Assessment Staging (FAST) Activities of Daily Living (ADL) Neuropsychiatric Inventory Nursing Home Version (NPI-NH) MOBID-2 Pain Scale
Reduction of behavioural disturbances by pain treatment in nursing home patients with dementia: A cluster randomized clinical trial of efficacy Results >50% of NH patients with dementia have behavioural disturbances (BPSD) Few patients with BPSD receive adequate pain treatment, but antipsychotics Pain treatment reduces BPSD (P<0.001) compared to control Husebo BS, Ballard C, Aarsland D et al. Reduction of behavioural disturbances by pain treatment in nursing home patients with dementia: A cluster randomized clinical trial of efficacy. BMJ 2011; accepted for publication.
Stepwise Protocol for Treatment of Pain (SPTP) SPTP Intervention 1 2 3 3 4 Number of patients, N (%) Paracetamol 3g/day 111 (63) Morphine ret 4 (2) Buprenorphine transdermal patch 31 (18) Increased buprenophine 8 (5) Pregabaline 12 (7) 5 Combination 8 (5) Drop-out During 8 weeks 20 and 28 patients were lost in the control and the SPTP group, respectively (p=0.298) 14 deaths during the study period 8 in the control and 6 in the intervention group bettina.husebo@isf.uib.no
Comparison of CMAI total between control and intervention group using repeated measures ANCOVA.* Week Mean (SD) CMAI total Control 0 56.2 (16.1), n=177 2 53.9 (17.0), n=161 Intervention The effect of intervention on CMAI total** Estimate (95% CI) ICC p-value 56.5 (15.2), n=175 0.162 52.0 (19.5), n=158-3.6 (-0.5, -6.7) 0.022 0.261 4 52.5 (16.3), n=160 49.4 (19.0), n=148-4.1 (-0.9, -7.4) 0.012 0.231 8 52.8 (16.8), n=157 46.9 (18.7), n=147-7.0 (-3.7, -10.3) <0.001 0.226 12 52.5 (16.0), n=152 50.3 (20.3), n=142-3.2 (0.1, -6.4) 0.058 0.253 bettina.husebo@isf.uib.no
Comparison of NPI-NH total score between control and intervention group using repeated measures ANCOVA.* Week Mean (SD) NPI-NH total The effect of intervention on NPI-NH total** Control Intervention Estimate (95% CI) 0 31.4 (21.4), n=177 34.8 (21.9), n=175 2 26.1 (19.2), n=161 26.5 (20.3), n=158-2.9 (0.03, -5.9) 0.052 4 26.0 (20.1), n=160 23.4 (20.0), n=148-5.7 (-2.3, -9.1) 0.001 8 26.9 (20.7), n=157 21.0 (19.3), n=147-9.0 (-5.5, -12.6) <0.001 12 28.0 (21.1), n=152 23.0 (20.0), n=142-8.4 (-4.7, -12.2) <0.001 ICC p-value 0.106 bettina.husebo@isf.uib.no 0.129 0.116 0.157 0.210
Comparison of MOBID-2 total score between control and intervention group using repeated measures ANCOVA.* Week Mean (SD) MOBID-2 total The effect of intervention on MOBID-2 total** Control Intervention Estimate (95% CI) 0 3.7 (2.5), n=163 3.8 (2.7), n=164 2 3.5 (2.4), n=159 2.9 (2.5), n=152-0.7 (-0.4, -1.1) <0.001 4 3.3 (2.4), n=155 2.7 (2.2), n=146-0.8 (-0.4, -1.2) <0.001 8 3.5 (2.6), n=154 2.3 (2.1), n=145-1.3 (-0.8, -1.7) <0.001 12 3.5 (2.5), n=151 2.9 (2.6), n=140-0.8 (-0.3, -1.2) 0.001 ICC p-value 0.094 bettina.husebo@isf.uib.no 0.070 0.059 0.082 0.139
CMAI items CMAI total 1 Pacing (3) 5 Constant request for attention(2) 10 Pushing (15) Mann-Withney U 0.001 0.050 0.001 0.030 18 Complaining (4) 0.001 19 Negativism (5) 28 Physical sexual advances (15) 0.001 0.004 29 General restlessness (1) 0.017 Husebo et al. Effect of pain treatment on behavioural disturbances in dementia. In preparation
Forutsetninger Review artikkel Internasjonalt samarbeid CONSORT STATEMENT Registreringer http://clinicaltrials.gov/ http://www.legemiddelverket.no/ bettina.husebo@isf.uib.no
Utfordringer og muligheter Informert samtykke (2 måneder) NH ressurser Motivasjon og mangel av motivasjon Kompensasjon for NH innsats Reell: ca 3000 kr/pas det facto: 800 kr/pas som avsluttet studien total: 240 000 kr plus medikamentkostnader Undervisning og oppfølging 1 mnd undervisning, 1 mnd oppfølging 3 hel-dager avslutning for all, diplom, heder, ære Unik forbedring av kompetanse, oppmerksomhet og holdninger 3 Master- 2 PhD studenter; 4 artikler in preparation bettina.husebo@isf.uib.no
Improving mental health and end-of-life care by complex intervention in NH patients: A RCT trial of efficacy National Dep Public Health Prim Health Care, UiB Kavli Research Centre for Dementia, UiB Dignity Centre, Bergen Red Cross Nursing Home Centre of Excellence for Ageing and Dementia, UiO Regional Centre for Elderly Medicine and Collaboration, UiS International Kings College, London Karolinska University, Stockholm COST-Action: Assessment of Pain in Patients with Dementia EU 7th FP http://www.cost.eu/ bettina.husebo@isf.uib.no
Forskning innenfor Helse og omsorg Økt kompetanse Økt rekruttering Økt livskvalitet for pasienter og deres familie Velferdsteknologi Etiske grenser Robot-kjæledyr Økonomisk vekst Samfunn og familie 14% dekning for 80-åringer Omsorgslønn for å styrke familiens ansvar Frivillighet Hjemmebasert omsorg og avlastningstilbudt
Activity THANK YOU! bettina.husebo@isf.uib.no