08/09/2016. APMs are not approved for use in patients with dementia. The FDA has issued a black box warning regarding the use

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1 Nancy M. Birtley, DNP, APRN, PMHCNS BC, PMHNP BC Owner, Psychiatric Consultation Services Assistant Teaching Professor University of Missouri, Columbia 1 Identify the risks of antipsychotic medications in the treatment of dementia behaviors. Recognize alternative psychotropic medications with less risk and similar or greater efficacy than antipsychotic medications. Distinguish when the use of an antipsychotic medication may be appropriate in the treatment of dementia behaviors. 2 11% of Americans over the age of 65 and 14% over the age of 71 have dementia (Alzheimer s Association, 2014) The prevalence of dementia increases with age to 37.4% in Americans over 90 years old (Plassman et al., 2007) 30 to 50% of the approximate 5.2 million individuals with dementia will suffer from psychosis and agitation (Ballard et al., as cited in Seitz et al., 2011) 3 1

2 Up to 33% of skilled nursing facility (SNF) residents are prescribed antipsychotic medications (APM) for neuropsychiatric symptoms (NPS) (Huybrechts et al., 2012b) APM are prescribed more often than other psychotropic medications for psychosis and agitation (Gurvich & Cunningham, 2000; Huybrechts et al., 2012b; Seitz et al., 2011) APM are frequently prescribed and often the first line treatment for NPS associated with dementia (Ballard, Waite, & Birks, 2012; Declercq et al., 2009; Gurvich & Cunningham, 2000; Huybrechts et al., 2012a; Motsinger, Perron, & Lacy, 2003; Pariente et al., 2012; Schneider et al., 2006) 4 Participants exposed to APMs were more than twice as likely to suffer a myocardial infarction (MI) than those not exposed (Pariente et al., 2012) Crude death rates associated with the prescription of individual APMs range from 18.6 to 45.8 per 100 person years (Huybrechts et al., 2012a; Kales et al., 2012) APMs are associated with a 54% increase in death (Maher et al., 2011; Schneider, Dagerman, & Insel, 2005) 5 APMs are not approved for use in patients with dementia (United States Food and Drug Administration, 2010) The FDA has issued a black box warning regarding the use of APM in treating dementia behaviors (United States Food and Drug Administration, 2010) SNFs are being cited by Centers for Medicare and Medicaid (CMS), with some losing Medicare and Medicaid certification, because of inappropriate use of APMs 6 2

3 To reduce the prescription of APM in the treatment of NPS associated with dementia through the introduction of an evidence based practice (EBP) protocol establishing a hierarchy of psychotropic medications based on risk and efficacy. 7 8 Ranking Study Description 4 Pariente et al. (2012) Retrospective Cohort 4 Kales et al. (2012) Retrospective Cohort 4 Huybrechts et al. (2012a) Prospective Cohort 2 Sultzer et al. (2008) Randomized Controlled Trial 1 Schneider, Dagerman, & Insel (2005) Meta analysis 1 Maher et al. (2011) Systematic Review; Metaanalysis 1 Ballard, Waite, & Birks (2012) Systematic Review (Melnyk & Fineout Overholt, 2011) 9 3

4 Ranking Study Description 6 Siddique, Hynan, & Weiner (2009) Descriptive Study 3 Porsteinsson et al. (2003) Open Label Extension of RCT 2 Finkel et al. (2003) Randomized Controlled Trial 2 Tariot et al. (2005) Randomized Controlled Trial 2 Pollock et al. (2007) Randomized Controlled Trial 2 Porteinsson et al. (2001) RandomizedControlled Trial 2 Tariot et al. (2004) Randomized Controlled Trial 2 Hermann et al. (2007) Randomized Controlled Trial 1 Seitz et al. (2011) Systematic Review (Melnyk & Fineout Overholt, 2011) 10 Intervention Tool

5 Memantine: Significant efficacy in cognitive, functional, global, and psychiatric symptoms (Cummings et al., 2006; Tariot et al., 2004) 13 Sertraline: Greater efficacy than placebo for severe psychiatric symptoms (Finkel et al., 2004) Citalopram: Similar efficacy to and greater tolerability than risperidone (Pollock et al., 2007) Other SSRIs: Better efficacy than and similar tolerability as APMs (Seitz et al., 2011) Trazadone: Similar efficacy and tolerability as placebo and APMs (Seitz et al., 2011) 14 Valproic Acid: Improved BPRS agitation factor and CGI ratings and similar safety and tolerability to placebo (Tariot et al., 2005; Porsteinsson et al., 2001) 15 5

6 Quetiapine: The relative risk (RR) of death was reduced for quetiapine in comparison to risperidone (Kales et al. 2012) and quetiapine was not associated with cardiovascular symptoms (Maher et al., 2011) Aripiprazole: Associated with modest efficacy, but with significant adverse events (Ballard et al., 2012; Maher et al., 2011) Risperidone: Improved NPI and CGIC scores compared to placebo, but significant adverse events (Maher et al., 2011; Sultzer et al., 2008) Olanzapine: Associated with improved aggression and NPI scores, but with significant adverse events (Ballard et al., 2012; Maher et al., 2011; Sultzer et al., 2008) 16 AVOID HALOPERIDOL: 57% greater mortality risk than risperidone (Huybrechts et al., 2012; Kales et al., 2012) Mortality rate 109.1/100 person years (Huybrechts et al., 2012) 17 Study Design, Setting, and Sample 18 6

7 This study used a single group pretest/posttest design. Prior to and after an in service education, nurses completed a test to evaluate their understanding of the material. 100% medical record review of long term care residents was completed pre and post implementation to determine the frequency of APM use. 19 Data was collected and stored in an encrypted Excel document. Diagnosis and psychotropic rates were calculated using Excel formulas SPSS Version 22 was used for statistical analysis Descriptive statistics were analyzed A paired t test and Wilcoxon signed ranks test were used for analysis 20 SNF 188 beds total 137 LTC occupied beds pre implementation 135 LTC occupied beds post implementation 21 7

8 Sample Staff nurses (N = 27) Key medical providers (N = 4) 100% of LTC SNF residents (N = 137 pre and N = 135 post) 22 Inclusion Criteria Long term care SNF residents Long term care SNF nursing staff LPNs & RNs Full time, Part time, & Perdiem Key medical providers (MDs and NPs) Exclusion Criteria Short term rehab residents Short term rehab nursing staff 23 Risks Stress Additional workload Benefits Increased awareness of the risks of APM and alternatives to their use. Reduced risk of CMS citations Fewer adverse events 24 8

9 Nursing staff demographics SNF resident demographics Nursing staff s pretest and posttest scores Number of APM prescribed routinely and as needed to each resident prior to and after implementation Prescription of other psychotropic medications % of nursing staff will attend one of four scheduled one hour in service education programs on risk of APMs, communication to providers, and use and documentation of EBP protocol by November 30, Seven one hour in service education programs were conducted between October 29, 2014 and January 7, % (27/40) of all nursing staff (full time, part time, & prn) attended 27 9

10 90% of key SNF providers (MDs, APRNs, PAs) will be informed of EBP protocol and CMS guidelines by November 30, % (4/5) of key SNF providers were informed These key providers oversee 90% of the residents 28 APM use in the chosen facility will decrease by 5% by March 1, 2015 Figure 3. Comparison of APM rate in the nation, state, and facility per CMS, and pre implementation (CMS, n.d.) 29 Data Analysis for Nurses Education 30 10

11 Table 1 Nursing Demographics 31 Figure 4. Histograms of pretest and posttest scores with normal curve superimposed. Pretest scores have normal distribution (m = 7.04 (1.81), p <.001, 95% CI [6.32, 7.75] n = 27). Posttest scores are skewed to the left (m = (1.70), p <.001, CI [12.59, 13.93], mdn = 14.00, IQR = 3.00, n = 27). 32 Figure 5. Normal Q Q Plot of pretest (left) and posttest (right). The points of the normal plots fall roughly along the reference line, with the exception of the one outlier on the posttest plot

12 Paired Samples t Test A paired samples t test was conducted revealing that the mean score (standard deviation in parentheses) increased from 7.04 (1.81), p <.001, 95% CI [6.32, 7.75] on the pretest to (1.70), p <.001 CI [12.59, 13.93] on the posttest. The difference between the two means is statistically significant at the.001 level (t = 17.26, m = 6.22 (1.89), CI [ 6.96, 5.47], df = 26). The effect size as measured by d was.1, indicating a very small treatment effect. 34 Wilcoxon Signed Ranks Test A Wilcoxon signed ranks test was also conducted and revealed a statistically significant change from pretest to posttest scores (pretest mdn = 7.00, posttest mdn = 12.00, Z = 4.554, p =.001) 35 Pre and Post implementation APM Use 36 12

13 APM use in the chosen facility actually increased from 21.2% to 22.2% by March 1, % APM Use 20 Percentage % APM Use 5 0 Figure 6. Comparison of CMS, pre implementation, and postimplementation APM rate (CMS, n.d.) 37 Table 3 Facility total APM prescription rate and APM prescription rate for NPS associated with dementia. 38 Figure 7. Comparison of CMS and study pre implementation, and postimplementation APM rates (CMS, n.d.; 2015) 39 13

14 Figure 8. Comparison of individual APM and overall APM pre implementation and post implementation. The resident with Schizophrenia was on Thioridazine. 40 Figure 9. Comparison of pre implementation and post implementation %APM use for dementia behaviors new residents were included in the postimplementation chart review Several new residents had a major mental illness other than Schizophrenia and few had dementia 18% (5/28) new residents had Bipolar disorder 29% (8/28) new residents had Dementia 42 14

15 67% (92/137) of residents had a diagnosis of dementia upon pre implementation 61% (83/135) of residents had diagnosis of dementia upon post implementation Antipsychotic Use 20 Percentage CMS Nation CMS State CMS Facility Overall Pre implementation (September, 2014) Post implementation (March, 2015) April, 2016 Figure 10. Comparison of CMS, study pre implementation, study postimplementation, and current APM rates (CMS, n.d.) 45 15

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