Appropriate diagnoses for antipsychotics

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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 Appropriate diagnoses for antipsychotics Schizophrenia/Schizoaffective disorder Tourette s disorder Huntington s disease (CMS, 2013) 2 1

2 Diagnoses which may be appropriate for antipsychotics (CMS, 2013) Schizophreniform disorder Delusional disorder Mood disorders with psychotic features Medical illnesses with psychotic symptoms Hiccups Nausea and vomiting associated with cancer or chemotherapy 3 Inappropriate indications for antipsychotics (CMS, 2013) Wandering Poor self care Restlessness Impaired memory Mild anxiety Insomnia Inattention to surroundings Sadness or crying Fidgeting or nervousness Uncooperativeness with care 4 2

3 Antipsychotics may be used without appropriate diagnosis if: (CMS, 2013) Medical, physical, functional, psychological, emotional, social, and environmental causes have been identified and addressed and in the plan of care Behaviors present a danger to self or others AND The symptoms are identified as being due to mania or psychosis 5 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) 6 3

4 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) 7 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) 8 4

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 9 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. 10 5

6 11 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) 12 6

7 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) Randomized Controlled 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) 13 Intervention Tool 14 7

8 Memantine: Significant efficacy in cognitive, functional, global, and psychiatric symptoms (Cummings et al., 2006; Tariot et al., 2004) 15 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) 16 8

9 Valproic Acid: Improved BPRS agitation factor and CGI ratings and similar safety and tolerability to placebo (Tariot et al., 2005; Porsteinsson et al., 2001) 17 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) 18 9

10 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) 19 Level I Memantine (Cummings et al., 2006; Tariot et al., 2004) Level II Antidepressants #1 Sertraline (Finkel et al., 2004) #2 Citalopram (Siddique, Hynan, & Weiner, 2009; Pollock et al., 2007) #3 Other SSRIs (Seitz et al., 2011) #4 Trazadone (Seitz et al., 2011) Level III Valproic Acid and Derivatives (Porsteinsson et al., 2001; Porsteinsson et al., 2003; Tariot et al., 2005; Tariot et al., 2001) Level IV Antipsychotics #1 Quetiapine (Ballard et al., 2012; Huyerbrechts et al., 2012a; Kales et al., 2012; Maher et al., 2011) #2 Aripiprazole (Ballard et al., 2012; Maher et al., 2011) #3 Risperidone (Ballard et al., 2012; Maher et al., 2011; Sultzer et al., 2008) #4 Olanzapine (Ballard et al., 2012; Maher et al., 2011; Sultzer et al., 2008) 20 10

11 Study Design, Setting, and Sample 21 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

12 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 23 SNF 188 beds total 137 LTC occupied beds pre implementation 135 LTC occupied beds post implementation 24 12

13 Sample Staff nurses (N = 27) Key medical providers (N = 4) 100% of LTC SNF residents (N = 137 pre and N = 135 post) 25 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 26 13

14 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 27 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 28 14

15 29 90% 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 30 15

16 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 31 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.) 32 16

17 Data Analysis for Nurses Education 33 Table 1 Nursing Demographics 34 17

18 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). 35 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

19 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. 37 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) 38 19

20 Pre and Post implementation APM Use 39 APM use in the chosen facility actually increased from 21.2% to 22.2% by March 1, % 20% 15% 10% 5% 0% Antipsychotic Use Figure 6. Comparison of CMS, pre implementation, and postimplementation APM rate (CMS, n.d.) 40 20

21 Table 3 Facility total APM prescription rate and APM prescription rate for NPS associated with dementia % Antipsychotic Use 20% 15% 10% 5% 0% Pre implementation (September, 2014) Post implementation (March, 2015) Figure 7. Comparison of CMS and study pre implementation, and postimplementation APM rates (CMS, n.d.; 2015) 42 21

22 Figure 8. Comparison of individual APM and overall APM pre implementation and post implementation. The resident with Schizophrenia was on Thioridazine. 43 Figure 9. Comparison of pre implementation and post implementation %APM use for dementia behaviors 44 22

23 28 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 45 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 46 23

24 47 25% Antipsychotic Use 20% 15% 10% 5% 0% 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.) 48 24

25 Comparison of Facility APM Use (August 2016 and March 2017) 25% 20% 15% 10% 5% 0% Figure 11. Comparison of APM Rate for the State, Nation, and Facilities Where Protocol is Used. (CMS, n.d.)

26 Alzheimer s Association. (2014) Alzheimer s disease facts and figures. Retrieved from Ballard, C. G., Waite, J., & Birks, J. (2012). Atypical antipsychotics for aggression and psychosis in Alzheimer s disease. Cochrane Database of Systematic Reviews, 2012(5), doi: / CD pub2 Cummings, J. L., Schneider, E., Tariot, P. N., & Graham, S. M. (2006). Behavioral effects of memantine in Alzheimer disease patients receiving donepezil treatment. Neurology, 67(1), doi: /01.wnl f1 Declercq, T., Petrovic, M., Stichele, R. V., DeSutter, A. I. M., vandriel, M. L., & Christiaens, T. (2009). Withdrawal versus continuum of chronic antipsychotic drugs for behavioural [sic] and neuropsychiatric symptoms in elderly patients with dementia. Cochrane Database of Systematic Reviews, 2009(2), doi: / CD Finkel, S. I., Mintzer, J. E., Dysken, M., Krishnan, K. R. R., Burt, T., & McRae, T. (2004). A randomized, placebo controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer s disease in outpatients treated with donepezil. International Journal of Geriatric Psychiatry, 19, doi: /gps Gurvich, T., & Cunningham, J. A. (2000). Appropriate use of psychotropic drugs in nursing homes. American Family Physician, 61(5), Huybrechts, K. F., Gerhard, T., Crystal, S., Olfson, M., Avorn, J., Levin, R.,... Schneeweiss, S. (2012a). Differential risk of death in older residents in nursing homes prescribed specific antipsychotic drugs: Population based cohort study. British Medical Journal, 344, doi: /bmj.e977 Huybrechts, K. F., Schneeweiss, S., Gerhard, T., Olfson, M., Avorn, J., Levin, R.,... Crystal, S. (2012b). Comparative safety of antipsychotic medications in nursing home residents. Journal of the American Geriatrics Society, 60, doi: /j x Kales, H. C., Hyungjin, J. K., Zivin, K., Valenstein, M., Seyfried, L. S., Chiang, C.,... Blow, F. C. (2012). Risk of mortality among individual antipsychotics in patients with dementia. American Journal of Psychiatry, 169(1), Lindsey, P. L. (2009). Psychotropic medication use among older adults: What all nurses need to know. Journal of Gerontological Nursing, 35(9), doi: /

27 Maher, A. R., Maglione, M., Bagley, M., Suttorp, M., Hu, J. H., Ewing, B.,... Shekelle, P. G. (2011). Efficacy and comparative effectiveness of atypical antipsychotic medications for off label uses in adults: A systematic review and meta analysis. Journal of the American Medical Association, 306(12), doi: /jama Melnyk, B. M., & Fineout Overholt, E. (2011). Making the case for evidencebased practice and cultivating a spirit of inquiry. In B. M. Melnyk & E. Fineout Overholt (Eds.), Evidence based practice in nursing and healthcare: A guide to the best practice (2 nd ed., pp. 3 24). Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins. Motsinger, C. D., Perron, G. A., & Lacy, T. J. (2003). Use of atypical antipsychotic drugs in patients with dementia. American Family Physician, 67(11), Pariente, A., Reglat, A. F., Ducruet, T., Farrington, P., Beland, S. G., Dartigues, J. F.,... Moride, Y. (2012). Antipsychotic use and myocardial infarction in older patients with treated dementia. Archives of Internal Medicine, 172(8), doi: /archinternmed Plassman, B. L., Langa, K. M., Fisher, G. G., Heeringa, S. G., Weir, D. R., Ofstedal, M. B.,... Wallace, R. B. (2007). Prevalence of dementia in the United States: The aging, demographics and memory study. Neuroepidemiology, 29, doi: / Pollock, B. G., Mulsant, B. H., Rosen, J., Mazumdar, S., Blakesley, R. E., Houck, P. R., & Huber, K. A. (2007). A double blind comparison of citalopram and risperidone for the treatment of behavioral and psychotic symptoms associated with dementia. American Journal of Geriatric Psychiatry, 15(11), Porsteinsson, A. P., Tariot, P. N., Erb, R., Cox, C., Smith, E., Jakimovich, L.,... Irvine, C. (2001). Placebo controlled study of divalproex sodium for agitation in dementia. American Journal of Geriatric Psychiatry, 9(1), Schneider, L. S., Dagerman, K. S., & Insel, P. (2005). Risk of death with atypical antipsychotic drug treatment for dementia: Meta analysis of randomized placebo controlled trials. Journal of the American Medical Association, (294)15, doi: /jama

28 Schneider, L. S., Tariot, P. N., Dagerman, K. S., Davis, S. M., Hsiao, J. K., Ismail, M. S. (2006). Effectiveness of atypical antipsychotic drugs in patients with Alzheimer s disease. The New England Journal of Medicine, 355(15), Retrieved from Seitz, D. P., Adunuri, N., Gill, S. S., Herrmann, N., Rochon, P. (2011). Antidepressants for agitation and psychosis in dementia. Cochrane Database of Systematic Reviews 2011(2), doi: / CD pub2 Sultzer, D. L., Davis, S. M., Tariot, P. N., Dagerman, K. S., Lebowitz, B. D., Lyketsos, C. G.,... Schneider, L. S. (2008). Clinical symptom response to atypical antipsychotic medications in Alzheimer s disease: Phase 1 outcomes from the CATIE AD effectiveness trial. American Journal of Psychiatry, 165(7), doi: /appi.ajp Tariot, P. N., Farlow, M. R., Grossberg, G. T., Graham, S. M., McDonald, S., & Gergel, I. (2004). Memantine treatment in patients with moderate to severe Alzheimer s disease already receiving donepezil. Journal of the American Medical Association, 291(3), doi: /jama Tariot, P. N., Raman, R., Jakimovich, L., Schneider, L., Porsteinsson, A., Thomas, R.,... Thal, L. (2005). Divalproex sodium in nursing home residents with possible or probable Alzheimer disease complicated by agitation. American Journal of Geriatric Psychiatry, 13(11), U. S. Department of Health and Human Services, Centers for Medicare and Medicaid Services. (n.d.). Nursing home compare. Retrieved from U. S. Department of Health and Human Services, Centers for Medicare and Medicaid Services. (2015). Partnership to improve dementia care in nursing homes antipsychotic drug use in nursing homes trend update. Retrieved from and Education/Outreach/NPC/Downloads/ Trends.pdf U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services. (2013). Advanced copy: Dementia care in nursing homes: Clarification to Appendix P State Operations Manual (SOM) and Appendix P in the SOM for F309 Quality of Care and F329 Unnecessary Drugs. Retrieved from Enrollment and Certification/SurveyCertificationGenInfo/Downloads/Survey and Cert Letter pdf 56 28

29 U. S. Department of Health and Human Services, U. S. Food and Drug Administration. (2010). Public health advisory: Deaths with antipsychotics in elderly patients with behavioral disturbances. Retrieved from entsandproviders/drugsafetyinformationforheathcareprofessionals/publichealth Advisories/ucm htm 57 29

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