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Research Update: Early Intervention: The RAISE Early Treatment Program John M. Kane, M.D. Chairman, Dept. of Psychiatry The Zucker Hillside Hospital Executive.

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Presentation on theme: "Research Update: Early Intervention: The RAISE Early Treatment Program John M. Kane, M.D. Chairman, Dept. of Psychiatry The Zucker Hillside Hospital Executive."— Presentation transcript:

1 Research Update: Early Intervention: The RAISE Early Treatment Program John M. Kane, M.D. Chairman, Dept. of Psychiatry The Zucker Hillside Hospital Executive VP for Behavioral Health Services The North Shore–Long Island Jewish Health System Professor and Chairman Department of Psychiatry Hofstra North Shore LIJ School of Medicine

2 Disclosure 2014 – John M. Kane CompanyConsultant/ Advisory Board Speakers bureauShareholderGrants/ Research support AlkermesX Bristol-Meyers SquibbXX Eli LillyXX EnVivo PharmaceuticalsX Forest LaboratoriesX GenentechX H. Lundbeck A/SX Intracellular TherapeuticsX Janssen PharmaceuticaXX Johnson and JohnsonX MedAvanteX Otsuka PharmaceuticalXX RevivaX RocheX 2

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9 Evolution of Psychosis Fusar-Poli P. et al. JAMA Psychiatry. 2013;70(1):

10 Clinical characteristics of first-episode psychosis  Typically adolescent or young adult  Have lived with severe untreated psychotic symptoms  On average, for at least a year  Compared to peers  Cognitively impaired  Poorer psychosocial functioning  More likely to smoke  More likely to abuse substances  Families are typically actively engaged  Goals are to return to mainstream functioning 10

11 Reported mean duration of untreated psychosis Presented by Diana O. Perkins, MD, MPH. University of North Carolina at Chapel Hill, 26 th Sept 2003 (available at: Loebel 1992* Szymanski 1996 Larsen 1996 McGorry 1996** Robinson 1999* Barnes 2000 Browne 2000 Drake 2000 Ho 2000 Hoff 2000 Larsen 2000 Black 2001 Verdoux 2001 Linszen 2001 Malla 2002 Amminger 2002** Wiersma 2000 Weeks 1 year

12  Median DUP=74 weeks (mean=193.5±262.2 weeks)  68% of participants had DUP >6 months  Correlates of longer DUP included: earlier age of first psychotic symptoms substance use positive and general symptom severity poorer functioning referral from outpatient treatment settings Duration of Untreated Psychosis RAISE ETP n=404 Addington J et al. Submitted for publication

13 Participant CharacteristicsN%Weeks of DUP (Mean±SD) GenderFemale Male ±6.5 53±7 Racial backgroundWhite Black or African-American American Indian Asian/Pacific Islander ±6.5 63±7 52±1 55±4.5 EthnicityHispanic or Latino Not Hispanic or Latino ±8 58±6.5 Prior Psychiatric Hospitalization***Yes No ±7 156±4 Diagnosis at study entrySchizophrenia Schizophreniform disorder Schizoaffective disorder Brief psychotic disorder Psychotic disorder NOS < ±4.5 5±4 138±5 2±1.5 26±7 Substance use**Yes No ±6.5 48±7 Table 1: Characteristics of RAISE-ETP participants and associated Duration of Untreated Psychosis (DUP; N=404) *p<.05, **p<.01, ***p<.001

14 14 Mental Health treatment status at study entry* Outpatient Inpatient/partial hospital Unknown/other ±7 37±7 62±5.5 Geographic region where receiving treatment*** North South Mid-West West ±6.5 79±8 63±6 40±7 Community population densityRural Urban Suburban ±7 48±7 57±6.5 Insurance coveragePrivate or private & public Public only No insurance Insurance status unknown ±6 73±7 57±7 58±7.5 Participant CharacteristicsN%Weeks of DUP (Mean±SD) Table 1 continued: Characteristics of RAISE-ETP participants and associated Duration of Untreated Psychosis (DUP; N=404) *p<.05, **p<.01, ***p<.001

15 Implications of delayed treatment  Greater decrease in functioning  Loss of educational opportunities  Impaired psychosocial and vocational development  Personal suffering/family burdens  Potential poorer response once treatment is provided  Greater costs 15

16 Strategies to Reduce the Duration of Untreated Psychosis Anonymous E-surveys of high school and college students, linkages to psycho-ed website and referral to specialty program Interviews of early phase patients (and families) to understand pathways to care and internet social media utilization and how it was effected by incipient psychosis Asking for access to social media communications for further examination using word count/linguistic analysis Working with teenagers to develop social media strategies to educate and respond

17 Key concepts for optimal first-episode medication treatment  Response rates for positive symptoms are very high  No antipsychotic has demonstrated superior efficacy for the treatment of the initial psychotic episode. Tolerability is key  Effective antipsychotic doses are usually lower than those needed for multi-episode patients  Despite low antipsychotic doses, rates of side effects are high  Relapse is frequent and the most important factor driving relapse is medication non-adherence  There is often an overwhelming drive by patients and their families to stop treatment 17

18 The risk for psychotic relapse is high Year* Relapse rate (%) 95% CI Patients still at risk at end of year, n Lower limitUpper limit Robinson et al. Arch Gen Psychiatry 1999;56:241–247 n=104 first-episode schizophrenia patients; *year(s) after recovery from the previous episode; CI=confidence interval 18

19 Stopping medication is the most powerful predictor of relapse  Survival analysis: risk of a first or second relapse when not taking medication is ~5 times greater than when taking it Robinson et al. Arch Gen Psychiatry 1999;56(3):241–247 n= Hazard ratio for the first and second relapse

20 Relapse fuels the progression of illness  With each relapse:  Recovery can be slower and less complete  More frequent admissions to hospital  Illness can become more resistant to treatment  Increased risk of self-harm and homelessness  Regaining previous level of functioning is harder  Patient has a loss of self-esteem and social and vocational disruption  Greater use of healthcare resources  Increased burden on families and caregivers Kane. J Clin Psychiatry 2007;68(Suppl 14):27–30 20

21 Consequences of a first and second relapse in early phase illness  After a first episode a young person might go back to school or work  What happens if they relapse, will they be able to return a second time, or a third time?  How do close friends or lovers react to a psychotic episode, and then a relapse?  Many of life’s opportunities, and a person’s potential, can be eroded by a small number of relapses early in the illness 21

22 UCLA recovery criteria  Recovery criteria must be met in each of 4 domains  Improvement in each domain must be sustained concurrently for  2 years  Level of recovery in these 4 domains is measured by symptom remission, appropriate role function, ability to perform day-to-day living tasks without supervision, and social interactions Liberman et al. Int Rev Psychiatry 2002;14:256–272 22

23 Cumulative recovery rates by year in study Year Cumulative recovery rate (%) 95% CI Lower limit Upper limit Robinson et al. Am J Psychiatry 2004;161(3):473–479 CI=confidence interval 23

24 Jääskeläinen et al. Schizophr Bull 2013;39(6):1296– A systematic review and meta-analysis of recovery in schizophrenia Conclusions: Based on the best available data, approximately, 1 in 7 individuals with schizophrenia met our criteria for recovery. Despite major changes in treatment options in recent decades, the proportion of recovered cases has not increased

25 Tiihonen et al. Am J Psychiatry 2011;168:603– A nationwide cohort study of oral and depot antipsychotics after first hospitalisation for schizophrenia

26 Is there a case for earlier use of LAI antipsychotics?  The percentage of time spent experiencing psychotic symptoms in the first 2 years is the strongest predictor of long-term symptoms and disability 1  With subsequent exacerbations, patients may experience a decrease in their treatment response 2  Neuropathological brain changes often progress with subsequent clinical episodes 3  LAI antipsychotics allow for swift identification of overt non- adherence and elimination of covert nonadherence 4 1. Harrison et al. Br J Psychiatry 2001;178(6):506–517; 2. Lieberman et al. Neuropsychopharmacology 1996;14:13S–21S; 3. Lieberman et al. Psychiatr Serv 2008;59(5):487–496; 4. Fenton et al. Schizophr Bull 1997;23(4):637–651 LAI=long-acting injectable 26

27 Impact of initiating LAI atypical antipsychotics early in the disease course  Patients initiated on an atypical LAI within 5 years of onset of illness (24.2%) were compared with those on an atypical LAI >5 years after the onset of illness (75.8%): Detke et al. Poster presented at the 52 nd Annual New Clinical Drug Evaluation Unit (NCDEU) meeting; 29 th May–1 st June, 2012; Phoenix, AZ n=1,879; BPRS=Brief Psychiatric Rating Scale; LAI=long-acting injectable; PANSS=Positive and Negative Syndrome Scale 27 Greater improvements in BPRS scores (p<0.01) Longer median time to discontinuation (p=0.003) Greater improvement in PANSS scores (p<0.01) Higher remission rates (p<0.001) Longer time to relapse (p=0.018)

28 Relapse risk despite RIS-LAI adherence  Stepwise Cox proportional predictors: Canada vs US: HR=2.8; illness duration ˃ 10 years vs ≤5 years: HR=2.3; previous AP >4 vs ≤4 mg/day: HR=1.8 Nasrallah et al. Poster presented at the 52 nd Annual New Clinical Drug Evaluation Unit (NCDEU) meeting; 29 th May–1 st June, 2012; Phoenix, AZ n=323; post-hoc analysis of a 1-year relapse prevention study of R-LAI 25 mg vs 50 mg/2 weeks: 18.3% relapsed; RIS-LAI=risperidone long-acting injectable; AP=antipsychotic; HR=hazard ratio % 17.6% 21.9% Weeks Proportion relapse free Illness ≤5 years Illness 6–10 years Illness ˃ 10 years % relapsed

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30 Bartzokis et al. Sch Res 2012

31 John Kane – Principle Investigator The Zucker Hillside Hospital (ZHH) Delbert RobinsonZHH Nina SchoolerSUNY Downstate Jean AddingtonUniversity of Calgary Sue EstroffUNC Christoph CorrellZHH Kim MueserBoston University David PennUNC Robert RosenheckYale University Patricia MarcyZHH – Project Director ETP=early treatment program 31 RAISE-ETP: Executive Committee

32 Principal NIMH Collaborators  Robert Heinssen  Susan Azrin  Amy Goldstein

33 Specified aims of RAISE  Develop a comprehensive and integrated intervention to  Promote symptomatic recovery  Minimise disability  Maximise social, academic, and vocational functioning  Be capable of being delivered in real-world settings utilising current funding mechanisms  Assess the overall clinical impact and cost-effectiveness of the intervention as compared to currently prevailing treatment approaches  Conduct the comparison in non-academic, real-world community treatment settings in the United States 33

34 RAISE – ETP Site Distribution 34 sites in 21 states

35 RAISE Trial: Methods Sites are randomly assigned to administer either the RAISE Intervention or their current treatment program A central team of raters conducts structured diagnostic interviews and assesses subjects via live, two-way video interviews ― Assessors are masked to treatment condition Compatible with the site randomization model ― Expert assessors available to all sites ― Central rater team allows ongoing maintenance of high reliability of assessment Subjects are assessed for a minimum of 2 years

36 RAISE Trial Design: Subjects Sample size: 404 Age The following diagnoses are included in the differential ― schizophreniform disorder ― schizophrenia ― schizoaffective disorder ― psychotic disorder NOS ― brief psychotic disorder Less than six months of treatment with antipsychotic medications

37 RAISE Trial: Outcomes  Primary outcome measure: Quality of Life scale  Primary hypothesis  RAISE intervention compared to community care will improve Quality of Life  Other measured outcomes  Service utilization  Cost  Consumer perception  Prevention of relapse  Enhanced recovery

38 Navigate  Team based  Shared decision-making  Strength & resiliency focus  Psychoeducational teaching skills  Motivational enhancement teaching skills  Collaboration with natural supports  Four components  Psychopharmacology – COMPASS  Individual Resiliency Training (IRT)  Family psychoeducation  Supported employment/education 38

39 Individual Resiliency Training (IRT)  Strength and Goal oriented  Skill based  Recovery emphasis  Motivational techniques utilized throughout  Connecting skills and information to goals  Reframing events in positive light  Promoting hope and positive expectations  Tailored for first-episode clients  Clinicians have at least Bachelor’s level education and prior clinical experience  Most have Master’s level degrees  Modular and sequenced  But sequence can be modified to address client’s needs

40 IRT Modules  Standard :  Orientation  Assessment  Resiliency training  Wellness management  Psychoeducation/processing the illness  Goal setting  Relapse prevention  Advanced  Managing distress and grief  Coping with depression and other symptoms  Reducing substance abuse/dependence  Improving social relationships

41 Family Psychoeducation  Begins soon after initial contact  Includes client, relatives, other significant persons  Basic and Advanced modules  Coordinated with Individual Resiliency Training  Assessment and identification of client and family goals  Education about disorder and treatment  Opportunity to process experience of psychotic episode and reduce stigmatizing beliefs about mental illness  Strategies for improving quality of communication and problem solving

42 Supported Education / Employment  Established principles of supported employment in chronic populations modified for first episode  Focus on return to school or work as soon as possible after symptom stabilization  Goals determined by client preferences  Supports provided to  enroll/re-enroll in school  re-enter or obtain work  Ongoing supports provided to maintain school/work  Coordination with clinical treatment and team  Benefits counseling

43 The Value of Measurement  Contribution to diagnostic process  Establishing baseline severity  Providing targets and treatment goals  Evaluating the efficacy of treatment  Evaluating tolerability and adverse effects  Influencing level of care  Medical record documentation

44 Obstacles to Measurement  Inadequate appreciation of benefit  Perceived value of global judgment  Time constraints  Lack of appropriate instruments  Inadequate training  Reimbursement concerns

45 Figure 1. Patient Evaluation Screen Computerized Decision Support System Longitudinal Symptom Assessment

46 Ease of use Web-based: available for desk tops, lap top, I Pad Incorporating patient self-report Interactive (results are constantly modified based on patient and prescriber input) Grade school level reading for self-report Validated assessment tools Incorporates psychiatric and medical data Substance abuse Nicotine use Adherence (including assessment of attitudes towards medication) Comprehensive side effect assessment Senior national experts involved in designing Extensive prescriber feedback Desired Characteristics of a Decision Support System

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48 Little red boxes indicate items not yet addressed Patient Self Report Form

49 Clinician Rated Form Includes Information From Patient Self-Rated Form On Corresponding Items And Adjusts The Prompt Questions Accordingly This item includes prompt question for a patient who did not endorse depressed mood on the Self-Report Form Prompt question for patient who did endorse anxious mood

50 Referral Source of Participants  335 (79%) came from the usual referral sources for the agency (e.g. an inpatient unit, ER)  88 (21%) came from community outreach activities

51 Diagnoses at Enrollment

52 Prior Psychiatric Hospitalizations  316 (78%) had a prior psychiatric hospitalization  88 (22%) had no prior psychiatric hospitalizations

53 Demographic Characteristics  293 (73%) men and 111 (27%) women  340 (84%) were between the ages of 18 and 30 years old  Mean age is 23.1 years; modal age is 19.

54 404 subjects entered the RAISE-ETP study  We examined their medication prescriptions at the time of study entry before any influence of treatment by study guidelines or procedures  We identified 159 (39.4%) subjects who might have benefitted from one or more changes in their psychotropic prescriptions Robinson et al. In Press Amer J Psych ETP=early treatment program

55 Of these 159 subjects…  14 (8.8%) were prescribed recommended antipsychotics at higher than recommended doses  51 (32.1%) were prescribed olanzapine (often at high doses)  37 (23.3%) were prescribed more than one antipsychotic  58 (36.5%) were prescribed an antipsychotic, but, also an antidepressant, without a clear indication  16 (10.1%) were prescribed psychotropic medications without an antipsychotic  5 (1.2%) were prescribed stimulants Robinson et al. In press Amer J Psych 55

56 RAISE: smoking, lipid abnormalities, hypertension diabetes + metabolic syndrome with related drug treatment Correll et al. In press JAMA Psych After 47 days average lifetime antipsychotic treatment, olanzapine and quetiapine were related to higher metabolic values; dyslipidemia: TC ≥200 mg/dL or TG ≥150 mg/dL, or low HDL; TC=total cholesterol; TG=triglyceride; HDL=high-density lipoprotein; LDL=low-density lipoprotein 56 Prevalence / lack of intervention (%) SmokingLow HDL-C High total cholesterol High LDL-C High triglyceride High BP Pre- diabetes mellitus (HbA1C) DiabetesMetabolic syndrome Dys- lipidemia

57 Smoking at study entry  51.2% of subjects reported smoking cigarettes at the time of study entry  No subject was being prescribed nicotine replacement or varenicline  Only 11 subjects (7 currently smoking) were prescribed bupropion (indication for bupropion not recorded) Robinson et al. Unpublished data 57

58 E-Health: Potential to Address Problem Areas of In-Person Services 1.Severe mental illness: treatment is insufficient  >50% do not receive specialty mental health services (Mojtabai et al, 09),  4%-15% receive minimally adequate treatment (far short of standards for care) (Wang et al, 02) years for EBPs to reach routine care (IOM, 01)  Lack of expertise in community treatment settings  High cost of setting up & maintaining an EBP  Too few clients for economy of scale in clinics, or geographic areas 3.Once reach routine care EBPs often lack fidelity (Drake et al, 01) 4.Travel adds burden 5.Families/supporters left out of treatment 6.Healthcare is poorly understood--regardless of education level 7.Chronic illness management occurs at home

59 The Improving Care Reducing Cost (ICRC) Program Translates to The Health Technology Program (HTP) John Kane, Delbert Robinson, Nina Schooler, Mary Brunette, Kim Mueser, Dror Ben-Zeev, Jennifer Gottlieb, Armondo Rotundi, Christoph Correll, Susan Gingrich, James Robinson, Bob Rosenheck, Patricia Marcy

60 Program Overview  Goal:  To reduce ER visits and hospital days while providing better care, better health and increased patient satisfaction. This will be done by fostering innovation in the use of technology and by training and deploying a new cadre of personnel in the behavioral health field: Mental Health/Health Technology (MH/HT) Case Managers.

61 Hospitalization and schizophrenia  Schizophrenia is characterized by relapses (hospitalizations) and returns to the community  Challenging for making progress toward recovery  Hospital stays are a major cost driver  Six month cost for newly discharged patients  16,300  Re-hospitalization 11,900  Medication 3,000  Other 1,400  Six month cost for other patients  8,200  Risk for rehospitalization is greatest in the months immediately following discharge

62 Health Technology Program  Focuses on critical 6 months following hospital discharge  Engages patient with a treatment team  Uses innovative tech tools to provide treatment  Outcome assessment and monitoring is integrated in treatment  Treatment is tailored to patient needs and preferences  Shared decision making

63 The Health Technology Team  Project director  Identifies and enrolls patients at the critical time  At or immediately following a hospitalization  Leads the team  Psychiatrist/prescriber  Assesses symptoms, side effects and adherence  Prescribes medication based on assessment and evidence- based treatment guidelines  Mental Health/Health Technology Case Manager  Provides case management services  Guides the patient in use of new tech tools

64 The Health Technology Program Components  Relapse Prevention Plan  In-person guidance to create “My Relapse Prevention Plan”  Daily Support Website  Web-based support for patients and families  FOCUS  smart phone app to cope with adherence, mood, sleep, social dysfunction and voices  Coping with Voices and Paranoia  Web-based computer CBT programs  Prescriber Decision Assistant  Web-based Medication Decision Support System

65 Relapse Prevention Planning (RPP)  Five in person sessions occurring in the first 2 months of treatment  Session 1: Orientation to Program and goals  Session 2: Medication Strategies  Session 3: Stress  Session 4: Substance Use  Session 5: Putting it All Together

66 The Daily Support Website (DSW)  Web-based support for patients and families  Provide illness & coping education material to patients and families  Social networks with participants and family members  Chat rooms for patients, families, and patients and families  Help individuals and families with the illness  Opportunity to interact with an online therapist  Identify early warning signs and prevent relapse  Option to identify early warning signs and receive daily text reminders  Case managers alerted if early warning signs are present

67 FOCUS – A smart phone application 5 treatment targets: Med adherence, voices, social functioning, mood and sleep Up to 3 targets can be selected at one time Patients can receive up to 3 push notifications/check-ins per day Each check-in= 4 messages Case Managers work with patient to select appropriate targetsCase Managers work with patient to select appropriate targets Case managers have access to a real time report of patient responsesCase managers have access to a real time report of patient responses Targets can be changed throughout the programTargets can be changed throughout the program

68 “Coping with Voices and Paranoia” Interactive, game-based program that teaches CBT skills to persons with psychotic disordersInteractive, game-based program that teaches CBT skills to persons with psychotic disorders Self-paced but forced exposure to all program components in orderSelf-paced but forced exposure to all program components in order Cumulative building of skills, complexity increases somewhat over sessionsCumulative building of skills, complexity increases somewhat over sessions “Multi-Modality” – animated tutorials, readings, audio and video, interactive games, symptom reporting and tracking, social feed component, interactive quizzes“Multi-Modality” – animated tutorials, readings, audio and video, interactive games, symptom reporting and tracking, social feed component, interactive quizzes

69 PDA Decision Support System The PDA is a web-based decision support system that assists patient-provider communication and decision making Patients complete a self assessment prior to seeing the prescriber The prescriber interview is tailored based on the patients responses on the self assessment The HTP program uses evidence-based medication treatment to decrease patient risk of relapse The appropriate use of clozapine and efforts to promote medication adherence (e.g. long-acting injectable antipsychotics) are crucial for this goal

70 Implementation  Project Director & Case Manager identify patient  Patient consents to participate and receives baseline assessments  Patient meets with case manager  Goal to develop and implement a plan for preventing relapse and rehospitalization that incorporates appropriate tech tools  Laptop computer, internet connection and Smart Phone are provided  Patient meets with prescriber for assessment and medication management  Treatment continues for SIX months

71 Conclusions  Early and effective intervention is key for achieving the best outcomes in schizophrenia  Non-adherence remains a major challenge and is a frequent cause of relapse and re-hospitalisation  Recovery rates remain disappointingly low  A combination of pharmacotherapy and psychosocial treatments are critical to facilitate recovery 71


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