EvidenceEvidence--Based Approaches to Based Approaches to Medication Management in Psychiatry:Medication Management in Psychiatry:

Promises and PitfallsPromises and Pitfalls

Michael Flaum, MDMichael Flaum, MDDepartment of PsychiatryDepartment of Psychiatry

University of Iowa Carver College of MedicineUniversity of Iowa Carver College of Medicine

Director, Iowa Consortium for Mental HealthDirector, Iowa Consortium for Mental Health

April 8, 2005April 8, 2005

OutlineOutline

IntroductionIntroductionWho I am, ICMH activities around EBPWho I am, ICMH activities around EBP’’ss

EvidenceEvidence--based practicesbased practicesdefinitions and conceptsdefinitions and concepts

Why the push for EBPWhy the push for EBP’’s?s?PORT studyPORT study

Using evidenceUsing evidence--based approaches in based approaches in psychoactive prescribing psychoactive prescribing -- MedMAPMedMAP

My My Contact InfoContact Info

ee--mail: mail: michaelmichael--flaum@uiowa.eduflaum@uiowa.edu

Phone: 319Phone: 319--353353--4340 4340

Web site: Web site: www.icmentalhealth.orgwww.icmentalhealth.org

Iowa Consortium for Mental HealthIowa Consortium for Mental Health

Began in 1994Began in 1994

Mission: To enhance mutually Mission: To enhance mutually beneficial collaboration between Iowabeneficial collaboration between Iowa’’s s universities and its public mental universities and its public mental health system health system

Focus over past several years: Focus over past several years: EvidenceEvidence--based practices in mental based practices in mental healthhealth

ICMH Technical Assistance Center for ICMH Technical Assistance Center for EvidenceEvidence--Based PracticesBased Practices

Supported by:Supported by:

Iowa DHSIowa DHSCommunity Mental Health Block GrantCommunity Mental Health Block Grant

Magellan Behavior HealthMagellan Behavior HealthCommunity ReinvestmentCommunity Reinvestment

National Institute of Mental HealthNational Institute of Mental HealthOutreach Partners ProgramOutreach Partners Program

ICMH EBPICMH EBP--TAC ActivitiesTAC Activities

ICN Series: EvidenceICN Series: Evidence--Based Practices in Based Practices in Mental Health: Ready or Not Here They ComeMental Health: Ready or Not Here They Come

TA to CMHCTA to CMHC’’s on EBPs on EBP’’s as per new legislations as per new legislationSF 2288SF 2288Mandates that all CMH Block Grant money be used Mandates that all CMH Block Grant money be used for EBPfor EBP’’ss

ACT TACACT TAC

WMR TACWMR TAC

EvidenceEvidence--Based Practice in Mental Based Practice in Mental Health: Health: Ready or Not, Here They ComeReady or Not, Here They Come

ICN Site

ICN Series, Summer-Fall, 2004

Objectives of Session I: Objectives of Session I: EBP Overview, Definitions and ConceptsEBP Overview, Definitions and Concepts

Understand what is meant by the term Understand what is meant by the term ““evidence based practice(s)evidence based practice(s)””

Review the main factors driving public Review the main factors driving public mental health systems towards EBPmental health systems towards EBP’’ss

Describe the concept of Describe the concept of ““model fidelitymodel fidelity”” and and methods of its evaluationmethods of its evaluation

Recognize the limitations of the EBP Recognize the limitations of the EBP approach in mental healthapproach in mental health

Discuss barriers to implementation and Discuss barriers to implementation and strategies to overcome themstrategies to overcome them

Cautionary noteCautionary note

““As is true with any newly popularized As is true with any newly popularized term, the term term, the term ‘‘evidenceevidence--basedbased’’ has an has an almost intuitive ring of credibility to italmost intuitive ring of credibility to it……

……But thisBut this ring may be hollowring may be hollow””..

Hoagwood K et al: EvidenceHoagwood K et al: Evidence--Based Practice in Child and Adolescent Based Practice in Child and Adolescent Mental Health Services.Mental Health Services. Psychiatr Serv 52:1179Psychiatr Serv 52:1179--1189, 20011189, 2001

Medline Search ResultsMedline Search Results

YearsYears EBPEBP EBMEBM19661966--9191 00 0019921992--9393 00 2219941994--9595 1414 959519961996--9898 179179 2,0032,00319991999--05*05* 1,0941,094 14,95314,953

EBPEBP = = ““EvidenceEvidence--Based Practice(s)Based Practice(s)””EBM = EBM = ““EvidenceEvidence--Based MedicineBased Medicine””

*Last updated March (week 5), 2005*Last updated March (week 5), 2005

Selected DefinitionsSelected Definitions

Best PracticeBest Practice

EvidenceEvidence--Based PracticeBased Practice

Evidence Based MedicineEvidence Based Medicine

““Best PracticeBest Practice””: : Selected Generic DefinitionsSelected Generic Definitions

…… policies, principles, standards, policies, principles, standards, guidelines, and procedures that guidelines, and procedures that contribute to the highest, most contribute to the highest, most resourceresource-- effective performance of a effective performance of a discipline.discipline.

……a technique or methodology that, a technique or methodology that, through experience and research, has through experience and research, has proven to reliably lead to a desired proven to reliably lead to a desired result.result.

EvidenceEvidence--Based PracticesBased PracticesSelected Definitions (1)Selected Definitions (1)

Interventions for which there is Interventions for which there is consistent scientific evidence showing consistent scientific evidence showing that they improve client outcomes.that they improve client outcomes.

Source: Drake RE et al, Psychiatric Services, 52:179Source: Drake RE et al, Psychiatric Services, 52:179--82, 200182, 2001

EvidenceEvidence--Based PracticesBased PracticesSelected Definitions (2)Selected Definitions (2)

Intervention with a body of evidence:Intervention with a body of evidence:-- rigorous research studies rigorous research studies -- specified target population specified target population -- specified client outcomesspecified client outcomes

Specific implementation criteria (e.g., Specific implementation criteria (e.g., treatment manual)treatment manual)

A track record showing that the practice can A track record showing that the practice can be implemented in different settingsbe implemented in different settings

Source: Bond G, et al, 2001Source: Bond G, et al, 2001

““ EvidenceEvidence--based medicinebased medicine””Selected definitionsSelected definitions

"Evidence"Evidence--based medicine involves based medicine involves evaluating rigorously the effectiveness of evaluating rigorously the effectiveness of healthcare interventions, disseminating the healthcare interventions, disseminating the results of evaluation and using those findings results of evaluation and using those findings to influence clinical practice.to influence clinical practice.

It can be a complex task, in which the It can be a complex task, in which the production of evidence, its dissemination to production of evidence, its dissemination to the right audiences, and the implementation the right audiences, and the implementation of change can all present problems". of change can all present problems".

Source: Appleby J, Walshe K and Ham C (1995).Source: Appleby J, Walshe K and Ham C (1995). Acting on Acting on the Evidence (NAHAT Research Paper No. 17). Birminghamthe Evidence (NAHAT Research Paper No. 17). Birmingham

Why the push for EBPWhy the push for EBP’’s? s?

Many advances in understanding and Many advances in understanding and treating mental illnesses over past few treating mental illnesses over past few decadesdecades

Limited evidence of improved Limited evidence of improved outcomesoutcomes

““Science to serviceScience to service”” gapgap

Why EBPWhy EBP’’s? Surgeon Generals? Surgeon General’’s s Report on Mental Health (1999)Report on Mental Health (1999)

““A wide variety of effective, communityA wide variety of effective, community--based based services, carefully refined through years of services, carefully refined through years of research, exist for even the most severe research, exist for even the most severe mental illnesses yet are not being translated mental illnesses yet are not being translated into community settings.into community settings.””

““Numerous explanations for the gap between Numerous explanations for the gap between what is known from research and what is what is known from research and what is practiced beg for innovative strategies to practiced beg for innovative strategies to bridge it.bridge it.””

From Ch 8: A vision for the futureFrom Ch 8: A vision for the future

Why the push for EBP's? Why the push for EBP's?

Despite extensive evidence and agreement on Despite extensive evidence and agreement on effective mental health practices for persons effective mental health practices for persons with SMI, research shows that routine mental with SMI, research shows that routine mental health programs do not provide EBPhealth programs do not provide EBP’’s to the s to the great majority of clients with these illnessesgreat majority of clients with these illnesses

This finding was a major conclusion of the This finding was a major conclusion of the surgeon generalsurgeon general’’s report (1999)s report (1999)

PORT study PORT study –– the most extensive the most extensive demonstration of the problem. demonstration of the problem.

Source: Drake RE et al, Psychiatric Services, 52:179Source: Drake RE et al, Psychiatric Services, 52:179--82, 200182, 2001

PORT Study: Patient Outcomes PORT Study: Patient Outcomes Research TeamResearch Team

Sponsors and PartnersSponsors and PartnersNIMH and AHCPR (Agency for Health Care Policy NIMH and AHCPR (Agency for Health Care Policy and Research) 1992and Research) 1992Joint effort: Hopkins, University of MarylandJoint effort: Hopkins, University of Maryland

2 major components and goals2 major components and goalsPORT 1: To develop recommendations for the PORT 1: To develop recommendations for the treatment of persons with treatment of persons with schizophreniaschizophrenia, based on , based on a synthesis of the best scientific evidence. a synthesis of the best scientific evidence. PORT 2: To quantify concurrence of actual PORT 2: To quantify concurrence of actual practice with these recommendationspractice with these recommendations

Source: Lehman et al: Schizophrenia Bulletin, Source: Lehman et al: Schizophrenia Bulletin, 24:1124:11--20, 199820, 1998

PORT 1: Generating RecommendationsPORT 1: Generating Recommendations

Literature reviewLiterature review

Strength of evidence evaluated for a Strength of evidence evaluated for a variety of interventions (A variety of interventions (A –– C)C)

30 level A recommendations generated30 level A recommendations generatedStrong evidence baseStrong evidence base

PORT PORT –– Levels of Evidence Criteria*Levels of Evidence Criteria*

Level A: Good researchLevel A: Good research--based evidence, with based evidence, with some expert opinion to support some expert opinion to support recommendationrecommendation

Level B: Fair researchLevel B: Fair research--based evidence, with based evidence, with substantial expert opinion to support substantial expert opinion to support recommendationrecommendation

Level C: Minimal researchLevel C: Minimal research--based evidence, based evidence, primarily based on expert opinion and primarily based on expert opinion and significant clinical experience to support significant clinical experience to support recommendationrecommendation

*Adapted from AHCPR Depression Guidelines*Adapted from AHCPR Depression Guidelines

PORT 1 Results: 30 Treatment PORT 1 Results: 30 Treatment Recommendations (Level A)Recommendations (Level A)

Somatic Treatments: 21Somatic Treatments: 21Pharmacotherapy: 18Pharmacotherapy: 18ECT: 3ECT: 3

Psychological Treatment: 2Psychological Treatment: 2

Family Treatment: 3Family Treatment: 3

Vocational Rehabilitation: 2Vocational Rehabilitation: 2

Service Systems: (ACT) 2Service Systems: (ACT) 2

PORT 2: Conformance StudyPORT 2: Conformance Study

Survey of a stratified random sample of 719 Survey of a stratified random sample of 719 pts with schizophrenia in 2 statespts with schizophrenia in 2 states

Public, private, VAPublic, private, VAInpatient, outpatientInpatient, outpatientDrawn from multiple communitiesDrawn from multiple communities

Looked at concurrence of practice with 12 Looked at concurrence of practice with 12 PORT treatment recommendationsPORT treatment recommendations

Dichotomous ratings (conform vs. not)Dichotomous ratings (conform vs. not)

Source: Lehman et al: Schizophrenia Bulletin, Source: Lehman et al: Schizophrenia Bulletin, 24:1124:11--20, 199820, 1998

PORT Study: Care for Schizophrenia PORT Study: Care for Schizophrenia Lags Behind ScienceLags Behind Science

Schizophrenia PORTSchizophrenia PORT ActualActualTreatment RecommendationsTreatment Recommendations Treatment Rates (%)Treatment Rates (%)

Antipsychotic medication for new orAntipsychotic medication for new orrelapsed symptomsrelapsed symptoms11 89.289.2

Appropriate dose of antipsychoticAppropriate dose of antipsychoticmedication for new or relapsed symptomsmedication for new or relapsed symptoms11 62.462.4

Antipsychotic medication on an ongoing basisAntipsychotic medication on an ongoing basis22 92.392.3

Appropriate dose of ongoing antipsychotic medicationAppropriate dose of ongoing antipsychotic medication 29.129.1

Antiparkinsonian medication for side effectsAntiparkinsonian medication for side effects 46.146.1

LongLong--lasting injections of antipsychotic medicationlasting injections of antipsychotic medication 35.035.0

1Data from inpatients studied.2Data for this box and all remaining categories are from outpatients studied.1Data from inpatients studied.2Data for this box and all remaining categories are from outpatients studied.

PORT 2 PORT 2 -- Conformance Study: Conformance Study: Sample Findings Sample Findings –– Antipsychotic DosingAntipsychotic Dosing

Acute Phase: 62.4 % receiving Acute Phase: 62.4 % receiving appropriate doses appropriate doses

15 % on a lower dose (<300 CPZ equiv.)15 % on a lower dose (<300 CPZ equiv.)

22.5 % on a higher dose (>1000 CPZ equiv.)22.5 % on a higher dose (>1000 CPZ equiv.)

Maintenance Phase: 29.1 % receiving Maintenance Phase: 29.1 % receiving appropriate dosesappropriate doses

39.1 % on a lower dose (<300 CPZ equiv.)39.1 % on a lower dose (<300 CPZ equiv.)

31.9 % on a higher dose (>600 CPZ equiv.)31.9 % on a higher dose (>600 CPZ equiv.)

PORT 2 PORT 2 -- Conformance Study: Conformance Study: Sample Findings (2)Sample Findings (2)

Urban patients more likely than rural to Urban patients more likely than rural to be out of range and to be on high dosesbe out of range and to be on high doses

Minority patients more likely to be on Minority patients more likely to be on high doseshigh doses

No evidence behind either of these trendsNo evidence behind either of these trends

PORT 2 StudyPORT 2 StudySample Findings Sample Findings -- NonNon--somatic Txsomatic Tx

InterventionIntervention Inpt. (%)Inpt. (%) Outpt. (%)Outpt. (%)

Family PsychoFamily Psycho--educationeducation 31.631.6 9.69.6

Vocational RehabilitationVocational Rehabilitation 30.430.4 22.522.5

Assertive Community Assertive Community TreatmentTreatment

8.68.6 10.110.1

% of pts with SZ % of pts with SZ receiving Txreceiving Tx

PORT PORT -- ConclusionsConclusions

Real world practice is inconsistent with Real world practice is inconsistent with practice as recommended by practice as recommended by academicsacademics

““EvidenceEvidence--based practicesbased practices”” are are markedly underutilizedmarkedly underutilized

Reasons for this need to be better Reasons for this need to be better understoodunderstood

Other strategies necessary to enhance Other strategies necessary to enhance implementation of EBPimplementation of EBP’’ss

National EvidenceNational Evidence--Based Practices Based Practices Project: SponsorsProject: Sponsors

SAMHSA SAMHSA –– Center for Mental Health ServicesCenter for Mental Health Services

Robert Wood Johnson FoundationRobert Wood Johnson Foundation

National Alliance for the Mentally IllNational Alliance for the Mentally Ill

Several state and local mental health Several state and local mental health authoritiesauthorities

New HampshireNew HampshireMarylandMarylandOhioOhioTexasTexasNorth CarolinaNorth Carolina

National EvidenceNational Evidence--Based Practices Based Practices Project: PhasesProject: Phases

Identification/selection of EBPIdentification/selection of EBP’’s (~ s (~ ‘‘98) for 98) for adults with SMIadults with SMI

6 practices selected6 practices selected

Development of initial training and evaluation Development of initial training and evaluation materials for each practice materials for each practice –– resource kits resource kits v.1.0 (v.1.0 (‘‘98 98 –– 9999’’))

Including methods to evaluate fidelity Including methods to evaluate fidelity

Piloting of EBP resource kits in multiple Piloting of EBP resource kits in multiple states with fidelity and outcome evaluation states with fidelity and outcome evaluation ((‘‘99 99 –– 0202’’))

Full development of Full development of ““implementation implementation resource kitsresource kits”” ((‘‘01 01 –– 0202’’))

National EBP Project:National EBP Project:6 Selected Practices6 Selected Practices

Assertive Community TreatmentAssertive Community Treatment

CoCo--occurring Disorders: Integrated occurring Disorders: Integrated TreatmentTreatment

Family PsychoFamily Psycho--educationeducation

Illness Management and Recovery Illness Management and Recovery

Medication Management Approaches in Medication Management Approaches in PsychiatryPsychiatry (MedMAP) (MedMAP)

Supported EmploymentSupported Employment

2001 2001 –– year long seriesyear long series

Presented rationale for emphasis on EBPPresented rationale for emphasis on EBP’’ss

Formal literature reviews on evidenceFormal literature reviews on evidence--based based practices in mental healthpractices in mental health

Introduced Introduced ““National EBP projectNational EBP project””6 6 ““blessedblessed”” practicespractices

National EBP project: Phases (2)National EBP project: Phases (2)

Demonstrate that resource kits can be used to Demonstrate that resource kits can be used to facilitate the faithful implementation of EBPfacilitate the faithful implementation of EBP’’s s in routine mental health settings and that this in routine mental health settings and that this results in improved client outcomes (results in improved client outcomes (‘‘0303-- ‘‘06)06)

Additional 7 state effectiveness studyAdditional 7 state effectiveness study

Broad dissemination of resource kitsBroad dissemination of resource kits

Dangers of EBPDangers of EBP’’ss

Dogma Dogma –– top down approachtop down approach

““CookbookCookbook”” approachapproach

OverOver--reliance on diagnostic reliance on diagnostic categoriescategories

Loss of individualityLoss of individualityProviderProviderClientClient

EvidenceEvidence--Based PracticeBased Practicess vs. vs. EvidenceEvidence--Based PracticeBased Practice

TopTop--down vs. bottom up approach down vs. bottom up approach to EBPto EBP

““BlessedBlessed”” practices vs. a practices vs. a commitment to continually use commitment to continually use outcome data to drive resource outcome data to drive resource allocation, training, etc. allocation, training, etc.

Bottom up approach to evidenceBottom up approach to evidence--based based practicepractice

Identifying desired outcomes and target Identifying desired outcomes and target population for a program or interventionpopulation for a program or intervention

Developing and implementing processes to Developing and implementing processes to assess and track those outcomes in a valid assess and track those outcomes in a valid mannermanner

Developing and implementing feedback Developing and implementing feedback processes in which outcome evaluation can processes in which outcome evaluation can and do impact programs/interventions and do impact programs/interventions (meaningful QA)(meaningful QA)

Can be organizational (e.g., CMHCCan be organizational (e.g., CMHC--wide) or wide) or specific to a programspecific to a program

Is there a problem with psychiatric Is there a problem with psychiatric prescribing patterns?prescribing patterns?

Inconsistent prescribing across providers Inconsistent prescribing across providers

Polypharmacy is rampantPolypharmacy is rampant

Costs are going through the roofCosts are going through the roof

New drugs are widely usedNew drugs are widely used

Huge influence of advertising/detailingHuge influence of advertising/detailingConsumerConsumer

ClinicianClinician

Opinion LeadersOpinion Leaders

Current Practice:Current Practice:Everyone Everyone ““Just Doing Their BestJust Doing Their Best””

One Goal of EvidenceOne Goal of Evidence--based Approach: based Approach: Aligning the ArrowsAligning the Arrows

Medication Management Approaches Medication Management Approaches in Psychiatryin Psychiatry (MedMAP) (MedMAP)

What is the goal of MedMAP in the What is the goal of MedMAP in the treatment of schizophrenia? treatment of schizophrenia?

To improve outcomes through the To improve outcomes through the optimal use of medications through optimal use of medications through implementation of the following implementation of the following principles: principles:

Utilization of a systematic approach to medication Utilization of a systematic approach to medication management management

Objective assessment of the symptoms that the Objective assessment of the symptoms that the medications are supposed to affect medications are supposed to affect

Clear, concise documentation of the treatments and Clear, concise documentation of the treatments and their outcomes their outcomes

Efforts to enhance medication adherence through Efforts to enhance medication adherence through consumer education and involvement in medication consumer education and involvement in medication decisions. decisions.

What are the core components of What are the core components of MedMAP?MedMAP?

A systematic approach to medication A systematic approach to medication managementmanagement

Guidelines and algorithmsGuidelines and algorithms

Standardized documentation Standardized documentation Identified target symptoms and quality of life goalsIdentified target symptoms and quality of life goals

Outcomes trackedOutcomes trackedSymptoms and quality of lifeSymptoms and quality of life

Consumer involvement / educationConsumer involvement / educationDecision making and symptom/outcome monitoringDecision making and symptom/outcome monitoring

DefinitionsDefinitions

GuidelinesGuidelines——Options with levels of evidence and Options with levels of evidence and principles of treatment. Suggests tactics, yet principles of treatment. Suggests tactics, yet user develops sequencesuser develops sequences

AlgorithmsAlgorithms——Specifies sequences (stages) with Specifies sequences (stages) with specific options and tactics. specific options and tactics. StepStep--byby--step flow step flow charts of best practices in medication use.charts of best practices in medication use.Recommends key decision points Recommends key decision points

““Algorithm: A step by step procedure for solving a problem Algorithm: A step by step procedure for solving a problem or accomplishing some end.or accomplishing some end.”” –– WebsterWebster’’s Dictionarys Dictionary

Guideline/Algorithm Citations for Guideline/Algorithm Citations for Treatment of SchizophreniaTreatment of Schizophrenia

Expert Consensus GuidelinesExpert Consensus GuidelinesJ. Clinical Psychiatry J. Clinical Psychiatry 6060 (Supplement 11), 1999(Supplement 11), 1999

Texas Medication Algorithm Project (TMAP)Texas Medication Algorithm Project (TMAP)J. Clinical Psychiatry, J. Clinical Psychiatry, 6565 (4); 500(4); 500--508, 2004 508, 2004

American Psychiatric AssociationAmerican Psychiatric AssociationAmerican J. Psychiatry American J. Psychiatry 161161 (Supplement), 2004(Supplement), 2004

Patient Outcomes Research Team (PORT)Patient Outcomes Research Team (PORT)Schizophrenia Bulletin Schizophrenia Bulletin 3030 (2), 193(2), 193--217, 2004217, 2004

ClarificationClarification

Guidelines and algorithms are available for Guidelines and algorithms are available for many disordersmany disorders

Tend to be diagnostically drivenTend to be diagnostically driven

““MedMapMedMap”” as currently configured is limited as currently configured is limited to Rx of Schizophreniato Rx of Schizophrenia

Principles and processes are applicable Principles and processes are applicable across conditionsacross conditions

Algorithm/Guideline DevelopmentAlgorithm/Guideline Development

Sponsoring Group/ProjectSponsoring Group/Project Abv.Abv. YearYearPatient Outcome Research TeamPatient Outcome Research Team PORTPORT ‘‘94, 94, ‘‘0404

TMAPTMAP

ExpertExpert

APAAPAVAVA

CPACPACanadian Psychiatric AssociationCanadian Psychiatric Association ‘‘9898

Texas Medication Algorithm Texas Medication Algorithm ProjectProject

‘‘96, 96, ‘‘99, 99, ‘‘0404

Expert Consensus Guidelines for Expert Consensus Guidelines for the Treatment of Schizophreniathe Treatment of Schizophrenia

‘‘96, 96, ‘‘9999

American Psychiatric Association American Psychiatric Association ‘‘97, 97, ‘‘0404Department of Veterans AffairsDepartment of Veterans Affairs ‘‘9797

Parameters of Antipsychotic Parameters of Antipsychotic Management in Selected GuidelinesManagement in Selected Guidelines

ParameterParameter ExpertExpert19991999

TMAP TMAP 20042004

APA APA 20042004

PORT PORT 20042004

Choice of Choice of drug drug

XX XX XX XX

Effective Effective dose rangedose range

XX XX XX XX

Duration Duration XX XX XX XXSide Effect Side Effect ManagementManagement

XX XX XX XX

Levels, Levels, SwitchingSwitching

XX XX XX XX

Choosing and Antipsychotic by Choosing and Antipsychotic by Sequence and StageSequence and Stage

First episodeFirst episode

First failureFirst failure

Number of failures before clozapineNumber of failures before clozapine

Clozapine failureClozapine failure

Clozapine augmentationClozapine augmentation

Combination antipsychoticsCombination antipsychotics

Example of Algorithm from

Texas Medication Algorithm Project

(TMAP)

Expert TMAPExpert TMAP VAVA APA CPAAPA CPA19961996 1996 19971996 1997 1997 19981997 1998

First episode First episode A,TA,T A,TA,T A,TA,T A,TA,T A A

Second choice Second choice A,TA,T A,TA,T A,TA,T A,T,C A,TA,T,C A,T

Third choice Third choice CC AA CC C CC C

Fourth choice Fourth choice –– CC –– –– ––

Fifth choice Fifth choice –– –– –– –– ––

Combinations Combinations –– –– –– –– ––

Key: A=Atypicals T=Typicals C=Clozapine C+=Clozapine Augmentation CF=Clozapine Failure

Schizophrenia Guideline/Algorithm Schizophrenia Guideline/Algorithm Recommendations: 1Recommendations: 1stst WaveWave

SchizophreniaSchizophrenia Guideline/Algorithm Guideline/Algorithm Recommendations: 2Recommendations: 2ndnd WaveWave

Expert TMAP TMAP APA PORTExpert TMAP TMAP APA PORT

1999 1999 2004 2004 20041999 1999 2004 2004 2004

First episode First episode AA AA A A A,TA A A,T

Second choiceSecond choice AA AA A A,T, C A,TA A,T, C A,T

Third choiceThird choice CC A C(A,T) C C A C(A,T) C C

Fourth choiceFourth choice C+ CC+ C C+ C+ C+ C+ ––

Fifth choiceFifth choice –– C+C+ A,T A,T –– ––

CombinationsCombinations –– CFCF CF CF –– ––

Key: A=Atypicals T=Typicals C=Clozapine C+=Clozapine Augmentation CF=Clozapine Failure

The Evidence PyramidThe Evidence Pyramid

Strength of Efficacy Evidence at Different StagesStage of Stage of IllnessIllness Strong EvidenceStrong Evidence Moderate Moderate

EvidenceEvidence Weak EvidenceWeak Evidence

First EpisodeFirst Episode Treat with Treat with antipsychoticantipsychotic

Use newer Use newer (atypical) (atypical)

antipsychoticantipsychotic

Choice of specific Choice of specific antipsychoticantipsychotic

Failure of first Failure of first antipsychoticantipsychotic

Use another Use another antipsychotic antipsychotic

(other than (other than clozapine)clozapine)

Choice of specific Choice of specific antipsychoticantipsychotic

Failure of Failure of second second

antipsychoticantipsychoticUse clozapineUse clozapine

Use another Use another antipsychotic (other antipsychotic (other

than clozapine)than clozapine)

Failure of third Failure of third antipsychoticantipsychotic Use clozapineUse clozapine

Failure of Failure of clozapineclozapine

Augment Augment clozapineclozapine

Failure of Failure of clozapine clozapine

augmentationaugmentation

Use another Use another antipsychotic or antipsychotic or combination of combination of antipsychoticsantipsychotics

% of Iowa Medicaid clients on % of Iowa Medicaid clients on antipsychoticsantipsychoticsreceiving 2 or more receiving 2 or more atypicalsatypicals

1818--64 yo, eligible August64 yo, eligible August--MayMay

00.5

11.5

22.5

33.5

4

95 96 97 98 99 '00

%

≥ 2 Atypical AP's

Daily Reimbursed Cost of Atypical APDaily Reimbursed Cost of Atypical AP’’ssFY 2000FY 2000

$16.55

$7.82

$14.15

$9.87

$0.00

$5.00

$10.00

$15.00

$20.00

$25.00

$

clozapine risperidone olanzapine quetiapine

*Mean ± SD

Daily Cost of Antipsychotics: Mono Daily Cost of Antipsychotics: Mono vs. vs. PolytherapyPolytherapy, FY 2000, FY 2000

$10.88

$17.57

$26.32

$0.00

$5.00

$10.00

$15.00

$20.00

$25.00

$30.00

$35.00

$40.00

$

AP monotherapy any AP polytherapy atypical polytherapy

*Mean ± SD

Clinical Reasons for Clinical Reasons for Algorithms/GuidelinesAlgorithms/Guidelines

Improve quality of careImprove quality of care

Facilitate clinical decisionFacilitate clinical decision--makingmaking

Make treatment plans consistent Make treatment plans consistent across sites and physiciansacross sites and physicians

Decrease influence of advertising, Decrease influence of advertising, commercial detailing, samples etc. commercial detailing, samples etc.

Administrative Reasons for Administrative Reasons for Algorithms/GuidelinesAlgorithms/Guidelines

Consistent documentation and outcomes Consistent documentation and outcomes across sites and providersacross sites and providers

Improve quality monitoringImprove quality monitoring

Provide a rational process for introducing Provide a rational process for introducing new treatmentsnew treatments

Improve cost efficiency Improve cost efficiency Define costs related to specific treatments or Define costs related to specific treatments or outcomesoutcomes

Make costs more predictableMake costs more predictable

What Do We Know About Clinical What Do We Know About Clinical Adherence to Guidelines?Adherence to Guidelines?

CME is ineffective*CME is ineffective*CME plus academic detailing is helpfulCME plus academic detailing is helpfulPrompts are more effective than audit/Prompts are more effective than audit/feedbackfeedbackCME plus audit/feedback is helpfulCME plus audit/feedback is helpfulPatients influence providersPatients influence providersChart reviews reveal low likelihood Chart reviews reveal low likelihood (<50%) of interpretable information by (<50%) of interpretable information by which to gauge adherencewhich to gauge adherence

*Davis DA, et al. JAMA 1995;274:700-705.

Components of MedMAP Resource KitComponents of MedMAP Resource Kit

Information for StakeholdersInformation for Stakeholders

Implementation Tips for Mental Health Implementation Tips for Mental Health Program LeadersProgram Leaders

Implementation Tips for Public Mental Health Implementation Tips for Public Mental Health AuthoritiesAuthorities

Fidelity ScaleFidelity Scale

Monitoring Client OutcomesMonitoring Client Outcomes

Manual for Practitioners and Provider Manual for Practitioners and Provider OrganizationsOrganizations

MedMap ElementsMedMap Elements

Guideline for medication treatments, with Guideline for medication treatments, with strategy and tacticsstrategy and tactics

Systematic documentation of medicationSystematic documentation of medication--related informationrelated information

Measurement of outcomesMeasurement of outcomes

PatientPatient--oriented approach to adherenceoriented approach to adherence

Example of Documentation:Outpatient Clinic Visit from TIMA

Documentation and Outcomes: Documentation and Outcomes: Use of clinical rating scalesUse of clinical rating scales

Specific algorithm clinical rating scalesSpecific algorithm clinical rating scales

General symptom Likert scalesGeneral symptom Likert scales

Patient rated scalesPatient rated scales

Clinician defined Likert scalesClinician defined Likert scales

Clinical global scalesClinical global scales

The patient’s progress as shown in symptoms and side effects are measured with the use of clinical rating scales in accordance with TIMA guidelines. Use of scales includes the following sub-elements that apply to primary and secondary diagnoses:

OUTCOMES ASSESSMENTSOUTCOMES ASSESSMENTS

Outcome Outcome ParameterParameter

Expert Expert 19991999

TMAP TMAP 20042004

APA APA 20042004

PORT PORT 20042004

Symptom Symptom DomainDomain

PositivePositive

NegativeNegative

PositivePositive

NegativeNegative

PositivePositive PositivePositive

Specific Specific MeasuresMeasures

NoNo YesYes NoNo NoNo

Failure CriteriaFailure Criteria NoNo YesYes NoNo NoNo

Documentation Documentation FormsForms

NoNo YesYes NoNo NoNo

Outcome Measures Used Across SitesOutcome Measures Used Across Sites* TMAP TIMA UHS NMPI OMAP DMHT

AIMS Abnormal Involuntary Movement Scale X X X

SAS Simpson Angus Scale X

GAF Global Assessment of Functioning Scale X

MSE Mental Status Exam X X

POS Positive Symptoms X X X

NEG Negative Symptoms X X X

PANSS Positive and Negative Syndrome Scale X

BNS Brief Negative Scale X

IDS-SR Inventory of Depressive Symptomatology self report

X X

IDS-C Inventory of Depressive Symptomatology clinician administered

X

BPRS Brief Psychiatric Rating Scale X X

ALTMAN X X

CGI Clinical Global Impression X

Example of items on client quality of life self reportExample of items on client quality of life self report(Circle one choice for each

statement)Overall, how would you rate …0 1 2 3

The place where you live (your housing). Poor Fair Good Excellent Yes No

The amount of money you have to buy what you need. Poor Fair Good Excellent Yes No

Your involvement in work, employment. Poor Fair Good Excellent Yes No

Your level of education. Poor Fair Good Excellent Yes No

Your access to transportation to get around. Poor Fair Good Excellent Yes No

Your participation in community activities (leisure, sports, spiritual, volunteer work).

Poor Fair Good Excellent Yes No

Your ability to have fun and relax. Poor Fair Good Excellent Yes No

Your physical health. Poor Fair Good Excellent Yes No

Your level of independence. Poor Fair Good Excellent Yes No

Your ability to take care of yourself (staying healthy, eating right, avoiding danger). ETC, ETC

Poor Fair Good Excellent Yes No

Should this be on your service plan?

Patient/Family EducationPatient/Family Education

Education PromotesEducation PromotesTreatment AdherenceTreatment Adherence

Partnership/Therapeutic AlliancePartnership/Therapeutic Alliance

Better Clinical DecisionsBetter Clinical Decisions

Better SelfBetter Self--carecare

Better symptom and relapse recognitionBetter symptom and relapse recognition

Better OutcomesBetter Outcomes

The Evidence Based CycleThe Evidence Based Cycle

Quantify Priority

OutcomesRegularly

Modify Core

Comp-onents of Practice

Review OutcomesRegularly

Specify Core Components of Practice

Optimize Priority

Outcomes

““FidelityFidelity””

The degree to which the actual The degree to which the actual implementation of a practice is consistent implementation of a practice is consistent with the intent of the modelwith the intent of the model

Must guard against Must guard against ““changing the sign on the changing the sign on the doordoor””

Research on Assertive Community Treatment Research on Assertive Community Treatment (ACT) shows that degree of fidelity to the (ACT) shows that degree of fidelity to the original model is correlated with outcomesoriginal model is correlated with outcomes

Much effort now in developing, evaluating and Much effort now in developing, evaluating and implementing methods to assess fidelityimplementing methods to assess fidelity

Fidelity Evaluation: Fidelity Evaluation: MedMAP Fidelity ScaleMedMAP Fidelity Scale

2 overall levels of assessment2 overall levels of assessment

Prescriber Level of AssessmentPrescriber Level of Assessment

Organizational Level of AssessmentOrganizational Level of Assessment

Prescriber ScalePrescriber Scale

16 items, scored 116 items, scored 1--55

1 = poor, 3 = satisfactory, 5 = excellent1 = poor, 3 = satisfactory, 5 = excellent

Covers multiple aspects of medication Covers multiple aspects of medication management and coordination with other management and coordination with other providers and aspects of treatmentproviders and aspects of treatment

Domains of Prescriber ScaleDomains of Prescriber Scale

Adequate information about diagnosis and treatment?Adequate information about diagnosis and treatment?

Measurement and use of outcomes?Measurement and use of outcomes?

Reduce medication burden and side effects?Reduce medication burden and side effects?

Dosing, monitoring okay?Dosing, monitoring okay?

Failures identified?Failures identified?

Patient and family involved in decisions, adherence Patient and family involved in decisions, adherence strategies?strategies?

Coordination with treatment team?Coordination with treatment team?

Organization ScaleOrganization Scale

13 items, scored 113 items, scored 1--55

1 = poor, 3 = satisfactory, 5 = excellent1 = poor, 3 = satisfactory, 5 = excellent

Rates organization on administrative support Rates organization on administrative support for prescribers, provision of materials to for prescribers, provision of materials to patients and prescribers, monitoring of patients and prescribers, monitoring of prescribersprescribers

Domains of Organization ScaleDomains of Organization Scale

Useful standardized Useful standardized forms?forms?

Rapid and reliable Rapid and reliable information access?information access?

Medications readily Medications readily available?available?

Failures identified?Failures identified?

Quality control?Quality control?

Materials for patient Materials for patient education?education?

Materials for Materials for guideline guideline implementation?implementation?

Scheduling Scheduling flexibility?flexibility?

Integration of Integration of servicesservices

Staff training?Staff training?

Use of Fidelity Scale in MedMAPUse of Fidelity Scale in MedMAPBaseline measurements of prescribers, Baseline measurements of prescribers, organizationorganization

Analyze results, identify strengths and Analyze results, identify strengths and weaknessesweaknesses

Design and implement changesDesign and implement changes

ReRe--do fidelity scale assessmentsdo fidelity scale assessments

Analyze results, identify effects of changesAnalyze results, identify effects of changes

ReRe--design implementation strategiesdesign implementation strategies

Limitations of Algorithms/GuidelinesLimitations of Algorithms/Guidelines

Tend to be diagnostically drivenTend to be diagnostically drivenDx categories likely to be heterogeneous Dx categories likely to be heterogeneous with respect to pathophysiology and with respect to pathophysiology and treatment responsetreatment responseMust adapt to individual patientMust adapt to individual patient

Evolve with new treatmentsEvolve with new treatmentsEfficacy versus effectivenessEfficacy versus effectivenessScience versus clinical wisdomScience versus clinical wisdom

Resistance to the overall approachResistance to the overall approach

““Cookbook medicineCookbook medicine””

Unique or different Unique or different –– ““more ill, rural, more ill, rural, urban, real world vs University, etcurban, real world vs University, etc””

Information collected (rating scales) Information collected (rating scales) not clinically usefulnot clinically useful

Data is collected for research purposesData is collected for research purposes

Based on University research and has Based on University research and has no relevance to the real worldno relevance to the real world

Resistance (cont.)Resistance (cont.)

Takes more timeTakes more time

Adds more paperworkAdds more paperwork

Costs more moneyCosts more money

Old way is better Old way is better –– ““if it ainif it ain’’t broke, t broke, dondon’’t fix itt fix it””

No one else is doing itNo one else is doing it

““Fad that will go away eventuallyFad that will go away eventually””

Leading the Implementation Leading the Implementation

MedMAP is more likely to be MedMAP is more likely to be successfully implemented if a clearly successfully implemented if a clearly identified person is responsible for identified person is responsible for leading the initiative. leading the initiative.

The identified person is most likely to succeed if he The identified person is most likely to succeed if he or she is a senior administrator or clinician or has or she is a senior administrator or clinician or has the backing of executive level staff and decisionthe backing of executive level staff and decision--making authority. making authority.

Clearly, the likelihood of success is greatly Clearly, the likelihood of success is greatly enhanced if this person has the respect of the onenhanced if this person has the respect of the on--line staff and fully understands the operation of the line staff and fully understands the operation of the facility/agency. facility/agency.

Readiness for EBPReadiness for EBP’’s?s?

ResearchResearchClinicalClinicalServicesServices

Administrative Administrative Data Data infrastructureinfrastructureFinancingFinancingCredentialingCredentialing

ClinicalClinical

EducationalEducationalCMECME’’ss

TraineesTrainees

Selected Guideline/Algorithm WebsitesSelected Guideline/Algorithm Websites

MEDMAPMEDMAP--CMHSCMHS http://www.mentalhealth.samhsa.gov/cmhttp://www.mentalhealth.samhsa.gov/cmhs/communitysupport/toolkits/medicatiohs/communitysupport/toolkits/medication/default.aspn/default.asp

APA GuidelinesAPA Guidelines http://http://www.psych.org/psych_pract/treatg/www.psych.org/psych_pract/treatg/pg/prac_guide.cfmpg/prac_guide.cfm

1999 Expert Consensus 1999 Expert Consensus Guidelines SeriesGuidelines Series

http://www.psychguides.com/glhttp://www.psychguides.com/gl--treatment_of_schizophrenia_1999.htmltreatment_of_schizophrenia_1999.html

Texas Medication Texas Medication Algorithm ProjectAlgorithm Project

http://www.mhmr.state.tx.us/centralofficehttp://www.mhmr.state.tx.us/centraloffice/medicaldirector/TMAP.html/medicaldirector/TMAP.html

Texas Implementation of Texas Implementation of Medication Medication AglortihmsAglortihms

http://http://www.dshs.state.tx.us/mhprowww.dshs.state.tx.us/mhprograms/TIMA.shtmgrams/TIMA.shtm

Department of Veterans Department of Veterans Affairs Affairs

http://http://www.oqp.med.va.gov/cpg/psy/psy_www.oqp.med.va.gov/cpg/psy/psy_base.htmbase.htm

My My Contact InfoContact Info

ee--mail: mail: michaelmichael--flaum@uiowa.eduflaum@uiowa.edu

Phone: 319Phone: 319--353353--4340 4340

Web site: Web site: www.icmentalhealth.orgwww.icmentalhealth.org