MIAMI Project: MIAMI Project:

MIRECC Initiative on Antipsych

M tI t anagemen

t

Improvemen

t

Noosha Niv, Ph.D.

(310) 528-7554

noosha.niv@va.gov
MIAMI Journey MIAMI Journey

3⁄4 1998-2000

3⁄4 Increased recognition of the metabolic effects of 

Increased recognition of the metabolic effects of generation antipsychotic medications

3⁄4 2003

3⁄4 VA/DOD Clinical Practice Guideline for the Mana

VA/DOD Clinical Practice Guideline for the Mana

Diabetes Mellitus in Primary Care

3⁄4 2004

3⁄4 C id li f h i l h lth it 

Consensus guid

elines 

for p

hysical health monitor

patients with schizophrenia (Am J Psych, 2004)

3⁄4 ADA consensus conference on antipsychotic drug

ob it d di b t (Di b t C 2004) besity an

d di

a

b

e

tes (Di

a

b

e

tes 

Care, 2004)

3⁄4 Updated VA/DOD Clinical Practice Guidelines for 

Management of Psychosis
MIAMI Journey MIAMI Journey

3⁄4 2003-2008

3⁄4 Emerging evidence that despite the various guide

Emerging evidence that despite the various guide

rates of metabolic monitoring were fairly low

3⁄4 2007 - VA OIG Report: Healthcare Inspection: Atypic

Antipsychotic Medications and Diabetes Screening aAntipsychotic Medications and Diabetes Screening a

Management. Recommendations included:

3⁄4 Implement and document weight reduction strate

3⁄4 I dd i fi 

Improve treatment an

d

documentation o

f interven

elevated fasting blood glucose levels

3⁄4 Implement interventions to maintain blood pressu

th 140/90 f ti t ith t di b t than 140/90

for younger patien

ts withou

t di

a

b

e

tes 

prescribed atypical antipsychotic medications

3⁄4 Achieve target blood glucose levels for younger p

with di b t h ib d t i l ti 

ith di

a

b

e

tes w

ho are prescrib

e

d a

typical antipsy

medication
MIAMI Journe

y

3⁄42008 - VA Office of Mental Health Services: Rep

Workgroup on Atypical Antipsychotic MedicationWorkgroup on Atypical Antipsychotic Medication

Diabetes Screening and Management.

3⁄4Assure access by primary care and mental he

clinicians to guidance documents

3⁄4Ensure mental health clinics are able to follow 

recommendations for monitoring of metabolic recommendations for monitoring of metabolic 

factors

3⁄4Improve coordination of care between primary 

and mental health for patients treated with antipsychotic medication

3⁄4Improve referral of patients with identified met

Improve referral of patients with identified met

risk factors to MOVE! or other wellness progra
MIAMI Journey MIAMI Journey

3⁄4 2009 - MIAMI Project is funded: VA Office of Mental 

Se ces t at e rvices Ini

tiativ

e

3⁄4 2-year national program designed to implement 

recommendations from the Atypical Antipsychotics W

3⁄4 Administered by the VISN 22 and 16 MIRECCs in co

Administered by the VISN 22 and 16 MIRECCs in co

with Mental Health QUERI

3⁄4 Project Goals: improve monitoring for and managem

physical health problems among veterans taking atyphysical health problems among veterans taking aty

antipsychotic medications

3⁄4 Improve adherence to guidelines around metabolic mo

for anti

p ys

ychotic medication 

3⁄4 Decrease the number of veterans who are prescribed 

antipsychotic medications who are obese

3⁄4 Increase the use of wei

g g ht interventions amon

g vetera

are prescribed antipsychotic medications and are obes
MIAMI Activities MIAMI Activities

3⁄4Develop and disseminate effective tools 

Develop and disseminate effective tools 

implementing antipsychotic monitoring p

3⁄4Educate champions who will go back to t

Educate champions who will go back to t

facilities/VISNs and educate others

3⁄4Assist with implementation of metabolic Assist with implementation of metabolic

monitoring/management at VA clinics

3⁄4Utilize VHS DSS and VA Cor

porate Data 

Warehouse to evaluate change in monitoVA
MIAMI Resources:

Practice Guidelines an

Wellness Resources Wellness Resources

3⁄4 vaww.mirecc.va.gov/miamiproject/

3⁄4Includes background information regarding M

3⁄4 vaww.mirecc.va.gov/miamiproject/guidelines.as

3⁄4Clinical practice guidelines for obesity diabet

Clinical practice guidelines for obesity, diabet

hypertension, dyslipidemia, and atypical antip

3⁄4 vaww.mirecc.va.gov/miamiproject/resources.asp

3⁄4EQUIP Wellness Manual3⁄4Food and Physical Activity Diary3⁄4BMI Chart BMI Chart
MIAMI Resources: 

Educational Tools

3⁄4 vaww.mirecc.va.gov/miamiproject/educat

3⁄4 Metabolic Monitoring and Management for Pa

Taking Antipsychotic Medications: Guidance Taking Antipsychotic Medications: Guidance 

Primary Care Providers

3⁄4A poster including essential information rega

metabolic monitoring and management

3⁄4Educational slides to help promote awarenes

problem and educate other clinicians problem and educate other clinicians

3⁄4Downloadable powerpoint presentations from 

MIAMI Conference
MIAMI Resources:

Technical Assistance Ce

(TAC)

3⁄4 vaww.mi / recc.va.gov/

mi i jt am pro

jec

t/t h i 

/tec

h

nica

ance_center.asp

3⁄4 Goal of center is to support sites implemen

Goal of center is to support sites implemen

routine monitoring

3⁄4 Located in Little Rock at CeMHOR

3⁄4 Monday thru Friday3⁄48:00-4:303⁄4Phone: 

1

-888

-

357-19 87

8

3⁄4Email: vhalitmiamiproject@va.gov
TAC Services TAC Services

3⁄4 Clinical consultations

3⁄4 Metabolic Effects of Antipsychotic Medication3⁄4Current Monitoring and Management Guideli

3⁄4

Advice about implementation strategies

3⁄4General – how to get started, who to involve3⁄4Specific

– how to manage a particular challen

how to manage

a particular challen

specific site

3⁄4

Advice re: wellness resources for individuals wit

3⁄4Accessing programs3⁄4How they fit with monitoring/management pro3⁄4How to engage veterans in these programs
TAC Services TAC Services

3⁄4Central repository for implementation t

Central repository for implementation t

3⁄4Sites can send tools to TAC to share 

other sites other sites

3⁄4Distribution of “hardcopy” tools

3⁄4“C t ” b t it d b t 

“Connec

tor

”

b

e

tween sites an

d

b

e

twee

and experts
Improving the Health of Veteran

Prescribed Antipsychotic Medications:Recommendations for Monitoriand Mana

gement 

Alexander S. Young, M.D., M.S.H.S.VA VISN-22 MIRECCUCLA Department of PsychiatryJune, 2010
Overview

• Metabolic risk• Monitoring & Management

– how we’re doing– guidelines– practical strategies
CATIE Results: 

Weight Gain Per Month of Treatm

2

er month

1

gain (lb) p

0

Weight 

-1

olanzapine quetiapine quetiapine risperidone perphenizine risperidone perphenizine z

z
CATIE Results: 

Metabolic Changes From Baselin

14

Glucose (mg/dL)

13.7

1012

Glucose (mg/dL)Glycosylated Hg (% Hg

8

5 4

6.6

7.5

46

5.4

02 

0.04 0.07 0.0

0.4

olanzapine quetiapine quetiapine risperidone perphenizine risperidone perphenizine 
Treatment of Early Treatment of Early-Onset Schizophren

Onset Schizophren

Spectrum Disorders (TEOSS)

• 8-19 year old patients this schizophreni

• randomly assigned to molindone 10-140 

olanzapine 2.5-20 mg, or risperidone 0.5

• 8 weeks• Primary outcome was responder status

– much or very much improved on CGI; ≥20

reduction in total PANSS; and tolerating tr

Sikich et al, Am J Psych
TEOSS: PANSS Score Change
TEOSS: BMI Percentile Change for 

Patient
Monitoring in the U S Monitoring in the U

.

S

.

• Hi

ghl

y variable

• In most public mental health settings, medica

and mental health are separate

• In settings like VA, patients have full access t

primary care, but monitorin

g is still a problem

• Monitoring during 1st month

– Medicaid 2005 (Morrato et al, Arch Gen Psychiatr– glucose: antipsychotic = 28% vs. albuterol = 31%– lipid panel: antips

ychotic = 12% vs. albuterol = 
Glucose & Lipid Testing at Baseline an

weeks (2004)

Haupt et al, Am J Ps

Physical Health Monitoring

• Where should it occur?• Who should monitor?• What should be monitored and how ofte
Where Should It Occur?

• Patients may see a mental health clinici

more often than a primary care clinician

• Primary care clinicians may not be awar

the risks associated with psychiatric illn

• Patients may have limited access to prim

care clinicians

• Psychiatric settings may lack tools for 

monitoring – including scales and press

cuffs
Who Should Monitor?

• Ps

ychiatrists ma

y be reluctant to monit

medical problems when they are 

uncomfortable intervenin

g

• Psychiatrists and other medical special

tend to do poorly in routine monitoring

• Many public and private settings have n

infrastructure for monitoring 
ADA Consensus on Antipsychotic Dru

Obesity and Diabetes: Monitoring Pro

Start 4 wks 8 wks 12 wks 6 mos 

Weight (BMI) XXX X X 

Waist circumference X Blood 

pressure

X

X

Fasting glucose X XFasting lipid profile

X

X

* More frequent assessments can be warranted based on clinica

Diabetes Care. 27:596-601, 2004
Mount Sinai Consensus Conference on 

Antipsychotic Prescribing (October, 2002)

O i S tt St

•

O

r

ganizers

– Susan Essock– Alexander Miller

–

Scott Stroup

– Catherine Craig– Ellen Weissman

– Steve Marder

• Antipsychotic Experts

Jeffrey Lieberman

– Steven Shon

• Medical Experts

– Jeffrey Lieberman– John Davis– Bob Buchanan

Ni Sh l

Medical Experts

– Len Pogach– Bonnie Davis

Xavier Pi Suney

– Nina

S

c

hooler

– John Kane– Dan Casey

– Xavier Pi-Suney– J. Thomas Bigger– Steve Yevich

D id Kl i b

– Nancy Covell– Donna Wirshing

–

David Kl

ein

ber

g

– Alan Friedman
Weight Monitoring

• Clinics that mana

ge patients with schizophrenia sho

able to weigh patients at every visit 

• Mental health clinicians should monitor BMI of every 

– weigh patients at every visit – calculate BMI

• BMI monitoring may be supplemented by knowledge 

patient’s waist circumference

– intervene if waist circumference is greater than 35” for a wo

40” f 40” for

a man

• Clinicians should encourage patients to monitor thei

weight 
Weight Monitoring

• P ti t h ld b i h d t i it f th fi t 

P

atien

t

s

s

hould b

e weigh

ed 

at every 

visit for th

e first 

months following a medication change 

• The relative risk of weight gain among antipsychotics 

b id ti i d l ti f ti t h b

e

a consideration i

n drug selection for patien

t

s

w

h

o 

BMI greater than 25

• Unless a patient is underweight (BMI<18.5), a weight g

1 BMI it i di t d f i t ti 1 BMI unit i

ndica

tes

a need for an i

n

tervention

• Interventions include closer monitoring of weight, 

engagement in a weight management program, or cha

i ti h ti di ti in antips

y

c

h

oti

c medication

• The clinician should consider switching to medication 

less weight gain liability 
Diabetes Monitoring

• Mental health practitioners should be aw

risk factors for diabetes for all patients 

schizophrenia. 

• A baseline measure of glucose should b

collected for all patients before starting a t psyc ot c ast g g ucose s p e 

n

tipsyc

hotic. A fastin

g

glucose i

s

p

r

e

f

but HbA1C is sufficient if fasting glucosfeas b e i l .
Diabetes Monitoring (cont)

• Ps

ychiatrists should inform patients of the s

y

of diabetes and ask them to contact a medica

cli i i if th li

nician if th

ey occur.

• Mental health clinicians should assure that pa

with diagnosed diabetes are followed by a meclinician who is knowledgeable about diabete

• The psychiatrist and medical clinician should 

communicate when medication changes are ithat ma

y p affect the control of the 

patient’s dia
Lipid Monitoring

• Mental health clinicians should be aware of li

profiles for all patients with schizophrenia 

• Psychiatrists should follow National Choleste

Education Program (NCEP) guidelines to iden

patients at high risk for cardiovascular diseas

– www.nhlbi.nih.gov/about/ncep

• If li id l i t il bl h ld b If a lipid panel is not available, one should be

obtained and reviewed 
Lipid Monitoring (cont)

• Mental health clinicians should assure t

NCEP guidelines are followed for patien

ab l h l t l (t t l LDL HDL) 

bnormal 

c

h

oles

terol (t

o

t

al, LDL, HDL) a

triglyceride levels.

• Wh ti t ith b l l l When patien

t

s

with 

a

bnormal levels are

identified they should be referred to a mclinician or in the absence of such a cliclinician or, in the absence of such a clitreatment may be implemented by the psychiatrist.
Guidelines for Monitoring

Monitoring APA ADA / APA M

Body BMI every visit for 6 BMI at baseline; every BMI at basweight and height

months; quarterl

y

thereafter

4 weeks for the 12 weeks; quarterly thereafter

visit for nequarterly w

Fasting plasma glucose at Fasting plasma Fasting pla

Fasting glucoseor HgA1c

Fasting plasma glucose at baseline. Fasting plasma glucose or HbA1c at 4 months after 

Fasting plasma glucose at baseline, 12 weeks and annually thereafter

Fasting plaor HbA1c initiating aantipsychoth ft or HgA1c initiatin

g new treatment 

and annually thereafter

thereafter

At least every 5 years Baseline; at 12 weeks; 

every 5 years

Every 2 yeoften if lev

Lipid panel normal ran

months if L>130mg/dL

Diabetes Care, Vol 27, No 1, February 2004. Am J Psychiatry. 161:2, February 2004 Supplement.Am J Psychiatry. 2004; 161:1334-1349.Diabetes Care, Vol 27, No 1, February 2004. Am J Psychiatry. 161:2, February 2004 Supplement.Am J Psychiatry. 2004; 161:1334-1349.
Goal: Lower Risk for Cardiovascular D

• Bl d h l t l Blood 

c

h

oles

terol 

– 10% 

↓ = 30% 

↓ in CHD (200-180)

• High blood pressure (> 140 SBP or 90 DBP)

– 4-6 mm Hg 

↓ = 16% 

↓ in CHD & 42% 

↓ in stroke

• Cigarette smoking cessation

– 50%-70% 

↓ in CHD

• Maintenance of ideal body weight (BMI = 25) 

– 35%

-55% 

↓ in CHD

• Maintenance of active lifestyle (20-min walk daily)

– 35%

-55% 

↓ in CHD

Hennekens CH. Circulation. 1998;97:1095-1102.
Management: Lipids

Risk Category * LDL Goal

(mg/dL)

Initiate Lifestyle 

Chan

ges 

(mg/dL)

g

(mg/dL) 

High risk:

CAD or CAD equivalents **

< 100

≥100

CAD or CAD equivalents Moderately high risk: 2+ risk factors

< 130

≥130

Moderate risk: 2+ risk factors

< 130

≥130

L i k Low

risk: 160

≥160

0-1 risk factor

< 160

≥160

*Risk factors: tobacco, HTN, family history, age (> 45 

♂, > 55 

♀ ), HDL (< 40 

♂, < 

**CAD equivalents: diabetes, abdominal aortic aneurysm, peripheral or coronary 

carotid stenosis
Management: Blood Pressure

• BP 120

-139 / 80

-89

– counsel on diet and exercise– re-evaluate medications– recheck at next visit 

• BP > 130/80

– refer to primary care if patient has an

y of these:

• diabetes• chronic kidne

y disease

• cerebrovascular disease• coronary artery disease

• BP > 140 / 90

– refer to primary care
Management: Fasting Glucose

• 110-126 m

g/dl or > 126 with H

gbA1c < 

– counsel on diet/exercise– re-evaluate medications– recheck blood sugar at a reasonable interv

• 126-199 with HgbA1c > 7%

– refer to 

p y rimar care

• > 200 or symptoms of diabetes

– urgent visit at primary care
Management: Weight

• Risk of wei

ght 

gain should be considered in 

medication choice for patients with BMI > 25

• Intervene when

– weight gain of 1 BMI unit, or– BMI > 30

• (1) Provide a weight management program

– group and individual education

• (2) Change patient’s antipsychotic medication 

– consider switching to medication with less weight 

liabilit

y
Body Mass Index
Weight Management Programs Are Eff

• Group and individual ps

ychoeducation

improves weight in people with serious 

mental illness

– numerous controlled research trials

• Weight loss is modest: average 5 lbs• Modest weight loss has been associated 

with health benefits
EQUIP Weight Management Progra

• Patients referred b

y clinician

• Sixteen, 45-minute sessions

• Minimum once-weekly sessions• 8 - 10 

p p pg p artici

pants 

per 

grou

p

• Patients can join program at any point during 

session c

ycle

– should complete all 16 sessions– should repeat program as needed

• To be discussed by Amy Cohen
Changing Medication Can Cause Weig

Loss

• CATIE t d CATIE 

s

t

udy

– 1493 patients, 57 sites– 18 months

• Among patients who gained more than 

Ph 1 th f ll i l t th 7% Phase 1, th

e f

ollowing lost more than 7%

– olanzapine: 0%– quetiapine: 7%

– risperidone: 20%

– ziprasidone: 42%
Changing from Changing from Olanzapine Olanzapine to

Aripiprazole Aripiprazole Causes Wei Causes Weight Loss

• N t l 2008 Newcomer et al 2008• Overweight patients on olanzapine• Switch to aripiprazole vs. remain on olanzapi

– randomized controlled trial, n=173, 16 weeks

• Results

– weight change (pounds): -4.0 vs. +3.1– lost more than 7%: 11% vs. 3%– lipids improved, glucose unchanged– CGI-Improvement: no change - minimal improvem
Metformin Metformin and Lifestyle Intervention fo

and Lifestyle Intervention fo

Antipsychotic Weight Gain

• 128 patients with schizophrenia who gained 10% 

on antipsychotics

• Randomized to placebo life style intervention Randomized to placebo, life style intervention, m

m

(750 mg / day), or metformin plus life style interve

• 12 week weight change: 

– placebo: +4.8%– lifestyle alone: -2.2%– metformin alone: -4 9%.– metformin plus lifestyle: -7.3%

Wu et al, JA
Other Approaches

• Reserve antips

ychotics with metabolic s

effects for illnesses where there is an ad

evidence base

– recent VA stud

y py that 60% of anti

p

s

ychotic 

prescriptions were for off label uses

–

q p uetia

pine

• Be cautious using other medications wi

weight gain liability and limited effective

– valproate
Education

• Clinicians and managers• Patient, family, caregivers

– knowledgeable about medications and th

weight gain diabetes and cardiovascular weight gain, diabetes, and cardiovascular 

• Patients

– chart their own weight– weight and blood pressure can be monitored – pursue recommended diet and exercise
Summary

• I di id l t ki ti h ti di ti Individuals taking antipsychotic medication 

at a high risk for weight gain, metabolic synand cardiovascular disease

• Monitoring

– weight: at every visit & at home– metabolic syndrome: blood pressure, glucose, 

• Interventions

– medication change– weight management groups– referral to primary care