Treatment Resistant Depression Through a Performance Improvement Approach

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(No Transcript)
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Treatment Resistant DepressionThrough a
PerformanceImprovement Approach
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Sponsorship and Support

• Presented by The Johns Hopkins University School
  of Medicine in collaboration with Baylor College
  of Medicine and the Depression and Bipolar
  Support Alliance, and developed through a
  strategic educational facilitation with
  MJConsulting Group.
• Supported by an educational grant from Eli Lilly
  and Company and Bristol-Myers Squibb, Inc.

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Accreditation and Credit Designation

• Accreditation
• The Johns Hopkins University School of Medicine
  is accredited by the Accreditation Council for
  Continuing Medical Education to provide
  continuing medical education for physicians.
• The Johns Hopkins University School of Medicine
  takes responsibility for the content, quality,
  and scientific integrity of this CME activity.
• CME Credit Designation
• The Johns Hopkins University School of Medicine
  designates this educational activity for a
  maximum of 1.0 AMA PRA Category 1 Credit.
  Physicians should only claim credit commensurate
  with the extent of their participation in the
  activity.
• Performance Improvement
• The Johns Hopkins University School of Medicine
  designates this activity for a maximum of 20.0
  AMA PRA Category 1 Credits. Physicians should
  only claim credit commensurate with the extent of
  their participation in the activity.

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Disclaimer

• The opinions and recommendations expressed by
  faculty and other experts whose input is included
  in this program aretheir own.
• This enduring material is produced for
  educational purposes only. Use of the Johns
  Hopkins University School of Medicine, MJ
  Consulting Group, LLC, and PeerPoint, LLC name
  implies review of educational format design and
  approach.
• Please review the complete prescribing
  information for specific drugs or combinations of
  drugs, including indications, contraindications,
  warnings and adverse events before administering
  pharmacologic therapy to patients.

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Faculty

• Course Director
• Glenn J. Treisman, MD, PhD
• Professor of Psychiatry and
• Behavioral Sciences, and of Medicine
• The Johns Hopkins University School of Medicine
• Baltimore, Maryland
• Joyce E. King, MD
• Associate Director, Family Medicine Residency
• Franklin Square Hospital
• Baltimore, Maryland

• Andrew A. Nierenberg, MD
• Professor of Psychiatry, Harvard Medical School
  Director, NIMH Bipolar Trials Network
• Co-Director, Bipolar Clinic and Research Program
  Associate
• Director, Depression Clinical and Research
  Program
• Massachusetts General Hospital
• Boston, Massachusetts

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Financial Disclosures

• Faculty Presenters
• Andrew A. Nierenberg, MD, discloses the
  following
• Forest Pharmaceuticals, Inc., National Institute
  of Mental Health (NIMH), Pam Labs, Pfizer
  Pharmaceuticals, Inc. (grant/research support)
  Appliance Computing, Inc., Astra Zeneca PLC,
  Basilea Pharmaceutica, Ltd., Brain Cells, Inc.,
  Bristol-Myers Squibb, Inc., PGX Health, Eli Lilly
  and Co., Jazz Pharmaceuticals, MGH Psychiatry
  Academy, Merck Co., Inc., NIMH, Novartis
  Pharmaceuticals, Inc., Schering-Plough Corp.,
  Shire Pharmaceuticals Group, Takeda
  Pharmaceutical, Co., Targacept (advisory board,
  consultant, honorarium)
• Dr. Nierenberg has indicated that his
  presentation will not include information on
  off-label products.
• Course Director
• Glenn J. Treisman, MD, PhD, discloses the
  following
• No relevant financial or advisory relationships
  with corporate organizations related to this
  activity.

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Learning Objectives

• Understand appropriate strategies to enhance
  accurate diagnosis of patients with TRD
• Implement appropriate TRD staging methods in the
  context of their impact on patient outcomes
• Select appropriate and effective continuum of
  care strategies for optimal utilization of a
  multidisciplinary approach to TRD

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Major Depressive Disorder (MDD) and Treatment
Resistant Depression
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Major Depressive Disorder (MDD)

• Affects 18 million US residents and 340 million
  worldwide1 (16.2 lifetime risk)2 2/3 are female
• Depression is chronic or recurrent
• 25 to 40 experience a recurrence within 2 years
  of the index episode3
• 85 experience recurrence after 15 years3
• 20 to 35 of patients who experience one episode
  of depression have chronic depression4-6

1. Greden JF. J Clin Psychiatry. 200162(suppl
22)5-9. 2. Kessler RC, et al. JAMA.
20032893095-3105. 3. Keller MB, et al. Biol
Psychiatry. 199844348-360. 4. Keller MB, et al.
Am J Psychiatry. 1982139438-442. 5. Mueller TI,
et al. Psychiatr Clin North Am. 19961985-102.
6. Fava M, et al. for the STARD Investigators
Group. Psychiatr Clin North Am. 200326457-494.
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Gaps in Clinical Care in1-3

• Detection/Diagnosis
• Average delay to detection of depression 8
  years
• 30-40 patients correctly diagnosed with
  depression at presentation
• Treatment
• Correct diagnosis ? effective treatment
• PCPs write 80 all antidepressant prescriptions

1. Docherty JP. J Clin Psychiatry. 1997585-10.
2. Hirschfeld RM, et al. JAMA. 1997277333-340.
3. Pirraglia PA, et al. J Eval Clin Pract.
200713473-475.
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Major DepressionOutcomes and the Frequency of TRD

• If Bipolar Disorder has been ruled out, over 20
  of patients with MDD may have TRD

TRD, treatment resistant depression. MDD, major
depressive disorder.


1. Depression in Primary Care, Vol 2.
Treatment of Major Depression. Rockville, Md
Agency for Healthcare Policy and Research, US
Department of Health and Human Services 1993.
AHCPR Publication 93-0551. 2. Fava M, et al. for
the STARD Investigators Group. Psychiatr Clin
North Am. 200326457-494.3. Poirier MF, Boyer
P.. B r J Psychiatry 1999175126.
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Identifying Treatment Resistant Depression and
When to Refer
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Potential Causes of TRD

• Misdiagnosis
• Inadequate treatment, undertreatment, or starting
  treatment too late1
• Failure to achieve initial remission2
• Nonadherence
• Failure to address concurrent disorders1
• Occult substance abuse
• Occult general medical conditions (GMCs)
• Concurrent Axis I or II disorders

1. Thase ME, et al. J Clin Psychiatry.
199758(suppl 13)23-29. 2. Judd LL, et al. J
Affect Disord.19985097-108.
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TRD Mortality

• TRD is associated with
• Increased mortality
• High risk of suicide (15 of patients with TRD)1
• Patients with well-characterized TRD are likely
  to report hopelessness and prominent suicidal
  ideation
• One third of patients studied reported
  significant suicidal ideas or gestures2
• Suicidal thoughts have a negative impact on the
  courseof depression

1. American Pharmacists Association
http//www.pharmacist.com/ . Accessed March 23,
2009. 2. Papakostas GI, et al. J Nerv Ment Dis.
2003191444.
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TRD Morbidity

• TRD is associated with
• Increased economic burden
• Greater healthcare utilization and costs1-3
• Patients with depression made more than 3 the
  number of doctor visits than those without
  depression2
• Hospitalized TRD group had 7 the annual
  healthcare costs of the outpatient TRD group and
  19 the costs of the comparison group3

1. Russell JM, et al. J Clin Psychiatry.
200465341-347. 2. Lépine J-P, et al. on behalf
of the DEPRES Steering Committee. Int Clin
Psychopharmacol. 19971219-29. 3. Crown WH, et
al. J Clin Psychiatry. 200263963-971.
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Assessing Current Treatment andChecking for
Nonadherence1,2

• Did the patient receive adequate treatment?
• An inadequate dose or duration of treatment can
  prevent remission
• Experts recommend a minimum trial period between
  6 12 weeks in length
• Pharmacokinetics can differ in elderly and
  pediatric populations
• Is patient nonadherent?
• Ask patient what they are taking and when
• 50 of patients fail to take antidepressants as
  prescribed due to
  lack of understanding of instructions or
  unnatural fears of
  side effects/drug dependence
• Ask about troubling and intolerable side effects,
  including sexual dysfunction, nausea, akathisia,
  etc.

• Reus VI. Psychiatr Clin North Am.
  199619201-213.
• 2. Trivedi MH. Ann Clin Psychiatry. 20031559-70.

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TRD Patients More Severely Impaired Than
Non-TRD Patients
plt0.05


Duration of Current Episode (mean in weeks)
Total number of Hospitalizations (mean)
Job Loss
Financial Distress
(Individuals reporting, )
Amital D, et al. J Affect Disord.
2008110260-264.
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Factors Associated with TreatmentResistance in
MDD
p0.009
p0.018
p0.003
p0.019
p0.001
p0.049
p0.009
p0.008
plt0.001
plt0.001
plt0.001
Odds Ratio
AD, antidepressant DSM-IV, Diagnostic and
Statistical Manual of Mental Disorders , Fourth
Edition. Souery D, et al. J Clin Psychiatry.
2007681062-1070.
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Remission and Residual Symptoms Predictors in
Major Depression

• Residual Symptoms Predict Subsequent Early
  Relapse2

Plt0.001 at 15 months. Paykel ES, et al. Psychol
Med. 1995251171-1180.
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Could Some Patients with Treatment Resistant
Depression be Bipolar?

• Reevaluation of patients who failed at least 2
  appropriate antidepressant trials

N61
Initial Reevaluation Using SCID (DSM-IV)
Later Reevaluation Within 1 Year 59 prevalence
of bipolar disorder
NOS, not otherwise specified SCID, structural
clinical interview for DSM disorders.



Sharma V, et al. J
Affect Disord. 200584251-257.
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Lack of Improvement of Painful Symptoms inMDD
Decreases Chances of Remission
Plt0.001 2 pooled studies
Patients Achieving Remission (9-Week Studies),


n77
n49
?50 Improvement in Painful Physical Symptoms
?50 Improvement in Painful Physical Symptoms
Remission HAM-D17 Total Score ?7 Painful
physical symptom improvement measured by the
Visual Analog Scale (VAS) overall pain score
HAM-D, Hamilton Depression Rating Scale. Fava M,
et al. J Clin Psychiatry. 200465521-530.
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Managing Patients with Treatment Resistant
Depression
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Factors to Consider in Patients FailingFirst
Trial of Antidepressant Monotherapy
Correct Diagnosis
Comorbid Psychiatric Conditions
Comorbid Medical Conditions
Treatment- Refractory Patient
Adequate Dose
Appropriate Drug Therapy
Adequate Duration
Severity of Illness
Treatment Adherence
Nemeroff CB. J Clin Psychiatry. 200768 Suppl
817-25.
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A Proposed Model for Optimizing OutcomesThe 4-D
Model
D
D
D
D
Right Diagnosis
Right Drug
Right Duration
Right Dose
Fava M. Biol Psychiatry. 200353649-659.
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FIRST DRight DiagnosisDo We Have the Right
Diagnosis(or Diagnoses)?

• Diagnosis
• Is this major depression?
• Has bipolar disorder been ruled out?
• Has a medical cause been ruled out?
• Has psychosis been ruled out?
• Has substance/alcohol misuse been ruled out?

Fava M. Biol Psychiatry. 200353649-659
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SECOND DRight DrugHave we Selected the Right
Drugfor the Patient?

• Was the appropriate drug (or drug combinations)
  selected for the patients individual needs?
• Were co-morbidities considered when selecting the
  drug?
• Were adverse events optimally managed?

Fava M. Biol Psychiatry. 200353649-659
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THIRD DRight DoseWas the Right Dose of the
Medication Given?

• Was the patient administered the right dose of
  the medication?
• Was the patients age, body weight, sex, ethnic
  background considered in determining the optimal
  dose?
• Was the patient compliant with the medication?

Fava M. Biol Psychiatry. 200353649-659
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FOURTH DRight DurationWas the Duration of
Medication Exposure Adequate?

• Did the patient take the medication(s) for a
  minimum of6 to 8 weeks?
• Did the patient skip doses or reduce the dose on
  their own?

Fava M. Biol Psychiatry. 200353649-659
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A Clinicians Guide to Optimum Management of
Major Depression
Trial
Optimization of dose and duration should be used
as the strategies in each step.
Remission
Yes
No
No response?
Partial response?
Maintenance
Switching
Augmentation
Combination
Remission ?
Yes
No
No response?
Partial response?
Maintenance
Switching
Augmentation
Combination
Berlim MT, et al. Ann Med. 200840149-159.
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MeasurementBased Care

• measurement-based care affords the greatest
  probability that an individual will achieve
  remission.
• Huynh NN, et al.
  Primary Care Companion. J Clin Psychiatry.
  20081091-96.
• An accurate and systematic assessment of TRD is
  a challenge to both clinicians and researchers,
  with the use of clinician-rated or self-rated
  instruments being perhaps quite helpful.
• Fava M. Biol Psychiatry. 200353649-659.

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Quality and Performance Improvement in Treatment
Resistant Depression
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Key Components of All Quality Improvement/
Performance Improvement Projects

• Performance Measurement
• QI is impossible without performance measurement
• Answers the question How will I know a change is
  an improvement?
• Continuous measurement is best
• Data collection over time increases
  understanding of variation (common cause vs.
  special cause)
• Measurement for judgment vs. measurementfor
  improvement

QI, quality improvement.
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Key Components

• Every process is perfectly designed to produce
  the result it produces. Donald Berwick, MD
• For a stable process to get a different result,
  you must change the process
• Must be able to document processes

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Why is Performance Improvement Needed?

• Federal Government
• Medicare changing from pay-for-service to
  apay-for-performance model
• AAFP/societies/organizations
• Recognition that performance improvement
  success
• MOC Criteria
• American Board of Medical Specialties (ABMS)
  requirements

AAFP, American Academy of Family Physicians MOC,
Maintenance of Certification.
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Why is Performance Improvement Needed? (contd)

• Pay-for-performance (P4P) and pay-for-outcomes
  improvement
• All of the P4P programs now in place include
  performance improvement metrics in the care of
  chronic disease patients
• Essential to the Personal Medical Home
  philosophy of primary patient care
• Acquired expertise in the science of PI is a
  transferable skill set that can be applied to
  most aspects of medical practice
• The resulting improved performance and efficiency
  will positively impact patient care

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Drill Down to Treatment Resistant Depression

• Why use TRD as a model condition for PI?
• Correct diagnosis can be difficult
• Appropriate treatment is essential
• Undiagnosed/untreated/undertreated patients
• Fourfold risk of relapse/recurrence1-3
• More chronic depressive episodes1
• Neurodegeneration (hippocampus)
• Increased all-cause mortality (e.g., suicide,
  CV)4,5

1. Judd LL, et al. Am J Psychiatry.
20001571501-1504. 2. Paykel ES, et al. Psychol
Med. 1995251171-1180. 3. Thase ME, et al. Am J
Psychiatry. 19921491046-1052. 4. Murphy JM, et
al. Arch Gen Psychiatry. 198744473-48. 5.
Penninx BW, et al. Arch Gen Psychiatry.
200158221-227.
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Financial Disclosures

• Faculty Presenters
• Joyce E. King, MD, discloses the following
• No relevant financial or advisory relationships
  with corporate organizations related to this
  activity.
• Dr. King has indicated that her presentation will
  not include information on off-label products.
• Course Director
• Glenn J. Treisman, MD, PhD, discloses the
  following
• No relevant financial or advisory relationships
  with corporate organizations related to this
  activity.

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The Need for Performance Improvement

• Time and resources of primary care practices are
  under increasing pressure from
• Increasing patient numbers, incidence of chronic
  disease, and patient costs
• Increasing complexity within the clinic and
  bureaucracy beyond the clinic
• A growing requirement for more practice
  transparency and accountability
• Performance Improvement is designed to improve
  efficiency, and ease the burden on practices

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Why This PerformanceImprovement Initiative?

• This programs structure is easy to implementand
  maintain
• Baseline Period (12 weeks)
• Practice assessment through simplescreening logs
• Implementation Period (12 weeks)
• Using Tools based on best-practice criteria
• Closeout Period
• Comparison of Baseline and Implementation
• No HIPAA Concerns
• Central IRB Exemption Waiver was granted

HIPAA , Health Insurance Portability and
Accountability Act IRB, Institutional Review
Board.
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Why Join This Performance Improvement
Initiative?

• Ease of Implementation
• You will be given all necessary information and
  tools
• Live support to assist you and your staff to
  assessyour progress
• Follows established Plan-Do-Study-Act (PDSA)
  criteria
• PDSA is a simple, effective way of improving your
  practice structure using a logical approach
• Easy to teach and do personally fulfilling for
  the physician and staff
• Simple reporting mechanism

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What are the Personal Benefits ofJoining This
Program?

• Opportunity to participate in a program leading
  to measurable change in patients
• Personal improvement and satisfaction with
  medical practice
• Enhance the feel good factor about the care
  given at the end of every day
• Alignment with MOC requirements
• Aligns your practice in accordance with ABMS
  criteria
• Enhance coordination between care team members
• Invigoration of the practice culture
• Escape from the tyranny of the urgent

ABMS, American Board of Medical Specialties.
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What are the Personal Benefits ofJoining This
Program? (contd)

• Publications
• Participation in a peer-reviewed piece to
  improvenational care
• Free to participate
• This program involves no fees, and is totally
  voluntary
• Johns Hopkins Physician Recognition Award
• Recognition of top physician performers
• CME Credit
• Receive up to 20 AMA PRA Category 1 Credits for
  successful completion of the program

Registrants must complete the entire program to
receive the maximum available CME credit.
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Perceived Barriers to ImplementingThis
Performance Improvement Program

• What is the time commitment?
• Very little time is required to institute this
  Performance Improvement (PI) program into the
  workflow of a Primary Care Physician (PCP)
  practice
• Utilizes easy to use tools, resources and
  performance measures are based on validated tools
• Pay off may be clinical outcomes improvement and
  enhanced Pay-for-performance (P4P) financial
  outcomes
• Will this program impact my practice's resources?
• Impact should be minimal or non-existent, as this
  PI process is not labor intensive

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• Treatment Resistant Depression Performance
  Improvement Program Overview

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PDSA PI Cycle is Based onSame Model as the
Scientific Method
PDSA , Plan-Do-Study-Act PI, Performance
Improvement.
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TRD PerformanceImprovement Program Overview

• Goal
• To measurably improve delivery of care to
  patients afflicted with Treatment Resistant
  Depression
• Plan
• Obtain a clinical snapshot of your current
  practice patterns
• Use evidence-based medicine and tools to address
  anyneed areas
• Perform a Reassessment to determine program
  benefit

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TRD PI Program Baseline Period

• You will
• Fill out the Baseline Patient Screening Log over
  12-week period (runtime analysis)
• Fill out and return (fax) to PeerPoint the
  Baseline Patient Screening Log for all patients
  currently under care for depression
• Data recorded by the de-identified patient
  screening log
• 1) Presence of bipolar disease
• 2) Nature of major depressive disorder
• 3) Current therapies
• 4) Patient adherence
• 5) Was the patient referred?

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TRD PI Program Baseline
Period
Baseline Patient
Screening Log
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TRD PI Program Implementation Period

• You will
• Implement the supplied tools into your practice
  in the order supplied to you
• Fill out over 12-week period (runtime analysis)
• Fill out and return (fax) to PeerPoint the
  Implementation Patient Screening Log for all
  patients currently under care for depression
• PeerPoint will check in with you at 3-week
  intervals to determine utilization and
  feasibility

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TRD PI Program Implementation Period
Program Overview
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TRD PI Program Implementation Period
Implementation

Patient Screening

Log
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TRD PI Program Implementation Period
DSM-IV-TR Criteria
DSM-IV-TR, Depression, Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition, Text
Revision. DSM-IV-TR Criteria for Major Depressive
Disorder
http//www.aan.com/globa
ls/axon/assets/4959.pdf. Accessed January 28,
2009.
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TRD PI Program Implementation Period
MDQ Screener
MDQ, Mood Disorder Questionnaire. Hirschfeld RA,
et al. Am J Psychiatry. 20001571873-1875.
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TRD PI Program Implementation Period
TRD Screener
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TRD PI Program Implementation Period
Determine Depression
Severity Using QIDS-SR1,2
QIDS-SR, Quick Inventory of Depressive
Symptomatology Self-report.

1. IDS QIDS http//www.ids-qids.org/.
Accessed February 3, 2009.

2. Rush AJ,
et al. Biol Psychiatry. 200354573-583.
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TRD PI Program Implementation Period
Perform One-Time Evaluation of Patient Treatment
Stage Using Thase and Rush Staging Model with
TMAP-08 Update1,2
TMAP-08, Texas Medication Algorithm Project. 1.
Thase ME, et al. J Clin Psychiatry. 199758
(suppl 13)23-29. 2. Suehs BT, et. al. TMAP-08
Procedural Manual Major Depressive Disorder
Algorithms. The Texas Department of State Health
Services. 2008.
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TRD PI Program Implementation Period
Indicate Treatment Stage Using TMAP-08
Suehs BT, et. al. TMAP-08 Procedural Manual
Major Depressive Disorder Algorithms. The Texas
Department of State Health Services. 2008.
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TRD PI Program Implementation Period
Assess if Referral is Required Using MQIC
MQIC, Michigan Quality Improvement Consortium.

MQIC
Guideline Management of Adults with Major
Depression http//www.mqic.org/guid.htm.
Accessed January 29, 2009.
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TRD PI Program Close-out Period

• PeerPoint will
• Ask you to complete a qualitative assessment(did
  you learn anything?)
• Determine delta between Period 1 (Baseline) and
  Period 2 (Implementation) based on the Patient
  Screening Logs
• Report back to you on your results and national
  aggregatedata results
• Provide you a ranking based on your data

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Conclusions (contd)

• Implementation of this Performance Improvement
  initiative isimportant because
• It will address and improve deficits in the
  primary care system related to diagnosis and
  treatment of TRD
• It will help align your practice to current and
  future requirements for all primary care
  providers
• The skills you learn in this initiative can be
  translated to other aspects of your practice and
  other disease states

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Conclusions (contd)

• Although there is no guarantee that this
  initiative will improve or change every practice,
  PeerPoint will
• Provide you with ongoing resources and support to
  take you through the PI process
• Minimize any extra work on your part
• Work with you to maximize the effectiveness of
  the program
• You will receive up to 20 AMA PRA Category 1
  Credits for each registrant on successful
  completion of the program
• Patient outcomes may be improved

Registrants must complete the entire program to
receive the maximum available CME credit .
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Frequently Asked Questions

• The first question is for Dr. Nierenberg
• In your opinion, what is the primary role of
  primary care physicians in the long-term
  management of patients with TRD?

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Frequently Asked Questions

• The next question is for Dr. King
• My practice has a large number of clinicianswill
  they be able to follow the requirements of the
  program if they have not viewed this webinar?

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Frequently Asked Questions

• The next question is for Dr. King
• Will this program increase my practices
  efficiency?

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Frequently Asked Questions

• The last question is for Dr. King
• Is this program transferrable to other
  therapeutic areas?

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Have additional questions?Speak to a PI site
coordinator by calling 800-777-5790