Monitoring Protocol for Clozapine-induced Myocarditis...• Clinical symptoms of myocarditis noted in patients treated with clozapine • An expert was consulted who determined that

Copyright © 2017, CAMH

Monitoring Protocol for Clozapine-induced Myocarditis

1

1


Agenda

2

Problem Identification / Importance

Baseline Workflow

Baseline Data

Design and ImplementationLocal Problem How Health IT was Used Value Derived

Objectives

Solution Selection

Interventions

End-User Involvement

Revised Workflow

Solution Details

Effect of Interventions on Data

Post-Implementation Adherence Data

Post-Implementation Outcome Data

Return on Investment

Problem Identification / Importance

Baseline Workflow

Baseline Data

Objectives

Solution Selection

Interventions


Revised Workflow

Solution Details


Overview of Clozapine

• 25-30% of all individuals with schizophrenia meet criteria for treatment resistance (Remington 2010)

• Clozapine is the only antipsychotic with proven efficacy (Remington, Addington et al. 2017)

• Substantial side-effects

Side Effect Prevalence

Agranulocytosis Rare (<1%)

Constipation 60%

Myocarditis <5%

• CAMH houses the largest clozapine clinic in North America (~750 patients)• Goal to double volume over a 5-year period

Design and ImplementationLocal Problem How Health IT

was Used Value Derived

3


Problem Identification

• Clinical symptoms of myocarditis noted in patients treated with clozapine• An expert was consulted who determined that the cause was myocarditis• Agranulocytosis is the only standard monitoring for clozapine treatment

Problem Identification

• Clozapine-induced Myocarditis is a potentially fatal yet likely under diagnosed complication of Clozapine therapy Incidence estimated ~ 3% Develops within the first 4 weeks of Clozapine initiation and titration Hypersensitivity reaction with a fatality rate of 10%

Why is this Important?



4


Baseline Workflow

Patient presents with TRS

Alternative treatment prescribed

Continue treatment

Clozapine order(s) entered

Review and stop

treatment

Decision to

prescribe Clozapine

Myocarditis symptoms?

Can re-challenge

patient after 1 year

Yes

No



5


Myocarditis Monitoring

Cardiac Troponin Positive C-Reactive Protein > 50

Suspected myocarditis

6




Baseline Data



Nov 2013 – Oct 2014Myocarditis Monitoring Protocol 4.2%

0% 0% 0% 0% 0% 0% 0% 0%

17%

0% 0% 0%0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14

Perc

enta

ge o

f Pat

ient

s

Month

Clozapine-naïve Patients with Myocarditis Monitoring Protocol

n = 1

Cardiac Specialist

7


Objectives

Standardize myocarditis monitoring protocol for Clozapine-naïve patients

Increase compliance to myocarditis monitoring protocol

Discontinue Clozapine for patients showing warning signs of myocarditis

Streamline ordering process to save clinician time and prevent errors



8


Solution Selection



Standardized practice

Standardized documentation

Communication tools

The implementation of I-CARE provided an opportunity to standardize care through order sets.

-Decision to standardize practice through order sets was made through the Hospitalist User Group and the Pharmacy and Therapeutics Committee

Tracking and feedback

Clinician familiarity

Dynamic reporting

Existing changemanagement

Existing governance

CAMH identified a method to increase myocarditis monitoring for Clozapine patients.

9


• Included Myocarditis monitoring protocol into Clozapine policy (Oct. 2014)

Interventions



• Integrated Myocarditis monitoring protocol into I-CARE order sets (Nov. 2014)

• Reinforced education with cardiology expert (Apr. 2015); monitoring protocol elements made mandatory within I-CARE order sets (Jun. 2015)

Policy Order Sets Mandatory Fields(Locking)

10


Strategic Governance

11 ** Advisory / Working Groups established as required

High-level Decisions

Mid-Level Decisions

Medical Advisory Committee

Physician in Chief

Health Information Interdisciplinary CommitteeDir. Interprofessional Practice

Dir. Medical Informatics

Executive Leadership TeamCEO

Physician / Hospitalist User Groups

Dir. Medical InformaticsLead Hospitalist

Pharmacy &TherapeuticsDir. Pharmacy

Order Sets Sub-Committee

Dir. Medical InformaticsPharmacist

Practice Adoption & Optimization Council

Manager, Clinical Education

Advanced Practice Clinical Lead

Clinical Applications Change Advisory

BoardSr. Manager, Clinical

Applications

Data and Reporting Governance Committee (ELT Sub-Committee)Exec. Dir. Performance

ImprovementMed. Dir. Performance

Improvement

Collaborative Practice Advisory Committee

Chief of Nursing

APPROVED

Clinical Care CommitteeDir. Interprofessional Practice

Chief Medical Officer

Integrated Health Record CouncilDir. Clinical Information Systems


• Chair: Medical Head, Hospitalist Services• Developers and subject matter experts for Clozapine

Order Sets• Representation from physicians, nurses, Pharmacy,

Professional practice, and Health Records

• Chair: Chief Medical Information Officer• Representation of front-line physicians• Contains 15 physicians from throughout CAMH


Hospitalist User Group

Physician User Group



• Co-chairs: Appointed Physician and Dir. Pharmacy• Owners and approvers of Order Set• Includes a minimum of 6 physicians, 4 pharmacists

Pharmacy & Therapeutics

• Chairs: Dir. Interprofessional Practice, Dir. Medical Informatics

• Includes clinicians and other stakeholders• Initial approval of need

Integrated Health Record Committee

12


Pre-Clozapine Initiation

Order Set (Baseline)*

Revised Workflow

Patient presents with TRS

Mandatory blood work

for 4 weeks*

Alternative treatment prescribed

Continue treatment

Select Clozapine

with Titration or Clozapine

without Titration

Order Set*

Review and stop

treatment

Decision to

prescribe Clozapine

Results normal or abnormal

?

Can re-challenge

patient after 1 year

Abnormal

Normal

Health IT used within intervention*



13


Mandatory Monitoring Protocol

• Baseline ECG, CRP, and Troponin• Identification of pre-existing cardiac disease

Pre-initiation



Troponin lab test CRP lab test

14


Mandatory Monitoring Protocol

Troponin lab test CRP lab test 4 week duration

*



• Weekly clinical assessments• CRP and Troponin monitoring x 4 weeks• Regular Agranulocytosis monitoring

Post-initiation

15


Effect of Interventions on Data



Policy Order Sets Mandatory Fields(Locking)

• Included Myocarditis monitoring protocol into Clozapine policy (Oct. 2014)

• Integrated Myocarditis monitoring protocol into I-CARE order sets (Nov. 2014)

• Reinforced education with cardiology expert (Apr. 2015); monitoring protocol elements made mandatory within I-CARE order sets (Jun. 2015)In

terv

entio

nEf

fect

• Increased clinical awareness and regulations to educate staff about clozapine-induced myocarditis and the effective monitoring protocol

• Integration of monitoring protocol increased speed of ordering and provided a visual reminder about the monitoring protocol for clinicians

• Increased clinical awareness and enforced regulations to standardize practice for Clozapine-naïve patients

16


0% 0% 0%7%

88%

100% 100% 100%

89%

100%95%

100% 100% 100% 100% 97% 94%89%

100%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

110%

2013Q4

2014Q1

2014Q2

2014Q3

2014Q4

2015Q1

2015Q2

2015Q3

2015Q4

2016Q1

2016Q2

2016Q3

2016Q4

2017Q1

2017Q2

2017Q3

2017Q4

2018Q1

2018Q2

Perc

enta

ge o

f Pat

ient

s

Calendar Quarter

Clozapine-naive Patients with Myocarditis Monitoring ProtocolPolicy

Order Sets Locking

Post-Implementation Adherence Data



Nov 2013 – Oct 2014 Nov 2014 – May 2018Myocarditis Monitoring Protocol 4.2% 97.0%

17

Pre-implementation Post-implementation


Post-Implementation Outcome Data



0

27

0

5

10

15

20

25

30N

umbe

r of P

atie

nts

Number of patients discontinued from Clozapine due to suspected Myocarditis

Nov 2013 - Oct 2014 Nov 2014 - May 2018

18


Discontinued Patient Demographics

12

1 1 1

13

2 24

0

2

4

6

8

10

12

14

16

Less than 21 21 to 32 33 to 42 43 to 53 53 to 64

Num

ber o

f Pat

ient

s

Age

Number of Clozapine Patients with Myocarditis Risk by Age and SexFemale Male

19



*13.5%

*13 / 96 (13.5%) of males aged 21 to 32 discontinued





Twenty-seven Clozapine-naïve patients had suspected myocarditis detected in early stages.

Savings = (Cost of adverse event * # of patients detected)

Patients on Clozapine with Myocarditis Monitoring

Flagged as at risk and taken off Clozapine No risk

n = 27Cost averted = $108,756

n =283

20





Able to measure the true incidence

(8.6%) of Clozapine-induced

myocarditis; 27 patients removed from Clozapine due to warning

signs

Clinicians are able to more easily

screen for Clozapine associated Myocarditis

Developed guidelines for

Clozapine cessation and reintroduction

CAMH is locallyleading the way for Clozapine-induced

myocarditis monitoring and we expect uptake on a

regional and national level after

publishing

21

27 patients removed from Clozapine due to myocarditis warning signs (3 lives saved)


Lessons Learned

22

Policy change can be supported by health IT to support adoption and enforcement

Order sets are effective at driving adoption of mandatory protocols

Data sharing with clinicians is an effective method for practice awareness




Thank You

Monitoring Protocol for Clozapine-induced Myocarditis...• Clinical symptoms of myocarditis noted in patients treated with clozapine • An expert was consulted who determined that

Documents