Monitoring Protocol for Clozapine-induced Myocarditis...• Clinical symptoms of myocarditis noted...
Transcript of Monitoring Protocol for Clozapine-induced Myocarditis...• Clinical symptoms of myocarditis noted...
Copyright © 2017, CAMH
Monitoring Protocol for Clozapine-induced Myocarditis
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Agenda
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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
End-User Involvement
Revised Workflow
Solution Details
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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
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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?
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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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
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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Myocarditis Monitoring
Cardiac Troponin Positive C-Reactive Protein > 50
Suspected myocarditis
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Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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Baseline Data
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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
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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
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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Solution Selection
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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.
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• Included Myocarditis monitoring protocol into Clozapine policy (Oct. 2014)
Interventions
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
• 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)
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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
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• 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
End-User Involvement
Hospitalist User Group
Physician User Group
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
• 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
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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*
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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Mandatory Monitoring Protocol
• Baseline ECG, CRP, and Troponin• Identification of pre-existing cardiac disease
Pre-initiation
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
Troponin lab test CRP lab test
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Mandatory Monitoring Protocol
Troponin lab test CRP lab test 4 week duration
*
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
• Weekly clinical assessments• CRP and Troponin monitoring x 4 weeks• Regular Agranulocytosis monitoring
Post-initiation
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Effect of Interventions on Data
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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
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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
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s
Calendar Quarter
Clozapine-naive Patients with Myocarditis Monitoring ProtocolPolicy
Order Sets Locking
Post-Implementation Adherence Data
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
Nov 2013 – Oct 2014 Nov 2014 – May 2018Myocarditis Monitoring Protocol 4.2% 97.0%
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Pre-implementation Post-implementation
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Post-Implementation Outcome Data
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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
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Discontinued Patient Demographics
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1 1 1
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2 24
0
2
4
6
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Less than 21 21 to 32 33 to 42 43 to 53 53 to 64
Num
ber o
f Pat
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Age
Number of Clozapine Patients with Myocarditis Risk by Age and SexFemale Male
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Design and ImplementationLocal Problem How Health IT
was Used Value Derived
*13.5%
*13 / 96 (13.5%) of males aged 21 to 32 discontinued
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Return on Investment
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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
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Return on Investment
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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
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27 patients removed from Clozapine due to myocarditis warning signs (3 lives saved)
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Lessons Learned
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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
Design and ImplementationLocal Problem How Health IT
was Used Value Derived
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Thank You