Monitoring Protocol for Clozapine-induced Myocarditis. Copyright 2017, CAMH

Transcription

1 1 Monitoring Protocol for Clozapine-induced Myocarditis 1

2 Agenda Problem Identification / Identification Importance / Importance Baseline Workflow Baseline Workflow Baseline Data Baseline Data Objectives Solution Selection Interventions Interventions End-User Involvement End-User Involvement Revised Workflow Solution Details Effect of Interventions on Data Post- Adherence Data Post- Outcome Data Return on Investment 2

3 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 3

4 Problem Identification 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 Why is this Important? 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% 4

5 Baseline Workflow Review and stop treatment Alternative treatment prescribed Can rechallenge patient after 1 year Yes Patient presents with TRS Decision to prescribe Clozapine Clozapine order(s) entered Myocarditis symptoms? No Continue treatment 5

6 Myocarditis Monitoring Cardiac Troponin Positive C-Reactive Protein > 50 Suspected myocarditis 6

7 Baseline Data 100% 90% Nov 2013 Oct 2014 Myocarditis Monitoring Protocol 4.2% Clozapine-naïve Patients with Myocarditis Monitoring Protocol Cardiac Specialist 80% Percentage of Patients 70% 60% 50% 40% 30% 20% 10% 0% 17% 0% 0% 0% 0% 0% 0% 0% 0% n = 1 0% 0% 0% Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Month 7

8 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

9 Solution Selection CAMH identified a method to increase myocarditis monitoring for Clozapine patients. 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 Clinician familiarity Dynamic reporting Communication tools Existing change management Tracking and feedback Standardized practice Existing governance Standardized documentation 9

10 Interventions 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) 10

11 Strategic Governance High-level Decisions Executive Leadership Team CEO Medical Advisory Committee Physician in Chief Mid-Level Decisions Pharmacy & Therapeutics Dir. Pharmacy Health Information Interdisciplinary Committee Dir. Interprofessional Practice Dir. Medical Informatics Clinical Care Committee Dir. Interprofessional Practice Chief Medical Officer Order Sets Sub-Committee Dir. Medical Informatics Pharmacist Physician / Hospitalist User Groups Dir. Medical Informatics Lead Hospitalist Practice Adoption & Optimization Council Manager, Clinical Education Advanced Practice Clinical Lead Collaborative Practice Advisory Committee Chief of Nursing Data and Reporting Governance Committee (ELT Sub-Committee) Exec. Dir. Performance Improvement Med. Dir. Performance Improvement Clinical Applications Change Advisory Board Sr. Manager, Clinical Applications Integrated Health Record Council Dir. Clinical Information Systems APPROVED 11 ** Advisory / Working Groups established as required

12 End-User Involvement Integrated Health Record Committee Hospitalist User Group Physician User Group Chairs: Dir. Interprofessional Practice, Dir. Medical Informatics Includes clinicians and other stakeholders Initial approval of need 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 Pharmacy & Therapeutics Co-chairs: Appointed Physician and Dir. Pharmacy Owners and approvers of Order Set Includes a minimum of 6 physicians, 4 pharmacists 12

13 Revised Workflow Can rechallenge patient after 1 year Alternative treatment prescribed Review and stop treatment Abnormal Patient presents with TRS Decision to prescribe Clozapine Pre- Clozapine Initiation Order Set (Baseline)* Select Clozapine with Titration or Clozapine without Titration Order Set* Mandatory blood work for 4 weeks* Results normal or abnormal? Normal Continue treatment Health IT used within intervention* 13

14 Mandatory Monitoring Protocol Pre-initiation Baseline ECG, CRP, and Troponin Identification of pre-existing cardiac disease Troponin lab test CRP lab test 14

15 Mandatory Monitoring Protocol Post-initiation Weekly clinical assessments CRP and Troponin monitoring x 4 weeks Regular Agranulocytosis monitoring * Troponin lab test CRP lab test 4 week duration 15

16 Effect of Interventions on Data Policy Order Sets Mandatory Fields (Locking) Intervention 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) Effect 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

17 Post- Adherence Data Nov 2013 Oct 2014 Nov 2014 May 2018 Myocarditis Monitoring Protocol 4.2% 97.0% 110% 100% 90% Clozapine-naive Patients with Myocarditis Monitoring Protocol Policy 88% Order Sets Locking 100% 100% 100% 89% 100% 95% 100% 100% 100% 100% 97% 94% 89% 100% Percentage of Patients 80% 70% 60% 50% 40% 30% Pre-implementation Post-implementation 20% 10% 0% 0% 0% 0% 2013 Q Q Q2 7% 2014 Q Q Q Q Q Q Q Q2 Calendar Quarter 2016 Q Q Q Q Q Q Q Q2 17

18 Post- Outcome Data 30 Number of patients discontinued from Clozapine due to suspected Myocarditis 25 Number of Patients Nov Oct 2014 Nov May

19 16 Discontinued Patient Demographics Number of Clozapine Patients with Myocarditis Risk by Age and Sex Female Male 14 Number of Patients *13.5% Less than to to to to 64 Age *13 / 96 (13.5%) of males aged 21 to 32 discontinued 19

20 Return on Investment Patients on Clozapine with Myocarditis Monitoring n = 27 Cost averted = $108,756 n =283 Flagged as at risk and taken off Clozapine No risk Twenty-seven Clozapine-naïve patients had suspected myocarditis detected in early stages. Savings = (Cost of adverse event * # of patients detected) 20

21 Return on Investment 27 patients removed from Clozapine due to myocarditis warning signs (3 lives saved) 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 locally leading the way for Clozapine-induced myocarditis monitoring and we expect uptake on a regional and national level after publishing 21

22 Lessons Learned 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 22

23 Thank You