IDCO Research Study: Direct Patient Messaging ICD Data Implementation and Randomization Michael J. Mirro, MD, FACC, FAHA, FACP Chief Academic/Research Officer Parkview Health

Funding Feasibility IDCO Study (SJM-MIE) Office of the National Coordinator for Health Information Technology Challenge Grant awarded to Indiana Health Information Technology (IHIT). NoMoreClipboard and Parkview Research (grant sub-recipients) SJM-EPIC ICD messaging Study Industry Support ($150,000)

Patients Speak Out About Access to Data

Implantable Cardioverter-Defibrillators: High Value Data Why implantable cardioverter-defibrillators (ICDs)? Patients at risk for sudden cardiac deathPatients at risk for sudden cardiac death Why remote monitoring? ICD data (status, settings, episodes, events) available to clinic through patient home monitoring systemICD data (status, settings, episodes, events) available to clinic through patient home monitoring system Reduces time between cardiac events and clinician review of the dataReduces time between cardiac events and clinician review of the data Reduces the number of emergency room and officeReduces the number of emergency room and office visits visits --> HIGH VALUE DATA FOR PATIENTS

Current Practice Remote Monitoring

Current ICD patient notification standards Patients receive letter through the mail Simple statement that the device check is satisfactory Little or no details about the actual transmission content Many patients feel that they have a right to access and view the data their ICD is transmitting Current Standard of Care

Current Information Shared - Patient Letter RE: RECENT ICD/PACEMAKER CHECK Dear Patient, Your recent ICD check by phone shows essentially normal function. You did have 1 rapid heart rate recorded briefly. NO therapy was needed from your device.

Feasibility Study Remote Monitoring NoMoreClipboard ePHR WebChart EHR Health Information Exchange(MedWeb) Cloverleaf Secure Courier IDCO Profile Merlin.net Discrete data elements

Goal of Study

Study Design Study Design Sample: 21 St. Jude ICD patients undergoing remote monitoring (Merlin.net) Site: Parkview Physicians Group – Cardiology, Fort Wayne Duration: 3 months Intervention: electronic delivery of Patient Notification Summary using the Implantable Device Cardiac Observation Profile (standard) Measures : - Baseline patient survey and three month survey to assess Patient Activation (Patient Activation Measure, Insignia Health LLC) -Semi-structured interview at 3 months -Number of logins into NoMoreClipboard PHR -Provider survey at PPG-Cardiology

IDCO Profile IDCO Profile Implantable Device Cardiac Observation (IDCO) Profile Standard message Nomenclature - same language X systems IEEE Structure - where data lands HL7 v. 2 orders and observations Specification of integration – rules for data transfer Integrating the Healthcare Enterprise (IHE)

IDCO Profile IDCO Profile Pacemaker & ICD data interoperability Allows device data to be captured in EMR systems automatically which reduces workflow complexity EMR implementation costs are reduced for those systems that comply with IDCO profile Ensures quality of care by conforming data to standard data format and terminology Oversight from Heart Rhythm Society (HRS)

IDCO Profile: IEEE data elements & display IDCO Profile: IEEE data elements & display

NoMoreClipboard – Patient Notification Summary NoMoreClipboard – Patient Notification Summary

Patient Notification Summary Patient Notification Summary 1

Member Summary Page Member Summary Page Patient Notification Summary

WebChart EMR – Flowsheet of data elements WebChart EMR – Flowsheet of data elements

Patients want to know what their device is doing, if there is “anything wrong”, and their battery status Patient Notification Summary – lessons learned

Study AIM - Demonstrate the value of electronically messaging data from remote monitoring of ICDs via an electronic personal health record (PHR) to improve patient engagement RESEARCH STUDY: Patient Notification of Remote Implantable Cardioverter - Defibrillator (ICD) Monitoring Data: Impact of Patient Engagement on Outcomes – Merlin.net™ System AKA….SJM-IDCO STUDY

To evaluate the impact of sharing remote monitoring ICD data with patients through their PHR on: patient engagement. provider--patient communication. healthcare utilization. To determine patient satisfaction about access to remote monitoring ICD data To explore providers’ attitudes and perceptions regarding the value of the ICD Patient Notification Summary, its impact on clinic workflow and its effect on patient-provider communication. Primary Objectives of the Study

Survey PATIENTS at baseline, 3 months, and 6 months on: –level of engagement (PAM) / attitudes –expectations about remote monitoring / receiving ICD data Survey PROVIDERS on: –attitudes/perceptions of the ICD Patient Notification Summary ENROLLMENT IS ONGOING (191 patients to date) Inclusion Criteria Implanted with a St. Jude Medical ICD Undergoing remote monitoring by the Merlin.net™ system Have access to computer and/or Internet (Group A and B only) Patient has a scheduled ICD download within the study period at the time of enrollment SJM-IDCO Pilot Study

Project Overview Project Overview Patients divided into three groups Group A - Receive ELECTRONIC notification summary. The intervention group will activate a MyChart account and will receive training on how to use their PHR and how to view/read their ICD Patient Notification Summary online Group B - Receive PAPER notification summary. Subjects will activate a MyChart account and will receive training on how to use their PHR and how to view/read their ICD Patient Notification Summary on paper Group C – Standard of Care, only

Number of patientsTotal (191)Group A (73)Group B (71 )Group C (47) Gender Female62 (32%)24 (33%)19 (27%)19 (40%) Male129 (68%)49 (67%)52 (73%)28 (60%) Age (2%)3 (4%)1 (1%)0 (0%) (3%)3 (4%)2 (3%)0 (0%) (5%)5 (7%)4 (6%)0 (0%) (16%)15 (19%)9 (19%)7 (15%) (29%)20 (27%)25 (35%)11 (23%) (31%)21 (28%)21 (30%)18 (38%) (14%)6 (8%)9 (13%)11 (23%) SJM-IDCO STUDY Enrollment is ongoing 191 patients to date…

MyChart Information Flow Research Subjects Epic

Patient Notification Summary- Patient view in MyChart

MyChart Display Design MyChart Display Design ACC/HRS Guidance Provide Patients with High Value Data Minimum Data Set Battery Status Lead and Shock Coil Status Ventricular Therapies (ATP/Shocks)

MyChart Display Design MyChart Display Design Feedback (Patient Interviews-feasibility study) For example: Patients appreciated and desired having explanations, However hovering over was not intuitive. Lesson applied: current study EPIC DISPLAY includes the definitions on the display page

Patient Notification Summary- Patient view in MyChart

Device Information

Easy to read definitions

Overview of heart rate and pacing

Date and time of episodes

Weekly Conference Calls:  Parkview  Saint Jude  Epic  -input from Cardiologist ACC/HRS Rules -> Match Patient Name, DOB, MRN (otherwise route to error queue) ALL Saint Jude Merlin.net patients routed to Epic Discrete Data Programming “Rules”- Epic 1.To Receive Reports (IDCO Profile) 2.Order type needed to be created Technical Details Research Flags Programming Capability - Auto release to MyChart (after 4 bus days). Manual Release Used for this study. – defined reports sent were those “processed” by ADC clinic.

Will the patients understand? Will the clinic be inundated with calls? Who is responsible, and when? What is normal and what is abnormal? Should information be held or flow directly to the patient portal? What will patients do with this information Lessons Learned Some Concerns Expressed Prior to Implementation

Lessons Learned FEASIBILITY STUDY Provider Perspectives 31% believe the Patient Notification Summary could reduce work for the clinic 73% believe it will allow for better patient care 44% think it has a positive effect on patient-provider communication, and the remaining 66% were undecided. No participants reported a negative effect on communication. Providers (including physicians, nurses, and ADC technologists, N=41) completed a survey to explore attitudes and perceptions about the Patient Notification PPG-Cardiology

FEASIBILITY STUDY FEASIBILITY STUDY Patient-Provider Communication Patient-Provider Communication

Lessons Learned The right information – High Value Data The right Time – Information in a timely manner to bring relevance Customized and personal to patient needs from reassurance to high level details Apply patient feedback to the development of tools that will better serve and engage patients in their healthcare

Thank you! Questions: Michael J. Mirro MD FACC Lisa Heral RNBA CCRC Carly Daley BA CCRC

Extra Slides

Number of patients Total (191) Group A (73)Group B (71 )Group C (47) First ICD Patient Notification Summary released N/A Second ICD Patient Notification Summary released 11 0 N/A Number of patients who had transmissions (Merlin) Total number of transmissions (Merlin) TO DATE: TRANSMISSIONS SENT Merlin.net IDCO MyChart

Lessons Learned Semantics iEEE Enumeration List PATIENT: 2am device Check PATIENT: 2am device Check MERLIN: Alert Initiated EPIC: Remote Scheduled