ONC Project Drives Results with High- Value, Consumer- Friendly Data. [Font: Verdana Size 30]

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ONC Project Drives Results with High- Value, Consumer- Friendly Data [Font: Verdana Size 30]

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

Patients Speak Out About Access to Data [Font: Verdana Size 18]

Shift of Power Data direct to patients Relevant, useful information

Current Practice Remote Monitoring Merlin.net Arrhythmia Diagnos5c Center (RN) PACEART Health Informa5on Exchange(MedWeb) EHR (WebChart)

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.

RATIONALE: Feasibility Study Providing patients with high value data in a direct, electronic, human-readable format has the potential to improve patient engagement and communication with healthcare providers.

Feasibility Study Remote Monitoring Merlin.net IDCO Profile Cloverleaf Secure Courier Discrete data elements Health Informa5on Exchange(MedWeb) WebChart EHR NoMoreClipboard ephr

Goal of Study 1. Integrate technology capable of transmitting data seamlessly from device to patient portal 2. High Value Data Minimum Data Set (ACC/HRS Guidance) Battery Status Lead and Shock Coil Status Ventricular Therapies (ATP/Shocks)

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

Demographics: Total number of patients Gender Female Male Age 36-45 46-55 56-65 66-75 76-85 86-90 Highest level of education High School graduate/ged Trade/some college College graduate Post-graduate degree Hispanic or Latino ethnicity Yes No Type of ICD Single chamber Dual chamber Indication for ICD Primary prevention Secondary prevention 21 (100%) 5 (24%) 16 (76%) 3 (14%) 1 (5%) 4 (19%) 9 (43%) 3 (14%) 1 (5%) 7 (35%) 7 (35%) 1 (5%) 5 (25%) 1 (5%) 20 (95%) 6 (29%) 15 (71%) 8 (38%) 13 (62%)

IDCO Profile Implantable Device Cardiac Observation (IDCO) Profile Standard message Nomenclature - same language X systems IEEE 11073-10103 Structure - where data lands HL7 v. 2 orders and observations Specification of integration - rules for data transfer Integrating the Healthcare Enterprise (IHE)

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 [Font: Verdana Size 18]

NoMoreClipboard Patient Notification Summary [Font: Verdana Size 18]

Patient Notification Summary 1 2 Step 2: Proceed to Your Personal Health Record -Patients selected View Messages

Member Summary Page [Font: Verdana Size 18] Patient Notification Summary

WebChart EMR Flowsheet of data elements

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

Patient Notification Summary Development: Questions & Concerns 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?

Patient-Provider Communication

Provider Perspectives Providers (including physicians, nurses, and ADC technologists, N=41) completed a survey to explore attitudes and perceptions about the Patient Notification Summary @ PPG-Cardiology 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.

Patient Response letter versus more information Patients overall prefer to have more detailed information Any time you get more information it s good for you to know how you can control your own health issues and, and uh know what to do when The letter doesn t it just says everything s normal But what s normal? You know? I think the information would be just great to have all the time, I really do. I know I d be runnin and checkin it often Patients seek guidance I think it s a neat idea but I just wasn t understanding as much of it as I should I LIKE getting more information cause the more information you get, the more control or understanding you have about your problem, but I don t quite understand, the terminology Some patients believe less is more Yeah this (Patient Notification Summary) is probably more than I need to see. I just got the your whole thing is ok I just go along with that you know...

Patient Feedback & Action What would patients like to see? Battery life Date, time, heart rate, episodes Abnormalities in rhythm Help from family: Six out of 21 people brought a family member(s) with them; others mentioned assistance at home Log-ins: 2-17 times between visits (approx 3 months) Email notifications Email prompts were desired strongly by most patients

Useful Feedback from Direct Messaging Scenario: Home monitor failed to deliver transmission Patient reset monitor and transmitted Patient viewed the result instantaneously Instant feedback inspired by the patient s action PEACE OF MIND EMPOWERMENT

Patient Notification Summary lessons learned Semantics across interfaces: Merlin system-emr-clinic-phr-patient EXAMPLE: Meanings of Remote Scheduled : Merlin: Monitor is programmed to search for the device at a specific time, not necessarily followed by a transmission Clinic: Remote transmissions for patients are scheduled at 14 week intervals The IEEE code for transmission type was inserted here in the display to inform the patient but the meaning was misinterpreted. To the patient, it appears that their next scheduled transmission is @ date & time

Patient Notification Summary lessons learned Patients appreciated and desired having explanations, However hovering over was not intuitive. Lesson applied: current study has definitions on the display page

Patient Activation

WHAT DRIVES RESULTS? Patient Engagement! the right information high value data. Battery status and device activity the right time information in a timely manner to bring relevance the right way Customized to patient needs from overview to high level details Apply pa'ent feedback to the development of tools that will be7er serve and engage pa'ents in their healthcare

Current & Future Work Pa'ent No'fica'on of Remote Implantable Cardioverter - Defibrillator (ICD) Monitoring Data: Impact of Pa'ent Engagement on Outcomes Merlin.net System Merlin.net IDCO Profile Cloverleaf Secure Courier Epic - EMR MyCHART All St. Jude device transmissions in Merlin.net route to Epic Study patients are matched to Epic chart by name, gender, DOB, MRN ICD Summary generated from IDCO profile Programming capable to auto-release ICD Summary to MyChart after 4 business days

Patient view in MyChart: Current & Future Work

Current & Future Work Survey patients at baseline, 3 months and 6 months Survey providers Enrollment: 191 patients to date Group A (N=73) receives ICD Patient Randomized Notification Summary in MyChart Group B (N=71) receives ICD Patient Notification Summary on paper in the mail Group C continues with standard of care only To measure and assess: Patient engagement Provider-patient communication Healthcare utilization Patient satisfaction

Michael J. Mirro, MD Carly N. Daley, BA Parkview Research Center