IDCO Research Study: Direct Patient Messaging ICD Data

Implementation and Randomization

Michael J. Mirro, MD, FACC, FAHA, FACP

Chief Academic/Research OfficerParkview 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 StudyIndustry 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 death

Why remote monitoring?• ICD data (status, settings, episodes, events) available to clin

through patient home monitoring system• Reduces time between cardiac events and clinician review o

the data• Reduces the number of emergency room and office

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 1rapid 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

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

Implantable Device Cardiac Observation (IDCO) Profile Standard message

Nomenclature - same language X systemsIEEE 11073-10103

Structure - where data landsHL7 v. 2 orders and observations

Specification of integration – rules for data transferIntegrating 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

NoMoreClipboard – Patient Notification Summary

Patient Notification Summary

1

Member Summary Page

Patient Notification Summary

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

• 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 patients Total (191) Group A (73) Group B (71 ) Group C (47)Gender

Female 62 (32%) 24 (33%) 19 (27%) 19 (40%)Male 129 (68%) 49 (67%) 52 (73%) 28 (60%)

Age18-29 4 (2%) 3 (4%) 1 (1%) 0 (0%)30-39 5 (3%) 3 (4%) 2 (3%) 0 (0%)40-49 9 (5%) 5 (7%) 4 (6%) 0 (0%)50-59 30 (16%) 15 (19%) 9 (19%) 7 (15%)60-69 56 (29%) 20 (27%) 25 (35%) 11 (23%)70-79 60 (31%) 21 (28%) 21 (30%) 18 (38%)80-89 26 (14%) 6 (8%) 9 (13%) 11 (23%)

SJM-IDCO STUDYEnrollment is ongoing 191 patients to date…

MyChart

Information Flow Research Subjects

Epic

Patient Notification Summary-Patient view in MyChart

Patient Notification Summary-Patient view in MyChart

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

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 DataProgramming “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 LearnedFEASIBILITY 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 Summary @ PPG-Cardiology

FEASIBILITY STUDYPatient-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 CCRCLisa.Heral@parkview.com - 260-266-5615

Carly Daley BA CCRCCarly.daley@parkview.com 260-266-5587

Extra Slides

Number of patients Total (191)

Group A (73) Group B (71 ) Group C (47)

First ICD Patient Notification Summary released

33 23 10 N/A

Second ICD Patient Notification Summary released

1 1 0 N/A

Number of patients who had transmissions (Merlin)

87 37 35 15

Total number of transmissions (Merlin)

129 58 52 19

TO DATE: TRANSMISSIONS SENT Merlin.net IDCO MyChart

Lessons Learned

Semantics

iEEE Enumeration List

PATIENT: 2am device Check

MERLIN: Alert Initiated EPIC: Remote Scheduled