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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 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 Standard of Care
• 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 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
Merlin.net
IDCO Profile
Discrete data elements
Cloverleaf Secure Courier
Health Information Exchange(MedWeb)
WebChart EHR
NoMoreClipboard ePHR
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 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
NoMoreClipboard – Patient Notification Summary
Patient Notification Summary
1
Member Summary Page
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
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
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
Primary Objectives of the 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.
SJM-IDCO Pilot 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
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
SJM-IDCO STUDY
Enrollment is ongoing 191 patients to date…
Number of patients
Total (191)
Group A (73)
Group B (71 )
Group C (47)
Female
62 (32%)
24 (33%)
19 (27%)
19 (40%)
Male
129 (68%)
49 (67%)
52 (73%)
28 (60%)
18-29
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%)
Gender
Age
Information Flow Research Subjects
Epic
MyChart
Patient Notification SummaryPatient view in MyChart
Patient Notification SummaryPatient 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 SummaryPatient 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

Technical Details
ALL Saint Jude Merlin.net
patients routed to Epic
-input from
Cardiologist
ACC/HRS
Discrete Data
Programming “Rules”- Epic
1.
2.
To Receive Reports (IDCO
Profile)
Order type needed to be
created
Rules -> Match Patient Name,
DOB, MRN
(otherwise route to error queue)
•
•
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.
Lessons Learned
Some Concerns Expressed Prior to Implementation
•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
FEASIBILITY STUDY 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.
FEASIBILITY STUDY
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
[email protected] - 260-266-5615
Carly Daley BA CCRC
[email protected] 260-266-5587
Extra Slides
TO DATE: TRANSMISSIONS SENT
Merlin.net
IDCO
MyChart
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
Lessons Learned
iEEE Enumeration List
Semantics
PATIENT:
2am device Check
MERLIN: Alert Initiated
EPIC: Remote Scheduled