April 8, 2013
Registries – where are we today?
– Public health registries have manual and/or semi-automated
abstraction and the data latency that process entails
– Registries require substantial resources to create and
maintain due to largely manual processes in data acquisition
--- and multiple heterogeneous data sources
– Registry case data should be more tightly integrated with
clinicians providing care for individual patients
• Any cancer-related data is valuable to all providers caring for the patient
(PCPs, urgent care, etc...), regardless if it is distant clinical history
• If it were available, its clinical use would render it of higher quality
(correctness, completeness, timeliness)
– The flow of information is generally to the registry and not
back to the clinic for aid in clinical care.
The Process –
California Cancer Registry
EHRs – where are we today?
“Next Generation Registries”
• EHR Data Capture
– As EHR adoption increases, we can envision a day when
registry data is captured much differently
• Health Information Exchange
– We can use HIE to leverage summary case data bound for
the registry and make it available for providers, thus
improving care (care coordination)
• Higher Data Quality
– If case data is also being used for care coordination, it will
have higher data quality (completeness, timeliness,
correctness)
Characteristics of
“Next Generation Registries”
• Timely Case Ascertainment and Data Submission by clinicians
– A next generation registry can leverage electronic submission from EHRs to perform
rapid case ascertainment at the registry
– Allowing registrars to become more information analysts rather than data entry
operators
• Structured Data
– EHR structured data entry (templates) offer a mechanism for substantially improving
the data and reducing the manual abstraction burden (and cost)
• A Complete Patient Record
– A “complete” picture can only be assembled by gathering registry submission data
from multiple facilities (can be facilitated through HIE)
• Immediate Care Improvement with Case Summary Data
– A ‘patient case summary’ document repository (PCDR) can be leveraged to support
care coordination across multiple providers
– Data bound for the registry is sent to the PCDR where it can
be made available to *all* providers that care for the patient
Project INSPIRE
INSPIRE – INteroperability to Support
Practice Improvement, Disease REgistries,
and Care Coordination
Goal-- “To improve the acquisition and
exchange of patient data in high impact
conditions in order to support care
coordination, practice improvement, and
longitudinal disease registries”
Note: INSPIRE will be demonstrated with cancer as the first “high-impact” condition
INSPIRE Should...
• Have immediate value to providers and patients
– “patient-centered document repository” (PCDR) accessible to
California’s HIE network EHRs to support care coordination
• Demonstrate the use of disease-specific data exchange
standards (ie, ‘caCCD’)
– ASCO/HL-7 CDA standard for Cancer Treatment Summaries
– CDC CDA standard for eligible provider reporting to registries (S2, MU)
• Demonstrate point-of-care data capture for next generation
registries
– Capture structured and coded breast cancer case summaries for 6
months across Athena’s participating institutions
– Evaluate data from Athena-INSPIRE demonstration to same case data
in the California Cancer Registry (CCR)
California Health eQuality (CHeQ)
ARRA (2009)
~34B invested
In Health IT
Cal
eConnect
$38.7 M
Apr 2010
~17.5 M
Oct 2012
CHeQ
Calif. Health
eQuality
program
California
Cancer Registry
(CCR)
Institute for Population
Health Improvement
$38.7 M
Mar 2010
ONC State Health
Information
Exchange Grants
$547.7 M (57 jurisdictions)
①Integrating Clinical Care with public
health
②Trusted Exchange Infrastructure
③Increasing Public Health Capacity
④Accelerating HIE Adoption
⑤Monitoring HIE Adoption
⑥Communication and Education
CHeQ Project Portolio (Feb 2013)
CHeQ’s Project INSPIRE
“Integrating Clinical Care with Public Health”
Dr. Kizer
Dr. Hogarth
Rim Cothran
INSPIRE and Athena –
“Structured Data and Exchange Supporting Registries”
The INSPIRE-Athena Initiative
• Goals
– Demonstrate structured data acquisition using EHR infrastructure
– Submit data to the CHeQ PCDR for comparison with traditionally acquired
cancer registry data for the same case
• Workplan Elements (12 months: Feb 2012 – Jan 2013)
– Workflow analysis
• The “as is” -- entire process from data generation to arrival at California Cancer Registry
• The “to be” – what is should be given EHRs and need to be timely, correct, etc..
– Electronic Data Capture (EDC)
• Of breast cancer cases diagnosed after implementation within Athena
• Implement data capture process for ~6 months
– Cancer Data Exchange
• Implement data submission as “caCCD” (ASCO/HL-7 CDA) from Athena repository to
CHeQ PCDR
ATHENA Opportunities Using Ideal Data
Sources
Continuous Learning System
Ideal Data Source
Patient Reported
data
Provider verified data
(CaCCD Notion)
Intake symptoms:
Risk factors, lifestyle
Clinical stage
Acute Treatmentrelated symptoms:
toxicity triggered by
interventions
Treatment Plan
Surgical stage
Systemic Treatment
Chronic
phase/Follow-up:
recurrence symptoms, Treatment Summary
toxicity
Services/Processes
• Automated risk assessment
• Quality Improvement
• Registry reporting
• Clinical Research
o Genetic
• Trial Matching and
counseling
registration
o Peer support
• Internal Registries
o Smoking
• Automated services
cessation
o Social work
for patient
o Psycho• Social networks
Oncology
o Life Training
ATHENA: meaningful use of patient
and physician reported data
Continuous Learning System
Subjectiive
• Patient
Reported
Outcomes
Objective
• Clinical Data
Elements
(caCCD)
Assessment
• Outcomes
Plan and
Improve
• Interventions
• Services
caCCD - Structuring Cancer Care Data
CDA Templates – extending CCD
American Society for Clinical Oncology, ASCO’s Approach to Oncology Standards, Feb 2013
caCCD: Breast
Diagnosis
caCCD
Clinical Stage
Tx Plan
Surgical Stage
Radiation Tx
Treatment
Summary
Several Proposed ‘Notes’ that make
up entire caCCD
- Any Treating Physician can ‘sign up’
to complete any sub-caCCD note
- Completion of Diagnosis triggers
down-stream notes
- Once note is completed & signed
(verified), data can be used to autopopulate databases like EMR/EHR,
State Registry, trial matching services,
etc.
- Ideally, notes for a patient are
available for physicians from other
institutions that are involved in their
care (create single source of data for
patient)
caCCD
caCCD: Breast using Data Standards
Example of draft Diagnosis Note
Diagnosis
Clinical Stage
Tx Plan
Surgical Stage
Radiation Tx
Treatment
Summary
•
Coded Data Elements at point of entry
caCCD: Breast using IHE Standards
The Retrieve Form for Data Capture (RFD) profile provides a method for gathering data
within a user’s current application to meet the requirements of an external system.
RFD supports the retrieval of forms from a form source (), display and completion of
a form (), and return of instance data from the display application to the source
application () with security built in for data capture process/trip.
caCCD Breast

caCCD Breast
Diagnosis Note
Note Source

Institutional EMR

Workflow analysis
• Purpose:
– To understand the current work flow at the
different UC academic medical centers for breast
cancer registry needs
– To understand the current work flow in registry
entry
Process
• Introductions
• Interviews
– Clinicians
– Support staff
– Registry & data entry staff
• Shadowing clinical and research staff for
workflow understanding
• Collection of any SOPs
• Chart/Data reviews
Output
• Process map
– Showing the different participants
– Showing the sequence of steps
• General discussion with all interviewees on
– How to increase the quality of the process
Cooperative Group Processing Activities
50 ft x 5 ft in 8pt font
Steps for Opening a
Phase III Cooperative Group Trial1
Cooperative
Group
>458
CTEP /
CIRB
>216
Cancer
Center
>95
>399
>179
>73
>651
…Decision Points (chute or ladder)
59
37
22
148
Potential Loops2 (all chutes)
26
15
8
49
No. of Groups Involved
11
14
11
36
Process Steps
…Working Steps
Total
>769
1. Representative Cooperative Oncology Group and Comprehensive Cancer Center
2. Process steps reported only show one loop in the process. Actual development frequently includes
multiple loops
Reviews Requiring Response
Calendar Days of Reviews and Group response by review type* for Phase III Cooperative Group
Studies (n=28 studies) activated from 2000 - 2005
CTEP/CIRB Review Group Response
Time
Time
Reviewer
n
median
min
max
median
min
max
Time Difference
(Positive,
Group slower than NCI)
Concept
CRM
CTEP
14
60.0
15
104
71.5
1
368
CEP
CTEP
4
48.0
19
66
35.5
22
84
Concept Re-review
CTEP
3
6.0
1
6
17.0
1
56
Industry **
Industry
14
32.5
1
168
Protocol Review Comm.
CTEP
33
32.0
5
69
32.0
1
188
Protocol Re-review
CTEP
22
7.5
1
84
8.5
1
266
CIRB
CIRB
43
29.0
5
55
21.0
2
83
Re-review after CIRB
CTEP
19
12.0
1
32
17.0
1
140
Protocol Re-Review
CTEP
2
9.0
1
17
5.5
5
6
CIRB
CIRB
10
12.0
2
34
29.5
3
67
Re-review after CIRB
CTEP
1
1.0
1
1
22.0
22
22
+11.5
-12.5
+11.0
Protocol
0.0
+1.0
CIRB
-8.0
+5.0
Amendment ***
• Reviews listed are only are partial list of required reviews. Other reviews including RAB, PMB, and CTSU
are required but were not available at the time of data collection.
** Group response time to industry cooperation not available
*** Recorded time for amendments only include study amendments prior to study activation
-3.5
+17.5
A Perception Issue: Processing Time
Variance
High Variance = High Uncertainty = High Dissatisfaction
Maister The Psychology of Waiting Lines
Blue – SRC time
Red - PI holding time
Green - IRB time
Key problem: High Variance
Deliverables to ONC
April 15, 2013
– Project Plan – and Standards Plan Document
– Meet with Peter Yu ASCO (HIT CaQLINK integration ). May 11 2013
June 1, 2013
– Workflow Analysis completed at initial sites; ongoing site visits and final workflow analyses
through month of June.
July 1, 2013
– Progress Report #1 -- A report on the activities during the Q1-Q2 reporting period
– Workflow Analysis Report – and revision of implementation plan, and plan for stds harmonization
July 15, 2013
– 2 Athena sites start electronic collection of structured
August 1, 2013
– Athena-CHeQ Interface Go-live: using the ASCO-HL-7 CDA Treatment Plan and Summary (caCCD)
October 1, 2013
– Progress Report #2 – Q3 reporting period (July 1 – September 30, 2013)
January 31, 2014
– Final Report
Deliverables to ONC
July 15, 2013
•
Initial Athena sites will have started electronic collection of structured data on breast
cancer cases (first cases) using the workflow jointly identified by the site and Athena, and
documented in the Implementation Plan.
August 1, 2013
• Athena-CHeQ Interface Go-live: Athena interface with CHeQ’s Patient-centered Document
Repository HIE system goes live, and breast cancer case data starts flowing to CHeQ from Athena
using the ASCO-HL-7 CDA Treatment Plan and Summary (caCCD)
October 1, 2013
• Progress Report #2 -- A report on the activities during the Q3 reporting period (July 1 – September
30, 2013)
January 31, 2014
• Final Report -- A final report from Athena on the results of the project – data submission, lessons
learned, experience with the implementation of the ASCO-HL-7 CDA Treatment Plan and Summary
(caCCD), recommendations.
Deliverables to Sites
• Clinical Care (Treatment Summary, risk assessment in
breast care for treatment, automated services)
• Registry reporting improvements (move away from data
mining and toward data verification; utilize expertise of
registrars to full potential)
• IT : developed technology that can be leveraged at all
sites and interoperable; reduce one-off methods for
finding data at site-specific level
• Research efficiency will be enabled by collection of
mission critical information as single source of data.
Internal registries can be automated