precise patient registries for clinical research and population management
DESCRIPTION
Patient registries have evolved from external, mandatory reporting databases to playing a critical role in internal clinical research, clinical quality, cost reduction, and population health management. This slide deck describes how to design those precise registries.TRANSCRIPT
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Dale Sanders, November 2014
Precise Patient Registries:
The Foundation for Clinical Research &
Population Health Management
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Agenda
• Assertions and criticisms of the current state
• What is a patient registry?
• History and definitions
• What should we be doing differently?
• Designing precise registries
• An example from our registry work at
Northwestern University
• Nitty Gritty data details
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Acknowledgements & Thanks
• Steve Barlow
• Cessily Johnson
• Darren Kaiser
• Anita Parisot
• Tracy Vayo
• And many others…
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Poll Question
Have you ever been directly involved in the design
and development of a patient registry?
Yes
No
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Assertion #1Without precise definitions and registries of patient types,
you can’t have…
• Precise clinical research
• Precise comparisons across the industry
• Precise financial and risk management
• Precise, personalized healthcare
• Predictable clinical outcomes
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Assertion #2
• We can’t keep building disease registries at each
organization, from scratch
• It takes too long, it’s too expensive, it’s not
standardized to support disease reporting,
surveillance, and comparative medicine
• Federal involvement has helped, but projects are
moving too slowly
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Healthcare Analytics Adoption Model
Level 8Personalized Medicine
& Prescriptive Analytics
Tailoring patient care based on population outcomes and
genetic data. Fee-for-quality rewards health maintenance.
Level 7Clinical Risk Intervention
& Predictive Analytics
Organizational processes for intervention are supported
with predictive risk models. Fee-for-quality includes fixed
per capita payment.
Level 6Population Health Management
& Suggestive Analytics
Tailoring patient care based upon population metrics. Fee-
for-quality includes bundled per case payment.
Level 5 Waste & Care Variability ReductionReducing variability in care processes. Focusing on
internal optimization and waste reduction.
Level 4 Automated External ReportingEfficient, consistent production of reports & adaptability to
changing requirements.
Level 3 Automated Internal ReportingEfficient, consistent production of reports & widespread
availability in the organization.
Level 2Standardized Vocabulary
& Patient RegistriesRelating and organizing the core data content.
Level 1 Enterprise Data Warehouse Collecting and integrating the core data content.
Level 0 Fragmented Point SolutionsInefficient, inconsistent versions of the truth. Cumbersome
internal and external reporting.
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Achieving “High Resolution” Medicine
It starts with precise registries
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Patient Registry Definitions
Computer Applications used to capture, manage, and provide information on specific conditions to support organized care management of patients with chronic disease.”
— ”Using Computerized Registries in Chronic Disease Care” California Healthcare Foundation and First Consulting Group, 2004
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AHRQ’s Patient Registry Definition
A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves one or more predetermined scientific, clinical, or policy purposes.”
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AHRQ’s Patient Registry Definition
The National Committee on Vital and Health Statistics describes registries used for a broad range of purposes in public health and medicine as "an organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual persons who have either a particular disease, a condition (e.g., a risk factor) that predisposes [them] to the occurrence of a health-related event, or prior exposure to substances (or circumstances) known or suspected to cause adverse health effects."
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Patient Registry Definitions
A database designed to store and analyze information about the occurrence and incidence of a particular disease, procedure, event, device, or medication and for which, the inclusion criteria are defined in such a manner that minimizes variability and maximizes precision of inclusion within the cohort.”
— Dale Sanders, Northwestern University
Medical Informatics Faculty, 2005
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History of Patient Registries
Historically, the term implies stand-alone, specialized products
and clinical databases for external reporting
Long precedence of use and effectiveness in cancer
1926: First cancer registry at Yale-New Haven hospital
1935: First state, centralized cancer registry in Connecticut
1973: Surveillance, Epidemiology, and End Results (SEER)
program of National Cancer Institute, first national cancer registry
1993: Most states pass laws requiring cancer registries
Pioneered by GroupHealth of Puget Sound in the early 1980s
for diseases other than cancer
“Clinically related information system”
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What’s a Diabetic Patient?
How do we define a “diabetic” patient with data?
• Intermountain, 1999: 18 months to achieve consensus
• Northwestern, 2005: 6 months to achieve consensus,
borrowing from Intermountain and other “evidence
based” sources
• Cayman Islands, 2009: 6 weeks to achieve consensus,
borrowing from Intermountain, Northwestern, and BMJ
• Medicare Shared Savings and HEDIS: 54 ICDs
• Meaningful Use: 43 ICDs
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Sources of “Standard” Registry DefinitionsThere is growing convergence, but still lots of disagreement
HEDIS/NCQA
Medicare Shared Savings
NLM Value Set Authority Center
Meaningful Use
NQF
Specialty Groups and Journals
OECD
WHO
And others…!
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Precise Patient Registries Example
Asthma
Supplemental ICD9 (38,250)
Medications
(72,581)
Problem List
(22,955)
ICD9 493.XX (29,805)
Additional
Potential Rules
(101,389)
17
18
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Medscape Summary of Article
• 11.5 million patient records
• 9000 primary-care clinics across the United
States
• 5.4% of those likely to have diabetes in the
databases were undiagnosed
• Undiagnosed proportion rose to 12% to 16% in
"hot spots," including Arizona, North Dakota,
Minnesota, South Carolina, and Indiana
• Patients without an ICD for diabetes received
worse care, had worse outcomes
19
"It may be that a 'free-text' entry was added to the
record, but unless it is coded in electronically, the
patient has not been included in the diabetes register
and cannot therefore benefit from the structured care
that depends on such inclusion." -- Dr. Tim Holt
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Types of Registries, Not Necessarily
Disease Oriented
Product Registries
● Patients exposed to a health care product, such as a drug or a device
Health Services Registries
● Patients by clinical encounters such as
‒ Office visits
‒ Hospitalizations
‒ Procedures
‒ Full episodes of care
Referring Physician Registry
● Facilitates coordination of care
Primary Care Physician Registry
● Facilitates coordination of care
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More Types of Registries
Scheduling Events Registry
● Facilitates analysis for Patient Relationship Management (PRM)
● Can drive reminders for research and standards of care protocols
Mortality registry
● An important thing to know about your patients
Research Patient Registry
● Clinical Trials
● Consent
Disease or Condition Registries
● Disease or condition registries use the state of a particular disease or condition as the inclusion criterion.
Combinations
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Innumerable Uses & Benefits
Registries
How does my drug perform in disease prevention, progression, and cure?
How well am I managing diseases?
Who else is treating patients like this?
How is this disease expressed in the genome?
How do I analyze patient trends and outcomes for a disease?
How do I know which drug/procedure works best for me?
Who else matches my specific profile for disease, medication, procedure, or device… and can I interact with them?
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Patients exist in one of three states, relative to a patient registry
23
The patient is a member of a particular registry; i.e., they fit the inclusion criteria
Patient was once a member of a registry and fit the inclusion criteria, but is now excluded. The exclusion could be “disease free.”
Disease Registry
On Registry
Off Registry
At Risk
The patient fits the profile that could lead to inclusion on the registry, but does not yet meet the formal inclusion criteria, e.g. obesity as a precursor to membership on the diabetes and or hypertension registry.
24
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Patient Registry Engine
LAB RESULTS
CPT CODES
ICD9 CODES
MEDICATIONS
CLINICAL OBS
PROBLEM
LIST
PATIENT
VALIDATION
CLINICIAN
VALIDATION
PATH
DISEASE
REGISTRY
MORTALITY
REGISTRATION
SCHEDULING
INCLUSION
CRITERIA &
STRUCTURED
EXCLUSION
CODES
PATIENT
PROVIDER
RELATIONSHIP
* DISEASE MANAGEMENT
* OUTCOMES ANALYSIS
* RESEARCH
* P4P REPORTING
* CLINICAL TRIALS ENROLLMENT
RAD RESULTS
TUMOR REG
COSTS &
REIMBURSEMENT
DATA
CARDIOLOGY
IMAGING
How do we define a particular disease?
Who has the disease?
What is their demographic profile?
Are we managing these patients according to accepted best
protocols?
Which patients had the best outcomes and why?
Where is the optimal point of cost vs. outcome?
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The Healthcare Process vs. Supportive Data Sources
Diagnostic systems
Lab System
Radiology
Imaging
Pathology
Cardiology
Others
DiagnosisRegistration &Scheduling
PatientPerception
Orders & Procedures
Results & Outcomes
Billing &AccountsReceivable
Claims Processing
EncounterDocumentation
ADT System
Master Patient Index
Pharmacy Electronic
Medical Record
SurveysResults
Billing and AR
System
Claims Processing
System
Patient data lies in many disparate sources
Geometrically More Complex In Accountable Care and Most IDNsA Data Warehouse Solves the Data Disparity Problem
EDWA single data perspective
on the patient care process
Physician Office X
Hospital Y Physician Office Z
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A well designed data warehouse can be the platform that feeds
many of these registries, and more, in an automated fashion
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Mini-Case Study From Northwestern University Medicine, 2006
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Target Disease Registries*‒ Amyotrophic Lateral Sclerosis
‒ Alzheimer's
‒ Asthma
‒ Breast cancer
‒ Cataracts
‒ Chronic lymphocytic leukemia
‒ Chronic obstructive pulmonary disease
‒ Colorectal cancer
‒ Community acquired bacterial pneumonia
‒ Coronary artery bypass graft
‒ Coronary artery disease
‒ Coumadin management
‒ Diabetes
‒ End stage renal
‒ Gastro esophageal reflux disease
‒ Glaucoma
‒ Heart failure
‒ Hemophilia
‒ Stroke (Hemorrhagic and/or Ischemic)
‒ High risk pregnancy
‒ HIV
‒ Hodgkin's Disease
– Hypertension
– Lower back pain
– Systemic Lupus
– Macular degeneration
– Major depression
– Migraines
– MRSA/VRE
– Multiple myeloma
– Myelodysplastic syndrome & acute leukemia
– Myocardial infarction
– Obesity
– Osteoporosis
– Ovarian cancer
– Prostate cancer
– Rett Syndrome
– Rheumatoid Arthritis
– Scleroderma
– Sickle Cell
– Upper respiratory infection (3-18 years)
– Urinary incontinence (women over 65)
– Venous thromboembolism prophylaxis
*Northwestern
University Medicine,
2006
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Inclusion & Exclusion for Heart Failure Clinical Study
31
• Inclusion codes based entirely on ICD9, which was a
good place to start, but not specific enough● Heart failure codes for study inclusion
‒ 398.91, 402.01, 402.11, 402.91, 404.01, 404.03, 404.11, 404.13, 404.91, 404.93, 428.xx
● Exclusion criteria for beta blocker use†
‒ Heart block, second or third degree: 426.0, 426.12, 426.13, 426.7
‒ Bradycardia: 427.81, 427.89, 337.0
‒ Hypotension: 458.xx
‒ Asthma, COPD: see above
‒ Alzheimer's disease: 331.0
‒ Metastatic cancer: 196.2, 196.3, 196.5, 196.9, 197.3, 197.7, 198.1, 198.81, 198.82, 199.0, 259.2, 363.14, 785.6, V23.5-V23.9
● † Exclusion criteria were only assessed for patients who did not have a medication prescribed; thus, if a patient was prescribed a medication but had an exclusion criteria, the patient was included in the numerator and the denominator of the performance measure. If a patient was not prescribed a medication and met one or more of the exclusion criteria, the patient was removed from both the numerator and the denominator.
Acknowledgements to Dr. David Baker, Northwestern University Feinberg School of Medicine
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Disease Registry “Exclusions”
Our first attempts at adjusting the numerator
The industry will need standard vocabularies for excluding patients
Removing patients from the registry whose data would otherwise
skew the data profile of the cohort
“Why should this patient be excluded from this registry, even though
they appear to meet the inclusion criteria?”
Disease Registry
On Registry
Off Registry
At Risk
Patient has a conflicting clinical condition
Patient has a conflicting genetic condition
Patient is deceased
Patient is no long under the care of this facility or
physician
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Not all patients in a registry can functionally participate in a protocol, but
you can’t just exclude and ignore them. You still have to treat them and
their data is critical to understanding the disease or condition.
At Northwestern (2007-2009), we found that 30% of patients fell into one
or more of these categories:
• Cognitive inability
• Economic inability
• Physical inability
• Geographic inability
• Religious beliefs
• Contraindications to the protocol
• Voluntarily non-compliant
Our View On “Exclusion” Evolved
Excluding patients might be a bad idea in many situations
33
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Diabetes Registry Data Model
35
Diabetes
Patient
Typical Analyses Use Cases
• How many diabetic patients do I have?
• When was their result for each HA1C, LDL, Foot Exam, Eye Exam over last 2 years?
• What are all their medications and how long have they been taking each?
• What was addressed at each of their visits for the last 2 years?
• Which doctors have they seen and why?
• How many admissions have they had and why?
• What co-morbid conditions are present?
• Which interventions (diet, exercise, medications) are having the biggest impact on LDL, HA1C scores?
Procedure
History
Vital Signs
History
Current Lab
Result
Lab Result
History
Office
Visit
Exam
Type
Exam
History
Diagnosis
History
Diagnosis
CodeProcedure
Code
Lab TypeThis data model applies to virtually all
disease registries. Just change the name
of the central table.
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Building The Diabetes Registrydiabetes (registries_dm)
mrd_pt_id int
birth_dt datetime
death_dt datetime
gender_cd varchar(20)
problem_list_diabetes... int
encntrs_diabetes_dx_... int
orders_diabetes_dx_n... int
meds_diabetes_dx_num int
last_hba1c_val float
last_hba1c_dts datetime
max_hba1c_val float
max_hba1c_dts datetime
min_hba1c_val float
min_hba1c_dts datetime
tobacco_user_flg varchar(50)
alcohol_user_flg varchar(50)
last_encntr_dts datetime
last_bmi_val decimal(18, 2)
last_height_val varchar(50)
last_weight_val varchar(50)
data_thru_dts datetime
meta_orignl_load_dts datetime
meta_update_dts datetime
meta_load_exectn_guid uniqueidentifier
Column Name Data Type Allow Nulls
Problem List
Orders
Encounters
Epic-Clarity
Problem List
Orders
Encounters
Cerner
CPT’s Billed
Billing Diagnosis
IDX
Inclusion
and
Exclusion
Criteria
for
Specific
Disease
Registry
ETL Package
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Data Quality & The Disease Registry
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Investigating Bad Data
3345 kg = 7359 lbs
Hello, CNN?
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Closed Loop AnalyticsIdeally, disease registry information should be available at point of care
Guideline-based intervals for tests, follow-ups, referrals
Interventions that are overdue
“Recommend next HbA1C testing at 90 days because patient is not at
goal for glucose control.”
How do you implement this in Epic?
Invoke web services within Epic programming points to display
information inside Epic
Invoke external web solutions within Hyperspace
Write data back in epic
FYI Flags
CUIs
Health Maintenance Topics
Etc.
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cc
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Geisinger & Cleveland Clinic Make It Commercially Available
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Nitty Gritty Data DetailsThank you, Tracy Vayo
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Poll Question
Does your organization have a patient registry data
governance and stewardship process?
• Yes and it’s very active
• Yes, somewhat
• No, but we are talking about it
• No, not at all
• I’m not part of an organization that manages
patient registries
43
Not
exhaustive; for
illustrative
purposes only
Diabetes,
continued
Not
exhaustive; for
illustrative
purposes only
Not
exhaustive; for
illustrative
purposes only
Sepsis,
continued
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In Conclusion
• Precise registries are required for precise, high resolution healthcare
• So much of what we do depends on registries and the dependence is growing
• Precise registries are tough to build
• We can’t afford to keep building them from scratch
• Federal efforts at standardization are moving slowly
• Precise registries are a commercial differentiator in the vendor space, but most vendors are stuck on ICD codes, only
• For questions and follow-up, please contact me
• @drsanders
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