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Integration of Registry Data into Clinical Care Process

Session 119, February 13, 2019

Alexander Elbert, Senior Director, Patient Registry

Shathiya Navaneeth, IT Project Manager

Cystic Fibrosis Foundation (CFF)

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Alexander Elbert, PhD, PMP

Has no real or apparent conflicts of interest to report.

Shathiya Navaneeth

Has no real or apparent conflicts of interest to report.

Conflict of Interest

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• About Cystic Fibrosis Foundation (CFF)

• About Cystic Fibrosis Foundation Patient Registry (CFFPR)

• Uses of CFFPR data

• Shifting Paradigm for CFFPR data: CFSmartReports

• Using CFSmartReports for

o Pre-visit planning

o Population management

o Clinical trial recruitment

o Co-production of care

• CFFPR and EMR data exchanges

• Summary and future steps

Agenda

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• Describe main uses of disease-specific registry data

• Explain how registry data provides value to clinicians

• Demonstrate practical use of registry data in clinical care

• Identify differences between EMR and registry data

Learning Objectives

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Autosomal recessive genetic disorder

• 800 - 900 new cases/year in USA

• 30 - 35,000 US patients (80 - 110,000+ worldwide)

Most common life-shortening inherited disease of Caucasians

• Complex, multi-system chronic disease

• Majority of deaths due to lung disease

Cystic Fibrosis (CF)

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CF Foundation History

Founded by parents of CF

patients in 1955

Cystic Fibrosis Foundation

now

Mission: To assure the

development of means to cure

and control CF and to improve

quality of life for individuals with

CF

Mission: To cure cystic fibrosis

and to provide all people with

the disease the opportunity to

lead full, productive lives by

funding research and drug

development, promoting

individualized treatment, and

ensuring access to high-quality,

specialized care.

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CF Survival Data

Cystic Fibrosis Foundation Patient Registry, Annual Data Report 2017

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CF Foundation Strategic Pillars

Field / fundraising /

investments

Communications

People, operations,

& technology

Accelerate

research

and drug

develop-

ment to

enable

discovery

of a cure

Define and

enable

high-

quality,

specialized

care

Engage and

enable

people with

CF to lead

full and

productive

lives

Ensure that

patients

have

access to

care

I II IVIII

Program areas

Enabling

functions

Research &

Tx DevtClinical Affairs

Access &

Advocacy

Community

Partnerships

• Investigators

• TDNs

• Patients &

families

• Care

providers

• Care centers

• Patients &

families

• Payers

• Policy-makers

• Regulators

• Patients &

families

• Patients and

families

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CF Foundation Care Center Network

The CF Foundation sustains a network of 121 accredited CF care

centers (comprised of 121 pediatric care programs, 105 adult care

programs and 51 affiliate programs) across the United States.

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CFF Patient Registry HistoryMetrics on

center

outcomes

made

public

CF Registry

started by

Dr. Warwick

Paper

questionnaires

Annual

• Demographics

• Treatments

• Exacerbations

1960

s

1980

s

Data transfer on

floppy disks

Quarterly

• Height

• Weight

• Pulmonary

Functions

• Microbiolog

y

1994

Center

Specific

Reports

1999

Separate

reports

created

for clinical

and lay

audience

s

2003

Genotypes

Web-based

platform

Encounter

based

• Height

• Weight

• Pulmonary

Functions

• Microbiolog

y

2002

Detailed

medication

collection

• Mucolytics

• Inhaled

antibiotics

• Bronchodilat

ors

• Corticosteroi

ds

2006

Annual

Reports

Produce

d

Enhanced

Web-based

platform

Encounter based

• Ability to embed

studies

• CRMS and

CFTR –related

diagnoses

added disorders

• Expanded data

collection in

microbiology,

genotypes and

infants under 2

y.

2017

Centers

started

using

registry

data via

CFSmartRe

ports in

pre-visit

planning

2010

CFF begins to

maintain Registry

under leadership of

Dr. Bob Beall

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CFFPR Today

“The best registry in

America, in my opinion,

is the Cystic Fibrosis

registry”

Martin Adel Makary, M.D., M.P.H.

Surgical Director, Johns Hopkins Multidisciplinary Pancreas

Clinic

Professor of Surgery, Interview to National Public Radio, 2015

Inclusion criteria• Seen at CF Care Center

• Consent to participate

Data collected at:• Diagnosis

• Clinic visits

• Hospitalizations and Home IV treatments

• Annually

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• Generalizability

– Approximately 84% of individuals with CF in the US enrolled

• Lost-to-follow-up

– Retention rate for the 2009 cohort through 2013 was 90.6%

• Completeness

– 95% of encounters and 90% of hospitalizations in the medical record captured

• Accuracy

– Registry data matched the medical record 82.6% to 99.9% of the time depending on the data element

About CFFPR Data

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Data for Clinical Trials

Data for Phase IV studies

Quality Improve-

ment

Data Researc

h

Internati-onal

Compar-isons

Disease Surveilla

-nce

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CF RegistryCF Registry

Data Research Results

- Guidelines- Treatment

- Knowledge

Uses of the CFFPR

- Publications

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Uses of CFFPR data: Annual Reports

Highlights Report:

4 pages

Annual Data Report:

85-90 pages

Center Specific

Report:

182 pages

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Uses of CFFPR data: Annual Reports

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Uses of CFFPR data: Data Transparency

“In December 2006,

CFF succeeded in

persuading its centers

to make public their

individual results,

adjusted for the

severity of disease in

their population “

Gawande, Atul. Better. New

York: Henry Holt and

Company, 2007

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Registry data

collection

Data transfer to CFF and

cleansing

Data processin

g

Data reporting

CF clinic

CF RegistryCF Registry

Accelerating data availability

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Patient-centric data

There are ~4000 patients in CFFPR whose data has been

entered by CF Centers located in at least three different States.

Images: GNU from https://icons8.com

CFFPRCFFPR

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How CFFPR data brings value to clinicians

• History from birth to now (or to death) for majority patients

• All disease-specific information in one place

• Reports highlight missing or recommended tests/screening

• Identifying patients for clinical trials

• Quality improvement (CF Learning Network)

• Analytic capabilities

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• About Cystic Fibrosis Foundation (CFF)

• About Cystic Fibrosis Foundation Patient Registry (CFFPR)

• Uses of CFFPR data

• Shifting Paradigm for CFFPR data: CFSmartReports

• Using CFSmartReports for

o Pre-visit planning

o Population management

o Clinical trial recruitment

o Co-production of care

• CFFPR and EMR data exchanges

• Summary and future steps

Agenda

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Shifting Paradigm for CFFPR data

CFSmartReports – reporting application with patient–level data

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Pre-visit planning

Weekly

Meetin

g

Weekly

Meetin

g

Select patients

to be seen

soon

Print one or all

reports and

review data

Clinical

care

decisions

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Pre-visit planning: care decision examples

• Review pulmonary function and nutrition trends

• Identify any labs required (e.g. glucose screening)

• Analyze patient’s current and past medications and complications

• Evaluate patient’s microbiology infections

• Identify patients potentially eligible for clinical trial enrollment

Weekly

Meetin

g

Weekly

Meetin

g

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Patient Summary Report (PSR)Home IV

treatment

Hospitalization

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PSR: Microbiology History

Tim

eli

ne

of

cu

ltu

res

Species

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Population Management Reports

• Pre-built customized reports to identify patient

population that can benefit from special

management (e.g. low spirometry function)

• Custom reports requested by the care teams

• Integrated with Patient Cohort Tool

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Population Management Reports

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Patient Cohort Tool

• Group patients based on

one or more clinical

criteria

• Over 400 data fields

from CFFPR forms

available to choose from

• Cohort fields pull

patient’s most recent

data

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Patient cohorts used in population management

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Clinical Trial Recruitment

20+ active clinical trials are hosted on CFSmartReports

Study Identified Potentially

eligible patient

list + relevant

data

Query built based on

inclusion and

exclusion criteria of

the study protocol

Daily

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Clinical Trial Recruitment

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0

20

40

60

80

100

120

140

9/1/2017 11/1/2017 1/1/2018 3/1/2018 5/1/2018

Number of times Rare CFTR Mutation Cell

Collection Query (RARE)run

Number times run

CFSmartReports contributes to enrollment in clinical trials

Clinical Trials in CFSmartReports

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Co-production of Care

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Co-production of care

“I want to know how many of you have HEARD of

CFSmartReports, how many of you have RECEIVED your

CFSmartReports, and how many of you (like me) have

never heard of it.”

“CFSmartReports

should be an essential

part of your clinic visit.”

Gunnar Esiason*

9/17/2018

*Gunnar has over 6,000 followers on Facebook and Twitter

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CFSmartReports: Other functions

• Benchmarking of health outcomes

• Data verifications

• Data entry analyses

• Testing new measures

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Pre-visit planning

Share Summary Reports

with patients

Review patients’

clinical

trial eligibility

Population management

Other

54.7%

51.4%

43.1%

22.0%

7.7 %

Based on 2018 survey of the CFF Care Center Network (n=328)

How clinicians use CFSmartReports

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• About Cystic Fibrosis Foundation (CFF)

• About Cystic Fibrosis Foundation Patient Registry (CFFPR)

• Uses of CFFPR data

• Shifting Paradigm for CFFPR data: CFSmartReports

• Using CFSmartReports for

o Pre-visit planning

o Population management

o Clinical trial recruitment

o Co-production of care

• CFFPR and EMR data exchanges

• Summary and future steps

Agenda

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CFFPR and EMR differences

Data area EMR Records CFFPR

Medications Detailed records for each

prescribed drug

Classes of medications,

e.g. classes of antibiotics

Pulmonary

Exacerbations

N/A Collected, one of key

concepts in CF

Complications/

Comorbidities

Could be in medical

transcription

Granular data

CFTR Genotype Scanned lab reports Two alleles and poly-T

tract data for select

mutations

SES data, participation

in clinical trials, etc.

May or may not be

present

Collected for 30-95% of

registry population

General rule: CFFPR collects only data that is relevant or might be

relevant to health outcomes of people with CF

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CFFPR and EMR data exchanges

1. Most common EMR in the CF Care Center Network: Epic

2. Both inpatient and outpatient data are needed for CFFPR

3. Not all data elements required for CFFPR are in EMR

Pilot project launched November 2018 to evaluate feasibility of

electronic data exchanges between EMRs and CFFPR

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CFSmartReports Usage by Program, 2017-18

100-150 CF care programs are using CFSmartReports every week

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Patient Summary Report (PSR) Downloads, 2017-18

1000 or more PSRs are downloaded by CF Care Teams every week

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• “Saves an incredible amount of time to not have to dig through labs, charts, etc… joy in work!”

• Allows to use time more valuably to track down referrals and other important info

• “Provides great historical information about each patient (we project the report on the screen during PVP meetings and have had some great team dialogue about care)”

• “Serves as a great data quality check – we have found some missing data variables based on reviewing the reports together”

• “Motivates our team to be more responsive to changes in data -e.g. respond to a small change in lung function that we may not have responded to before”

• “Highlights which patients are not consented for PortCF and getting them on board so they can benefit from these reports”

CFSmartReports feedback from care teams

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CFFPR data is helping care teams with pre-visit planning, population

management, and finding patients eligible for clinical trials. CF-specific

PSRs stimulate interest of patients and their families in co-production of

care. Use of CFSmartReports presents further opportunities to drive

care improvement by:

• Development of appropriate measures to evaluate outcomes

• Delivering clinical care alerts

Predictive analytics? Patients like me reports?

Decision Support? Giving access to patients and

families? Other?

Summary

Our model can be adopted by other disease foundations or

healthcare organizations that have disease-specific registries.

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Contact info: Reghelp@cff.org

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