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Journey from QI to Pragmatic Trial:
Towards a Learning Health System
Cheryl Bushnell, MD, MHS, Professor of Neurology
Director, Wake Forest Baptist Stroke Center
Objectives
• How does quality improvement inform research
and vice versa?
• Development of a pragmatic trial
• PCORI, the COMPASS trial and the stroke
service line—becoming a learning health
system
Wake Forest School of Medicine
What is a Learning Health System?
• “A learning healthcare system is one that is
designed to generate and apply the best
evidence for the collaborative healthcare
choices of each patient and provider; to
drive the process of discovery as a natural
outgrowth of patient care; and to ensure
innovation, quality, safety, and value in
health care.”
Institute of Medicine. http://www.iom.edu/Reports/2007/The-LearningHealthcare-System-Workshop-Summary.aspx
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TRAnsition Coaching for Stroke
(TRACS)
Neuroscience service line-funded, Neurology
department-built
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TRACS History: Adherence eValuation After
Ischemic stroke—Longitudinal (AVAIL)
What factors influence
medication-taking behavior?
Bushnell, et al. Arch Neurol 2010
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AVAIL II: Medication coaching
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TRACS history
• FY 2011: investment in personnel to enroll
patients and track outcomes using REDcap
• September 2012: Second stroke NP hired
• January 2014: RN was added to the team of 2
stroke NPs with task of calling patients 2 days
after discharge and allowing for transitional
care management billing
• As of Dec 2015, 675 patients have been
enrolled
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TRACS and Stroke Follow-up Clinic
• NPs assess for risk of readmission
• > 2 prior admissions in year prior to stroke
• NIHSS
• CHF, CAD
• Stroke complications (UTI, pneumonia, acute renal
failure)1
• Socioeconomic or psychosocial issues
• Discharged on warfarin and/or bridging rx
• TRACS RN: 2-day phone calls, then standardized and
comprehensive stroke NP assessment within 2 weeks.
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1. Strowd, et al. Am J Med Quality 2014
Factors Associated with 30-day
Readmissions
Variable
30-day
readmission
(n=46)
3 (1-7)
No 30-day readmission
(N=464)
P value
2 (1-5)
0.235
Prior hosp. n (%)
16 (34.8)
90 (19.5)
0.015
Transitional Stroke Clinic visit,
n (%)
Multi-risk (DM, CAD, or CHF)
None
1 of 3
2 of 3
3 of 3
Prior stroke or TIA, n (%)
Follow-up call completed, n
(%)
28 (60.8)
354 (76.3)
0.021
NIH Stroke Scale, median
(IQR)
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0.042
14(30.4)
22 (47.8)
8 (17.4)
2 (4.4)
23 (50.0)
34 (73.9)
244 (52.6)
150 (32.3)
56 (12.1)
14 (3.0)
134 (28.9)
364 (78.4)
0.003
0.478
Transitional Stroke Clinic Cuts 30-day
Readmissions by Half
Variable
30-day readmission OR
(95% CI)
P value
Transitional Stroke Clinic
visit
Multiple Comorbidities
(diabetes, CAD, or CHF)
0.518 (0.272, 0.986)
0.046
1.462 (1.029, 2.076)
0.020
Prior stroke/TIA
2.233 (1.188, 4.199)
0.004
Data presented as a platform at the 2016
International Stroke Conference by Christina
Condon, NP-C, manuscript under review by Stroke
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From TRACS to PCORI/COMPASS
TRACS model laid the groundwork
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Acknowledgement
Funding
• This research was supported through a Patient-Centered
Outcomes Research Institute (PCORI) Project Program
Award (PCS-1403-14532)
Disclaimer
• All statements in this presentation, including its findings
and conclusions, are solely those of the authors and do not
necessarily represent the views of the Patient-Centered
Outcomes Research Institute (PCORI), its Board of
Governors or Methodology Committee
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What is PCORI?
• Patient Centered Outcomes Research Institute
• nonprofit, nongovernmental organization
• authorized by Congress as part of Patient
Protection and Affordable Care Act of 2010
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PCORI and Engagement
Active incorporation of perspectives
beyond those of the researchers
across all phases of the research
project
Engagement is one way to make
research
• Patient-centered
• Findings matter to patients and
healthcare providers
• Lead to greater use and uptake
of research results
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What is a pragmatic clinical trial?
Patsopoulos. Dialogues in Clinical
Neuroscience 2011;13:217-24
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• Intended to provide information
that can be directly adopted by
healthcare providers.
• Conducted in routine clinical
settings.
• Large sample of broad
representative population
• Seek to determine the effectiveness
of an intervention in a real-world
setting to inform clinical decision
making.
• Address critical clinical choices faced
by patients, their caregivers,
clinicians, and/or delivery systems.
• Outcomes often ascertained from
EMR or administrative data
WHY A TRIAL OF
COMPREHENSIVE POST-ACUTE
STROKE SERVICES?
16
Leading Causes of Death in North Carolina
2013 Update
Wake Forest School of Medicine
NC State Center for Health Statistics
Stroke Hospital Discharge Rates by
County of Residence, NC, 2012
Stroke: ICD-9 codes 430-438.
Discharge rates per 100,000 population, age-adjusted to the 2000 U.S. standard population.
Data Source: North Carolina Division of Public Health, State Center for Health Statistics. North Carolina Inpatient Hospital Discharges, 2012.
Produced by the State Center for Health Statistics, 04/16/2014.
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Health Disparities in Stroke in NC
• 40% of stroke deaths in African American men occur
before age 65 vs 17% of white men
• 24% of stroke deaths in African American women before
age 65 vs 8% of white women
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19
Evidence for interventions that improve
post-acute care for the elderly and those
with CHF
• Transitional care management (Naylor, et al.
Health Affairs 2011;30:45-54)
• Billing codes for patients with psychosocial and/or
medical problems that represent moderate to high
complexity decision making (CPT codes 99495 and
99496)
• Only for the transitional care performed in the 30 days
after hospital discharge (www.cms.gov)
• 2 day post discharge interaction – phone, email, face to
face plus
• 7 or 14 day face to face by NP, PA or Physician
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TCM requirements for billing
• Services furnished at time of discharge (physicians or APPs)
• Obtain and review discharge information
• Interact with other health care professionals who will assume or
reassume care
• Provide education to the beneficiary, family, guardian, and/or caregiver;
• Establish or re-establish referrals and arrange for needed community
resources;
• Assist in scheduling required follow-up with community providers.
• Services furnished in postacute care (licensed clinical staff under
the direction of a physician or APP)
• Communicate with agencies and community services
• Provide education to the patient, family, guardian, and/or caretaker to
support self-management, independent living, and activities of daily
living;
• Assess and support treatment regimen adherence and medication
management;
• Identify available community and health resources
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21
Evidence for post-acute care
• Early supported discharge (ESD) is a hospitalbased multidisciplinary team with stroke
expertise providing coordinated rehab services in
the home
• Effectively reduces the negative impact of stroke:
• Improved functional outcomes, patient
satisfaction, reduced death and dependency at
6 months, reduced costs
• All data are from Europe and Canada, ESD is
now best practice in the U.K. and Canada
Prvu-Bettger, et al. Ann Intern Med 2012
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The Challenges
• Can an intervention to improve care for stroke
patients regardless of the settings and providers
be adapted to the U.S. health care system?
• What might be the best setting for testing a
complex intervention for post-acute care?
N
N
Stroke
Recovery
EE
W
W
SS
Secondary
Prevention
Comprehensive Coordinated Services
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What happens to stroke patients after
discharge now?
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Stroke Care: Many gaps remain
Stroke
Hyper
acute
Acute
Rehab
Community
• 42% of stroke patients were not referred to any
post-acute care (Gage, et al. U.S. DHHS 2009)
• 65% of patients under age 65 discharged without
post-acute services (Bettger, et al. J Am Heart Assoc
2015)
• No performance indicators for processes of care
after discharge
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Why Do Patients Have Trouble After
Discharge?
• New Disability—e.g., 44% cannot walk independently at
discharge
• Falls and fractures
• Aspiration pneumonia
• Deep vein thrombosis
• Infections
• Depression
• Adverse events associated with warfarin therapy
• Cognitive deficits (often undetected during acute
hospitalization) that interfere with function, and risk
factor and medication management.
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Caregivers are essential
Caregivers may be at risk for…
• Poorer mental health
• Less social contact and activity
• Depression and anxiety
• These factors can impact recovery of the
stroke patient
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Key Players in Post-Acute Care
Therapists
(PT, OT, SLP)
Community
Resources
Home
Health
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Patient
and
Caregiver
Stroke
Neurology
Team
Primary
Care
Stroke patient voices
“With my brain not working
properly, it was important to
“Stroke
is just slower,
as
have things
explained
hard on family
and in non-medical
terms. It
They for
carry
was members.
also important
the
31 year old, white
a large
portion
of the to
doctors
and the
therapists
female, living in rural NC, explainweight
of recovery.”
it multiple
times—not
high school graduate,
to assume I knew why I needed
associate’s degree (stroke
this.”
at 22)
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Stroke patient voices
60 year old, white
male, living in urban
NC, member of the
business community
“A follow-up phone call
has got to be the prime
piece that has to happen
in stroke recovery.”
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“After the stroke I had new
prescriptions…I couldn’t
dispense my medications into
daily doses. This math
deficit was not recognized
until I got home. I lived
alone and I had to take care
of myself and I was unable to
cope.”
What is important to stroke survivors and
caregivers?
• Reassurance that they will get better!
• Preventing another stroke
• Support from peers and health professionals
that understand what happens after discharge
• Access to information after discharge
• All providers (stroke experts, primary care,
home health, therapists, community services)
understand the plan of care
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Effects of Post-Acute Care on Patient and
Caregiver
• Evidence from early supported discharge
shows that organized post-acute care can:
• Improve stroke survivor functional status with
ADLs
• Reduce the risk of death or institutionalization
• Reduce costs
• Improve patient/caregiver satisfaction
• No added burden on caregivers
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COMPASS: Closer to a Learning
Health System
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Introduction: The Team
• PI: Pamela Duncan, PhD, PT, FAPTA,
FAHA
• Professor of Neurology,
Wake Forest Baptist Health
• Co-PI: Cheryl Bushnell, MD, MHS, FAHA
• Professor of Neurology and Director,
Wake Forest Baptist Comprehensive Stroke
Center
• Co-PI: Wayne Rosamond, PhD, MS, FAHA
• Professor of Epidemiology,
UNC Gillings School of Global Public Health
Director,
North Carolina Stroke Care Collaborative
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COMPASS Objectives
• Address the needs of stroke survivors
discharged home and their caregivers for
optimal outcomes
• Connect hospitals, community providers,
and community agencies for improved
chronic disease management
• Develop an individualized care plan for
each patient
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COMPASS Aims
Primary aim
• Determine the comparative effectiveness of
COMprehensive Post-Acute Stroke Service model vs
usual care on stroke survivor functional status at 90 days
post-stroke
Secondary aims
• Assess caregiver strain at 90 days
• All-cause readmissions at 30 and 90 days
• Mortality, health care utilization, use of TCM billing codes
using claims data at 1 year
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COMPASS Pragmatic ClusterRandomized Trial
• Phase I: Early randomized hospitals and usual care
(control group)
• Phase II: Control group adopts the intervention and
the phase I hospitals maintain the intervention without
grant support (sustainability)
• Stratification by hospital characteristics and stroke
volumes: Primary stroke centers (<300, and >300)
and non-primary stroke centers (<175 vs. > 175)
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Study Design
Hospitals Assessed for Eligibility & Interest
Randomization
COMPASS Intervention
Phase 1 Allocation
Usual Care
1 Year
1 Year
Sustain COMPASS
Intervention
Phase 2 Allocation
COMPASS Intervention
1 Year
1 Year
Sustain COMPASS Intervention
39
How Many Patients
How Many Hospitals
• 6000 patients in phase 1
• 3000 patients in phase 2
• 50 hospitals from the mountains to the sea
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COMPASS Model: Finding The Way
Forward
NUMBERS
Know your numbers: BP; A1C;
Cholesterol etc.
NUMBERS
N
N
EE
W
W
ENGAGE
WILLINGNESS
SS
SUPPORT
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ENGAGE
Be active: Engage your mind,
your hands, your arms and your
feet
SUPPORT
Take advantage of Support
systems/resources: Community,
Family and caregivers
WILLINGNESS
What medication are you on?
Why are you on them?
When do you take them?
Changing Processes and Structures of Care
Post-acute Nurse
Coordinator (PAC):
Registered nurse
• Education prior to discharge
Advanced Practice
Practitioner (APP):
Nurse practitioner or
physician assistant
• 2-day follow-up phone call
• See patients within 7 to 14
days
• Coordinate appointments with
NP and PCP
• Establish an individualized
care plan
• See patients within 7 to 14
days
• Provide referrals to home
health, outpatient therapy, and
community services
• Connect with community
referrals
• Support PCP, provide notes
and communications related to
post-acute care
Inputs
APP Assessment
Post-Stoke
Functional
Assessment
Caregiver
Assessment
Domains
Risk Factor
Management,
Alcohol / Drug/
Tobacco Abuse,
etc.
Functional
and Social
Problems
Caregiver
Challenges /
Burden
Outputs
eCare Plan for Patients
Self-Management
Community Referrals
Numbers
1.
Health Literacy/Stroke Risk
Management
2.
Primary Care
Engage
1.
Falls Prevention
2.
Mobility / Physical Activity
3.
IADL / Cognitive Dysfunction
4.
ADL / Spasticity
Support
1.
Depression
2.
Risk Factor Management
3.
Stress and Social Support
4.
Alcohol
5.
Tobacco use
6.
Drug abuse
7.
Transportation
8.
Nutrition/Swallowing
dysfunction
9.
Advanced directives
Willingness
1.
Medication Management /
Financial assistance
Directory of Community
Resources which will support
community referrals by the NP
and/or post-acute care
coordinator
1.Pt. Care Plan
2.Primary Care
Provider Note
3.Home Health
Referral
4. Out Patient
Referral
5. EPIC Note
Post-Acute Functional Assessment
Patient Summative Report
• Using the eCARE App
• Important concerns from Post-Acute
Functional Assessment (red flags)
• Higher level of care
• Stroke Complications
• Hospital Readmissions
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Provider Report
• The eCARE App will also generate a provider
report for the Advance Practice Provider, patient’s
home health agency, and the patient’s primary
care physician
• Summary report from the Two-Day Follow-up
Call
• Responses from the patient-reported Post-Stroke
Functional Assessment, and Stroke Caregiver
Assessment, and APP Assessment
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Cover Letter
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Patient Individualized Care Plan: Numbers
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Patient Individualized Care Plan: Engage
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Patient Individualized Care Plan: Support
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Patient Individualized Care Plan: Willingness
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Default messaging: Directional units of COMPASS
Community Resources
• The eCARE App will generate a list of community
resources for the patient.
• The APP will be able to choose and prioritize the
resources that are important to the patient’s stroke
recovery.
• The community resources will align with the directional
units of COMPASS.
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Community Resources: ENGAGE
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Structure: Electronic Care Plans
• Required by CMS to address functional and
social determinants of health and chronic care
management.
• A major product of the PCORI-funded grant:
COMPASS - eCare Plan Application
• The eCare Plan is required for CMS billing. It is
a scalable product and is intellectual property.
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59
Integrated Data: Clinical, Patient Report, and
Claims for Outcomes and Quality Metrics
Integrated data
1) Hospital Based Clinical Data From Get with the
Guidelines/North Carolina Stroke Care Registry
2) Functional and Clinical Assessments at 7-14 day visits,
eCare Plans, and 30 and 60 day follow-ups
3) Post-acute Quality metrics
4) 90 day patient reported outcomes: functional status,
cognition, depression, falls, readmissions, ED use, patient
satisfaction
5) Claims data for health care utilization and mortality
(Medicare, Medicaid, State Employees, and Blue Cross
Blue
Shield Medicare Advantage)
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Who Are Our COMPASS Stakeholders?
Stakeholders
involved in intervention design and implementation to maximize effectiveness and uptake
Stroke
Survivors
Family
Caregivers
Hospital
Stroke
Team
Primary
Care
AHEC
Community
Outpatient
-based
Pharmacy
Rehab
services
Influential Leaders
involved in high level advising to support dissemination and sustainability
•
•
Justus Warren Heart Disease and
Stroke Prevention Taskforce
Stroke Advisory Council
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•
•
AHA / ASA
NC DHHS
Home
Health
COMPASS Outcomes at 90-Days and
1-Year
• Primary: Stroke Impact Scale-16 (patient-reported
functional status)
• Secondary: Direct assessment at 90 days
• Caregiver strain, readmissions, medication
adherence, falls, self-rated health
• Secondary: Administrative claims over 1 yr follow-up
• Health care utilization, mortality, all cause
readmissions
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Quality Improvement and Web-based
Feedback
• Real-Time Feedback based on the
processes of the intervention
• % of patients called within 2 days
• % of patients seen by NP/PA within 7
days and 14 days
• % of eligible patients recommended
rehabilitation services
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Hospitals Across the State Signing Up
for COMPASS
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From COMPASS to the Learning
Health System
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Wake Forest Baptist Telestroke Network
= WFBH
= WF Telestroke Site
= WF WIP Site
= WF Prof Service Site
= WF DIP Site
WFBH Challenges with CMS Metrics
Stroke
Nation WFBH
Duke
UNC VIDANT
Novant
Readmissions
12.7
15.7
11.7
12.7
13.3
12.7
Mortality
14.8
16.8
14.8
14.3
16.6
16.6
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COMPASS and Learning Health
System
• Stroke volumes are increasing, especially
transfers from telestroke hospitals
• Bundled payments and penalties for
readmissions are challenges for improving
post-acute care
• COMPASS allows real time tracking of
readmissions and mortality, especially related
to telestroke hospitals
• Scale services for real world implementation
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Model for a Learning Health System
Health System Benefits
- Neuroscience Service
Line and Neurology
Department
- Other service lines and
departments
- Additional chronic care
models
- Medical school
curriculum
Research/Education
TRACS Quality
Improvement
Neuroscience Service Line
Neurology Department
WFBMC as Vanguard Site
- Epic Stroke Registry
- eCare Plans
- New patents
- Bundled payments
- Reduce mortality and
readmissions
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PCORI $14M contract
- Pragmatic Trial
- all eligible patients
- implement and
evaluate new care
model in NC
COMPASS and Clinical Care
• Personalized stroke care: COMPASS and the
eCare Plan
• Functional and social determinants of health
assessed systematically
• Caregiver’s ability to care for the patient
• Checklist for post-stroke complications,
recovery, and prevention
• Link to community services
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COMPASS and Research: Lessons
Learned
• Hospital recruitment
• Intervention development
• Training for real-world implementation and
workforce development
• Quality metric development
• Analyses of current practice
• Integration of acute and post-acute strategies
for stroke care
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COMPASS and Future Research
• Subgroups:
• Race-ethnic, gender, rural vs urban,
primary/comprehensive stroke centers vs
non-certified
• Implementation of the eCare Plan into the EMR
(Epic and beyond)
• Cost-effectiveness to inform health policy and
payers
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COMPASS and Education
• New curriculum for post-acute care and
personalized medicine?
• Adaptation of COMPASS to other chronic
conditions
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COMPASS and the Stroke and
Neuroscience Service Line
• Data will inform quality metrics and processes
• Real-time evaluation of 30-day readmissions
• Stroke core measures
• Post-acute care quality initiatives
• Development of registries within Epic
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Summary and take home
• Quality improvement was the basis for a model of care
that evolved into a pragmatic clinical trial
• We can scale the intervention at this institution and
sustain it for the new health care frontier
• This model can continue to inform our clinical
operations, research, and educational goals: A
Learning Health System
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Acknowledgements
• Paula Riddle, TRACS nurse
• eCare APP and data team: Rica Abbott, Ralph
D’Agostino, Sara Jones, Scott Rushing,
Jeannette Stafford, Ken Wilson
• Sabina Gesell, Stakeholder engagement
• Mysha Syssine, Project manager
• Sylvia Coleman, Post-acute Coordinator
manager
• Our patient and caregiver stakeholders
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Parting Thoughts…
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