Implementing a Pragmatic Trial of Physical Activity Coaching in COPD

Lessons Learned with Implementing
a Pragmatic Trial of Physical Activity Coaching
in COPD
Southern California Regional Dissemination, Implementation
and Improvement Science Webinar Series
April 5, 2017
Huong Q. Nguyen, PhD, RN
Research Scientist, Kaiser Permanente Southern California
Affiliate Associate Professor, University of Washington
Kaiser Permanente Research

Agenda
 COPD Care in the Current Health Policy
Landscape
 Gaps in the Evidence Base for COPD Self-
Management
 Lessons Learned in Generating Real-World
Evidence via a Pragmatic Trial of Physical Activity
Coaching
2 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017

External Health Policy Pressures
CMS Readmissions Reduction (2015) HEDIS Hospitalization for Potentially
Preventable Complications (2017)
(Ambulatory Care Sensitive Conditions, ACSC)
Chronic ACSC: COPD, asthma, diabetes, HTN, HF
Acute ACSC: pneumonia, UTI, cellulitis, pressure ulcer

Chronic Care Model
System
Design
5.Decision
Support
6. Clinical
Information
-
Management
Support
2. Health System
Resources and Policies
1. Community
Organization of Health Care
Informed,
Activated
Patient
Productive
Interactions
Prepared,
Productive
Interactions
Informed,
Activated
Patient
Prepared,
Proactive
Practice Team
Self-
Management
Support
Decision
Support
Clinical
Information
Systems
Resources and Policies
Community Health System
Organization of Health Care
Delivery
System
Design
Assess
Advise
AgreeAssist
Arrange
Functional and Clinical Outcomes
http://www.improvingchroniccare.org/

Self-Management Support
“the systematic provision of education and supportive
interventions by health care staff to:
increase patients’ skills and confidence in
managing their health problems, including regular
assessment of progress and problems, goal setting,
and problem-solving support.”
~ Institute of Medicine, 2004, Quality Chasm Summit

Multi-morbidity in COPD (+4)
Vanfleteren et al (2013) AJRCCM 187(7):728

Convergence >> Inactivity-Deconditioning
Substantial loss in
lung function
Anxiety
Social isolation/
Depression

Pulmonary Rehabilitation is the Gold Standard
Best “Medicine” for COPD
8
Uptake remains suboptimal
System Provider Patient
• Space
• Staffing
• Capacity
• Reimbursement
• Knowledge
• Attitude
• Referrals
• Transportation
• Distance
• Scheduling
• Motivation
Johnston et al. (2013). Prim Care Respir J. & Physiother Can 62(4): 368-373

Agenda
Landscape
 Gaps in the Current Evidence Base for COPD Self-
Management
Coaching

Physical inactivity is associated with worse outcomes
Annals of ATS, 2014
ERJ Open Research 2016

Physical Activity Associated with Lower Risk of 30-Day
Readmission
EVS RR, 95%CI P value
0 mins/wk 1.0 -
1-149mins/wk 0.67 (0.55, 0.81) <.001
>150mins/wk 0.66 (0.51, 0.87) <.001
11
Adjusted for age, gender, marital status, race/ethnicity, insurance status, BMI, smoking status,
flu & pneumonia vaccination, use of inhaler medications, comorbidities, previous
hospitalizations, length of stay, discharge disposition, ED/Obs. Stay, and receipt of inpatient
palliative care consultation
n=4,596 patients admitted for a COPD exacerbation with 5,862 index admissions
from Jan 1, 2011 – Dec 31, 2012
Any PA → ↓ 34% readmission risk
Nguyen et al. Annals of ATS (2014)

Conceptual Model for  Physical Activity
Outcomes
↓Hospitalizations
↓ED visits/Ob stays
↓COPD exacerbations
↓Death
↑ Physical
Activity
Physical
↓Ventilatory requirements
↓Dyspnea/fatigue
↓BMI, BP, A1C, lipids
↓Systemic inflammation
Psychological
↑Self-efficacy for self-care
↓Depression/anxiety
↑ Quality of life
Antecedents/Moderators
-Demographics, e.g. older age
-Clinical, e.g. disease burden, chronic pain
-Level of activation, e.g. depression, anxiety, cognition

Alternatives to clinic-based “rehab”

Pedometers & Coaching in COPD
PR vs.
PR + Pedometer/Coaching
(2-6 months) (n>5)
Pedometer/Coaching vs.
Usual Care
(1-12 months) (n>5)
Physical activity Uncertain added benefit ++
Exercise capacity Uncertain added benefit +
Symptoms Worse? ++
HRQL Worse? ++
AECOPD ? +
Acute care utilization ? ?
Survival ? ?
BOTTOM LINE Questionable added value Promising alternative
e.g. Nolan (2017) AJRCCM
Burtin (2015) PLOS
Altenburg (2015) Resp Med
deBlock (2006) Pt Ed Couns
e.g. Moy (2015) Chest
Demeyer (2017) Thorax
Nguyen (2013) JPSM
Altenburg (2015) Resp Med

Pedometers (PR alternative) vs. Usual Care
 Step goal increments/progression differed across studies but most
emphasize accrual of steps throughout day
 For every +1,000 steps/day @ low intensity -> COPD hospitalization
risk  20% (Donaire-Gonzalez, 2015 ERJ)
– High intensity PA did not have an impact on hospitalizations
 Limitations of current evidence: mild to moderate COPD, younger, men
 Short-medium term follow up,  PA plateaus at ~3 to 6 months
Automated
Step Goals
Clinic/home
Counseling
Semi-automated
Blended Telecoaching
Moy 2015 Chest
Tabak 2014 Clin Rehab
Mendoza 2015 ERJ
Hospes 2009 Pt Ed Couns
Nguyen 2015 JPSM
Demeyer 2017 Thorax
Altenburg 2015 Resp Med
$ $$$

Real-World Evidence to Inform Practice & Policy
(Valid/Generalizable)

Mark Cziraky, NAM 2016 Mtg
Inform decision making

The RCT-PCT Continuum
 No clinical trial is completely explanatory or pragmatic
 Tradeoffs with decisions to be more explanatory or
pragmatic
Explanatory Trial
Can an intervention work under
ideal conditions?
Pragmatic Trial
Can an intervention work
under usual conditions?

Agenda
Landscape
 Gaps in the Current Evidence Base for COPD Self-
Management
Coaching

Kaiser Permanente <-> National Health Care Landscape
Kaiser
Program
Kaiser
Regions
(n=8)
Medical
Service
Areas within
Regions
Medical
Offices/Clinics
Northern CA
Southern CA
Northwest
WashingtonMid-Atlantic
Georgia
Colorado
Hawaii
Southern CA
>4 Million Members
~50,000 with COPD
209 Medical Offices
14 Hospitals
6,035 Physicians
20,393 Nurses
61,897 Employees
 Pre-paid, capitated
health plan
 Independent
medical group
 Integrated delivery
system
 “Mini national
health system”
accountable for
total health of a
population
 Structure: Federal
> State >County
>City

Health System Care Structures & Processes
 Mature population management & QI/PI infrastructure
– Proactive preventive care
– Wellness coaching and health education classes
– Disease-based care management
– Case management for higher risk patients
 Care transition bundle for medium to high risk patients
– Post discharge phone call 48-72 hours
– Medication review
– Scheduled follow up clinic visit within 5-7 days post discharge
– Palliative care consult as appropriate
– Complex case conferences

Health System Structures to Facilitate PCTs
 Single IRB for 6 participating sites (could expand up to 12
sites if needed)
 Leverage existing workforce from pulmonary rehabilitation
or care management structure at most of the sites
 Comprehensive (almost) EMR facilitates
– Population-based screening for eligibility
– Passive outcome assessment

Research Question
 P: Patients with a history of a severe COPD
exacerbation in previous 12 months
 I: 12-month physical activity coaching (Walk On!)
 C: Standard care
 O: All-cause acute care utilization and survival

“Real-World” PCT
Patients w/a COPD-related hospitalization/ED/Obs encounter
in the previous 12 months (n=2,700) ( from n=1,650)
Randomization
Standard Care (n=1,350)Standard Care +
Physical Activity Coaching
(n=1,350)
-Baseline functional assessment to
individualize walking exercise
program; training in use of pedometer
-Intensive phone coaching (wks 1-4)
-Pro-active follow-up & support using
panel management tools (wks 5-52)
-Optional monthly group peer support
visits-skills training & problem solving
Primary Outcome: All-cause hospitalizations,
ED/Ob stays & death over12 months
Secondary Outcomes: COPD-related
hospitalizations and ED/Ob stays, COPD
exacerbations, physical activity, and cardio-
metabolic markers (BMI, BP, HbA1c, & lipids),
perception of support, symptoms, quality of life and
satisfaction
Nguyen et al. Contemporary Clinical Trials (2016) 46:18–29

Inclusion Criteria
 Any COPD hospitalization, ED or Ob Stays in the previous 12 months
– Principal discharge diagnoses of COPD (J44.1, J44.0, J41.8, J42, J43.1,
J43.2, J43.8, J43.9, J44.9, J44.0, or J44.1) or principal diagnosis of
respiratory failure (J96.00, J96.01, J96.02, J96.90, J96.91, J96.92, J80,
J96.20, J96.21, J96.22, or R09.2) and a secondary diagnosis of acute
exacerbation of COPD (J44.1 or J44.0)
 age >40 years
 on at least one bronchodilator or steroid inhaler prior to the index
admission or if not on an inhaler, had a previous COPD diagnosis
 Continuous health plan membership in the 12 months prior to the
index admission.
*Centers for Medicare and Medicaid Services (CMS) and National Quality Forum (NQF) proposed
criteria for the Hospital Readmission Reduction Program

Exclusion Criteria
 FEV1/FVC ratio >0.70 for those with spirometry data in previous
year
 Discharged to hospice, SNF, long term-care or another acute
care hospital during index admission
 Bed bound at admission or discharge during the index
admission
 Has Alzheimers disease, dementia or metastatic cancer
 Morbidly obese (BMI >40)
 Completed pulmonary rehabilitation in the last 6 months

Traditional RCT vs. Pragmatic RCT
COPD
Population
Patients who meet
eligibility criteria
(Pre-consent
Randomization)
 Generalizability
 Uptake/Participation
 Effectiveness
COPD
Population
Patients who
meet eligibility
criteria
Patients who
consent to
being
randomized
 Internal validity
 Efficacy

Study Design Essentials for this PCT
 A waiver of written consent for
– Individual-level randomization
– Primary outcome obtained on all eligible-randomized patients
 Outcome data are already captured as part of routine clinical care
 Primary analysis is intent-to-treat
 Advantages: “real world” uptake and effectiveness since not
dependent on motivated volunteers
 Disadvantage: diluted treatment effects if low uptake

Pragmatic-Explanatory Continuum (PRECIS-2)
(-) Not at point of care
(-) Managed care-
integrated system with
robust EMR
(-) Use of existing PR staff,
some additional training
(-) PROs at 6 & 12 months
(-) General intervention guidance
Who’s perspective?
Loudon (2015) BMJ; Thorpe (2009) CMAJ

Walk On! Program
Pre-Visit Tracking & Surveys
Targeted
Coaching
Dashboard
Baseline
Intake Visit
Step Goal Progression
& Self-Tracking
Peer Support

Automated Data Upload
(Validic, Open mHealth)
Data Integration, Processing, and Visual Display
for Patient- (kp.org) and Population-Level Management (Health Connect)
Manual Data Entry
Phone IVR or Texting
Bluetooth/Internet-enabled devices
$ $$$$
Targeted
Coaching
Dashboard

Walk On! Uptake & Top 3 Reasons for Declining
~32% agreed to participate
Not
interested
(22%)
Unable to
reach
(19%)
Too frail/ill
(14%)
~24% completed baseline visit
n=938 Outreached re: Walk On!
Age: 77 vs. 72
Charlson: 4.8 vs. 3.5
FEV1%pred: 60% vs. 58%
O2 use: 52% vs. 38%
Age: 68 vs. 72
Charlson: 3.3 vs. 3.5
FEV1%pred: 63% vs. 58%
Smoking: 29% vs. 11%

Enrollment by Site
n=85,
76%
n=134,
86%
n=78,
80%
n=118,
80%
n=130,
83%
n=168,
62%
n=716,
76%
n=27,
24%
n=21,
14%
n=19,
20%
n=29,
20%
n=27,
17% n=102,
38%
n=222,
24%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Bellflower (n=112) Fontana (n=155) LAMC (n=97) OC (n=147) Riverside (n=157) SD (n=270) Total (n=938)
Declined Enrolled
(n=938, up to wave #9 of 12)

Site Characteristics
Sites 1 2 3 4 5 6
COPD care management program + + +
Pulmonary rehabilitation program + + + +
Dual role of coach and rehabilitation
coordinator
+ + +
Dual role of coach and care manager +
Allocation of 0.5+ FTE on project + + +
Highly engaged physician champion + + + +
Coach feels “supported” in “proactive”
culture
+ +
Ease of access to clinic - - -
Total “Enabling” Score 1 2 4 4 4 5
Average Walk On! Uptake (Waves 1-10) 14% 17% 19% 24% 20% 37%

Baseline Sample Characteristics (up to wave #9 of 12)
Total (n=1,878) Standard Care
(n=940)
Walk On! (n=938)
Total
(n=938)
Participants
(n=212)
Non-P
(n=736)
Age 72 (10) 72 (10) 72 (10) 72 (9) 72 (11)
Female 1022 (54%) 520 (55%) 502 (54%) 117 (55%) 385 (53%)
FEV1/FVC* 54.8 (14.5) 54.4 (14.9) 55.2 (14.1) 52.9 (14.8) 56.0 (13.8)
FEV1% Predicted 60.3 (21.2) 59.7 (21.3) 61.0 (21.2) 57.6 (22.8) 62.1 (20.6)
Oxygen use 727 (39%) 385 (41%) 342 (36%) 80 (38%) 262 (36%)
Heart failure 565 (30%) 290 (31%) 275 (29%) 53 (25%) 222 (31%)
Depression 527 (28%) 258 (27%) 269 (29%) 55 (26%) 214 (29%)
Anxiety 537 (29%) 275 (29%) 262 (28%) 57 (27%) 205 (28%)
Chronic pain 379 (20%) 193 (21%) 186 (20%) 42 (20%) 144 (20%)
Charlson co-morbidity index 3.7 (2.3) 3.8 (2.2) 3.7 (2.3) 3.5 (2.2) 3.7 (2.4)
Hospitalizations 1065 (57%) 548 (58%) 517 (55%) 124 (58%) 393 (54%)
ED visits 1527 (81%) 771 (82%) 756 (81%) 159 (75%) 597 (82%)
Observational stays 523 (28%) 267 (28%) 256 (27%) 49 (23%) 207 (29%)
Primary care visits 6.2 (5.6) 6.2 (5.5) 6.3 (5.7) 6.6 (5.2) 6.1 (5.9)
Specialty care visits 9.4 (10.2) 9.7 (10.6) 9.0 (9.7) 10.3 (9.9) 8.6 (9.6)
*60% patients have spirometry results

Lessons Learned
Patients
 Timing of outreach
may not synchronize
with patient’s
readiness for change
 Activation with
coach’s outreach call
w/o “enrolling”
 Individualized tailoring
according to patient
needs & preferences
 Engaging family
caregivers
Engagement Data/Other
 EMR data quality &
timeliness
 Unable to integrate
study tools within
EMR
 Technology
challenges
 Evolving COPD care
practices at study
sites
 Multi-stakeholder
engagement in all
aspects of the study
 Executive sponsorship
 Partnership with 7-
member Patient
Advisory Board (PAB)
 Providers’ eagerness
to provide program to
more patients
 IRB engaged during
grant proposal & study
start up

Partnership with Patient Advisory Board (PAB)
 Deep commitment to help fellow
members and patients
 Recruitment/outreach scripting
– Input and insights on how best to
“motivate” peers
 Test out study processes e.g.
baseline visit, activity sensors
 Strategies to improve uptake and
retention
 Human subjects research training
 Co-lead monthly group visits with
coaches

Executive Sponsors Patient Advisors
Research Staff
Software/IT &
Database Teams
Physical Activity
Coaches
Pulmonary
Chiefs & DAs

Lessons Learned:
Use of Existing Clinical Staff (Respiratory Therapists)
Training
 No previous research
training or experience
 Variable experience
working in outpatient
setting with population
management lens
 Learning community
for best practices
– Motivational
interviewing skills
– Peer-to-peer
mentoring
Continuous QC“Culture”
 Study FTEs: 30-100%
 Clinical patient care
priorities trump research
study responsibilities
 Labor regulations &
different job class codes
disallowed home visits
 Motivate and empower
– Cross-coverage
 Turnover with 6 new
coaches at 3 sites
 Balancing pragmatism
and quality control by
research staff
 Study management
tools & weekly reports to
ensure timely
completion of study
tasks
 Cognitive overload with
many new processes &
disparate IT systems

Patient Feedback
I was in the hospital for 20 days. I had to learn to re-walk again. It was
quite a bit to overcome. Walk On! gave me courage every day. I did my
exercises. I totally enjoyed that. I had my little counter, I saw I walked
200, sometimes not even that 50. When they [coaches] checked on you
every week. They checked on you if you needed anything. They’d help get
your meds, call the doctor. It was wonderful. You had someone right there
at your hand if you needed them. It’s neat. You wait for the call, ‘oh boy I
did good,’ or ‘I didn’t do good.’
I don’t know who came up with the program but the way
it’s set up, you’re not intimidated at all. You name your
hour and what you want to do unlike the other program
that I participated in before (rehab) where the meetings
and exercise were set on specific days.

Patients have competing demands
“Patients have the power in chronic disease.
Patients decide what to eat, whether to
exercise, and how often to take their
medications. If people don’t want to do
something, they won’t do it”
Bodenheimer (2007) Motivating Change

Walk On! Estimated Per Patient Costs
# of Patients Estimated Cost Per Patient
(-25%) for
Research Activities
Patients Outreached n=1,350 $1000/patient $750/patient
Patients Enrolled Overall (~25%) n=350 $3700/patient $2700/patient
Assumptions: $45/hr (Respiratory therapist) x 1.56 benefits x 2080 hrs/year x
3.0 FTEs (1SD, .5RV, .5DO, .3OC, .35LA, .3FO)= $440K/year x 3 years= $1.3 mil
Note: Pulmonary rehab x 6 weeks ~$2500 (Medicare reimbursements)

What if results in Q3 2018 are…
PA utilization or death
PA  utilization or death
SPREAD(Internal)
-Funding
-Implementation
structure/refine
-Other applications,
e.g. PR maintenance
WHY?
-Who benefits?
-Who doesn’t
-Are there other
improvements?
-Additional studies
needed?
WHY?
-Weak intervention?
-Inadequate uptake?
-Who benefits?
-Who doesn’t?
Would improvements in QoL or functioning be enough to justify spread?

Click to edit Master title style
Population-based
proactive, collaborative
technology-enabled,
cost-effective, scalable,
care management

Implementing a Pragmatic Trial of Physical Activity Coaching in COPD

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