Lessons Learned about Embedding Complex Pragmatic Trials ... · Difference between “good”and...
Transcript of Lessons Learned about Embedding Complex Pragmatic Trials ... · Difference between “good”and...
Lessons Learned about Embedding Complex
Pragmatic Trials in Delivery Systems:
Collaborative Care for Chronic Pain
Lynn DeBar, PhD, MPH
Kaiser Permanente Washington Health Research Institute
Seattle, Washington
Supported by NIH Common Fund and by NINDS through cooperative
agreement (with NIDA scientific advisory support) (UH3NW0088731)
PPACT Study Design & Rationale
The “ask” from clinical and health plan leadership…
What do we do with the patients with
complex pain who “belong to
everyone and no one?” How do we keep our primary care
providers from burning out and
leaving the health care system?
adapted witti permission from Rollin Gallagher
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+660%0 Spine fusion surgeries
+307o/o8 / Lumbar spine MRI imaging'
+249%6 Epidural + Facet injections
+65%0 Back pain-related medical expenditures
-19o/o 0 Self-re po rte functioning
Multidisciplinary pain treatment
--....---....---....-----------------.-----.----....---....-- centers 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015
Are We Using an Acute Care Model for A Chronic Condition?
Addiction Medicine
Behavioral Health 11 - c:::::
Social ._W_o-rk---~ -1-P___.rimary C•e ~1-,,-1.,,...-_-_P-a=in=C=l-:::::in-ic----. ,.
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Case Management
Sleep Clinic
Patient
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Neurology I ~ - -Neurosurgery
Hospital
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.,
Rheumatology I
Occupational Medicine
Emergency Department
Chiropractic Services
I Acupuncture
Primary Care
Interdisciplinary Pain Management
Pain Management in Usual Care Embedded in Primary Care
Behavioral
Health Coach: Nurse: Goal setting &
Lifestyle Changes Care
Coordination
Pharmacist:
Medication Physical Review
Therapist: Improved
Movement
DeBar et al, Contemporary Clinical Trials, 2018; DeBar et al, Translational Behavioral Medicine, 2012
PPACT Overview
AIM: Integrate interdisciplinary services into primary care to help patients adopt
self-management skills to:
• Manage chronic pain (decrease pain severity / improve functioning)
• Limit use of opioid medication
• Identify exacerbating factors amenable to treatment
Focus on feasibility and sustainability
DESIGN: Cluster (PCP)-randomized PCT (106 clusters, 273 PCPs, 851 patients)
ELIGIBILITY: Chronic pain, long-term opioid tx (prioritizing ≥ 120 MED,
benzodiazepine co-use, high utilizers [≥ 12 visits in 3 months])
INTERVENTION: Behavioral specialist, nurse case manager, PT, and pharmacist
team; 12 week core CBT + adapted movement groups
OUTCOMES: Pain (3-item PEG), opioid MED, pain-related health services, and cost
RES 'EARCH Open Access
Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Trials Systems Research Collaboratory
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and Russell E. Gasgow
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ABATE Infection Eligibility s
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Selling
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Adherence Delivery
- - - Planning phase - Implementation phase
PPACT Elfgibility s
Setting
Organltalion
Adherence Delivery
TiME
Adherence Delivery
LIRE
Outco~ Setting
Folowup organization
Figure 3. PPACT PRECIS-2 Scoring
4.3 Eligibility
4.9 4.7Primary SettingOutcome
3.4
Fig. 1 PRECIS wheels as assessed by raters for ecJCh of the five trials at two time points. Ratings on a 1 - 5 seal 3.6 Flexibilitymore pragmati c ratings. The dashed line indicates the planning phase. The solid line Indicates the implementa (Adherence)
Johnson el al. Trials (2016) 17:32 00110 1186/s13063-016-1158-y
Barriers Scorecard
Barrier Level of Difficulty
1 2 3 4 5
Enrollment and engagement of patients/subjects
X
Engagement of clinicians and Health Systems
X
Data collection and merging datasets X
Regulatory issues (IRBs and consent) X
Stability of control intervention X
Implementing/Delivering Intervention Across Healthcare Organizations
X
1 = little difficulty 5 = extreme difficulty
“Opioids are what I would consider an adjunctive treatment. Everything we know about pain is that this is a complex biopsychosocial phenomenon,
and that we need to address the psychosocial contributors to pain.”
- Roger Chou (interviewed for Medscape, 5/1/2017)
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BIO MEDICAL
#1 Barrier…. Tackling the Mind-Body Divide
KPNW Cllusters
KPGA Clusters
KPHII Cllusters
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The plan, the reality, & generalizable lesson learned
If we knew then what we know now…the one predictable constant is change
• A sense of clinical urgency can lead to quick and sometimes unstable program shifts to which you may need to adapt
• Difference between “good” and “bad” contextual features can be a matter of timing (e.g., PCMH, behavioral health integration)
• Stakeholder engagement is a continuous and intensive activity, requires two-way communication, and needs to be both top down and bottom up
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Advice?... know what you are stepping into
• Local champions / surveillance invaluable
• Challenging the status quo requires persistent and vertical health care system partnership
• Rethink your process evaluation toolkit
Unique Benefits of the Collaboratory
• Very supportive group of investigators, CoC, and NIH personnel candid about challenges
• Great sounding board for helping one to construct most rigorous and interpretable trial possible
• Unique learnings from building partnerships with those in very different science domains