Lessons Learned about Embedding Complex Pragmatic Trials ... · Difference between “good”and “bad” contextual features can be a matter of timing (e.g., PCMH, behavioral health

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

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-19o/o 0 Self-re po rte functioning

Multidisciplinary pain treatment

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Are We Using an Acute Care Model for A Chronic Condition?

Addiction Medicine

Behavioral Health 11 - c:::::

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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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Adherence Delivery

- - - Planning phase - Implementation phase

PPACT Elfgibility s

Setting

Organltalion

Adherence Delivery

TiME

Adherence Delivery

LIRE

Outco~ Setting

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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

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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