Addressing the Opioid Crisis by Improving Pain Management · Addressing the Opioid Crisis by Improving Pain Management Christine Goertz, DC, PhD ... Erin E. Krebs, MD, MPH. Minneapolis

ANNUALMEETING

OCT. 31-NOV. 2ARLINGTON, VA

#PCORI2017

Addressing the Opioid Crisis by Improving Pain Management

Christine Goertz, DC, PhDVice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality@ChristineGoertzNovember 1, 2017

11/5/2017 2

ANNUAL MEETING | #PCORI2017

Christine Goertz, DC, PhDDisclosures

Relationship Company(ies)

Speakers Bureau

Advisory Committee Quality Insights of Pennsylvania Technical Expert Panel #’s 131, 182

Consultancy American Chiropractic Association, Healthwise, Inc., Quality Insights of Pennsylvania, RANDCorporation

Review Panel

Board Membership American Public Health Association, Chiropractic & Manual Therapies, Journal of Manipulative and Physiological Therapeutics, PCORI Board of Governors

Honorarium

Ownership Interests Prezacor, Inc.

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ObjectivesAt the conclusion of this activity, participants should be able to:• Understand the nature and extent of the opioid crisis and what

is known about the benefits and harms of opioids, non-opioid alternatives to pain management, and treatment for opioid use disorder

• Identify evidence patients and other stakeholders need to help them make better choices about managing pain

• Have a broad overview of PCORI’s investments in opioid and pain-related research and how two specific PCORI projects address evidence gaps

ANNUALMEETING


#PCORI2017

Christine Goertz, DC, PhDPCORI Board of Governors

Judy Zerzan, MD, MPHColorado Department of Healthcare Financing and Healthcare

Aleksandra Zgierska, MD, PhDUniversity of Wisconsin

Terrie CowleyThe TMJ Association, Ltd

Erin Krebs, MD, MPHUniversity of Minnesota

Lynn Debar, PhDKaiser Permanente

ANNUALMEETING


#PCORI2017

Overview of Opioid Crisis and Effective Nonpharmacologic Treatment Strategies for Pain

Erin E. Krebs, MD, MPHMinneapolis VA Health Care System, University of MinnesotaNovember 1, 2017

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Erin Krebs

Has nothing to disclose.Is speaking for herself, not for the VA or US government.

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ObjectivesAt the conclusion of this activity, participants should be able to describe:• Scope of the opioid crisis and its intersection with pain

management• Evidence for nonopioid pain therapies and opioid tapering• Key gaps and research needed to advance our knowledge of the

comparative effectiveness of strategies to address the opioid crisis

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Paulozzi et al, MMWR 2011;60:1487–92

Opioid overdose deaths

Opioid addiction treatment admissions

Opioid sales

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The Evidence for Opioids in Chronic Pain, 1996

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Management of Opioid Therapy for Chronic Pain Working Group, March 2003

Opinion of respected authorities, case reports, and expert committees

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Clin J Pain. 1997 Mar;13(1):6-8.

• “It is now accepted by practitioners of the specialty of pain medicine that respiratory depression induced by opioids tends to be a short-lived phenomenon, generally occurs only in the opioid-naive patient, and is antagonized by pain.”

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The Evidence for Opioids in Chronic Pain, 2016

• No study of opioid therapy versus placebo, no opioid therapy, or nonopioid therapy for chronic pain evaluated long-term (≥ 1 year) outcomes related to pain, function, or quality of life.

• Most placebo-controlled randomized clinical trials were ≤ 6 weeks in duration

Dowell D et al, MMWR 2016; 65(1);1–49

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Intertwined challenges of the opioid crisis

Chronic pain

Opioid addiction

Long-term opioid use

How can people prescribed high-dose opioids reduce opioid dosages and decrease risk of harm, while managing pain?

How can people with chronic pain find the best approaches to pain management for their situation?

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• Prompted by White House summit on opioid crisis• Focus on alternatives to opioid therapy• Goals: Synthesize existing evidence to identify approaches with

sufficient evidence (ready for use) and areas needing future research

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Behavioral therapies

CBTACT

MBSR

Manual therapiesMassage

AcupunctureManipulation

Exercise therapies

Strengthening-stretching

Aerobic exerciseYoga

Tai chi

Therapies with evidence of efficacy

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Areas needing additional research

• Selecting therapies• Combining and sequencing therapies• Dose/duration of therapies• Engaging and activating patients

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The evidence for opioids in chronic pain, 2016

• Findings• Interdisciplinary pain programs and multimodal behavioral

interventions may be effective in reducing opioid dose• Pain, function, and quality of life may improve during and

after opioid dose reduction• Overall, very low quality of evidence

Frank JW et al. Ann Intern Med 2017;167:181-191

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The evidence for opioids in chronic pain, 2016

• Research needs include:• Studies using innovative designs to overcome research

challenges (e.g., recruitment) • Testing more feasible/scalable treatment approaches • Studies to examine real-world changes in practice and

policy

Frank JW et al. Ann Intern Med 2017;167:181-191

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Future directions for research

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PCORI’s Investment in Pain and Opioid Research

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Christine Goertz, DC, PhDVice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality@ChristineGoertzNovember 1, 2017

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PCORI’s MissionTo help people make informed healthcare decisions and improve healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community.

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PCORI’s Role in a National Health Research Program

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PCORI Priority Area: Chronic Pain and Opioid Research

Development of Key Initiatives on Pain and Opioid

Research

Stakeholder Workshops:

Define CER Questions

Board Priority Area: Chronic Pain/Opioid

Crisis

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Research Addressing Questions That MatterClinicianWhat works best to safely and appropriate reduce opioid use for people with pain?

PatientI’m worried about becoming dependent on opioids. How effective are nondrug options for treating pain?

Health System LeaderHow can we improve our clinicians’ prescribing practices?

CaregiverHow can patients best become empowered about opioid use?

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59 studies related to chronic noncancer pain and/or opioids

209 million to fund

As of October 2017, PCORI has awarded

Chronic and Acute Pain Management

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Spanning the Care Continuum

Prevention Treatment Alternatives

Education and Communication

Management of Long-term Opioid

Use

Treatment for Opioid Use

Disorder

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PCORI’s Targeted Opioid Initiatives

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Strategies to Prevent Unsafe Prescribing in Primary Care among Patients with Acute or Chronic Pain

Funds and Duration:

• $30 million originally available (direct and indirect)

• Up to $5 million in total direct costs per project

• Projects should be completed within 3 years

Objective of this PFA:• Prevent unsafe opioid prescribing while

ensuring adequate pain management utilizing:

• health system or payer strategies

• patient and provider communication interventions addressing benefits and harms of treatments

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Clinical Strategies for Managing and Reducing Long-Term Use for Chronic Pain

Objective of this PFA:• Identify clinical strategies for managing

pain while:

• Reducing or eliminating long-term opioid use

• Limiting dose escalation

Funds and Duration:

• A total of $40 million (direct and indirect)


• Projects should be completed within 3-5 years

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Medication-Assisted Treatment Delivery for Pregnant Women with Substance Use Disorders Involving Prescription Opioids and/or Heroin

Objective of this PFA:• Generate evidence about different

models of MAT delivery to pregnant women with substance use disorder:

• Comprehensive care models that include prenatal care, MAT, and psychosocial support

• Remotely supported treatment delivery with varying levels of office-based induction and psychosocial support

Funds and Duration:

• A total of $16 million (direct and indirect)


• Projects should be completed in 3-4 years

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In Summary:• PCORI is taking a holistic approach; a one-size-fits-all approach

cannot answer all the patient, clinician, caregiver, and policymaker questions that need to be addressed

• As a patient-centered organization, PCORI research is committed to both addressing effective pain management and reducing harms associated with opioid use

• Addressing this challenge will require ongoing collaboration with all stakeholders

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Learn More

[email protected]

#PCORI2017

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Questions?

35


Thank You!

Christine Goertz, DC, PhDVice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality

@ChristineGoertz

11/5/2017 36


What Evidence Do Patients Need For Improved Pain Management?

Terrie CowleyPresident and Co-Founder, The TMJ AssociationCo-Founder, The Chronic Pain Research Alliance

https://twitter.com/tmjassociationhttps://twitter.com/CPRAlliance_org

November 1, 2017

https://twitter.com/tmjassociation

https://twitter.com/CPRAlliance_org

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Terrie CowleyChronic Pain Research Alliance has received a $10,000 grant from Purdue Pharma L.P. on December 13, 2016, for a Patient Guide to Improve Pain Function and Quality of Life for those with Chronic Overlapping Pain Conditions.

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ObjectivesAt the conclusion of this activity, participants should be able to:• Understand what we know about pain treatments and the

uncertainty patients face regarding pain management options• Learn about the evidence needs of chronic pain patients

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Patients have told us….

“I wish I had cancer because then my family and friends would understand…”

Individually and collectively we have a moral imperative to address the impact of and response to pain in America. People in pain need a cultural transformation in the way pain is viewed and treated. Source: Relieving Pain in America IOM Report

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The CPRA is an initiative of The TMJ Association

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• Pain treatment is haphazard, trial and error• Pain treatment is fragmented and treated by an array

of various professionals• Many long-used treatments and new complementary

therapies lack scientific rigor for pain in general as well as specific conditions

• Most research on pain management does not look at long-term outcomes, so there is really a lack of evidence on how to improve pain management while reducing risk to patients

What do we know about pain treatment?

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Benefit vs. Risk

ANNUALMEETING


#PCORI2017

What evidence do patients need?

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Evidence of effectiveness of various nonpharmacologic/non-opioid options

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Large clinical trials that include patients with comorbidities-what works best for patients like me?

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Time for one-person trials

Precision medicine requires a different type of clinical trial that focuses on individual, not average, responses to therapy, says Nicholas J. Schork

Schork, Nicholas J. “Personalized medicine: Time for one-person trials.” Nature 520.7549 (2015): 609-611.

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Patient involvement in all aspects of pain research

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Improved communication between patients and providers

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The Way Forward

Identify Decisional Dilemmas

Conduct CER Generate Evidence Base

Improve Education and

Communication

Improve Reimbursement

Reduce Uncertainty &

Improve Outcomes

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Learn more

www.tmj.orgchronicpainresearchalliance.org

[email protected]

#PCORI2017

http://www.tmj.org/

http://chronicpainresearchalliance.org/

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Questions?

52


Thank you!

Terrie CowleyWhat Evidence Do Patients Need?https://twitter.com/tmjassociationhttps://twitter.com/CPRAlliance_orgNovember 1, 2017

https://twitter.com/tmjassociation

https://twitter.com/CPRAlliance_org

ANNUALMEETING


#PCORI2017

Preventing Unsafe Opioid Prescribing

Lynn DeBar, PhD, MPHSenior Scientific Investigator, Kaiser Permanente Washington Health Research Institute

November 1, 2017


54

Lynn DeBar

• Has nothing to disclose.

November 5, 2017

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ObjectivesAt the conclusion of this activity, participants should be able to:

• Understand how the opioid crisis is affecting some states and what one state is doing to address the issue

• Outline the design of a PCORI-funded study to measure the effectiveness of a State Medicaid program change on preventing unsafe prescribing and improving management of low back pain

• Describe the potential impact of the study


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Opioids and Beyond: What happened to nonpharmacotherapy options for chronic pain?

November 5, 2017


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Oregon Medicaid Reimbursement Guidelines for Back Pain• Focus on biopsychosocial model

• Add coverage for evidence-based effective treatments• i.e., cognitive behavioral therapy (CBT), osteopathic or chiropractic

manipulative therapy, exercise-based therapies (including those offered in multidisciplinary intensive rehabilitation settings)

• Restrict or eliminate ineffective or potentially unsafe treatments• Opioids• Epidural steroid injections• Surgery limited to conditions with known effectiveness

November 5, 2017

OTC meds, muscle relaxers

4 visitsPT/OT/OMT/

Chiro/Acupuncture/massage

Low RiskOTC meds,

muscle relaxers

4 visitsPT/OT/OMT/

chiro/acupuncture/massage

OTC meds, muscle relaxers

High Risk

OTC meds, muscle relaxers,limited opioids

CBT

Office visitsOffice visits

Up to 30 visitsPT/OT/OMT/

chiro/acupuncture

If available:yoga,

interdisciplinary rehab, supervised exercise, massage

Not Recommended:First-line opioid

prescribing or long-term opioid use

Oregon Medicaid: New Back Pain Treatment Pathways


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Timeline for Oregon Guideline Implementation

November 5, 2017

July 1, 2016Start of new coverage for

non-opioid evidence-based therapies for back pain

January 1, 2017 For patients already on

chronic opioid treatment, taper plan with non-

pharmacologic treatment required

January 1, 2018 End to transitional coverage

of opioids for patients already on chronic opioid

treatment

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Goal: Evaluate impact of Oregon Medicaid Reimbursement

Guidelines for Back Pain

Substudy A: Compare opioid prescribing and use of other pain-

related health services(electronic health record)

Substudy B: Compare patient-centered outcomes

(patient surveys)

Substudy C: Understand contextual factors underlying successes and

challenges(qualitative data collection)

Oregon

California

Back on Track Study


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Study Setting: OCHIN

November 5, 2017

HRSA-designated nonprofit Health Center Controlled Network of federally qualified health centers

Supports organizations in all 50 states, partnering with 289 organizations with 10,000 clinicians serving over 10 million patients.


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Patient Survey Content (Provisional)

November 5, 2017

Pain and Functioning Services Received and Satisfaction

Adverse Events

Brief Pain Inventory – SF

STarT Back Screening Tool

Pain bothersomeness

Patient global impression of change

Evidence-based services (covered by guidelines) received in past 3 months

Satisfaction with services to manage back pain

Satisfaction with outcome of pain-related services

Negative outcomes from pain-related services

Use of illegal drugs or Rx meds for nonmedical reasons


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Engaging Patient and Stakeholder Partners

• Bullet

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Back on Track – Potential Impact

• Help reduce inappropriate prescribing of opioids in a vulnerable, socioeconomically disadvantaged population, especially among those at high risk for misuse and abuse

• Payers:• Potential to encourage widespread adoption (Medicaid insured and

broader healthcare systems)

• Patients:• Potential access to broad range of nonpharmacotherapy services

(match between patients and services)

• Clinicians and Healthcare Systems:• Understanding what it takes to connect patients to broader range of

evidence-based pain services

November 5, 2017


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Learn More

• www.pcori.org

• [email protected]

• #PCORI2017

November 5, 2017


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Questions?

November 5, 2017


November 5, 2017 67

Thank You!Lynn DeBar, PhD, MPHSenior Scientific Investigator, Kaiser Permanente Washington Health Research Institute

November 1, 2017

ANNUALMEETING


#PCORI2017

Behavioral Therapies to Improve Health and Safety of Patients with Opioid-Treated Chronic Pain

Aleksandra Zgierska, MD PhDUniversity of Wisconsin-MadisonDepartment of Family Medicine & Community HealthNovember 1, 2017, PCORI 2017 Annual Meeting

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Aleksandra Zgierska, MD PhD

Has nothing to disclose.

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ObjectivesAt the conclusion of this activity, participants should be able to:• Identify the existing evidence gaps related to the use of

mindfulness meditation (MM) and cognitive behavioral therapy (CBT) for chronic pain.

• Outline the ongoing study aimed to assess the impact of MM and CBT as treatments for severe opioid-treated chronic low back pain.

• Describe the potential impact of the study on practice.

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Pain Care

WikiCommons

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WikiCommons, Ajifo A: Synapse in Brain.

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MM and CBT offer different skills for pain coping and management of chronic pain.

Mindfulness Meditation (MM)Nonjudgmental, accepting awareness of present-moment experiences to change one’s relationship

with these experiences

Cognitive Behavior Therapy (CBT) Focus on modifying unhealthy thoughts, emotions

and behaviors to change the experience and control symptoms.

Creative Commons, Spirit-Fire: Meditation

Wiki Commons, Hokusai: The Great Wave off Kanagawa

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Strategies To Assist with Management of Pain: STAMP Study

Stakeholder-driven evolution of the STAMP study title• PCORI title: “Managing Long-Term Low Back Pain to Improve

Health and Reduce Reliance on Opioid Medicines: Comparing Mindfulness Meditation and Cognitive Behavioral Therapy.”

• Initial title: “A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain.”

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Madison, WIBoston, MA

Salt Lake, UT

Multicenter randomized controlled trial (Principal Investigator: A. Zgierska, University of Wisconsin)

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Patients with chronic low back pain (CLBP) treated with daily opioids

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjZ9Nq7jM_RAhWB8oMKHZNLDDYQjRwIBw&url=http://www.med.wisc.edu/&bvm=bv.144224172,d.amc&psig=AFQjCNHYRaZyrkUgiIJcTCV_Y_rIxk0BXA&ust=1484945835289607

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766 patients with opioid-treated CLBP

Mindfulness meditation (MM)

Cognitive behavior therapy (CBT)

eight weekly two-hour sessions; daily home practice

Patient-reported outcomes at 12 months:↓ pain, ↑ function, ↑ quality of life,

↓ pain medication use


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STAMP Study

Patient/stakeholder-led approach

Sound science/methods

Answers to questions that matterto patients and clinicians


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STAMP Study: Clinical Implications• Guide clinical decision making: patients and clinicians

• Is it effective for opioid-treated CLBP?• Which specific patient groups is it most effective for?

• Those with worse mental health or medication misuse?

• Guide coverage decisions by health plans• Evidence-based treatments are more likely to gain coverage

• Promote the holistic approach to health• Integration of “mind” and “body” treatments


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Wiki Commons, Mount Everest

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Learn More

www.fammed.wisc.edu/STAMPstudy

[email protected]

#PCORI2017

http://www.fammed.wisc.edu/STAMPstudy

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Questions?

85


Thank You!

Aleksandra Zgierska, MD PhDAssistant Professor, University of Wisconsin-Madison

[email protected]

11-1-2017

Documents

Addressing the Opioid Crisis by Improving Pain Management · Addressing the Opioid Crisis by Improving Pain Management Christine Goertz, DC, PhD ... Erin E. Krebs, MD, MPH. Minneapolis