Addressing th the Opioid Crisis b by y Improving Pain Management - - PowerPoint PPT Presentation

ANNUAL MEETING

• OCT. 31-NOV. 2

ARLINGTON, VA

#PCORI2017

Addressing th the Opioid Crisis b by y Improving Pain Management

Christine Goertz, DC, PhD

Vice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality @ChristineGoertz November 1, 2017

11/5/2017 2

ANNUAL MEETING | #PCORI2017

Ch Chri ristine Goe

• ert

rtz, D , DC, C, Ph PhD

Disc sclosu sures

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, RAND Corporation 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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ANNUAL MEETING | #PCORI2017

Objec ectives es

At 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

ANNUAL MEETING

• OCT. 31-NOV. 2

ARLINGTON, VA

#PCORI2017

Christine Goertz, DC, PhD PCORI Board of Governors Judy Zerzan, MD, MPH Colorado Department of Healthcare Financing and Healthcare Aleksandra Zgierska, MD, PhD University of Wisconsin Terrie Cowley The TMJ Association, Ltd Erin Krebs, MD, MPH University of Minnesota Lynn Debar, PhD Kaiser Permanente

ANNUAL MEETING

• OCT. 31-NOV. 2

ARLINGTON, VA

#PCORI2017

Overview of Opioid Crisis a and Effec ective Non e Nonpharmacol

• logi
• gic

Trea eatment St Strategies ies for

• r P

Pain

Erin E. Krebs, MD, MPH

Minneapolis VA Health Care System, University of Minnesota November 1, 2017

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Erin K Kre rebs

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

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Objec ectives es

At 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

11/5/2017 8

ANNUAL MEETING | #PCORI2017 Paulozzi et al, MMWR 2011;60:1487–92

Opioid overdose deaths Opioid addiction treatment admissions Opioid sales

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The Evidence f for O Opioids in Chronic P Pain, 1 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 f for O Opioids in Chronic P Pain, 2 2016

• No study of opioid therapy versus placebo, no opioid therapy, or

nonopioid therapy for chronic pain evaluated long-term (≥ 1 year)

• utcomes 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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Inter ertwined ed c cha hallen enges o es of the he o

• pi

pioid crisi sis

Chronic pain Opioid addiction Long-term

• pioid use

How can people prescribed high-dose

• pioids reduce
• pioid 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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ANNUAL MEETING | #PCORI2017

• 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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ANNUAL MEETING | #PCORI2017

Behavioral therapies

CBT ACT MBSR

Manual therapies

Massage Acupuncture Manipulation

Exercise therapies

Strengthening- stretching Aerobic exercise Yoga Tai chi

Therapies wi with e evidence of efficacy

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ANNUAL MEETING | #PCORI2017

Area eas ne needing a add dditional r rese esearch

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

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The e he eviden ence ce f for r opi pioids in n chr hronic pa pain, 2016 016

• 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 e he eviden ence ce f for r opi pioids in n chr hronic pa pain, 2016 016

• 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 directi tions for r research

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PC PCORI’s Investm tment i in Pain and Opioid Research

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Christine Goertz, DC, PhD

Vice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality @ChristineGoertz November 1, 2017

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ANNUAL MEETING | #PCORI2017

PCORI’s M Mission

To 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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ANNUAL MEETING | #PCORI2017

PCOR ORI’s R Role i in a National al H Health R Resear arch P Program am

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PCOR ORI P Prior

• rity

ty Ar Area: C Chron

• nic

ic P Pain a and Op Opioi

• id R

Resea earch ch

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 ch A Addressing Q Questions That M Matter

Clinician

What works best to safely and appropriate reduce opioid use for people with pain?

Patient

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

Health System Leader

How can we improve our clinicians’ prescribing practices?

Caregiver

How can patients best become empowered about opioid use?

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ANNUAL MEETING | #PCORI2017

59 studies related to chronic noncancer

pain and/or opioids

209 million to fund

As o

• f O

Oct ctober 2 2017, PC PCORI has a awarded

Chronic an and A Acute P Pai ain M Man anagement

ANNUAL MEETING

• OCT. 31-NOV. 2

ARLINGTON, VA

#PCORI2017

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ANNUAL MEETING | #PCORI2017

Spanning t the C Care C Continuum

Prevention Treatment Alternatives Education and Communication Management of Long-term Opioid Use Treatment for Opioid Use Disorder

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PCORI’ I’s T Targeted O Opioid I Initiatives

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Strategies t to P Prevent U Unsafe Prescr cribing i in Primary Care a among Patients w with A Acu cute o

• r C

Chronic P 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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ANNUAL MEETING | #PCORI2017

Clinical S Strategies for Managing a and R Reduci cing Long-Term U Use f for C Chronic Pain

Objective of this PFA:

• Identify clinical strategies for managing

pain while:

• Reducing or eliminating long-term
• pioid use
• Limiting dose escalation

Funds and Duration:

• A total of $40 million

(direct and indirect)

• Up to $10 million in total

direct costs per project

• Projects should be

completed within 3-5 years

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ANNUAL MEETING | #PCORI2017

Medication-Assisted T Treatment De Delivery f for P r Pregnant Women w with Substance ce U Use Disorders I Involvi ving Prescr cription Opioids a and/or H 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)

• Up to $4 million in total

direct costs per project

• Projects should be

completed in 3-4 years

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ANNUAL MEETING | #PCORI2017

In Su 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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ANNUAL MEETING | #PCORI2017

Learn arn M Mor

• re

www.pcori.org info@pcori.org #PCORI2017

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ANNUAL MEETING | #PCORI2017

Qu Ques esti tions?

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Thank Y k You! u!

Christine G Goe

• ertz, DC

DC, Ph PhD

Vice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality @ChristineGoertz

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ANNUAL MEETING | #PCORI2017

What E Eviden ence e Do Patien ents Ne Need ed For r Improved P Pain Management?

Terrie Cowley

President and Co-Founder, The TMJ Association Co-Founder, The Chronic Pain Research Alliance https://twitter.com/tmjassociation https://twitter.com/CPRAlliance_org November 1, 2017

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Terrie Cowl

• wley

Chronic 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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ANNUAL MEETING | #PCORI2017

Objec ectives es

At 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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Patien ents h s have t told u d 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
• f 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 t do we know about t pain treatm tment? t?

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Benefi fit v t vs. Risk

ANNUAL MEETING

• OCT. 31-NOV. 2

ARLINGTON, VA

#PCORI2017

What e evi vidence do p patients need?

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Eviden ence o e of effec ectiven enes ess of v variou

• us

nonpharm rmacologic/non-opi pioid o d opt ptions

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Large c clinical trials that include p patients with c comor

• rbidities

es-what works best for patie ients lik like m me?

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Tim ime f for

• r on
• ne-pe

person t n 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

• ne-person trials.” Nature 520.7549 (2015): 609-611.

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Patie ient in involvement in in all ll aspects of pain n research

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Improved communication n between n patients a and providers

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The W Way Fo Forward rd

Identify Decisional Dilemmas Conduct CER Generate Evidence Base Improve Education and Communication Improve Reimbursement Reduce Uncertainty & Improve Outcomes

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Learn arn m mor

• re

www.tmj.org chronicpainresearchalliance.org www.pcori.org info@pcori.org #PCORI2017

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ANNUAL MEETING | #PCORI2017

Qu Ques esti tions?

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Thank y you!

Terrie Cowley

What Evidence Do Patients Need? https://twitter.com/tmjassociation https://twitter.com/CPRAlliance_org November 1, 2017

ANNUAL MEETING

• OCT. 31-NOV. 2

ARLINGTON, VA

#PCORI2017

Preventing Unsafe Opioid Prescribing

Lynn DeBar, PhD, MPH

Senior Scientific Investigator, Kaiser Permanente Washington Health Research Institute November 1, 2017

ANNUAL MEETING | #PCORI2017

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Lynn DeBar

• Has nothing to disclose.

November 5, 2017

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ANNUAL MEETING | #PCORI2017

Objec ectives es

At 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

ANNUAL MEETING | #PCORI2017

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Opioids a and Beyond: W What happened t to nonpharmacotherapy options f for c chronic p pain?

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ANNUAL MEETING | #PCORI2017

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Oregon M n Medicai aid R Reimbu burse sement Guidelin lines f for

• r B

Back ck P 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 visits PT/OT/OMT/ Chiro/Acupuncture/ massage

Low Risk

OTC meds, muscle relaxers 4 visits PT/OT/OMT/ chiro/acupuncture/ massage OTC meds, muscle relaxers

High Risk

OTC meds, muscle relaxers, limited opioids CBT Office visits Office visits Up to 30 visits PT/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

ANNUAL MEETING | #PCORI2017

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Timeline f for O Oregon G Guideline Implementation

November 5, 2017

July 1, 2016 Start 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

• f 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

ANNUAL MEETING | #PCORI2017

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Study S y Setting ng: OCHI HIN

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.

ANNUAL MEETING | #PCORI2017

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Patient S Survey C 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

• f pain-related services

Negative outcomes from pain-related services Use of illegal drugs or Rx meds for nonmedical reasons

ANNUAL MEETING | #PCORI2017

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Engagi ging g Patient a and S Stakeholder P Partners

• Bullet

November 5, 2017

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Back ck o

• n Track

ck – Poten enti tial I 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

ANNUAL MEETING | #PCORI2017

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Learn More

• www.pcori.org
• info@pcori.org
• #PCORI2017

November 5, 2017

ANNUAL MEETING | #PCORI2017

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Questions?

November 5, 2017

ANNUAL MEETING | #PCORI2017

November 5, 2017 67

Thank You!

Lynn DeBar, PhD, MPH

Senior Scientific Investigator, Kaiser Permanente Washington Health Research Institute November 1, 2017

ANNUAL MEETING

• OCT. 31-NOV. 2

ARLINGTON, VA

#PCORI2017

Beha havi vioral Therapi pies t to I Improve Health and Safety o

• f Patients

with O Opioid-Trea eated ed Chron

• nic Pain

Aleksandra Zgierska, MD PhD

University of Wisconsin-Madison Department of Family Medicine & Community Health November 1, 2017, PCORI 2017 Annual Meeting

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Aleksandra Zgierska, MD PhD

Has nothing to disclose.

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ANNUAL MEETING | #PCORI2017

Objec ectives es

At 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 an and C CBT of

• ffer different skill

skills f for p pain ain coping a g and management o

• f chronic p

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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Str trategie ies T To Assist t with th M Management t

• f
• f Pain: S

: STAMP S Stu tudy

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, WI Boston, MA Salt Lake, UT

Multi ticen center er r random

• mized

ed contr trol

• lled

ed t trial

(Principal Investigator: A. Zgierska, University of Wisconsin)

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Patien ents w with chronic l low back p pain ( (CLBP) P) trea eated ed with daily o

• pioids

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766 p patients w with opioid-treated C CLB LBP

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 S Study dy

Patient/stakeholder-led approach Sound science/methods Answers to questions that matter to patients and clinicians

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STAMP S Study dy: 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 arn M Mor

• re

www.fammed.wisc.edu/ STAMPstudy www.pcori.org info@pcori.org #PCORI2017

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Qu Ques estion

• ns?

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Thank Y You! u!

Aleksandra Zgierska, MD PhD

Assistant Professor, University of Wisconsin-Madison Aleksandra.Zgierska@fammed.wisc.edu 11-1-2017