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Tu Ngo, PhD, MPH Julie Franklin, MD, MPH

International Conference on Opioids Boston, MA

June 11, 2017

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Disclosures

• Dr. Franklin has no disclosures

• Dr. Ngo has no disclosures

Objectives • Identify areas for improvement in opioid safety

within your practice.

• Identify barriers to improved opioid safety.

• Discuss use of EMR to improve and monitor opioid prescribing practices.

• Name two (2) strategies for promoting cultural change in an organization.

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Development of VIPS

• Veterans Integrated Pain System of Care (VIPS)

• Impetus for change

• Leadership Buy-in

• Year 1

• Year 2

• Directions for the Future

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Recognizing the Problem

• Opioids prescribed in US increased 400% between 1999-2010

• Opioid-related overdose deaths in US increased 400% between 1999-2010

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Veteran Specific Data

• Prescription medications prescribed in the military quadrupled from 2001-2009 (NIDA)

• Prescription drug abuse increased five-fold between 2002-2008 (IOM)

• Veterans are twice as likely to die from an accidental overdose (OD) than non-Veterans (Bohnert, 2011)

• Accidental OD linked to: (Bohnert, 2011) – Narcotics 51.4%

– Benzodiazepines 8%

– Antidepressants 8%

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• Retrospective cohort study of 141,029 Veterans with non-cancer pain diagnosis

• Veterans with mental health issues were more likely to receive opioids:

– Approximately 3 times as likely with PTSD,

– Approximately 2 times as likely with other mental health issues.

• Those with co-morbid PTSD were significantly more likely: – Highest quintile for dose; more than one opioid prescribed

concurrently; concurrent sedative hypnotics; early refills,

– Opioid related accidents, overdoses, alcohol and non-opioid related accidents and overdoes, self-inflicted injuries and violence related injuries.

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Seal et al (2012). JAMA, March, 307(9).

PTSD increases Risk for Opioid Prescriptions, High-Risk Use and Adverse Events

Opioid Prescribing and Opioid Use Disorder

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• Patients with CNCP prescribed opioids had significantly higher rates of OUDs compared to those not prescribed opioids. Effects varied by average daily dose and days supply:

– low dose, acute OR=3.03

– low dose, chronic OR=14.92

– medium dose, acute OR =2.80

– medium dose, chronic OR=28.69

– high dose, acute OR=3.10

– high dose, chronic OR=122.45

• Among individuals with a new CNCP episode, prescription opioid exposure was a strong risk factor for incident OUDs; magnitudes of effects were large. Duration of opioid therapy was more important than daily dose in determining OUD risk.

Edlund et al (2014). Clin J Pain, July 30(7): 557-64.

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Dunn Gomes Bohnert

Dose* (mg/day)

HR (95% CI) OR (95% CI) HR (95% CI)

1-<20 1.00 (REF) 1.00 (REF) 1.00 (REF)

20-<50 1.2 (0.4-3.6) 1.3 (0.9-1.8) 1.9 (1.3-2.7)

50-<100 3.1 (1.0-9.5) 1.9 (1.3-2.9) 4.6 (3.2-6.7)

≥100 or 100-199

11.2 (4.8-26.0) 2.0 (1.3-3.2) 7.2 (4.9-10.7)

≥200 2.9 (1.8-4.6)

*morphine equivalent Dunn et al. Annals IM 2010; Gomes et al. Archives IM 2011; Bohnert et al. JAMA 2011

Slide courtesy of JW Frank, MD, MPH

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Odds of overdose by increasing dose

Mortality: Opioid-Benzo Overdose Deaths

Source: CDC’s National Vital Statistics System Mortality File, 2014

31% 13%

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SELF CARE SELF EFFICACY

Promotion of Healthy Behaviors Addressing Co-Morbidities

Integrated Health System

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Behavioral therapies

Physical activation

Rational pharmaco therapy

IOM’s vision for multimodal chronic pain care (2011)

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VA New England Healthcare System VIPS Evolution

VISN 1- PC-MH Integration core team focusing on pain

VISN 1 OEF/OIF Training- consultative model to

address pain

Pain Management Directive published

Adoption of VISN 1 Pain Agreement

VISN 1 Primary Care Strategic Plan on Pain

Care Pain Champion and Facility level Primary Care

Pain Champion

Primary Care Sharing Best Practices-

Interdisciplinary meeting on Chronic Pain Management

Innovation Grant- Pain Workshops

VISN 1 Grand Rounds –

4 part series

VISN 1 Taskforce CARF Accredited Pain Program

National Informed Consent for Chronic Opioid Therapy

VISN Opioid Pain Report first deployed

VISN 1 OSI Pilot (2 year) Pain designated as VISN 1 Strategic Initiative

VISN 1 Pain Summit

VA Maine earns CARF accreditation

VISN 1 Integrated Pain Initiative funding approved

Initiative official start (FY16-FY20)

2007 2008 2009 2010

2012 2013 2014 2015

OSI rolled out Nationally

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VHA Pain Directive 2009

• Stepped Care Model Implemented

• Biopsychosocial Model Of Pain Care Introduced

• Focus on Quality of Life and Functional Improvement Encouraged

• Multidisciplinary Pain Management Oversight Committees Mandated

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Routine screening for presence & severity of pain; Assessment

and management of common pain conditions; Support from MH-

PC Integration; OEF/OIF, &

Post-Deployment Teams; Expanded care management;

Pharmacy Pain Care Clinics; Pain Schools

Multidisciplinary Pain Medicine Specialty Teams;

Rehabilitation Medicine;

Behavioral Pain Management; Mental Health/SUD

Programs

Advanced pain medicine diagnostics

& interventions;

CARF accredited pain rehabilitation

STEP 2

STEP 3

STEP 4

VHA Stepped Pain Care

Complexity

Treatment Refractory

Comorbidities

RISK

Nutrition/weight management, exercise/conditioning, & sufficient sleep;

mindfulness meditation/relaxation techniques; engagement in meaningful

activities; family & social support; safe environment/surroundings

STEP 1

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VHA Opioid Safety Initiative (OSI)

• National OSI Pilot (2013): no consensus on standard template and process

• National OSI Memorandum (2014)

– Dashboard Reports provided to identify high risk • Utilization,

• MEDD,

• Urine Drug Screen (UDS),

• Co-prescription of opioids/benzodiazepines

– 9 Goals in response to OIG report

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VHA OSI Goals

1) Educate prescribers on urine drug screen (UDS): each VISN standardized education system

2) Increase use of UDS graded on current performance

3) Facilitate use of state Prescription Drug Monitoring Program (PDMP)

4) Establish safe and effective tapering program for co-prescribed opioids and benzodiazepines

5) Develop tools to identify higher risk patients

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VHA OSI Goals cont’d

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6) Improve prescribing practices around long-acting opioid formulations

7) Review treatment plans on high dose of opioids: Mandated chart reviews over >200 MEDD

8) Offer Complementary and Integrated Health (CIH) modalities: at least one of CIH and one evidence-based psychotherapy (CBT, ACT)

9) Develop new models of mental health and primary care collaboration to manage prescribing of opioids and benzodiazepines in patients with chronic pain

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VHA Informed Consent for Long-term Opioid Therapy Directive (2014)

• Required that all patients on long-term opioid therapy have signed informed consent in charts by May 6, 2015

• Overseen by VHA Integrated Ethics Committee

• Barriers:

– Difficult to reach patients in rural areas,

– How to use the primary care team efficiently,

– Non-primary care prescribers were not complying,

– Database was not clean (i.e. included palliative care).

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VHA Opioid Overdose Education and Naloxone Distribution (OEND) Program (2014)

• National Implementation of OEND Program to reduce opioid-related deaths (Pharmacy Benefits/ SUD)

• VA actively engaged in promoting safe and effective practices

• Recommendations for naloxone education and distribution to high-risk Veteran population

• Resources provided

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VHA Academic Detailing Memorandum (2015)

• Implement system-wide Academic Detailing (AD) and pain program champions

• Aim to improve evidence-based delivery of health-care and disease management/ preventative services

• Support frontline providers with specialty trained AD staff, individualized benchmarking data and educational programming

• Target areas:

– Psychotropic Drug Safety Initiative

– Opioid Safety Initiative

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VHA Prescription Drug Monitoring Program (PDMP) Memorandum (2016)

• Required querying state PDMP for all patients prescribed opioids in the VA at initial prescription, at least annually, and more often as clinically indicated

– Must be documented in records with standard note

– Exclusion if less than 5 day prescription or patient is receiving hospice care

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CDC (2016) and VA/DoD Guidelines (2017)

• Patient selection

• Medication and dose selection

• Follow-up and discontinuation

• Assessment of risks

• Addressing harms

CDC Opioid Guidelines 2016; MMWR / March US Department of Health and Human Services/Centers for Disease Control and Prevention 18, 2016 / Vol. 65 / No. 1

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Concepts from Guidelines

• Initiation of Chronic Opioid Therapy

• Risk stratification

• Attention to Morphine Equivalent Daily Dose

– Opioid Conversion

• Attention to medication interactions

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Concepts from Guidelines

• Need for informed consent and patient education

• Monitoring and reassessment

• Need for alternatives to chronic opioid therapy for chronic pain

• Need for assistance to Primary Care Teams

CARA Memorandum (2017)

• Pain Care

– Pain Management Teams at each facility

– Availability of immediate consultation for opioid prescriptions

– Team reviews

– Availability of prescribing for high risk patients

• Expansion of OSI

• Availability of Complementary and Integrative Health Modalities

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Struggles from the Start

• Collateral Duty

• Lack of shared vision

• Lack of consensus with leadership about scope and goals

• Excessive focus on opioids/opioid safety vs. quality pain care

• Fragmented/ silo-effect / uncoordinated VISN-wide team

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Lessons Learned Year 0

• Need for consensus among group and with leadership

• Team development essential – Regular F2F meetings

– Regular phone meetings

• Protected time for clinicians

• Administrative support / project management

• Regular feedback to stakeholders – Leadership

– Frontline

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VA New England Healthcare System (VISN 1) VIPS (2015)

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Vision: To create a comprehensive, safe, evidence-based system of pain care that improves the function and quality of life for all Veterans with chronic pain Goal 1: Improve Safety- Improve the safety of care for Veterans with chronic pain in VISN 1 by achieving a VISN 1 Pain Composite Score of 97% by September 30, 2019. Goal 2: Enhance Access- Improve access to care for Veterans with chronic pain in VISN 1 by achieving 97% completion of the VIPS Pain Grid by September 30, 2019.

Informed Consent

Urine Drug Screen

State Prescription Drug Monitoring Program

Naloxone

Safety Tier 1 Review

Complexity

Chiropractic Care, Interdisciplinary Pain Care Team,

Interventional Pain Care, Acupuncture Care, Pain

School, Evidence Based Psychotherapy (EBP)

programs for chronic care, Complementary

Integrative Health (CIH) approaches, Medication

Assisted Therapy (MAT) for veterans with chronic

pain and substance use disorder

CARF accredited pain rehabilitation

program

STEP 1 FY15-FY17

STEP 2 FY16-FY17

STEP 3 FY17- FY18

VA Stepped Pain Care

Treatment Refractory

Comorbidities

RISK

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Year 1 Metrics (2016)

• Safety (Step 1)

– Informed consent

– Urine drug screen

– State PDMP checks

• Engaged teams (Steps 2 and 3)

– Interdisciplinary Comprehensive Pain

– Substance Use Disorder

– Complementary and Integrative Health

– Chiropractic Care

– CARF Pain Rehabilitation

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77.4% 79.5%

81.4% 82.6% 85.5% 85.9% 86.6% 87.6% 88.4% 89.4% 89.8% 89.8%

50%

55%

60%

65%

70%

75%

80%

85%

90%

95%

100% VISN 1 Informed Consent

VISN 1 Average Goal = 90% Aspirational Goal = 95%

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89.9% 90.7% 91.0% 88.2%

91.2%

82.0% 84.0% 82.5% 82.4% 83.9% 85.0% 86.3%

50%

55%

60%

65%

70%

75%

80%

85%

90%

95%

100% VISN 1 Urine Drug Screen

VISN 1 Average Goal = 90% Aspirational Goal = 95%

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21.9% 22.3% 24.5% 28.6% 29.9%

37.5%

49.5% 56.3%

66.5% 70.9% 73.6% 76.2%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100% VISN 1 PDMP

VISN 1 Average Goal = 50% Aspirational Goal = 55%

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Urine Drug Screen “Dip”

• Noted decrease in rates from December 2015 to January 2016

• Unclear reason for this/ processes variable across and within facilities

• Taskforce convened to develop and implement standard process

– Rapid Process Improvement Workshop (RPIW) • Standardized refill note

• Standardized VISN-wide UDS order set

• Plan for standard UDS confirmation process

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Lessons Learned

• Consensus development across 8 facilities and many stakeholders

– 100% not achievable- “What could you live with?”

– Differing resources

– Differing perspectives

– Resistance to change

• Lab

– Cost concerns

– Equipment

– Training

New England VERC - 36 36

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Project Approach- FY16

Workgroups

Current State, Future State, and Gap Analysis

Develop Inventory Criteria

Oct 2015 - Dec 2015

VIPS Leadership

Site Visits

Complete Inventory

Jan 2016

Workgroups

Review Inventory

Submit Recommendations

Feb 2016

VIPS Leadership

Revise Recommendations

Play Catchball

Obtain Approval

Mar 2016 - Aug 2016

Facilities

Receive & Review Recommendations

Implement Recommendations

Jun 2016 – Sept 2016

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Year 2 Metrics (2017)

• Safety Additions (Step 1)

– Naloxone education and distribution to high risk chronic opioid therapy patients

– Opioid safety review on all chronic opioid therapy patients

• Access (Steps 2 and 3)

– Measure Veteran access to non-opioid pain treatment

– Chiropractic care, interdisciplinary care, pain school, interventional pain, acupuncture and 2 additional CIH, medication assisted therapy, evidence based psychotherapy, CARF accredited pain rehabilitation

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35.1%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

Apr 2017 May 2017 Jun 2017 Jul 2017 Aug 2017 Sep 2017

VISN 1 Annual Safety Tier 1 Review

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Lessons Learned • VISN-level approval difficult and time-consuming

– Approval by 5 separate committees required

– 4 months

• Disagreement on how to use the team – Concern about use of provider time although they are prescribing

– Union issues for nurses – they are NOT prescribing

– P4P

– Call Center staff – is this improving safety?

• IT rollout slow – Competing priorities/ demands

– Limited functionality

– Limited engagement at facilities

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Target: Achieve a VISN 1 Pain Access Composite Score (Access to Step 2 Pain Services) of 70% (14 0f 20) by

September 30, 2017

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Education

Physicians Medical Students, Residents, Pain Fellows

Nurses Nursing Students, Nurse Practitioner Students, Nurse Practitioner Residents

Psychologists Pre-doctoral Interns, Post-Doctoral Fellows

Physical Therapists Physical Therapy Doctoral Students

Occupational Therapists Post grad Occupational Therapy Students

Recreational Therapists Undergrad Recreational Therapy Students

Pharmacists Pharm D Students, Post Doctoral Residents

VA Staff • Pain mini residency • 100% compliance with mandatory opioid safety training • Academic Detailing

Research • 21 Pain-specific Research projects totally $3.63 million

• Universal precautions – Consent – Timely UDS – PDMP – Evaluation- Pain history/exam/ assessment of risks and benefits

• Doses – Limits… – Conversion

• Co-prescribing (bzo/sedatives) • Identifying high risk patients

– SUD – Suicidality/depression/anxiety – Aberrant behaviors

• Evaluation/education re: naloxone

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Name the most important area of focus for your practice to improve opioid safety?

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• Staff time – Provider access – Time to check PDMP, f/u on labs, panel management

• Education – Not knowing what should be done – Not knowing how to do what should be done

• Ancillary Resources – Admin support – RN support – Logistics (UDS, patient visits) – Someone to call on for difficult questions/ patients

• Competing priorities • Buy-in from staff and/or Leadership

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Identify 3 barriers to improving the area named above.

• Basic clinical improvement tools (PDSA) – Define current process/outcomes

– Identify areas for improvement/change

– Monitor

• Education

• Taskforce/committee/practice management group

• P4P

• Clinical Pharmacy Support- Academic Detailing

• Clinical tools – Templates

– Reminders

– Panel management tools 50

Identify 2 strategies to change practice patterns/improve care

What data is important to feed back to prescribers to change practice? How will you measure it?

• What is measurable? – EMR (Panel management)

– Chart audit

• What can clinicians / management agree upon?

• How often can the team meet?

• How often can data be collected?

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Summary • Quality pain care is a team-sport

• Performance measures do improve practice

• Don’t give up too early!

• Site visits are crucial to know what is really happening at the front lines

• Relationship building helps: – To better understanding the barriers for more effective process

improvements

– To increase buy-in from frontline and leadership

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Questions?

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Thank you!

Contact information:

Tu Ngo - Tu.Ngo@va.gov

Julie Franklin - Julie.Franklin2@va.gov