Transforming Opioid Prescribing in Primary Care: The TOPCARE RCT Jane Liebschutz, MD MPH Chief, Division of General Internal Medicine University of Pittsburgh Medical Center NIDA 1R01DA034252-01 (Lasser- Multi PI) Clinical Addiction Research & Education Unit Boston Medical Center Ziming Xuan - Christopher Shanahan- Marc LaRochelle - Julia Keosaian - Donna Beers - George Guara - Kristen O’Connor - Daniel Alford - Victoria Parker – Roger Weiss - Jeffrey Samet - Julie Crosson – Phoebe A. Cushman - Karen E. Lasser

Background Opioid overdose deaths and prescribing Professional medical societies and CDC clinical guidelines for chronic opioid therapy (COT) Guidelines: Patient-provider agreements (PPAs) Urine Drug Testing (UDT) Prescription Drug Monitoring Programs (PDMPs) Risk assessment tools

Background Most clinicians do not follow guidelines for monitoring patients on opioids Strategies focus on changing individual provider behavior Observational studies suggest systems-based approach to be effective Westanmo A Pain Med 2015 Von Korff M, The Journal of Pain 2016

TOPCARE Study Objective To conduct a cluster randomized controlled trial among PCPs to test implementation of practice guidelines to improve monitoring and decrease misuse of prescription opioids for patients with chronic pain.

Website→ Clinical Decision Support (eCDS) tools TOPCARE Study Design Study Design 53 PCPs Randomized Intervention Website→ Clinical Decision Support (eCDS) tools Nurse Care Management (NCM) Electronic Registry Academic Detailing Control Website eCDS only vs. n=25 n=28 Based on: Chronic Care Model Bodenheimer et al. 2002

Nurse Care Manager Responsibilities Population management via registry Refills Urine drug screens Pill counts Patient provider agreement Prescription monitoring program Monitoring for aberrancies Pain and function assessment

Academic Detailing—Audit and Feedback Opioid prescribing experts met one-on-one with intervention PCP Feedback on aggregate patient data from registry “Dashboard” Review principles of chronic opioid therapy management Review challenging patients

TOPCARE Website TOPCARE Website Electronic decision support tools Validated risk assessment tools Evidence-based treatments, Interactive tools to interpret urine drug tests, assessments Patient and provider resources www.myTOPCARE.org

Recruitment Eligibility: > 4 patients on COT Recruited 53 PCPs from January 2014 to March 2015 Site 1: Boston Medical Center (n=24) Site 2: CHC (n=10) Site 3: CHC (n=9) Site 4: CHC (n=10) Patients of PCPs – waiver of informed consent

Primary Outcomes Electronic health record for all outcomes PCP adherence to chronic opioid therapy guidelines Signed PPA (ever) > 1 completed urine screen (over 12 months) Early refills 2 or more early refills

Secondary Outcomes Discontinuation of opioid prescription No opioid prescription days in months 11 and 12 10% reduction in morphine equivalent daily dose 30 days prior to intervention vs. last 30 days of follow up year

Analysis Intent to treat Patient-level outcomes Compared baseline and 12 m follow up Regression analysis adjusted for baseline characteristics and clustering among PCPs and sites.

Results: PCP Characteristics n=53 Primary Care Providers Intervention PCPs: 25 PCPs Control PCP: 28 PCPs Groups similar 66% female 34% >50 years old 67% white 91% physicians 30% certified to prescribe buprenorphine

Results- Patient Characteristics n=985 Patient Participants Intervention PCPs: 586 patients Control PCPs: 399 patients Groups similar 47% female Mean 55 years old 15% privately insured 52% non-Hispanic white

Results-Group Differences Intervention N=586 Control N=399 P value Drug use diagnosis 14% 18.8% 0.04 Mental Health diagnosis 59.0% 66.4% 0.02 English speaking 94.2% 90.7%

Urinary Drug Tests AOR = 3.0 (1.8, 5.0) p < 0.001 p = 0.08 74.6% 64.9% 59.4% 57.9%

Patient Provider Agreements 83.5% 64.2% 60.9% 58.4%

≥2 Early Refills AOR =1.1 (0.7, 1.8) p = 0.67 p = 0.82 24.7% 23.6% 20.7% 20.1%

Opioid Discontinuation AOR =1.5 (1.0, 2.1) p = 0.08 21.3% 16.8%

10% Dose Reduction AOR =1.6 (1.3, 2.1) p < 0.001 47.1% 35.8%

Conclusion TOPCARE intervention increased guideline-concordant opioid monitoring Intervention did not reduce likelihood of obtaining early refills More patients discontinued opioids Lower doses of opioids among those who continued opioids

Limitations EHR as sole source of patient data Lack of pharmacy fill data for early refill outcome Cannot distinguish relative impact each intervention component Inability to measure unintended consequences

Implications System approach to reduce opioid risk Future research Lower cost personnel (e.g. Medical Assistant) Academic detailing “lite” Patient outcomes of pain and addiction

TOPCARE Team Multi-PI: Karen E. Lasser, MD MPH Jane Liebschutz, MD MPH Co-investigators: Christopher W. Shanahan, MD Marc LaRochelle, MD MPH Daniel P. Alford, MD MPH Roger D. Weiss, MD Jeffrey H. Samet, MD MA MPH Phoebe A. Cushman, MD Victoria Parker DBA EdM Statistician: Ziming Xuan, ScD SM Study nurses: Donna Beers, MSN, RN-BC, CARN George Guara RN, CARN Kristen O’Connor RN BSN CARN Clinical Champions: Julie Crosson, MD Jessie Gaeta, MD Mohammed Azzam Mehssen, MD Project manager: Julia Keosaian, MPH Research Assistants: Olivia Gamble, MPH Sarah Kosakowski, BS

Thank you!

Patient Provider Agreements- among those without baseline agreement n=376 AOR = 11.0 (4.4, 32.4) p < 0.0001 53.8% 6.0%

Sustainability of Intervention Two sites adopted TOPCARE after trial completion Hired study nurse full time Largest site hired 2 additional nurses 2 CHCs adopting aspects of TOPCARE Funding issue to hire nursing staff