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Improving Adherence to Long-term Opioid Therapy Guidelines to Reduce Opioid Misuse in Primary CareA Cluster-Randomized Clinical Trial

Educational Objective
To determine whether a multicomponent intervention improves guideline adherence while decreasing opioid misuse risk.
1 Credit CME
Key Points

Question  Does a multicomponent intervention with a nurse care manager, electronic registry, data-driven academic detailing, and electronic decision tools improve adherence to opioid-prescribing guidelines and decrease early refills of opioids in patients with chronic pain compared with electronic decision tools alone?

Findings  The multicomponent intervention improved adherence to guideline-recommended monitoring but did not decrease early opioid refills.

Meaning  While the multicomponent intervention improved adherence to guideline-recommended monitoring of opioids in patients with chronic pain, further research is needed to determine whether guideline adherence reduces opioid-related risks.


Importance  Prescription opioid misuse is a national crisis. Few interventions have improved adherence to opioid-prescribing guidelines.

Objective  To determine whether a multicomponent intervention, Transforming Opioid Prescribing in Primary Care (TOPCARE; http://mytopcare.org/), improves guideline adherence while decreasing opioid misuse risk.

Design, Setting, and Participants  Cluster-randomized clinical trial among 53 primary care clinicians (PCCs) and their 985 patients receiving long-term opioid therapy for pain. The study was conducted from January 2014 to March 2016 in 4 safety-net primary care practices.

Interventions  Intervention PCCs received nurse care management, an electronic registry, 1-on-1 academic detailing, and electronic decision tools for safe opioid prescribing. Control PCCs received electronic decision tools only.

Main Outcomes and Measures  Primary outcomes included documentation of guideline-concordant care (both a patient-PCC agreement in the electronic health record and at least 1 urine drug test [UDT]) over 12 months and 2 or more early opioid refills. Secondary outcomes included opioid dose reduction (ie, 10% decrease in morphine-equivalent daily dose [MEDD] at trial end) and opioid treatment discontinuation. Adjusted outcomes controlled for differing baseline patient characteristics: substance use diagnosis, mental health diagnoses, and language.

Results  Of the 985 participating patients, 519 were men, and 466 were women (mean [SD] patient age, 54.7 [11.5] years). Patients received a mean (SD) MEDD of 57.8 (78.5) mg. At 1 year, intervention patients were more likely than controls to receive guideline-concordant care (65.9% vs 37.8%; P < .001; adjusted odds ratio [AOR], 6.0; 95% CI, 3.6-10.2), to have a patient-PCC agreement (of the 376 without an agreement at baseline, 53.8% vs 6.0%; P < .001; AOR, 11.9; 95% CI, 4.4-32.2), and to undergo at least 1 UDT (74.6% vs 57.9%; P < .001; AOR, 3.0; 95% CI, 1.8-5.0). There was no difference in odds of early refill receipt between groups (20.7% vs 20.1%; AOR, 1.1; 95% CI, 0.7-1.8). Intervention patients were more likely than controls to have either a 10% dose reduction or opioid treatment discontinuation (AOR, 1.6; 95% CI, 1.3-2.1; P < .001). In adjusted analyses, intervention patients had a mean (SE) MEDD 6.8 (1.6) mg lower than controls (P < .001).

Conclusions and Relevance  A multicomponent intervention improved guideline-concordant care but did not decrease early opioid refills.

Trial Registration  clinicaltrials.gov Identifier: NCT01909076

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Article Information

Accepted for Publication: April 27, 2017.

Correction: This article was corrected on November 6, 2017, to fix 2 incorrect reports of P value resulting from typographical errors.

Corresponding Author: Jane M. Liebschutz, MD, MPH, Boston Medical Center, 801 Massachusetts Ave, Boston, MA 02118 (jane.liebschutz@bmc.org).

Published Online: July 17, 2017. doi:10.1001/jamainternmed.2017.2468

Author Contributions: Dr Liebschutz had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Liebschutz, Xuan, Shanahan, Alford, Parker, Samet, Lasser.

Acquisition, analysis, or interpretation of data: Liebschutz, Xuan, Shanahan, LaRochelle, Keosaian, Beers, Guara, O’Connor, Weiss, Crosson, Cushman.

Drafting of the manuscript: Liebschutz, Xuan, Shanahan, Keosaian.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Liebschutz, Xuan, Shanahan, LaRochelle.

Obtained funding: Liebschutz, Lasser.

Administrative, technical, or material support: Liebschutz, Shanahan, LaRochelle, Keosaian, Beers, Guara, O’Connor.

Supervision: Liebschutz, Shanahan, Keosaian.

Conflict of Interest Disclosures: Dr Weiss consulted to GW Pharmaceuticals, Alkermes, and Indivior. No other disclosures are reported.

Funding/Support: This study was funded in part by the National Institute on Drug Abuse, grant R01DA034252-01 (Drs Liebschutz and Lasser).

Role of the Funder/Sponsor: the funders had no role in the design and conduct of the study; collection, management, analysis or interpretation of data; preparation, review or approval of manuscript; and decision to submit the manuscript for publication.

Additional Contributions: The authors wish to acknowledge Linda Rosen, MSEE, for aiding database extraction, Vinay Hooloomann, BE/BS, for development of the registry, Jessie Gaeta, MD, and Mohamed Azzam Mehssen, MD, for help as clinical champions, and the entire clinical staff at all sites for support in this project. Contributors Rosen and Hooloomann were compensated in the normal course of their employment for their contributions; Drs Gaeta and Mehssen each received a stipend for serving as clinical champions.

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