Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Jan:124:107012.
doi: 10.1016/j.cct.2022.107012. Epub 2022 Nov 17.

Design of a pragmatic clinical trial to improve screening and treatment for opioid use disorder in primary care

Rebecca C Rossom  1 , A Lauren Crain  2 , Patrick J O'Connor  3 , Eric Wright  4 , Irina V Haller  5 , Stephanie A Hooker  6 , JoAnn M Sperl-Hillen  7 , Anthony Olson  8 , Katrina Romagnoli  9 , Leif Solberg  10 , Steven P Dehmer  11 , Jacob Haapala  12 , Caitlin Borgert-Spaniol  13 , Lorraine Tusing  14 , Jule Muegge  15 , Clayton Allen  16 , Heidi Ekstrom  17 , Kristen Huntley  18 , Jennifer McCormack  19 , Gavin Bart  20
Affiliations
Randomized Controlled Trial

Design of a pragmatic clinical trial to improve screening and treatment for opioid use disorder in primary care

Rebecca C Rossom et al. Contemp Clin Trials. 2023 Jan.

Abstract

Background: Opioid-related deaths continue to rise in the U.S. A shared decision-making (SDM) system to help primary care clinicians (PCCs) identify and treat patients with opioid use disorder (OUD) could help address this crisis.

Methods: In this cluster-randomized trial, primary care clinics in three healthcare systems were randomized to receive or not receive access to an OUD-SDM system. The OUD-SDM system alerts PCCs and patients to elevated risk of OUD and supports OUD screening and treatment. It includes guidance on OUD screening and diagnosis, treatment selection, starting and maintaining patients on buprenorphine for waivered clinicians, and screening for common comorbid conditions. The primary study outcome is, of patients at high risk for OUD, the percentage receiving an OUD diagnosis within 30 days of index visit. Additional outcomes are, of patients at high risk for or with a diagnosis of OUD, (a) the percentage receiving a naloxone prescription, or (b) the percentage receiving a medication for OUD (MOUD) prescription or referral to specialty care within 30 days of an index visit, and (c) total days covered by a MOUD prescription within 90 days of an index visit.

Results: The intervention started in April 2021 and continues through December 2023. PCCs and patients in 90 clinics are included; study results are expected in 2024.

Conclusion: This protocol paper describes the design of a multi-site trial to help PCCs recognize and treat OUD. If effective, this OUD-SDM intervention could improve screening of at-risk patients and rates of OUD treatment for people with OUD.

Keywords: Opioid overdose; Opioid use disorder; Pragmatic clinical trial; Primary care; Shared decision-making.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figue 1.
Figue 1.
Opioid Use Disorder (OUD) Shared Decision Making (SDM) Workflow for At-Risk Patients.
Figure 2.
Figure 2.
Top of Shared Decision-Making Tool (Visible Across All Modules) and Screening and Diagnosis Module for Example Patient with Elevated Risk of Opioid Use Disorder.
Figure 3.
Figure 3.
Treatment Selection Module for Example Patient with a New Diagnosis of Opioid Use Disorder.
Figure 4.
Figure 4.
Suboxone Module for Example Patient Starting Buprenorphine via an At-Home Induction.
Figure 5.
Figure 5.
Other Care Module for an Example Patient who Uses Intravenous Drugs.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Drug Overdose Deaths in the U.S. Top 100,000 Annually. 2021. [cited 2022 May 22]; Available from: https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm.
    1. Treatment episode data set - admissions (TEDS-A) 2012. [cited 2018 May 15]; Available from: http://wwwdasis.samhsa.gov/webt/quicklink/US09.htm.
    1. Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health. 2020, Substance Abuse and Mental Health Services Administration: Rockville, MD.
    1. Jones CM, et al., National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment. Am J Public Health, 2015. 105(8): p. e55–63. - PMC - PubMed
    1. Substance Abuse and Mental Health Services Administration, Medications for Opioid Use Disorder. Treatment Improvement Protocol (TIP) Series 63 Publication No. PEP21-02-01-002. 2021, Rockville, MD: Substance Abuse and Mental Health Services Administration.

Publication types

MeSH terms