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

Rebecca C. Rossom; A. Lauren Crain; Patrick J. O'Connor; Eric Wright; Irina V. Haller; Stephanie A. Hooker; Jo Ann M. Sperl-Hillen; Anthony Olson; Katrina Romagnoli; Leif Solberg; Steven P. Dehmer; Jacob Haapala; Caitlin Borgert-Spaniol; Lorraine Tusing; Jule Muegge; Clayton Allen; Heidi Ekstrom; Kristen Huntley; Jennifer McCormack; Gavin Bart

doi:10.1016/j.cct.2022.107012

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

Rebecca C. Rossom
, A. Lauren Crain
, Patrick J. O'Connor
, Eric Wright
, Irina V. Haller
, Stephanie A. Hooker
, Jo Ann M. Sperl-Hillen
, Anthony Olson
, Katrina Romagnoli
, Leif Solberg
, Steven P. Dehmer
, Jacob Haapala
, Caitlin Borgert-Spaniol
, Lorraine Tusing
, Jule Muegge
, Clayton Allen
, Heidi Ekstrom
, Kristen Huntley
, Jennifer McCormack
, Gavin Bart

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

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.

Original language	English (US)
Article number	107012
Journal	Contemporary Clinical Trials
Volume	124
DOIs	https://doi.org/10.1016/j.cct.2022.107012
State	Published - Jan 2023

Bibliographical note

Funding Information:
This work was supported by the National Institutes of Health through the NIH HEAL Initiative under award number ( UG1DA040316 ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (NIH) or the NIH Helping to End Addiction Long-term (HEAL) Initiative. This research is also supported by the Department of Health and Human Services , National Institute on Drug Abuse , Center for the Clinical Trials Network, under contract numbers 75N95019D00013 (Data and Statistics Center, the Emmes Company).

Publisher Copyright:
© 2022 Elsevier Inc.

Keywords

Opioid overdose
Opioid use disorder
Pragmatic clinical trial
Primary care
Shared decision-making

PubMed: MeSH publication types

Randomized Controlled Trial
Journal Article
Research Support, N.I.H., Extramural

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Publisher link

10.1016/j.cct.2022.107012

Find It

Find It at U of M Libraries

Cite this

Rossom, R. C., Crain, A. L., O'Connor, P. J., Wright, E., Haller, I. V., Hooker, S. A., Sperl-Hillen, J. A. M., Olson, A., Romagnoli, K., Solberg, L., Dehmer, S. P., Haapala, J., Borgert-Spaniol, C., Tusing, L., Muegge, J., Allen, C., Ekstrom, H., Huntley, K., McCormack, J., & Bart, G. (2023). Design of a pragmatic clinical trial to improve screening and treatment for opioid use disorder in primary care. Contemporary Clinical Trials, 124, Article 107012. https://doi.org/10.1016/j.cct.2022.107012

Rossom, RC, Crain, AL, O'Connor, PJ, Wright, E, Haller, IV, Hooker, SA, Sperl-Hillen, JAM, Olson, A, Romagnoli, K, Solberg, L, Dehmer, SP, Haapala, J, Borgert-Spaniol, C, Tusing, L, Muegge, J, Allen, C, Ekstrom, H, Huntley, K, McCormack, J & Bart, G 2023, 'Design of a pragmatic clinical trial to improve screening and treatment for opioid use disorder in primary care', Contemporary Clinical Trials, vol. 124, 107012. https://doi.org/10.1016/j.cct.2022.107012

@article{26e2904a5af24d24b324f08fed19fc1b,

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

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",

author = "Rossom, \{Rebecca C.\} and Crain, \{A. Lauren\} and O'Connor, \{Patrick J.\} and Eric Wright and Haller, \{Irina V.\} and Hooker, \{Stephanie A.\} and Sperl-Hillen, \{Jo Ann M.\} and Anthony Olson and Katrina Romagnoli and Leif Solberg and Dehmer, \{Steven P.\} and Jacob Haapala and Caitlin Borgert-Spaniol and Lorraine Tusing and Jule Muegge and Clayton Allen and Heidi Ekstrom and Kristen Huntley and Jennifer McCormack and Gavin Bart",

note = "Funding Information: This work was supported by the National Institutes of Health through the NIH HEAL Initiative under award number ( UG1DA040316 ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (NIH) or the NIH Helping to End Addiction Long-term (HEAL) Initiative. This research is also supported by the Department of Health and Human Services , National Institute on Drug Abuse , Center for the Clinical Trials Network, under contract numbers 75N95019D00013 (Data and Statistics Center, the Emmes Company). Publisher Copyright: {\textcopyright} 2022 Elsevier Inc.",

year = "2023",

month = jan,

doi = "10.1016/j.cct.2022.107012",

language = "English (US)",

volume = "124",

journal = "Contemporary Clinical Trials",

issn = "1551-7144",

publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Design of a pragmatic clinical trial to improve screening and treatment for opioid use disorder in primary care

AU - Rossom, Rebecca C.

AU - Crain, A. Lauren

AU - O'Connor, Patrick J.

AU - Wright, Eric

AU - Haller, Irina V.

AU - Hooker, Stephanie A.

AU - Sperl-Hillen, Jo Ann M.

AU - Olson, Anthony

AU - Romagnoli, Katrina

AU - Solberg, Leif

AU - Dehmer, Steven P.

AU - Haapala, Jacob

AU - Borgert-Spaniol, Caitlin

AU - Tusing, Lorraine

AU - Muegge, Jule

AU - Allen, Clayton

AU - Ekstrom, Heidi

AU - Huntley, Kristen

AU - McCormack, Jennifer

AU - Bart, Gavin

N1 - Funding Information: This work was supported by the National Institutes of Health through the NIH HEAL Initiative under award number ( UG1DA040316 ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (NIH) or the NIH Helping to End Addiction Long-term (HEAL) Initiative. This research is also supported by the Department of Health and Human Services , National Institute on Drug Abuse , Center for the Clinical Trials Network, under contract numbers 75N95019D00013 (Data and Statistics Center, the Emmes Company). Publisher Copyright: © 2022 Elsevier Inc.

PY - 2023/1

Y1 - 2023/1

N2 - 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.

AB - 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.

KW - Opioid overdose

KW - Opioid use disorder

KW - Pragmatic clinical trial

KW - Primary care

KW - Shared decision-making

UR - https://www.scopus.com/pages/publications/85146364602

UR - https://www.scopus.com/pages/publications/85146364602#tab=citedBy

U2 - 10.1016/j.cct.2022.107012

DO - 10.1016/j.cct.2022.107012

M3 - Article

C2 - 36402275

AN - SCOPUS:85146364602

SN - 1551-7144

VL - 124

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

M1 - 107012

ER -

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

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

UN SDGs

Publisher link

Find It

Other files and links

Fingerprint

Cite this