Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods
Abstract Background Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Pr...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | Addiction Science & Clinical Practice |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13722-023-00424-8 |
| _version_ | 1797557369479102464 |
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| author | Jane M. Liebschutz Geetha A. Subramaniam Rebecca Stone Noa Appleton Lillian Gelberg Travis I. Lovejoy Amanda M. Bunting Charles M. Cleland Karen E. Lasser Donna Beers Catherine Abrams Jennifer McCormack Gail E. Potter Ashley Case Leslie Revoredo Eve M. Jelstrom Margaret M. Kline Li-Tzy Wu Jennifer McNeely |
| author_facet | Jane M. Liebschutz Geetha A. Subramaniam Rebecca Stone Noa Appleton Lillian Gelberg Travis I. Lovejoy Amanda M. Bunting Charles M. Cleland Karen E. Lasser Donna Beers Catherine Abrams Jennifer McCormack Gail E. Potter Ashley Case Leslie Revoredo Eve M. Jelstrom Margaret M. Kline Li-Tzy Wu Jennifer McNeely |
| author_sort | Jane M. Liebschutz |
| collection | DOAJ |
| description | Abstract Background Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. Methods The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. Discussion Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. Trial Registration: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020. |
| first_indexed | 2024-03-10T17:16:08Z |
| format | Article |
| id | doaj.art-482df8cb8ae34403b901e7588dd185f8 |
| institution | Directory Open Access Journal |
| issn | 1940-0640 |
| language | English |
| last_indexed | 2024-03-10T17:16:08Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Addiction Science & Clinical Practice |
| spelling | doaj.art-482df8cb8ae34403b901e7588dd185f82023-11-20T10:28:52ZengBMCAddiction Science & Clinical Practice1940-06402023-11-0118111710.1186/s13722-023-00424-8Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methodsJane M. Liebschutz0Geetha A. Subramaniam1Rebecca Stone2Noa Appleton3Lillian Gelberg4Travis I. Lovejoy5Amanda M. Bunting6Charles M. Cleland7Karen E. Lasser8Donna Beers9Catherine Abrams10Jennifer McCormack11Gail E. Potter12Ashley Case13Leslie Revoredo14Eve M. Jelstrom15Margaret M. Kline16Li-Tzy Wu17Jennifer McNeely18Division of General Internal Medicine, Center for Research On Health Care, University of PittsburghNational Institute On Drug AbuseDepartment of Population Health, NYU Grossman School of MedicineDepartment of Population Health, NYU Grossman School of MedicineDavid Geffen School of Medicine at UCLA, UCLA Fielding School of Public HealthDepartment of Psychiatry, Oregon Health & Science UniversityDepartment of Population Health, NYU Grossman School of MedicineDepartment of Population Health, NYU Grossman School of MedicineSection of General Internal Medicine, Boston Medical Center, Boston University Chobanian & Avedisian School of MedicineSection of General Internal Medicine, Boston Medical Center, Boston University Chobanian & Avedisian School of MedicineEmory University School of MedicineThe Emmes Company, LLCThe Emmes Company, LLCThe Emmes Company, LLCThe Emmes Company, LLCThe Emmes Company, LLCThe Emmes Company, LLCDepartment of Psychiatry and Behavioral Sciences, Duke University School of MedicineDepartment of Population Health, NYU Grossman School of MedicineAbstract Background Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. Methods The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. Discussion Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. Trial Registration: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.https://doi.org/10.1186/s13722-023-00424-8Risky Opioid UsePrimary CareCollaborative CareCluster-Randomized controlled trialSubstance use disorderPrevention |
| spellingShingle | Jane M. Liebschutz Geetha A. Subramaniam Rebecca Stone Noa Appleton Lillian Gelberg Travis I. Lovejoy Amanda M. Bunting Charles M. Cleland Karen E. Lasser Donna Beers Catherine Abrams Jennifer McCormack Gail E. Potter Ashley Case Leslie Revoredo Eve M. Jelstrom Margaret M. Kline Li-Tzy Wu Jennifer McNeely Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods Addiction Science & Clinical Practice Risky Opioid Use Primary Care Collaborative Care Cluster-Randomized controlled trial Substance use disorder Prevention |
| title | Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods |
| title_full | Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods |
| title_fullStr | Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods |
| title_full_unstemmed | Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods |
| title_short | Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods |
| title_sort | subthreshold opioid use disorder prevention stop trial a cluster randomized clinical trial study design and methods |
| topic | Risky Opioid Use Primary Care Collaborative Care Cluster-Randomized controlled trial Substance use disorder Prevention |
| url | https://doi.org/10.1186/s13722-023-00424-8 |
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