Jeffrey H Samet1,2,3,4, Judith I Tsui5, Debbie M Cheng3,6, Jane M Liebschutz7, Marlene C Lira1,2, Alexander Y Walley1,2,3, Jonathan A Colasanti8,9, Leah S Forman10, Christin Root9, Christopher W Shanahan1,3, Margaret M Sullivan3, Carly L Bridden1,2, Catherine Abrams9, Catherine Harris9, Kishna Outlaw9, Wendy S Armstrong8, Carlos Del Rio8,9. 1. Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center, Boston, MA. 2. Grayken Center for Addiction, Boston Medical Center, Boston, MA. 3. Clinical Addiction Research and Education (CARE) Unit, Department of Medicine, Boston University School of Medicine, Boston, MA. 4. Department of Community Health Sciences, Boston University School of Public Health, Boston, MA. 5. Department of Medicine, University of Washington, Seattle, WA. 6. Department of Biostatistics, Boston University School of Public Health, Boston, MA. 7. Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA. 8. Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA. 9. Department of Global Health, Emory University Rollins School of Public Health, Atlanta, GA. 10. Biostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, Boston, MA.
Abstract
BACKGROUND:Chronic pain is prevalent among people living with HIV (PLWH); managing pain with chronic opioid therapy (COT) is common. HIV providers often diverge from prescribing guidelines. METHODS: This two-arm, unblinded cluster-randomized clinical trial assessed whether the Targeting Effective Analgesia in Clinics for HIV (TEACH) intervention improves guideline-concordant care compared to usual care for PLWH on COT. The trial was implemented from 2015-2018 with 12-month follow-up at safety-net hospital-based HIV clinics in Boston and Atlanta. We enrolled 41 providers and their 187 patients on COT. Prescribers were randomized 1:1 to either a 12-month intervention consisting of a nurse care manager with an interactive electronic registry, opioid education, academic detailing and access to addiction specialists or a control condition consisting of usual care. Two primary outcomes were assessed through electronic medical records: ≥2 urine drug tests and any early COT refills by 12 months. Other outcomes included possible adverse consequences. RESULTS: At 12-months, the TEACH intervention arm had higher odds of ≥2 urine drug tests than the usual care arm (71% vs. 20%, adjusted odds ratio [AOR]: 13.38; 95% confidence interval [CI]: 5.85-30.60; p<0.0001). We did not detect a statistically significant difference in early refills (22% vs. 30%; AOR: 0.55; 95% CI: 0.26-1.15; p=0.11), pain severity (6.30 vs. 5.76; adjusted mean difference 0.10; 95% CI: -1.56-1.75; p=0.91), or HIV viral load suppression (86.9% vs. 82.1%; AOR: 1.21; 95% CI: 0.47-3.09; p=0.69). CONCLUSIONS:TEACH is a promising intervention to improve adherence to COT guidelines without evident adverse consequences.
RCT Entities:
BACKGROUND:Chronic pain is prevalent among people living with HIV (PLWH); managing pain with chronic opioid therapy (COT) is common. HIV providers often diverge from prescribing guidelines. METHODS: This two-arm, unblinded cluster-randomized clinical trial assessed whether the Targeting Effective Analgesia in Clinics for HIV (TEACH) intervention improves guideline-concordant care compared to usual care for PLWH on COT. The trial was implemented from 2015-2018 with 12-month follow-up at safety-net hospital-based HIV clinics in Boston and Atlanta. We enrolled 41 providers and their 187 patients on COT. Prescribers were randomized 1:1 to either a 12-month intervention consisting of a nurse care manager with an interactive electronic registry, opioid education, academic detailing and access to addiction specialists or a control condition consisting of usual care. Two primary outcomes were assessed through electronic medical records: ≥2 urine drug tests and any early COT refills by 12 months. Other outcomes included possible adverse consequences. RESULTS: At 12-months, the TEACH intervention arm had higher odds of ≥2 urine drug tests than the usual care arm (71% vs. 20%, adjusted odds ratio [AOR]: 13.38; 95% confidence interval [CI]: 5.85-30.60; p<0.0001). We did not detect a statistically significant difference in early refills (22% vs. 30%; AOR: 0.55; 95% CI: 0.26-1.15; p=0.11), pain severity (6.30 vs. 5.76; adjusted mean difference 0.10; 95% CI: -1.56-1.75; p=0.91), or HIV viral load suppression (86.9% vs. 82.1%; AOR: 1.21; 95% CI: 0.47-3.09; p=0.69). CONCLUSIONS: TEACH is a promising intervention to improve adherence to COT guidelines without evident adverse consequences.
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