Marlene C Lira1, Judith I Tsui2, Jane M Liebschutz3, Jonathan Colasanti4,5, Christin Root4, Debbie M Cheng6, Alexander Y Walley1,7, Meg Sullivan7, Christopher Shanahan1,7, Kristen O'Connor1, Catherine Abrams4, Leah S Forman8, Christine Chaisson8, Carly Bridden1, Melissa C Podolsky1, Kishna Outlaw4, Catherine E Harris4, Wendy S Armstrong5, Carlos Del Rio4,5, Jeffrey H Samet1,7,9. 1. a Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine , Boston Medical Center , Boston , MA , USA. 2. b Section of General Internal Medicine, Department of Medicine , University of Washington and Harborview Medical Center , Seatle , WA , USA. 3. c Division of General Internal Medicine, Department of Medicine , University of Pittsburgh School of Medicine , Pittsburgh , PA , USA. 4. d Department of Global Health, Rollins School of Public Health , Emory University , Atlanta , GA , USA. 5. e Division of Infectious Diseases, Department of Medicine , Emory University School of Medicine , Atlanta , GA , USA. 6. f Department of Biostatistics , Boston University School of Public Health , Boston , MA , USA. 7. g Department of Medicine , Boston University School of Medicine , Boston , MA , USA. 8. h Biostatistics and Epidemiology Data Analytics Center , Boston University School of Public Health , Boston , MA , USA. 9. i Department of Community Health Sciences , Boston University School of Public Health , Boston , MA , USA.
Abstract
Background: People living with HIV (PLWH) frequently experience chronic pain and receivelong-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods:HIV physicians and advanced practice providers (n = 41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent (n = 187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT (n = 170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT (n = 117). Conclusions: TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US.
RCT Entities:
Background: People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods:HIV physicians and advanced practice providers (n = 41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent (n = 187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT (n = 170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT (n = 117). Conclusions: TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US.
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