PMID- 32061968 OWN - NLM STAT- MEDLINE DCOM- 20210519 LR - 20240325 IS - 1559-2030 (Electronic) IS - 1551-7144 (Linking) VI - 90 DP - 2020 Mar TI - Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial. PG - 105957 LID - S1551-7144(20)30035-5 [pii] LID - 10.1016/j.cct.2020.105957 [doi] AB - There are adverse effects associated with long-term opioid therapy (LTOT) for chronic pain and clinicians infrequently adhere to opioid treatment guideline recommendations for reducing risk and mitigating opioid-related harms. The primary goal of the Improving the Safety of Opioid Therapy (ISOT) intervention is to reduce harms related to prescription opioids. Secondary aims focus on enhancing the clinician-patient relationship and not having a negative impact on pain-related outcomes (to be examined through a non-inferiority analysis). The study is a cluster-randomized trial and the 44 primary care providers (PCPs) who enrolled were randomized to receive either (1) a two-hour educational workshop about a patient-centered approach to opioid therapy or (2) the educational workshop plus a collaborative care intervention delivered by a nurse care manager (NCM). Patients were assigned to the same condition as their treating PCP. ISOT was based on the chronic care model and includes patient and provider activation, outcomes monitoring, and feedback to the PCP over 12 months. The NCM conducted a baseline assessment with intervention patients, tracked opioid-related behaviors and outcomes, and provided decision support to the opioid-prescribing clinician about opioid safety. Between June 2016 and October 2018, 293 veterans who were prescribed LTOT for chronic pain were enrolled, completed a baseline assessment, and assigned to a treatment condition. Participants were enrolled for 12 months. Masked assessments were conducted with participants at baseline, 6-months, and 12-months. This manuscript describes study rationale, research methods, and baseline findings. CI - Published by Elsevier Inc. FAU - Morasco, Benjamin J AU - Morasco BJ AD - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Psychiatry, Oregon Health & Science University, United States of America. Electronic address: benjamin.morasco@va.gov. FAU - Adams, Melissa H AU - Adams MH AD - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America. FAU - Maloy, Patricia E AU - Maloy PE AD - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America. FAU - Hooker, Elizabeth R AU - Hooker ER AD - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America. FAU - Iacocca, Megan O AU - Iacocca MO AD - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America. FAU - Krebs, Erin E AU - Krebs EE AD - Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, United States of America; Department of Medicine, Division of General Internal Medicine, University of Minnesota Medical School, United States of America. FAU - Carr, Thomas P AU - Carr TP AD - Primary Care Division, VA Portland Health Care System, United States of America; Department of Medicine, Division of General Internal Medicine, Oregon Health & Science University, United States of America. FAU - Lovejoy, Travis I AU - Lovejoy TI AD - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Psychiatry, Oregon Health & Science University, United States of America; School of Public Health, Oregon Health & Science University and Portland State University, United States of America. FAU - Saha, Somnath AU - Saha S AD - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Medicine, Division of General Internal Medicine, Oregon Health & Science University, United States of America; School of Public Health, Oregon Health & Science University and Portland State University, United States of America. FAU - Dobscha, Steven K AU - Dobscha SK AD - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Psychiatry, Oregon Health & Science University, United States of America. LA - eng GR - I01 HX001583/HX/HSRD VA/United States PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, U.S. Gov't, Non-P.H.S. DEP - 20200213 PL - United States TA - Contemp Clin Trials JT - Contemporary clinical trials JID - 101242342 RN - 0 (Analgesics, Opioid) SB - IM MH - Aged MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Analgesics, Opioid/administration & dosage/adverse effects/therapeutic use MH - *Chronic Pain/drug therapy MH - *Health Personnel/education MH - Opioid-Related Disorders/prevention & control MH - Patient-Centered Care MH - *Primary Health Care/organization & administration MH - Professional-Patient Relations MH - Quality of Life MH - Research Design MH - *Risk Management/organization & administration MH - Socioeconomic Factors MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - Collaborative care OT - Long-term opioid therapy OT - Risk mitigation strategies EDAT- 2020/02/18 06:00 MHDA- 2021/05/20 06:00 CRDT- 2020/02/17 06:00 PHST- 2019/10/25 00:00 [received] PHST- 2020/02/07 00:00 [revised] PHST- 2020/02/11 00:00 [accepted] PHST- 2020/02/18 06:00 [pubmed] PHST- 2021/05/20 06:00 [medline] PHST- 2020/02/17 06:00 [entrez] AID - S1551-7144(20)30035-5 [pii] AID - 10.1016/j.cct.2020.105957 [doi] PST - ppublish SO - Contemp Clin Trials. 2020 Mar;90:105957. doi: 10.1016/j.cct.2020.105957. Epub 2020 Feb 13.