Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial

Benjamin J. Morasco; Melissa H. Adams; Patricia E. Maloy; Elizabeth R. Hooker; Megan O. Iacocca; Erin E. Krebs; Thomas P. Carr; Travis I. Lovejoy; Somnath Saha; Steven K. Dobscha

doi:10.1016/j.cct.2020.105957

Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial

Benjamin J. Morasco, Melissa H. Adams, Patricia E. Maloy, Elizabeth R. Hooker, Megan O. Iacocca, Erin E. Krebs, Thomas P. Carr, Travis I. Lovejoy, Somnath Saha, Steven K. Dobscha

Medicine - Veteran's Administration Medical Center

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

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Abstract

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.

Original language	English (US)
Article number	105957
Journal	Contemporary Clinical Trials
Volume	90
DOIs	https://doi.org/10.1016/j.cct.2020.105957
State	Published - Mar 2020

Bibliographical note

Funding Information:
Research reported in this manuscript was supported by award 1I01HX001583 from the U.S. Department of Veterans Affairs , Health Services Research and Development Service. The work was also supported by resources from the VA Health Services Research and Development -funded Center to Improve Veteran Involvement in Care at the VA Portland Health Care System ( CIN 13-404 ). The funding source had no role in the study design, data collection, analysis or interpretation of data, writing of the manuscript, or decision to submit for publication. No author reports having any potential conflict of interest with this study. The content of this manuscript is solely the responsibility of the authors and does not represent the official views of the Department of Veterans Affairs.

Funding Information:
Research reported in this manuscript was supported by award 1I01HX001583 from the U.S. Department of Veterans Affairs, Health Services Research and Development Service. The work was also supported by resources from the VA Health Services Research and Development-funded Center to Improve Veteran Involvement in Care at the VA Portland Health Care System (CIN 13-404). The funding source had no role in the study design, data collection, analysis or interpretation of data, writing of the manuscript, or decision to submit for publication. No author reports having any potential conflict of interest with this study. The content of this manuscript is solely the responsibility of the authors and does not represent the official views of the Department of Veterans Affairs.

Publisher Copyright:
© 2020

Keywords

Collaborative care
Long-term opioid therapy
Risk mitigation strategies

PubMed: MeSH publication types

Journal Article
Research Support, U.S. Gov't, Non-P.H.S.
Clinical Trial Protocol
Randomized Controlled Trial

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title = "Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial",

abstract = "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.",

keywords = "Collaborative care, Long-term opioid therapy, Risk mitigation strategies",

author = "Morasco, {Benjamin J.} and Adams, {Melissa H.} and Maloy, {Patricia E.} and Hooker, {Elizabeth R.} and Iacocca, {Megan O.} and Krebs, {Erin E.} and Carr, {Thomas P.} and Lovejoy, {Travis I.} and Somnath Saha and Dobscha, {Steven K.}",

note = "Funding Information: Research reported in this manuscript was supported by award 1I01HX001583 from the U.S. Department of Veterans Affairs , Health Services Research and Development Service. The work was also supported by resources from the VA Health Services Research and Development -funded Center to Improve Veteran Involvement in Care at the VA Portland Health Care System ( CIN 13-404 ). The funding source had no role in the study design, data collection, analysis or interpretation of data, writing of the manuscript, or decision to submit for publication. No author reports having any potential conflict of interest with this study. The content of this manuscript is solely the responsibility of the authors and does not represent the official views of the Department of Veterans Affairs. Funding Information: Research reported in this manuscript was supported by award 1I01HX001583 from the U.S. Department of Veterans Affairs, Health Services Research and Development Service. The work was also supported by resources from the VA Health Services Research and Development-funded Center to Improve Veteran Involvement in Care at the VA Portland Health Care System (CIN 13-404). The funding source had no role in the study design, data collection, analysis or interpretation of data, writing of the manuscript, or decision to submit for publication. No author reports having any potential conflict of interest with this study. The content of this manuscript is solely the responsibility of the authors and does not represent the official views of the Department of Veterans Affairs. Publisher Copyright: {\textcopyright} 2020",

year = "2020",

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doi = "10.1016/j.cct.2020.105957",

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volume = "90",

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AU - Iacocca, Megan O.

AU - Krebs, Erin E.

AU - Carr, Thomas P.

AU - Lovejoy, Travis I.

AU - Saha, Somnath

AU - Dobscha, Steven K.

N1 - Funding Information: Research reported in this manuscript was supported by award 1I01HX001583 from the U.S. Department of Veterans Affairs , Health Services Research and Development Service. The work was also supported by resources from the VA Health Services Research and Development -funded Center to Improve Veteran Involvement in Care at the VA Portland Health Care System ( CIN 13-404 ). The funding source had no role in the study design, data collection, analysis or interpretation of data, writing of the manuscript, or decision to submit for publication. No author reports having any potential conflict of interest with this study. The content of this manuscript is solely the responsibility of the authors and does not represent the official views of the Department of Veterans Affairs. Funding Information: Research reported in this manuscript was supported by award 1I01HX001583 from the U.S. Department of Veterans Affairs, Health Services Research and Development Service. The work was also supported by resources from the VA Health Services Research and Development-funded Center to Improve Veteran Involvement in Care at the VA Portland Health Care System (CIN 13-404). The funding source had no role in the study design, data collection, analysis or interpretation of data, writing of the manuscript, or decision to submit for publication. No author reports having any potential conflict of interest with this study. The content of this manuscript is solely the responsibility of the authors and does not represent the official views of the Department of Veterans Affairs. Publisher Copyright: © 2020

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N2 - 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.

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.

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Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial

Abstract

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Keywords

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