Skip to main content
Top
Published in: Trials 1/2022

Open Access 01-12-2022 | Opioids | Study protocol

Improving the management of chronic pain, opioid use, and opioid use disorder in older adults: study protocol for I-COPE study

Authors: Ainur Kagarmanova, Heather Sparkman, Neda Laiteerapong, Katherine Thompson, Linda Rosul, Danielle Lazar, Erin Staab, Wen Wan, Amanda Kass, Mim Ari

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

Older adults with chronic pain, opioid use, and opioid use disorder (OUD) present complex management decisions in primary care. Clinical tools are needed to improve care delivery. This study protocol describes the planned implementation and evaluation of I-COPE (Improving Chicago Older Adult Opioid and Pain Management through Patient-centered Clinical Decision Support and Project ECHO®) to improve care for this population.

Methods

This study uses a pragmatic, expanding cohort stepped-wedge design to assess the outcomes. The study will be implemented in 35 clinical sites across metropolitan Chicago for patients aged ≥ 65 with chronic pain, opioid use, or OUD who receive primary care at one of the clinics. I-COPE includes the integration of patient-reported data on symptoms and preferences, clinical decision support tools, and a shared decision-making tool into routine primary care for more effective management of chronic pain, opioid prescribing, and OUD in older adults. Primary care providers will be trained through web-based videos and an optional Project ECHO® course, entitled “Pain Management and OUD in Older Adults.” The RE-AIM framework will be used to assess the I-COPE implementation. Effectiveness outcomes will include an increased variety of recommended pain treatments, decreased prescriptions of higher-risk pain treatments, and decreased patient pain scores. All outcomes will be evaluated 6 and 12 months after implementation. PCPs participating in Project ECHO® will be evaluated on changes in knowledge, attitudes, and self-efficacy using pre- and post-course surveys.

Discussion

This study will provide evidence about the effectiveness of collecting patient-reported data on symptoms and treatment preferences and providing clinical decision support and shared decision-making tools to improve management for older adults with chronic pain, opioid use, and OUD.

Trial registration

ClinicalTrials.gov NCT04878562.
Appendix
Available only for authorised users
Literature
1.
go back to reference Abdulla A, Adams N, Bone M, et al. Guidance on the management of pain in older people. Age Ageing. 2013;42(Suppl 1):i1-57.CrossRef Abdulla A, Adams N, Bone M, et al. Guidance on the management of pain in older people. Age Ageing. 2013;42(Suppl 1):i1-57.CrossRef
2.
go back to reference Kuerbis A, Sacco P, Blazer DG, Moore AA. Substance abuse among older adults. Clin Geriatr Med. 2014;30(3):629–54.CrossRef Kuerbis A, Sacco P, Blazer DG, Moore AA. Substance abuse among older adults. Clin Geriatr Med. 2014;30(3):629–54.CrossRef
3.
go back to reference Patel KV, Guralnik JM, Dansie EJ, Turk DC. Prevalence and impact of pain among older adults in the United States: findings from the 2011 National Health and Aging Trends Study. Pain. 2013;154(12):2649–57.CrossRef Patel KV, Guralnik JM, Dansie EJ, Turk DC. Prevalence and impact of pain among older adults in the United States: findings from the 2011 National Health and Aging Trends Study. Pain. 2013;154(12):2649–57.CrossRef
4.
go back to reference Wu LT, Blazer DG. Illicit and nonmedical drug use among older adults: a review. J Aging Health. 2011;23(3):481–504.CrossRef Wu LT, Blazer DG. Illicit and nonmedical drug use among older adults: a review. J Aging Health. 2011;23(3):481–504.CrossRef
5.
go back to reference US Department of Health & Human Services. Opioids in Medicare part D: concerns about extreme use and questionable prescribing. 2017. US Department of Health & Human Services. Opioids in Medicare part D: concerns about extreme use and questionable prescribing. 2017.
6.
go back to reference Reuben BD, Pacala JD, Pollock BJ, Potter JF, Semla TP. Geriatrics At Your Fingertips®. New York: American Geriatrics Society; 2021. Reuben BD, Pacala JD, Pollock BJ, Potter JF, Semla TP. Geriatrics At Your Fingertips®. New York: American Geriatrics Society; 2021.
7.
go back to reference Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016;65(1):1–49.CrossRef Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016;65(1):1–49.CrossRef
8.
go back to reference Makris UE, Abrams RC, Gurland B, Reid MC. Management of persistent pain in the older patient: a clinical review. JAMA. 2014;312(8):825–36.CrossRef Makris UE, Abrams RC, Gurland B, Reid MC. Management of persistent pain in the older patient: a clinical review. JAMA. 2014;312(8):825–36.CrossRef
9.
go back to reference Barth JH, Misra S, Aakre KM, et al. Why are clinical practice guidelines not followed? Clin Chem Lab Med. 2016;54(7):1133–9.CrossRef Barth JH, Misra S, Aakre KM, et al. Why are clinical practice guidelines not followed? Clin Chem Lab Med. 2016;54(7):1133–9.CrossRef
11.
go back to reference Gianni W, Ceci M, Bustacchini S, et al. Opioids for the treatment of chronic non-cancer pain in older people. Drugs Aging. 2009;26(Suppl 1):63–73.CrossRef Gianni W, Ceci M, Bustacchini S, et al. Opioids for the treatment of chronic non-cancer pain in older people. Drugs Aging. 2009;26(Suppl 1):63–73.CrossRef
12.
go back to reference Edwards M, Quinlivan EB, Bess K, et al. Implementation of PHQ-9 depression screening for HIV-infected patients in a real-world setting. J Assoc Nurses AIDS Care. 2014;25(3):243–52.CrossRef Edwards M, Quinlivan EB, Bess K, et al. Implementation of PHQ-9 depression screening for HIV-infected patients in a real-world setting. J Assoc Nurses AIDS Care. 2014;25(3):243–52.CrossRef
13.
go back to reference Elder JW, Wu EF, Chenoweth JA, et al. Emergency department screening for unhealthy alcohol and drug use with a brief tablet-based questionnaire. Emerg Med Int. 2020;2020:8275386.CrossRef Elder JW, Wu EF, Chenoweth JA, et al. Emergency department screening for unhealthy alcohol and drug use with a brief tablet-based questionnaire. Emerg Med Int. 2020;2020:8275386.CrossRef
14.
go back to reference Krebs EE, Gravely A, Nugent S, et al. Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA. 2018;319(9):872–82.CrossRef Krebs EE, Gravely A, Nugent S, et al. Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA. 2018;319(9):872–82.CrossRef
15.
go back to reference Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005;58(2):163–71.CrossRef Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005;58(2):163–71.CrossRef
16.
go back to reference Krall MA. The electronic health record “toolbox.” Perm J. 2005;9(2):49–52.CrossRef Krall MA. The electronic health record “toolbox.” Perm J. 2005;9(2):49–52.CrossRef
17.
go back to reference Austin CA, Mohottige D, Sudore RL, Smith AK, Hanson LC. Tools to promote shared decision making in serious illness: a systematic review. JAMA Intern Med. 2015;175(7):1213–21.CrossRef Austin CA, Mohottige D, Sudore RL, Smith AK, Hanson LC. Tools to promote shared decision making in serious illness: a systematic review. JAMA Intern Med. 2015;175(7):1213–21.CrossRef
18.
go back to reference McBain RK, Sousa JL, Rose AJ, et al. Impact of Project ECHO models of medical tele-education: a systematic review. J Gen Intern Med. 2019;34(12):2842–57.CrossRef McBain RK, Sousa JL, Rose AJ, et al. Impact of Project ECHO models of medical tele-education: a systematic review. J Gen Intern Med. 2019;34(12):2842–57.CrossRef
19.
go back to reference Page K, Qeadan F, Qualls C, Thornton K, Arora S. Project ECHO revisited: propensity score analysis and HCV treatment outcomes. Hepat Med. 2019;11:149–52.CrossRef Page K, Qeadan F, Qualls C, Thornton K, Arora S. Project ECHO revisited: propensity score analysis and HCV treatment outcomes. Hepat Med. 2019;11:149–52.CrossRef
20.
go back to reference Wood BR, Mann MS, Martinez-Paz N, et al. Project ECHO: telementoring to educate and support prescribing of HIV pre-exposure prophylaxis by community medical providers. Sex Health. 2018;15(6):601–5.CrossRef Wood BR, Mann MS, Martinez-Paz N, et al. Project ECHO: telementoring to educate and support prescribing of HIV pre-exposure prophylaxis by community medical providers. Sex Health. 2018;15(6):601–5.CrossRef
21.
go back to reference Zhou CCA, Serhal E, Kurdyak P, Sockalingam S. The impact of Project ECHO on participant and patient outcomes: a systematic review. Acad Med. 2016;91(10):1439–61.CrossRef Zhou CCA, Serhal E, Kurdyak P, Sockalingam S. The impact of Project ECHO on participant and patient outcomes: a systematic review. Acad Med. 2016;91(10):1439–61.CrossRef
22.
go back to reference Arora S, Thornton K, Murata G, et al. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011;364(23):2199–207.CrossRef Arora S, Thornton K, Murata G, et al. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011;364(23):2199–207.CrossRef
23.
go back to reference Lew RA, Miller CJ, Kim B, Wu H, Stolzmann K, Bauer MS. A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs. Implement Sci. 2019;14(1):46.CrossRef Lew RA, Miller CJ, Kim B, Wu H, Stolzmann K, Bauer MS. A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs. Implement Sci. 2019;14(1):46.CrossRef
24.
go back to reference Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–7.CrossRef Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–7.CrossRef
25.
go back to reference Hooper R, Teerenstra S, de Hoop E, Eldridge S. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med. 2016;35(26):4718–28.CrossRef Hooper R, Teerenstra S, de Hoop E, Eldridge S. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med. 2016;35(26):4718–28.CrossRef
26.
go back to reference Hooper R, Bourke L. Cluster randomised trials with repeated cross sections: alternatives to parallel group designs. BMJ. 2015;350:h2925.CrossRef Hooper R, Bourke L. Cluster randomised trials with repeated cross sections: alternatives to parallel group designs. BMJ. 2015;350:h2925.CrossRef
27.
go back to reference Li F, Hughes JP, Hemming K, Taljaard M, Melnick ER, Heagerty PJ. Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: an overview. Stat Methods Med Res. 2021;30(2):612–39.CrossRef Li F, Hughes JP, Hemming K, Taljaard M, Melnick ER, Heagerty PJ. Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: an overview. Stat Methods Med Res. 2021;30(2):612–39.CrossRef
28.
go back to reference Gleason LJ, Beiting KJ, Walker J, et al. Using telementoring to share best practices on COVID-19 in post-acute and long-term care facilities. J Am Geriatr Soc. 2020;68(11):E58–60.CrossRef Gleason LJ, Beiting KJ, Walker J, et al. Using telementoring to share best practices on COVID-19 in post-acute and long-term care facilities. J Am Geriatr Soc. 2020;68(11):E58–60.CrossRef
29.
go back to reference Gleason LJ, Martinchek M, Long M, et al. An innovative model using telementoring to provide geriatrics education for nurses and social workers at skilled nursing facilities(). Geriatr Nurs. 2019;40(5):517–21.CrossRef Gleason LJ, Martinchek M, Long M, et al. An innovative model using telementoring to provide geriatrics education for nurses and social workers at skilled nursing facilities(). Geriatr Nurs. 2019;40(5):517–21.CrossRef
30.
go back to reference Jafari P, Kostas T, Levine S, et al. ECHO-Chicago geriatrics: using telementoring to “geriatricize” the primary care workforce. Gerontol Geriatr Educ. 2020;41(3):333–41.CrossRef Jafari P, Kostas T, Levine S, et al. ECHO-Chicago geriatrics: using telementoring to “geriatricize” the primary care workforce. Gerontol Geriatr Educ. 2020;41(3):333–41.CrossRef
Metadata
Title
Improving the management of chronic pain, opioid use, and opioid use disorder in older adults: study protocol for I-COPE study
Authors
Ainur Kagarmanova
Heather Sparkman
Neda Laiteerapong
Katherine Thompson
Linda Rosul
Danielle Lazar
Erin Staab
Wen Wan
Amanda Kass
Mim Ari
Publication date
01-12-2022
Publisher
BioMed Central
Keywords
Opioids
Opioids
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06537-w

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue