I-COPE Study: Opioid Use and Pain Management in Older Adults

NCT04878562 | Completed DMC

• 1 other identifier: IRB20-1580
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 2

Brief Summary

Adults over 65 years of age are at higher risk of experiencing chronic pain and adverse events from opioids and opioid use disorder (OUD). Older adults are more likely to inadequately report their pain due to age-related health, which may lead to undertreatment of pain. In the last two decades, opioid prescriptions to treat chronic pain among older adults increased at a rate of nine times what it was previously. This surge is accompanied with a drastic increase of older adults visiting emergency departments due to opioid abuse, misuse, overdose, and addictions to heroin and cocaine. In consequence, chronic pain, opioids, and OUD have become a major crisis in the United States among older adults. The I-COPE program is an intervention that offers providers a set of smart tools for a more effective and efficient geriatric pain, opioid, and OUD management. The aim of the I-COPE program is to evaluate integration of shared decision-making, patient-centered clinical decision support tools, and Project ECHO® to address the critical need to integrate effective treatment for older adults with chronic pain, opioid use, and OUD. Patient-centered clinical decision support (PCCDS) tools provide clinicians with information presented at the right time and tailored to the individual patient, improving communications, care, and patient-provider satisfaction. Shared decision making (SDM) is a highly effective collaborative framework when there are many choices and there is uncertainty about the optimal treatment choice. Project ECHO® is a tested model for delivery of subspecialized medical knowledge to community clinicians. The research into these strategies is supported by the Agency for Healthcare Research and Quality (AHRQ) through the opioid action plan (OAP) initiative. Based on the survey responses the PCCDS will develop a list of pain treatments that are preferable for older adults to use, based on their individual histories. From the PCCDS, an individualized patient action plan will be generated. The action plan will be clearly laid out, use patient-centered language at an ≤ 6th grade level, and simple graphics. It will feature the patient-reported overall goal, current pain rating and pain goal, as well as provide information on changes made to the chronic pain treatment plan. Information about signs of opioid side effects, misuse and opioid overdoses will be included for patients who are taking opioids, as well as instructions for naloxone administration.

Conditions

Chronic Pain; Opioids; Opioid-use Disorder

Keywords

older adults; electronic health record; chronic pain; opioid use disorder

Outcome Measures

Primary Outcomes (3)

• Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores

  Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores

  6 months

• Increase diversity of recommended pain treatments

  More types of treatment are represented in patient's treatment plan. In I-COPE smartset pain treatments are grouped into 4 types: self-management, referrals to specialists, non-opioid medications, and opioid medications.

  6 months

• Decrease higher-risk pain treatments

  Discontinuation of opioid/Beer's Criteria medications or decrease in daily milligram equivalents of opioid/Beer's Criteria medications.

  6 months

Secondary Outcomes (7)

• Change in pain scores among older adults with and without chronic pain diagnoses and high initial pain scores

  6 months

• Increase in guideline concordant opioid prescriptions

  6 months

• Decrease in percentage of patients prescribed each high-risk treatments

  6 months

• Increase in percentage of patients prescribed each low-risk treatments

  6 months

• Percentage of eligible patients who receive an I-COPE action plan

  6 months

Study Arms (2)

I-COPE Intervention

EXPERIMENTAL

5 out of the 25 participating primary care sites are randomly assigned to any of the 5 steps. The ICOPE intervention is implemented after a pre interventional period of 3-15 months. The intervention is implemented during 8 weeks. The length of the post interventional period is 11-23 months.

Behavioral: I-COPE

No intervention

NO INTERVENTION

Standard of care offered to all patients.

Interventions

I-COPE BEHAVIORAL

The patient survey will be sent out via MyChart 3 days before the visit. It asks about current pain, goals, treatment history, treatment preferences, and health status. Alternatively, patients will be asked to compete a survey in clinic on paper or a tablet. The surveys will be identical, except screening for screening for depression and opioid use will depend on the availability of previous scores. Survey and the EHR will help auto-generate best practice advisories (BPAs) and a tailored smart set. The smartset is based on AGS and CDC guidelines for chronic pain and opioids. It shows which treatment options are not recommended based on the patient's history, comorbidities, and preferences. The smartset also includes links to decision aid and patient education tools. Personalized action plan will be created with pain rating and goal, treatment plan, and relevant tips and educational materials. Action plan will be clearly laid out using max 6 grade reading level, and simple graphics.

I-COPE Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age over 65 years AND
• receives care at a participating clinical site AND
• history of chronic pain AND/OR
• opioid prescription in the last 28 days AND/OR
• history of opioid use disorder AND/OR

Sponsors & Collaborators

• University of Chicago: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• ACCESS Community Health Network: collaborator

Study Sites (2)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Access Community Health Network

Chicago, Illinois, 60661, United States

Location

Related Publications (13)

• Gianni W, Ceci M, Bustacchini S, Corsonello A, Abbatecola AM, Brancati AM, Assisi A, Scuteri A, Cipriani L, Lattanzio F. Opioids for the treatment of chronic non-cancer pain in older people. Drugs Aging. 2009 Dec;26 Suppl 1:63-73. doi: 10.2165/11534670-000000000-00000.

  PMID: 20136170 BACKGROUND

• American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc. 2009 Aug;57(8):1331-46. doi: 10.1111/j.1532-5415.2009.02376.x. Epub 2009 Jul 2. No abstract available.

  PMID: 19573219 BACKGROUND

• Abdulla A, Adams N, Bone M, Elliott AM, Gaffin J, Jones D, Knaggs R, Martin D, Sampson L, Schofield P; British Geriatric Society. Guidance on the management of pain in older people. Age Ageing. 2013 Mar;42 Suppl 1:i1-57. doi: 10.1093/ageing/afs200.

  PMID: 23420266 BACKGROUND

• Guerriero F. Guidance on opioids prescribing for the management of persistent non-cancer pain in older adults. World J Clin Cases. 2017 Mar 16;5(3):73-81. doi: 10.12998/wjcc.v5.i3.73.

  PMID: 28352631 BACKGROUND

• West NA, Severtson SG, Green JL, Dart RC. Trends in abuse and misuse of prescription opioids among older adults. Drug Alcohol Depend. 2015 Apr 1;149:117-21. doi: 10.1016/j.drugalcdep.2015.01.027. Epub 2015 Jan 31.

  PMID: 25678441 BACKGROUND

• Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.

  PMID: 25581257 BACKGROUND

• Lewis ET, Cucciare MA, Trafton JA. What do patients do with unused opioid medications? Clin J Pain. 2014 Aug;30(8):654-62. doi: 10.1097/01.ajp.0000435447.96642.f4.

  PMID: 24281287 BACKGROUND

• Wu LT, Blazer DG. Illicit and nonmedical drug use among older adults: a review. J Aging Health. 2011 Apr;23(3):481-504. doi: 10.1177/0898264310386224. Epub 2010 Nov 17.

  PMID: 21084724 BACKGROUND

• Huhn AS, Strain EC, Tompkins DA, Dunn KE. A hidden aspect of the U.S. opioid crisis: Rise in first-time treatment admissions for older adults with opioid use disorder. Drug Alcohol Depend. 2018 Dec 1;193:142-147. doi: 10.1016/j.drugalcdep.2018.10.002. Epub 2018 Oct 18.

  PMID: 30384321 BACKGROUND

• Carter MW, Yang BK, Davenport M, Kabel A. Increasing Rates of Opioid Misuse Among Older Adults Visiting Emergency Departments. Innov Aging. 2019 Mar 7;3(1):igz002. doi: 10.1093/geroni/igz002. eCollection 2019 Jan.

  PMID: 30863796 BACKGROUND

• Kuerbis A, Sacco P, Blazer DG, Moore AA. Substance abuse among older adults. Clin Geriatr Med. 2014 Aug;30(3):629-54. doi: 10.1016/j.cger.2014.04.008. Epub 2014 Jun 12.

  PMID: 25037298 BACKGROUND

• Schultz SK, Arndt S, Liesveld J. Locations of facilities with special programs for older substance abuse clients in the US. Int J Geriatr Psychiatry. 2003 Sep;18(9):839-43. doi: 10.1002/gps.994.

  PMID: 12949852 BACKGROUND

• Kagarmanova A, Sparkman H, Laiteerapong N, Thompson K, Rosul L, Lazar D, Staab E, Wan W, Kass A, Ari M. Improving the management of chronic pain, opioid use, and opioid use disorder in older adults: study protocol for I-COPE study. Trials. 2022 Jul 27;23(1):602. doi: 10.1186/s13063-022-06537-w.

  PMID: 35897111 DERIVED

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mim Ari, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Neda Laiteerapong, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Katherine Thompson, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a nonhybrid pragmatic implementation-effectiveness stepped wedge cluster-randomized study in which clinics will be the randomized clusters.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: June 3, 2021
• Primary Completion: October 31, 2022
• Study Completion: March 31, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)