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I-COPE for Opioid Use Disorder (I-COPE Trial)

N/A

Waitlist Available

Led By Mim Ari, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

age over 65 years

opioid prescription in the last 28 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

I-COPE Trial Summary

This trial is testing a new way to manage pain in older adults that includes shared decision making, patient-centered clinical decision support tools, and Project ECHO.

Who is the study for?

The I-COPE study is for adults over 65 who are being treated at a participating site, have had an opioid prescription in the last month, and have a history of chronic pain or opioid use disorder. It aims to help them manage their pain and medication more effectively.Check my eligibility

What is being tested?

I-COPE provides smart tools to doctors for better management of geriatric pain, opioids, and OUD. It includes shared decision-making aids, patient-centered clinical support tools, and Project ECHO® for knowledge sharing among clinicians.See study design

What are the potential side effects?

While I-COPE itself may not cause side effects as it's a program rather than a drug, patients will be informed about potential opioid side effects like misuse or overdose risks and how to administer naloxone.

I-COPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 65 years old.

Select...

I have been prescribed opioids in the last 28 days.

I-COPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decrease higher-risk pain treatments

Increase diversity of recommended pain treatments

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

Secondary outcome measures

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

Decrease in percentage of patients prescribed each high-risk treatments

Increase in guideline concordant opioid prescriptions

+4 more

I-COPE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: I-COPE InterventionExperimental Treatment1 Intervention

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.

Group II: No interventionActive Control1 Intervention

Standard of care offered to all patients.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,002 Previous Clinical Trials

797,850 Total Patients Enrolled

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,802,348 Total Patients Enrolled

ACCESS Community Health NetworkOTHER

6 Previous Clinical Trials

42,739 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are engaging with this trial's enrollment process?

"Indeed, based on the information available at clinicaltrials.gov, this research study is actively searching for subjects to join. It was initially posted on June 3rd 2021 and modified most recently on October 29th 2021. The trial aims to recruit a total of 3000 participants from two sites."

Answered by AI

Is it possible to enrol in this investigation presently?

"According to clinicaltrials.gov, this trial is presently welcoming participants for enrollment. It was first listed on June 3rd 2021 and has been updated most recently on October 29th of the same year."

Answered by AI

What objectives are the researchers hoping to achieve with this clinical investigation?

"This six-month clinical trial seeks to improve the array of available pain treatments. Measurable objectives include annual drug screenings for patients with a morphine milligram equivalent surpassing 50, alterations in concurrent opioid and benzodiazepine prescriptions, as well as changes in prescription habits involving both opioids and non-opioid medications."

Answered by AI

Recent research and studies

Journal of the American Geriatrics SocietyJournal

Pharmacological Management of Persistent Pain in Older Persons

American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons. 2009. “Pharmacological Management of Persistent Pain in Older Persons”. Journal of the American Geriatrics Society. Wiley. doi:10.1111/j.1532-5415.2009.02376.x.

World Journal of Clinical CasesJournal

Guidance on Opioids Prescribing for the Management of Persistent Non-cancer Pain in Older Adults

Guerriero, Fabio. 2017. “Guidance on Opioids Prescribing for the Management of Persistent Non-cancer Pain in Older Adults”. World Journal of Clinical Cases. Baishideng Publishing Group Inc.. doi:10.12998/wjcc.v5.i3.73.

Drug and Alcohol DependenceJournal

Trends in Abuse and Misuse of Prescription Opioids Among Older Adults

West, Nancy A., Stevan G. Severtson, Jody L. Green, and Richard C. Dart. 2015. “Trends in Abuse and Misuse of Prescription Opioids Among Older Adults”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/j.drugalcdep.2015.01.027.

Drug and Alcohol DependenceJournal