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NCT04878562 · ClinicalTrials.gov registry record · NA
I-COPE Study: Opioid Use and Pain Management in Older Adults
A NA study, sponsored by University of Chicago.
- Completed
- Registry status
- NA
- Development phase
- 20,000
- Enrollment target
NCT04878562: Completed NA study, sponsored by University of Chicago.
NCT04878562 is a NA study that has completed, run by University of Chicago. The registered enrollment target is 20,000 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1326% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04878562, a NA study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 20,000 participants
- Enrollment target
Study 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 pl
Primary Outcome
Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores
Interventions
- BEHAVIORAL I-COPE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20,000 participants |
| Start Date | 2021-06-03 |
| Est. Completion | 2024-03-31 |
| Phase | NA |
What the finished NCT04878562 record still lists
NCT04878562 is an interventional study that assigns participants to a tested intervention. Its 20,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1326% higher).
The record links to 0 conditions, and to 1 intervention - of which I-COPE is the first listed.
NCT04878562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04878562 about?
NCT04878562 is a clinical study titled "I-COPE Study: Opioid Use and Pain Management in Older Adults". 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, opio...
What is the current status of trial NCT04878562?
This trial is currently completed. It is a NA study. The enrollment target is 20,000 participants. The study started on 2021-06-03. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT04878562?
The interventions under investigation include: I-COPE (BEHAVIORAL).
Who is sponsoring clinical trial NCT04878562?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04878562's enrollment target sits among peer trials
20,000 11th of 2000 higher than 1,990 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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