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

NCT04878562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20000

Last updated 2024-06-24

No results posted yet for this 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 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

Interventions

BEHAVIORAL

I-COPE

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.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED
  • ACCESS Community Health Network

    collaborator OTHER
  • University of Chicago

    lead OTHER

Principal Investigators

  • Mim Ari, MD · University of Chicago

  • Neda Laiteerapong, MD · University of Chicago

  • Katherine Thompson, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2022-10-31
Completion
2024-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878562 on ClinicalTrials.gov