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

NCT ID: NCT04878562

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2024-03-31

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.

Detailed Description

I-COPE program intervention includes four components: patient survey, geriatric PCCDS tool, patient action plan, and provider education.

Patient survey. Three days before each of their scheduled PCP visits, patients will be asked to complete a survey during electronic check-in. If patients have not completed the questionnaire when they arrive on the day of their appointment, they will be asked by the patient services representatives to complete it in the waiting area on paper or using a tablet, or by the medical assistant to complete it during patient triage. In addition to the I-COPE survey patients will be screened for depression and drug abuse. Medical assistants will be trained to enter their responses into the EHR. A caregiver may help the patient complete the questionnaire. Responses will be saved in the patient's medical record and accessible to their care team.

Geriatric PCCDS tool. Information from the patient questionnaire and the EHR will be used to automatically generate a passive alert (best practice advisory) and a tailored smart set which PCPs can open during the visit. The alert will be triggered if a patient responds that they want to discuss pain at their visit or if they screen positive for a possible substance use disorder. The PCCDS was designed with a set of decision rules based on AGS and CDC guidelines for chronic pain and opioids. The PCCDS tool features five sections: All patients (self-management strategies), Oral non-opioid medications, Acute-on-chronic pain only, Opioid medications, and OUD treatment. The PCCDS shows which treatment options are recommended, not recommended, or contraindicated based on the patient's history, comorbidities, and preferences. For instance, if a patient screens positive for depression the Antidepressants smartgroup within the Oral non-opioid medications section will be open and labelled as recommended. Alternative versions of other smartgroups exist for patients with chronic kidney disease of various stages, presence of certain medication, and results of the drug abuse screening. The PCCDS tool also includes links to a conversation tool and patient self-management education tools. The PCCDS tool may be accessed by a provider in cases where patient did not complete the survey.

Patient action plan. At the end of the visit, a personalized action plan will be generated for patients featuring their pain rating and goal, the treatment plan they agreed upon with their PCP, and relevant educational materials. The action plan will be clearly laid out using patient-centered language, maximum 6th grade reading level, and simple graphics. It will be printed out as a part of the after-visit summary.

Provider education. PCPs may opt into an intensive Project ECHO course that offers more geriatric clinical content and EHR updates with real-word cases. Project ECHO (Extension for Community Health Outcomes) is an innovative workforce development model for expanding primary care capacity in underserved communities. It uses videoconferencing technology to "telementor" community-based clinicians via didactic education, group problem solving with actual cases brought by clinicians, and expert advice on implementing best practices. Project ECHO® is possibly a cost-effective strategy for improving clinician competence and behaviors, while likely improving patient outcomes. The curriculum will be delivered in 8-weekly hour-long sessions. Each session will include didactic topics delivered by an interdisciplinary team of content experts, and two 15-minute problem-solving exercises using real-world cases brought by participating PCPs. PCPs will review how they can use the I-COPE Program toolkit with each case. Didactic content will include a walkthrough of the PCCDS and education on the demographics of pain and OUD, special considerations for pain management (e.g., cognitive impairment, functional impairment, social determinants, and caregivers), principles of SDM and assessing patient preferences, pharmacology and pain medications, non-pharmacologic pain management options, and recognition and management of OUD. The abridged version of the ECHO training will be made available online for PCPs to access on their own time if needed.

Conditions

Chronic Pain; Opioids; Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

I-COPE 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 Type: EXPERIMENTAL

I-COPE

Intervention Type: 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.

No intervention

Standard of care offered to all patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

-

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

ACCESS Community Health Network

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mim Ari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Neda Laiteerapong, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Katherine Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medicine

Chicago, Illinois, United States

Access Community Health Network

Chicago, Illinois, United States

Countries

United States

References

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Other Identifiers

IRB20-1580

Identifier Type: -

Identifier Source: org_study_id