Clinical trial NCT04878562: I-COPE Study: Opioid Use and Pain Management in Older Adults
Official title: Improving Chicago Older Adult Opioid and Pain Management Through Patient-Centered Clinical Decision Support and Project ECHO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioids
Opioid-use Disorder
Keywords: older adults
electronic health record
chronic pain
opioid use disorder
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: ACCESS Community Health Network
First posted: 2021-05-07
Enrollment: 20000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We will conduct a nonhybrid pragmatic implementation-effectiveness stepped wedge cluster-randomized study in which clinics will be the randomized clusters.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

-

Primary outcomes:
measure: Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores
timeFrame: 6 months
measure: Increase diversity of recommended pain treatments
timeFrame: 6 months
measure: Decrease higher-risk pain treatments
timeFrame: 6 months
Secondary outcomes:
measure: Change in pain scores among older adults with and without chronic pain diagnoses and high initial pain scores
timeFrame: 6 months
measure: Increase in guideline concordant opioid prescriptions
timeFrame: 6 months
measure: Decrease in percentage of patients prescribed each high-risk treatments
timeFrame: 6 months
measure: Increase in percentage of patients prescribed each low-risk treatments
timeFrame: 6 months
measure: Percentage of eligible patients who receive an I-COPE action plan
timeFrame: 6 months
measure: Percentage of physicians who use the I-COPE program
timeFrame: 6 months
measure: Percentage of clinics who use the I-COPE program
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Chicago
country: United States
facility: Access Community Health Network
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mim Ari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Neda Laiteerapong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Katherine Thompson, MD
role: PRINCIPAL_INVESTIGATOR
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