Chronic PainI-COPENCT04878562
I-COPE Study: Opioid Use and Pain Management in Older Adults
A study testing I-COPE in people with Chronic Pain and Opioids, run by University of Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain, Opioids, Opioid-use Disorder
- What is being tested?
- I-COPE
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago Medicine
Chicago, Illinois, 60637
Access Community Health Network
Chicago, Illinois, 60661
About this study
Official title: Improving Chicago Older Adult Opioid and Pain Management Through Patient-Centered Clinical Decision Support and Project ECHO
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.
Read the 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
- Being tested
- I-COPE
- Keywords
- older adults, electronic health record, chronic pain, opioid use disorder
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-COPEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| I-COPE Intervention | Experimental | 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. Receives: Behavioral: I-COPE |
| No intervention | No intervention | Standard of care offered to all patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores
Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores
Measured: 6 months
Increase diversity of recommended pain treatments
More types of treatment are represented in patient's treatment plan. In I-COPE smartset pain treatments are grouped into 4 types: self-management, referrals to specialists, non-opioid medications, and opioid medications.
Measured: 6 months
Decrease higher-risk pain treatments
Discontinuation of opioid/Beer's Criteria medications or decrease in daily milligram equivalents of opioid/Beer's Criteria medications.
Measured: 6 months
Secondary outcomes (7)
Change in pain scores among older adults with and without chronic pain diagnoses and high initial pain scores
Change in pain scores among older adults with and without chronic pain diagnoses and high initial pain scores
Measured: 6 months
Increase in guideline concordant opioid prescriptions
Increase in naloxone prescribing in patients with >50mg equivalents of opioids or OUD; Increase in the number of annual drug screens in patient with chronic opioid use; Decrease in co-prescribing of opioids and benzodiazepines
Measured: 6 months
Decrease in percentage of patients prescribed each high-risk treatments
High-risk treatments are defined as opioids and Beer's criteria medications
Measured: 6 months
Increase in percentage of patients prescribed each low-risk treatments
Low-risk treatments include all pain treatments except opioids and Beer's criteria medications.
Measured: 6 months
Percentage of eligible patients who receive an I-COPE action plan
Percentage of eligible patients who receive an I-COPE action plan
Measured: 6 months
Percentage of physicians who use the I-COPE program
Percentage of physicians in study sites who use the I-COPE program
Measured: 6 months
Percentage of clinics who use the I-COPE program
Percentage of clinics who successfully implement the I-COPE program
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start3 Jun 2021
- Primary completion31 Oct 2022
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We will conduct a nonhybrid pragmatic implementation-effectiveness stepped wedge cluster-randomized study in which clinics will be the randomized clusters.
- Masking
- None (open label)
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), ACCESS Community Health Network
- Responsible party
- Sponsor
- Investigators
- Mim Ari, MD, Principal investigator, University of ChicagoNeda Laiteerapong, MD, Principal investigator, University of ChicagoKatherine Thompson, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878562
- Sponsor's protocol ID
- IRB20-1580
- Acronym
- I-COPE
- Status last verified
- Jan 2024
- First submitted
- 4 May 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a clinic-level intervention study. Research team will only receive a limited data set with no individual participant data.
Publications
Gianni W, Ceci M, Bustacchini S, Corsonello A, Abbatecola AM, Brancati AM, Assisi A, Scuteri A, Cipriani L, Lattanzio F. Opioids for the treatment of chronic non-cancer pain in older people. Drugs Aging. 2009 Dec;26 Suppl 1:63-73. doi: 10.2165/11534670-000000000-00000.
PubMed 20136170American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc. 2009 Aug;57(8):1331-46. doi: 10.1111/j.1532-5415.2009.02376.x. Epub 2009 Jul 2. No abstract available.
PubMed 19573219Abdulla A, Adams N, Bone M, Elliott AM, Gaffin J, Jones D, Knaggs R, Martin D, Sampson L, Schofield P; British Geriatric Society. Guidance on the management of pain in older people. Age Ageing. 2013 Mar;42 Suppl 1:i1-57. doi: 10.1093/ageing/afs200.
PubMed 23420266Guerriero F. Guidance on opioids prescribing for the management of persistent non-cancer pain in older adults. World J Clin Cases. 2017 Mar 16;5(3):73-81. doi: 10.12998/wjcc.v5.i3.73.
PubMed 28352631West NA, Severtson SG, Green JL, Dart RC. Trends in abuse and misuse of prescription opioids among older adults. Drug Alcohol Depend. 2015 Apr 1;149:117-21. doi: 10.1016/j.drugalcdep.2015.01.027. Epub 2015 Jan 31.
PubMed 25678441Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
PubMed 25581257Lewis ET, Cucciare MA, Trafton JA. What do patients do with unused opioid medications? Clin J Pain. 2014 Aug;30(8):654-62. doi: 10.1097/01.ajp.0000435447.96642.f4.
PubMed 24281287Wu LT, Blazer DG. Illicit and nonmedical drug use among older adults: a review. J Aging Health. 2011 Apr;23(3):481-504. doi: 10.1177/0898264310386224. Epub 2010 Nov 17.
PubMed 21084724Huhn AS, Strain EC, Tompkins DA, Dunn KE. A hidden aspect of the U.S. opioid crisis: Rise in first-time treatment admissions for older adults with opioid use disorder. Drug Alcohol Depend. 2018 Dec 1;193:142-147. doi: 10.1016/j.drugalcdep.2018.10.002. Epub 2018 Oct 18.
PubMed 30384321Carter MW, Yang BK, Davenport M, Kabel A. Increasing Rates of Opioid Misuse Among Older Adults Visiting Emergency Departments. Innov Aging. 2019 Mar 7;3(1):igz002. doi: 10.1093/geroni/igz002. eCollection 2019 Jan.
PubMed 30863796Kuerbis A, Sacco P, Blazer DG, Moore AA. Substance abuse among older adults. Clin Geriatr Med. 2014 Aug;30(3):629-54. doi: 10.1016/j.cger.2014.04.008. Epub 2014 Jun 12.
PubMed 25037298Schultz SK, Arndt S, Liesveld J. Locations of facilities with special programs for older substance abuse clients in the US. Int J Geriatr Psychiatry. 2003 Sep;18(9):839-43. doi: 10.1002/gps.994.
PubMed 12949852Gopal P, Kagarmanova A, Staab E, Thompson K, Ari M, Lazar D, Rosul L, Zhao A, Laiteerapong N. Perceptions of older adults on chronic pain management in primary care settings. BMC Geriatr. 2026 Jul 31;26(1):1357. doi: 10.1186/s12877-026-08000-w.
PubMed 42947017Kagarmanova A, Sparkman H, Laiteerapong N, Thompson K, Rosul L, Lazar D, Staab E, Wan W, Kass A, Ari M. Improving the management of chronic pain, opioid use, and opioid use disorder in older adults: study protocol for I-COPE study. Trials. 2022 Jul 27;23(1):602. doi: 10.1186/s13063-022-06537-w.
PubMed 35897111
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Chicago Older Adult Opioid and Pain Management Through Patient-Centered Clinical Decision Support and Project ECHO
- ClinicalTrials.gov ID
- NCT04878562
- Acronym / sponsor ID
- I-COPE / IRB20-1580
- Conditions
- Chronic Pain, Opioids, Opioid-use Disorder
- Keywords
- older adults, electronic health record, chronic pain, opioid use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), ACCESS Community Health Network
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will conduct a nonhybrid pragmatic implementation-effectiveness stepped wedge cluster-randomized study in which clinics will be the randomized clusters.
| Arm | Type | Receives |
|---|---|---|
| I-COPE Intervention | Experimental | Behavioral: I-COPE5 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. |
| No intervention | No intervention | –Standard of care offered to all patients. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-COPEThe 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. | Behavioural | I-COPE Intervention |
Primary outcome
Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores
Time frame: 6 months
Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores
Increase diversity of recommended pain treatments
Time frame: 6 months
More types of treatment are represented in patient's treatment plan. In I-COPE smartset pain treatments are grouped into 4 types: self-management, referrals to specialists, non-opioid medications, and opioid medications.
Decrease higher-risk pain treatments
Time frame: 6 months
Discontinuation of opioid/Beer's Criteria medications or decrease in daily milligram equivalents of opioid/Beer's Criteria medications.
7 secondary outcomes
Change in pain scores among older adults with and without chronic pain diagnoses and high initial pain scores
Time frame: 6 months
Increase in guideline concordant opioid prescriptions
Time frame: 6 months
Decrease in percentage of patients prescribed each high-risk treatments
Time frame: 6 months
Increase in percentage of patients prescribed each low-risk treatments
Time frame: 6 months
Percentage of eligible patients who receive an I-COPE action plan
Time frame: 6 months
Percentage of physicians who use the I-COPE program
Time frame: 6 months
Percentage of clinics who use the I-COPE program
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Background: PubMed 20136170Gianni W, Ceci M, Bustacchini S, Corsonello A, Abbatecola AM, Brancati AM, Assisi A, Scuteri A, Cipriani L, Lattanzio F. Opioids for the treatment of chronic non-cancer pain in older people. Drugs Aging. 2009 Dec;26 Suppl 1:63-73. doi: 10.2165/11534670-000000000-00000.
- Background: PubMed 19573219American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc. 2009 Aug;57(8):1331-46. doi: 10.1111/j.1532-5415.2009.02376.x. Epub 2009 Jul 2. No abstract available.
- Background: PubMed 23420266Abdulla A, Adams N, Bone M, Elliott AM, Gaffin J, Jones D, Knaggs R, Martin D, Sampson L, Schofield P; British Geriatric Society. Guidance on the management of pain in older people. Age Ageing. 2013 Mar;42 Suppl 1:i1-57. doi: 10.1093/ageing/afs200.
- Background: PubMed 28352631Guerriero F. Guidance on opioids prescribing for the management of persistent non-cancer pain in older adults. World J Clin Cases. 2017 Mar 16;5(3):73-81. doi: 10.12998/wjcc.v5.i3.73.
- Background: PubMed 25678441West NA, Severtson SG, Green JL, Dart RC. Trends in abuse and misuse of prescription opioids among older adults. Drug Alcohol Depend. 2015 Apr 1;149:117-21. doi: 10.1016/j.drugalcdep.2015.01.027. Epub 2015 Jan 31.
- Background: PubMed 25581257Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
- Background: PubMed 24281287Lewis ET, Cucciare MA, Trafton JA. What do patients do with unused opioid medications? Clin J Pain. 2014 Aug;30(8):654-62. doi: 10.1097/01.ajp.0000435447.96642.f4.
- Background: PubMed 21084724Wu LT, Blazer DG. Illicit and nonmedical drug use among older adults: a review. J Aging Health. 2011 Apr;23(3):481-504. doi: 10.1177/0898264310386224. Epub 2010 Nov 17.
- Background: PubMed 30384321Huhn AS, Strain EC, Tompkins DA, Dunn KE. A hidden aspect of the U.S. opioid crisis: Rise in first-time treatment admissions for older adults with opioid use disorder. Drug Alcohol Depend. 2018 Dec 1;193:142-147. doi: 10.1016/j.drugalcdep.2018.10.002. Epub 2018 Oct 18.
- Background: PubMed 30863796Carter MW, Yang BK, Davenport M, Kabel A. Increasing Rates of Opioid Misuse Among Older Adults Visiting Emergency Departments. Innov Aging. 2019 Mar 7;3(1):igz002. doi: 10.1093/geroni/igz002. eCollection 2019 Jan.
- Background: PubMed 25037298Kuerbis A, Sacco P, Blazer DG, Moore AA. Substance abuse among older adults. Clin Geriatr Med. 2014 Aug;30(3):629-54. doi: 10.1016/j.cger.2014.04.008. Epub 2014 Jun 12.
- Background: PubMed 12949852Schultz SK, Arndt S, Liesveld J. Locations of facilities with special programs for older substance abuse clients in the US. Int J Geriatr Psychiatry. 2003 Sep;18(9):839-43. doi: 10.1002/gps.994.
- Individual participant dataSharing planned: No. This is a clinic-level intervention study. Research team will only receive a limited data set with no individual participant data.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mim Ari, MD principal investigator
University of Chicago
Neda Laiteerapong, MD principal investigator
University of Chicago
Katherine Thompson, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-COPE in people with Chronic Pain and Opioids, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04878562, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.