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This study will assess the impact of an opioid safety clinic intervention for patients prescribed chronic opioid therapy. Outcomes are visits to the clinic, naloxone dispensings, Prescription Drug Monitoring reviews, and Urine Drug Screens conducted
Given ongoing concerns about the risk of opioid overdose among people taking chronic opioid therapy for pain, Kaiser Permanente Colorado (KPCO) sought to develop a standardized approach to promote opioid safety. Operational stakeholders adapted an existing Opioid Safety Clinic model, tailored it for KPCO's context, and implemented it in three geographically dispersed KPCO clinics with leadership support. The approach was a multidisciplinary "Medication Health Center" to assess patients, educate them about overdose risk, provide naloxone, and ensure adherence to standard monitoring. Operations and the research team then collaborated to assess the effectiveness of the program to inform decisions to scale the program to other regions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MHC Early Outreach Intervention | Experimental | Early implementation of a MHC outreach intervention program. Clinics in the early outreach intervention arm will be assigned to the MHC Direct patient outreach, where MHC staff will encourage patients to schedule an appointment with the MHC and primary care (PC) staff will be educated to encourage MHC visits. |
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| MHC Delayed Outreach Intervention | No Intervention | Clinics in the usual care/delayed intervention arm will deliver usual care through the health plan, pharmacy and clinicians. As part of usual care, patients at these clinics can access naloxone through physician prescription or standing orders. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MHC Outreach Intervention | Behavioral | Adult PC clinics are randomized to receive the MHC Outreach Intervention early (n=7 clinics) vs. delayed (n=7 clinics). In early intervention clinics, patients prescribed chronic opioid therapy, on a chronic opioid registry, and receiving their medication from the intervention clinic are sent emails and letters inviting them to schedule an MHC appointment. Clinical staff at the early intervention clinic are educated to encourage attendance. During MHC visits, MHC staff assess patients prescribed Chronic Opioid Therapy (COT), educate them about overdose, prescribe naloxone, and order guideline-concordant opioid monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a Medication Health Center visit | Medication Health Center (MHC) Visits will be assessed using data from the electronic medical record. | Outcomes are assessed in a two-month post-intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a Naloxone dispensing | Naloxone dispensings are assessed using data from the electronic medical record | Outcomes are assessed in a two-month post-intervention period. |
| Number of participants with a Prescription Drug Monitoring Program (PDMP) review |
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Evaluation population:
Eligibility Criteria for Clinics:
Eligibility for an MHC visit included the following:
Patients enter the chronic opioid registry if they fulfill any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Colorado | Aurora | Colorado | 80011 | United States |
Investigators interested in using the data from this study must submit a written request. Requests must address regulatory and compliance requirements for data usage. Investigators must outline the necessary resources required to support their data request, including personnel and infrastructure. The original study team will evaluate each request based on scientific merit, ethical considerations, and alignment with the original study's objectives.
Deidentified electronic health record (EHR) data will be shared with investigators upon approval of written request. Investigators are responsible for obtaining necessary approvals and adhering to relevant laws and regulations and will be required to sign a Data Use Agreement (DUA) outlining the terms and conditions of data usage. The data sharing period is limited to three years following the publication of the primary study.
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3 years after following publication
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| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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Prescription Drug Monitoring Program (PDMP) reviews are assessed using data from the electronic medical record |
| Outcomes are assessed in a two-month post-intervention period. |
| Number of participants with a Urine Drug Screens completed | Urine Drug Screens Completed are assessed using data from the electronic medical record | Outcomes are assessed in a two-month post-intervention period. |
| D001523 | Mental Disorders |