Overdose
Conditions
Keywords
naloxone, opioids, safety
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALMHC Outreach Intervention
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.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Evaluation population: 1. Eligible Clinics 2. Patients prescribed Chronic Opioid Therapy Eligibility Criteria for Clinics: 1. Clinic leadership willing to be randomized to order of implementation 2. Not a pilot location Eligibility for an MHC visit included the following: 1. Patients in the KPCO chronic opioid registry 2. No Primary Care Physician (PCP) or MHC visit in the past 6 months 3. Not managed by the Integrated Pain Service, a specialty pain service that takes care of the highest risk and most complex pain patients Patients enter the chronic opioid registry if they fulfill any of the following criteria: * 2 opioid fills in the last 90 days; fills should be separated by 27 days, or * 1 opioid fill with pill number ≥100 pills in the last 90 days, or * 1 long-acting/extended-release opioid fill in the last 90 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a Medication Health Center visit | Outcomes are assessed in a two-month post-intervention period. | Medication Health Center (MHC) Visits will be assessed using data from the electronic medical record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a Naloxone dispensing | Outcomes are assessed in a two-month post-intervention period. | Naloxone dispensings are assessed using data from the electronic medical record |
| Number of participants with a Prescription Drug Monitoring Program (PDMP) review | Outcomes are assessed in a two-month post-intervention period. | Prescription Drug Monitoring Program (PDMP) reviews are assessed using data from the electronic medical record |
| Number of participants with a Urine Drug Screens completed | Outcomes are assessed in a two-month post-intervention period. | Urine Drug Screens Completed are assessed using data from the electronic medical record |
Countries
United States
Outcome results
None listed