Evaluation of a Medication Health Center to Promote Opioid Safety

Overdose Clinical Trial

Official title:

Evaluation of a Medication Health Center to Promote Opioid Safety

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06456294
• Other study ID #: 1840701
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: January 1, 2025
• Est. primary completion date: December 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Overdose

Intervention

Behavioral:
• MHC 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	Number of participants with a Prescription Drug Monitoring Program (PDMP) review	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.
Secondary	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.