Evaluation of a Medication Health Center to Promote Opioid Safety

NCT06456294 | Active Not Recruiting

• 1 other identifier: 1840701
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Overdose

Keywords

naloxone; opioids; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants with a Naloxone dispensing

  Outcomes are assessed in a two-month post-intervention period.

• Number of participants with a Prescription Drug Monitoring Program (PDMP) review

  Outcomes are assessed in a two-month post-intervention period.

• Number of participants with a Urine Drug Screens completed

  Outcomes are assessed in a two-month post-intervention period.

Study Arms (2)

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.

Behavioral: MHC Outreach Intervention

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.

Interventions

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.

MHC Early Outreach Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Colorado

Aurora, Colorado, 80011, United States

Location

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: June 15, 2022
• Primary Completion: December 3, 2024
• Study Completion: January 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: 3 years after following publication

Locations

US (1)