Evaluation of a Medication Health Center to Promote Opioid Safety

NCT ID: NCT06456294

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2025-01-01

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.

Conditions

Overdose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MHC Early Outreach Intervention

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.

Group Type: EXPERIMENTAL

MHC Outreach Intervention

Intervention Type: 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 Delayed Outreach 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaiser Permanente Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

1840701

Identifier Type: -

Identifier Source: org_study_id