Evaluation of a Medication Health Center to Promote Opioid Safety

Kaiser Permanente

Status: Active, not recruiting

Conditions: Overdose

Treatments: Behavioral: MHC Outreach Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06456294

1840701

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

MHC Early Outreach Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: MHC Outreach Intervention

MHC Delayed Outreach Intervention

No Intervention group

Description:

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.