Clinical trial NCT06456294: Evaluation of a Medication Health Center to Promote Opioid Safety
Official title: Evaluation of a Medication Health Center to Promote Opioid Safety
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overdose
Keywords: naloxone
opioids
safety
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with a Medication Health Center visit
timeFrame: Outcomes are assessed in a two-month post-intervention period.
Secondary outcomes:
measure: Number of participants with a Naloxone dispensing
timeFrame: Outcomes are assessed in a two-month post-intervention period.
measure: Number of participants with a Prescription Drug Monitoring Program (PDMP) review
timeFrame: Outcomes are assessed in a two-month post-intervention period.
measure: Number of participants with a Urine Drug Screens completed
timeFrame: Outcomes are assessed in a two-month post-intervention period.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
Study officials:
References: