Clinic Visits for Opioid Safety

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must be taking: Opioids

Disqualifiers: No PCP visit, Integrated Pain Service, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a special opioid safety program can assist long-term opioid users. The study will determine if visiting a specific clinic influences factors like obtaining naloxone (a medication that can reverse an overdose) and reviewing prescription histories. Researchers will compare two groups: one receiving extra encouragement to visit the clinic through the MHC Outreach Intervention (a program designed to enhance clinic visits) and another receiving usual care. It suits patients who have frequently filled opioid prescriptions in the last three months and have not seen a primary doctor or visited the specific clinic in six months. As an unphased trial, this study allows patients to contribute to important research that could improve opioid safety programs.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It focuses on patients already on chronic opioid therapy, so you may continue your current opioid medications.

What prior data suggests that this intervention is safe?

Research has shown that community outreach programs, such as the MHC Outreach Intervention, effectively engage individuals at high risk of opioid issues. One study found that a harm reduction program successfully reached 68% of injection drug users.

These programs aim to connect individuals with necessary healthcare services, improving access and support. Mobile health clinics (MHCs) are recognized for their innovation and cost-effectiveness, particularly for vulnerable groups. They enhance healthcare access, potentially leading to better health outcomes.

In terms of safety, these programs do not involve medications or medical procedures. Instead, they focus on support and education, minimizing any risk of negative effects. Overall, evidence suggests that participants tolerate these interventions well and find them safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a proactive approach to opioid safety through the MHC Outreach Intervention. Unlike standard care, which often relies on reactive measures like prescribing naloxone, this intervention focuses on early patient engagement by having MHC staff actively encourage clinic visits. This approach aims to strengthen the relationship between patients and healthcare providers, potentially leading to better management of opioid use and safer outcomes. By emphasizing early outreach, the trial could redefine how clinics support patients at risk of opioid-related issues.

What evidence suggests that the MHC Outreach Intervention is effective for opioid safety?

Research has shown that community programs like the MHC Outreach Intervention, which participants in this trial may receive, can help tackle opioid misuse and improve patient health. Evidence suggests that direct outreach to patients encourages the use of services like naloxone, a medication that can reverse opioid overdoses, and participation in regular drug monitoring. This trial will compare the MHC Early Outreach Intervention, where clinics implement early outreach to encourage clinic visits, with the MHC Delayed Outreach Intervention, which follows usual care protocols. Studies indicate that many people who need treatment for opioid use disorder (OUD) do not receive it, highlighting the importance of outreach programs. By directly contacting patients and encouraging clinic visits, these programs can increase access to necessary care and improve opioid treatment management. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients on chronic opioid therapy. It's designed to see if an opioid safety clinic can help them use opioids more safely. The study will track how often they visit the clinic, get naloxone (a drug that reverses overdoses), check their prescriptions, and do urine tests.

Inclusion Criteria

Patients in the KPCO chronic opioid registry

I am on long-term opioid medication.

No Primary Care Physician (PCP) or MHC visit in the past 6 months

Exclusion Criteria

Not a pilot location

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Medication Health Center intervention, including education on opioid safety, naloxone provision, and adherence to monitoring

2 months

Multiple visits to the Medication Health Center

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including Urine Drug Screens, Naloxone dispensing, and PDMP reviews

2 months

What Are the Treatments Tested in This Trial?

Interventions

• MHC Outreach Intervention

Trial Overview The 'MHC Outreach Intervention' is being tested to promote safe use of opioids among patients who take these drugs regularly. The intervention includes visits to a special clinic focused on opioid safety.

How Is the Trial Designed?

Group I: MHC Early Outreach Intervention Experimental Treatment 1 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 II: MHC Delayed Outreach Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK458653/

Evidence on Strategies for Addressing the Opioid Epidemic The purpose of this chapter is to review available evidence on strategies that have been used to address the problems of opioid misuse, OUD, and related deaths.

2. cms.gov cms.gov/outreach-and-education/outreach/partnerships/downloads/cms-opioid-misuse-strategy-2016.pdf

CENTERS FOR MEDICARE & MEDICAID SERVICES ( ... MAT is the most effective known intervention for long term recovery from opioid use disorder, yet ... States can use the data to compare ...

3. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

4. healthandjusticejournal.biomedcentral.com healthandjusticejournal.biomedcentral.com/articles/10.1186/s40352-022-00201-w

A scoping review of community-based post-opioid overdose ... The objective of the present review was to describe program structure and evaluated outcomes of community-based post-overdose interventions.

5. nam.edu nam.edu/perspectives/improving-access-to-evidence-based-medical-treatment-for-opioid-use-disorder-strategies-to-address-key-barriers-within-the-treatment-system/

Improving Access to Evidence-Based Medical Treatment ... ABSTRACT | Even though evidence-based treatment for opioid use disorders (OUD) is effective, almost four in five Americans with OUD do not ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9883127/

A scoping review of community-based post-opioid ... The objective of the present review was to describe program structure and evaluated outcomes of community-based post-overdose interventions.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547219301011

A community outreach intervention to link individuals with ... These interventions have proven to be effective in engaging high-risk individuals; of the injection drug users reached in a 12-site harm reduction study, 68% ...

8. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2802424

Postoverdose Outreach Programs and Subsequent Opioid ... The primary outcome was the quarterly fatal opioid overdose rate. We calculated municipal-specific rates per 100 000 residents of opioid-related ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8741230/

Awareness, perception and utilization of a mobile health ... Mobile health clinics (MHC) are an innovative, cost-effective health care delivery approach that increases healthcare access to vulnerable populations.

10. healthcity.bmc.org healthcity.bmc.org/providing-post-outreach-support-isnt-just-good-practice-its-reducing-deaths/

Communities That Implement Post-Overdose Outreach ... What's more: Cities or towns with an outreach program had reduced their opioid-related emergency encounter rates. Researchers noted that ...