Integrated Care for Opioid Use Disorder

Overseen By Audun J Lier, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe disability, HIV, HBV

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Opioid use disorder (OUD) confers a higher risk of acquiring and transmitting infectious diseases, which may have long-term health consequences in Veterans. Treatment of OUD with medication assisted therapy is highly effective, however this often occurs independently of infectious diseases care. This project will test out a new model that combines infectious diseases and OUD care within one VA clinic appointment. This new care model may improve the health of Veterans and reduce cost and time required for Veterans who often need to attend multiple outpatient appointments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Integrated Care for Opioid Use Disorder?

Research shows that integrating care for opioid use disorder with other health services, like HIV care, can lead to better patient outcomes. This suggests that combining different types of care into one treatment plan can be effective for managing opioid use disorder. ^{1 2 3 4 5}

Is Integrated Care for Opioid Use Disorder safe for humans?

The research does not provide specific safety data for Integrated Care for Opioid Use Disorder, but it discusses safety initiatives and risk reviews related to opioid use, which aim to reduce serious adverse events like overdoses and suicide-related events. ^{5 6 7 8 9}

How is the Integrated Care treatment for opioid use disorder different from other treatments?

Integrated Care for opioid use disorder is unique because it combines medical care with social services, addressing both health and social needs. This approach is designed to prevent patients from 'falling through the cracks' by ensuring coordinated care across different services, which is not typically offered in standard treatments. ^{1 2 5 10 11}

Research Team

Audun J Lier, MD

Principal Investigator

Northport VA Medical Center, Northport, NY

Eligibility Criteria

This trial is for Veterans with opioid use disorder (OUD) who are also at risk or suffering from infectious diseases like Hepatitis C, HIV/AIDS, and sexually transmitted infections. It aims to help those who typically attend multiple appointments for their conditions.

Inclusion Criteria

US Veteran

Able to provide written informed consent in English

Living in the community (Nassau, Suffolk, Kings, Queens, Bronx, Westchester, Rockland counties, NY)

Exclusion Criteria

Severe medical or psychiatric disability making participation unsafe

Unable to provide written consent

PrEP exclusion: HIV positive test; HBV positive test

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive integrated care with infectious diseases screening and medication assisted therapy for opioid use disorder

90 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PrEP uptake and infectious diseases screening

270 days

Treatment Details

Interventions

• Integrated Care

Trial Overview The study is testing a new care model that integrates treatment for OUD and various infectious diseases into one clinic appointment within the VA system, potentially improving health outcomes and efficiency.

Participant Groups

Group I: Integrated care Experimental Treatment 1 Intervention

Study visit 1: Participants will first complete a study interview, then will receive a prescription for laboratory testing for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), gonorrhea, chlamydia, and syphilis. Those who meet eligibility criteria for PrEP will receive a prescription for PrEP (emtricitabine 200 mg (FTC)/25 mg tenofovir alafenamide-emtricitabine (TAF) or once daily emtricitabine 200 mg (FTC)/300 mg tenofovir disoproxil fumarate-emtricitabine (TDF)), and will be referred to the Infectious Diseases clinic for PrEP follow-up. Participants will then complete a standard SUD clinic appointment. Study visit 2: Participants will follow-up at 90 days in the SUD clinic where they will repeat the study interview, followed by receipt of standard SUD clinical care.

Group II: Treatment as usual Active Control 1 Intervention

Study visit 1: Participants will first complete a study interview, then will complete a standard SUD clinic appointment. After the SUD appointment, participants will be referred to the Infectious Diseases clinic to receive standard infectious diseases laboratory testing, including HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), gonorrhea, chlamydia, and syphilis. Those who meet eligibility criteria for PrEP will receive a prescription for PrEP (emtricitabine 200 mg (FTC)/25 mg tenofovir alafenamide-emtricitabine (TAF) or once daily emtricitabine 200 mg (FTC)/300 mg tenofovir disoproxil fumarate-emtricitabine (TDF) through the infectious diseases clinic. Study visit 2: Participants will follow-up at 90 days in the SUD clinic where they will repeat the study interview, followed by receipt of their standard SUD clinical care.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A qualitative study involving 22 patients, 24 clinical staff, and 5 clinic leaders identified key themes for improving the integration of HIV and opioid use disorder (OUD) care, emphasizing the need to address social risks and knowledge gaps about treatments.

The development of a new measurement tool based on these insights aims to enhance service delivery for patients with HIV and OUD by focusing on patient-centered policies and effective communication between organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. Oldfield, BJ., Muñoz, N., Boshnack, N., et al.[2023]

Individuals with HIV who also use drugs face higher health risks compared to those without drug use, highlighting the need for integrated care models.

A systematic review of 22 studies revealed that while integrated HIV and opioid use disorder services exist, they often lack coordinated state-level policies and systems, suggesting that improved coordination and standardized tools could enhance service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinating Systems of Care for HIV and Opioid Use Disorder: A Systematic Review of Enablers and Barriers to Integrated Service Access, and Systems and Tools Required for Implementation. Duffy, M., Ghosh, A., Geltman, A., et al.[2022]

Only 2 out of 31 endorsed quality measures for opioid use disorder (OUD) considered patient preferences and needs, highlighting a significant gap in patient-centered care despite guidelines emphasizing its importance.

The study developed a new quality measurement taxonomy called EQuIITable Care, which includes six classifications aimed at improving patient-centered care in OUD treatment and identifying areas for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered quality measurement for opioid use disorder: Development of a taxonomy to address gaps in research and practice. Kelley, AT., Incze, MA., Baylis, JD., et al.[2023]

A review identified seven quality measures for treating opioid use disorder (OUD), all of which focus on the processes of service delivery, highlighting the need for better assessment of treatment outcomes and patient experiences.

There is a significant gap in quality measures specifically tailored for OUD, indicating that a unified framework, like an OUD Treatment Cascade, is necessary to improve care access and reduce opioid-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an opioid use disorder treatment cascade: A review of quality measures. Williams, AR., Nunes, EV., Bisaga, A., et al.[2022]

Multidisciplinary care models that integrate treatment for opioid use disorder (OUD), hepatitis C (HCV), and HIV are essential for preventing the spread of these conditions, with 17 different models identified across various care settings.

Key components of effective care models include medication-assisted treatment for OUD, treatment for HIV and HCV, HIV pre-exposure prophylaxis, and behavioral health services, highlighting the importance of comprehensive approaches in managing these interconnected health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV? Rich, KM., Bia, J., Altice, FL., et al.[2019]

In a study of 147 patients on high-dose opioid therapy, 34% reduced their opioid dosage after implementing the Opioid Safety Initiative, with the median daily dose decreasing from 315 mg to 278 mg.

There was a notable improvement in adherence to safety policies, including an increase in informed consent completion from 31% to 48% and biannual urine drug screenings from 44% to 61%, indicating enhanced monitoring practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of multidisciplinary chart reviews on opioid dose reduction and monitoring practices. Rivich, J., McCauliff, J., Schroeder, A.[2019]

A retrospective study showed that implementing data-based opioid risk reviews can potentially reduce serious adverse events (SAEs) related to opioid use, including overdoses and suicide-related events, in the 6 months following the review.

However, the study also found that tapering or discontinuing opioid therapy significantly increased the risk of suicide-related events and opioid-related SAEs, indicating that careful management is crucial during these processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Based Opioid Risk Review in Patients with Chronic Pain: A Retrospective Chart Review. Pogue, J., Lau, L., Boyer, J.[2023]

Despite the availability of effective FDA-approved medications for opioid use disorder (OUD), such as methadone and buprenorphine, most individuals with OUD do not receive these treatments, highlighting a significant treatment gap.

The proposed Cascade of Care framework aims to enhance the treatment of OUD by integrating prevention and treatment strategies, which has garnered interest from major health agencies and could improve outcomes by identifying key interventions and quality indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Cascade of Care for responding to the opioid epidemic. Williams, AR., Nunes, EV., Bisaga, A., et al.[2020]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., et al.[2022]

The study identified five distinct models of integrated care for families affected by opioid use disorder (OUD), emphasizing the need for supportive and frequent visits with various providers, although billing constraints hinder full integration of services.

Key components for effective dyadic care include prioritizing care coordination, overcoming barriers to integrate medical and behavioral services, and ensuring child safety while maintaining parental trust, highlighting the complexities of addressing both parental and infant health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs. Schiff, DM., Partridge, S., Gummadi, NH., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Coordinating Systems of Care for HIV and Opioid Use Disorder: A Systematic Review of Enablers and Barriers to Integrated Service Access, and Systems and Tools Required for Implementation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-centered quality measurement for opioid use disorder: Development of a taxonomy to address gaps in research and practice. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Developing an opioid use disorder treatment cascade: A review of quality measures. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV? [2019]

6. England pubmed.ncbi.nlm.nih.gov

Impact of multidisciplinary chart reviews on opioid dose reduction and monitoring practices. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Data-Based Opioid Risk Review in Patients with Chronic Pain: A Retrospective Chart Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Development of a Cascade of Care for responding to the opioid epidemic. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). [2022]

10. England pubmed.ncbi.nlm.nih.gov

Outcomes of a novel office-based opioid treatment program in an internal medicine resident continuity practice. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs. [2023]