Collaborative Care for Substance Use Disorders

Recruiting at 7 trial locations

Overseen By Joseph Lurio, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: MOUD

Disqualifiers: Pregnancy, Jail, Recent SUD treatment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a new care approach, called Co-Care, can assist individuals with serious substance use issues, specifically those using opioids, stimulants like cocaine or meth, and alcohol. The primary goal is to reduce the number of days participants use these substances. Participants will either receive a special care plan involving nurse visits and health coaching or standard care with additional educational materials. This trial suits adults who have frequently used two or more of these substances over the past month and are not currently in a treatment program that began in the last 30 days. As an unphased trial, the study offers a unique opportunity to explore innovative care strategies that could significantly improve substance use outcomes.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently being treated with medication for opioid use disorder (MOUD) and do not have moderate to severe alcohol or stimulant use disorder, you may be excluded from participating.

What prior data suggests that this collaborative care intervention is safe for patients with substance use disorders?

Research has shown that programs like Co-Care, which offer various types of support, are generally well-received by patients. These programs often include meetings with nurse care managers and sessions with addiction specialists. Studies have found that similar treatments can help reduce drug and alcohol use in people with substance use problems.

While specific safety data for Co-Care is not available, the program emphasizes support and guidance, which are typically safe and carry few risks. Since Co-Care involves non-medical support, such as coaching and specialist consultations, it is expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Co-Care treatment for substance use disorders because it integrates a comprehensive support system that is not typically part of standard care. Unlike traditional treatments, which often rely solely on primary care visits and educational materials, Co-Care involves a Nurse Care Manager to coordinate care, provides access to addiction specialist consultations when needed, and includes personalized health coaching sessions. This collaborative approach aims to address the multifaceted needs of patients, offering a more holistic and potentially more effective pathway to recovery.

What evidence suggests that the Co-Care intervention could be effective for substance use disorders?

This trial compares two approaches for treating substance use disorders. Participants in the "Co-Care" arm receive primary care treatment plus the full Co-Care intervention, which includes regular check-ins with a Nurse Care Manager, consultations with addiction specialists if needed, and health coaching sessions. Research has shown that this team-based approach can effectively treat substance use problems, helping individuals with opioid and alcohol issues reduce substance use and maintain sobriety. Meanwhile, participants in the "Enhanced Usual Care (EUC)" arm receive primary care treatment as usual plus educational materials. This method aims to address both substance use and mental health issues, providing comprehensive care in a regular doctor's office. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer McNeely, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe substance use disorders involving opioids, stimulants, or alcohol. Participants must be over 18, speak and understand the study language, and have used multiple substances in the past month. Primary care providers enrolled in the study can also join. Not eligible if they don't meet these criteria.

Inclusion Criteria

a) Patients having alcohol use disorder without an opioid or stimulant SUD are required to have current opioid or stimulant use, as measured on the TAPS tool or baseline monthly survey.

I have used two or more substances, including opioids or stimulants, non-medically in the last month.

I have used opioids or alcohol heavily for more than 10 days, or stimulants for more than 7 days in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Co-Care intervention, including Nurse Care Manager visits, addiction specialist consultations, and health coaching sessions

21 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Co-Care

Trial Overview

The Co-Care trial tests a collaborative approach to treat polysubstance abuse in primary care settings. It includes addiction specialist consultations, nurse visits, health coaching sessions, educational materials for patients and support for primary care providers.

How Is the Trial Designed?

Group I: Co-Care Experimental Treatment 4 Interventions

Patient participants with providers will receive primary care treatment plus the full Co-Care intervention which includes: Nurse Care Manager (NCM) visits, Addiction specialist consultations through NCM if indicated, and Health coaching sessions.

Group II: Enhanced Usual Care (EUC) Active Control 2 Interventions

Patient participants with providers will receive primary care treatment as usual plus educational materials.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Collaborative documentation (CD) in substance use treatment can enhance person-centered care by reducing documentation time and fostering trust between providers and clients, as reported by 22 treatment providers in focus groups.

While CD shows promise in promoting engagement, it also presents challenges, particularly with mandated populations or those with complex symptoms, highlighting the need for tailored strategies to optimize its use in these contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Collaborative Documentation to Support Person-Centered Care in Substance Use Settings. Matthews, EB., Peral, M.[2023]

The study developed a new collaborative care model called CLARO, specifically designed to improve treatment for patients with co-occurring opioid use disorders (OUD) and mental health issues like depression and PTSD, using input from a diverse team of stakeholders.

Twelve key adaptations were made to the traditional collaborative care approach, including the use of community health workers and modified training protocols, aimed at enhancing the model's effectiveness and acceptability in low-resource healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. Osilla, KC., Dopp, AR., Watkins, KE., et al.[2022]

The 12-month Collaborative Care (CC) intervention showed that patients with poorly controlled Type 2 Diabetes (T2D) and depression were more likely to maintain significant improvements in depressive symptoms and glucose levels at 36 months compared to those receiving usual care.

While there were no overall differences in health outcomes between the CC and usual care groups at 36 months, patients in the CC group who had improved outcomes at 12 months were more likely to sustain those improvements, indicating the long-term benefits of the CC approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. Suvada, K., Ali, MK., Chwastiak, L., et al.[2023]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

The pilot study involving 38 patients showed that the Substance Use Treatment and Recovery Team (START) significantly improved the initiation of medication for alcohol or opioid use disorders during hospitalization, with patients having over six times higher odds of starting treatment compared to usual care.

START also enhanced the likelihood of patients being linked to follow-up care after discharge, with nearly six times higher odds compared to those receiving standard care, indicating its potential effectiveness in supporting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of a hospital-based substance use treatment and recovery team (START) to improve initiation of medication for alcohol or opioid use disorder and linkage to follow-up care. Ober, AJ., Osilla, KC., Klein, DJ., et al.[2023]

Integrating behavioral health staff into primary care teams is crucial for effectively coordinating substance use disorder (SUD) services, as it helps facilitate important transitions in patient care.

The study identified operational practices from community health centers that successfully coordinate SUD services, but ongoing coordination remains a challenge, highlighting the need for further research to improve health and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing care for patients with substance abuse disorders at community health centers. Gurewich, D., Prottas, J., Sirkin, JT.[2013]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

Measurement-based care (MBC) could enhance clinical outcomes in substance use disorder (SUD) treatment by improving communication between patients and providers, as well as among clinicians, according to insights from 15 clinicians interviewed.

To increase the adoption of MBC in SUD settings, it should be designed to fit existing workflows, track clinically relevant outcomes like coping skills and motivation, and be presented as a supportive tool rather than a replacement for current practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do clinicians want? Understanding frontline addiction treatment clinicians' preferences and priorities to improve the design of measurement-based care technology. Tauscher, JS., Cohn, EB., Johnson, TR., et al.[2023]

In a study of 377 primary care patients with opioid and/or alcohol use disorders, the collaborative care (CC) model significantly increased access to evidence-based treatments compared to usual care, with 39% of CC participants receiving treatment versus only 17% in the usual care group.

CC participants also reported higher rates of abstinence from opioids or alcohol at 6 months (32.8% vs 22.3%), demonstrating that this model is effective in improving treatment outcomes for individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial. Watkins, KE., Ober, AJ., Lamp, K., et al.[2019]

Adverse drug events (ADEs) are a major cause of preventable harm in hospitals, particularly affecting older adults, prompting the creation of a National Action Plan to enhance medication safety.

The Action Plan focuses on preventing ADEs from three high-risk medication classes: anticoagulants, diabetes agents, and opioids, and emphasizes surveillance, evidence-based prevention, and education for both healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. Harris, Y., Hu, DJ., Lee, C., et al.[2019]

A coalition approach to collaborative care (CEP) significantly reduced alcohol consumption and the likelihood of behavioral health hospitalizations in individuals with comorbid depression and substance use disorders, compared to a technical assistance approach (RS).

CEP also increased the use of faith-based depression services, suggesting that community engagement can enhance treatment options for those struggling with both depression and substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of two quality improvement implementation interventions for depression services in adults with substance use problems. Morton, I., Hurley, B., Castillo, EG., et al.[2022]

Patients who received more continuity of care services were more likely to engage in ongoing treatment, with this effect being stronger for those with moderate to low psychiatric severity compared to those with high severity.

Engagement in continuing care was identified as the most significant predictor of abstinence, particularly for patients using both alcohol and other drugs, indicating that tailored continuing care interventions can greatly enhance recovery outcomes for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential relationships between continuity of care practices, engagement in continuing care, and abstinence among subgroups of patients with substance use and psychiatric disorders. Schaefer, JA., Cronkite, RC., Hu, KU.[2019]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

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