Care Navigation for Substance Use Disorder

(ABCSUD Pilot Trial)

Overseen By Joseph E Glass, PhD MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Opted out, Not enrolled, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach called Care Navigation to assist individuals with substance use disorders (struggles with drug or alcohol use) in accessing necessary treatment. The goal is to determine if a care navigator, who provides extra support and guidance, increases the likelihood of patients starting treatment. The trial compares two groups: one receiving the usual resources and the other receiving additional help from a care navigator. Suitable participants have visited a care coordinator for substance use assistance and have a history of substance use issues. As an unphased trial, this study presents a unique opportunity to contribute to innovative solutions in substance use treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Care Navigation is safe for patients with substance use disorder?

Research has shown that Care Navigation, where a care navigator guides patients through their treatment options, is generally safe. Studies indicate that coordinating care for substance use disorders (SUDs) can lead to better health outcomes. Patients often remain in treatment longer and report greater satisfaction with their care. Reports highlight improved care quality and fewer hospital visits, particularly for individuals with multiple health issues.

No serious safety concerns have emerged with care navigation itself. Instead, it appears to enhance support for individuals seeking treatment. Overall, Care Navigation is well-tolerated and may streamline the treatment process for those dealing with SUDs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Care Navigation approach for substance use disorder because it introduces a novel element to the standard treatment process. Unlike traditional methods that primarily focus on offering substance use resources and treatment options, this approach integrates the assistance of a care navigator. The care navigator plays a crucial role by providing personalized guidance and support, helping patients navigate the complex healthcare system more effectively. This added layer of support aims to enhance patient engagement and improve outcomes by ensuring individuals receive the most appropriate care and resources tailored to their specific needs.

What evidence suggests that Care Navigation is effective for increasing substance use disorder treatment utilization?

Research shows that care navigation, which participants in this trial may receive, can improve treatment outcomes for people with substance use disorders. Studies have found that coordinating care helps individuals access the right resources, leading to better health outcomes. For instance, similar programs have successfully managed methamphetamine addiction by guiding patients to appropriate support services. When patients receive assistance in finding and accessing treatment, they are more likely to continue with it and see positive results. This approach is recognized for its potential to increase treatment use and enhance overall well-being. ^{1 3 6 7 8}

Who Is on the Research Team?

Joseph E Glass, PhD MSW

Principal Investigator

Chestnut Health Systems Inc

Are You a Good Fit for This Trial?

This trial is for clinicians at a mental health treatment access center who conduct video or phone assessments and plan treatments for substance use disorders. They must do at least 3 assessments per day, have been employed for over a month, and completed relevant trainings.

Inclusion Criteria

Patient has an assessment and treatment planning visit for SUD with an enrolled care coordinator

Clinician has been employed for at least 1 month and has completed trainings related to their clinical role in the health system

Clinician is scheduled to conduct at least 3 assessments per day

Exclusion Criteria

Patients who have requested through the health system to opt out of research contact or chart review

I am not enrolled in Kaiser Permanente or Medicaid insurance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Care Navigation intervention is delivered by care navigators to increase utilization of substance use disorder treatment

16 weeks

Ongoing visits as needed

Follow-up

Participants are monitored for treatment utilization and outcomes after intervention

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Care Navigation

Trial Overview The study tests 'Care Navigation' to see if it helps patients with substance use disorders get more treatment after contacting the mental health center. Clinicians are randomly chosen to either provide this extra help or continue usual care.

How Is the Trial Designed?

Group I: Care Navigation (pilot) Experimental Treatment 1 Intervention

Mental health care coordinators offer and refer patients to a care navigator in addition to offering substance use resources and treatment options as usual.

Group II: Services as Usual (pilot) Active Control 1 Intervention

Mental health care coordinators offer substance use resources and treatment options to patients as usual

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Patient navigation (PN) significantly improved treatment adherence and engagement in opioid use disorder (OUD) among pregnant individuals, with better outcomes in medication use and substance use disorder treatment attendance compared to usual care (UC).

The pilot study, involving 102 pregnant participants, demonstrated that those receiving PN had fewer reported overdoses at 2 and 6 months postpartum, suggesting that PN may enhance safety and effectiveness in managing OUD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Cochran, G., Smid, MC., Krans, EE., et al.[2023]

In a study of 395 hospitalized adults with substance use disorder, post-discharge telephonic navigation did not significantly reduce substance use compared to standard care, with both groups showing similar decreases in use after one month.

However, participants who completed all four navigation calls experienced a notable reduction in substance use, suggesting that consistent follow-up may enhance outcomes for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of post-discharge navigation added to an inpatient addiction consultation for patients with substance use disorder; a randomized controlled trial. Wakeman, SE., Rigotti, NA., Herman, GE., et al.[2022]

The implementation of New Jersey's Office-Based Addiction Treatment (OBAT) Program in 2019 led to a steady increase in provider enrollment and utilization of medications for opioid use disorder (MOUD), indicating improved access to treatment for patients.

While enhanced reimbursements and patient navigation services were beneficial, barriers such as limited enrollment of primary care physicians and administrative challenges hindered broader uptake of the program, suggesting that further adaptations could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an office-based addiction treatment model for Medicaid enrollees: A mixed methods study. Treitler, P., Enich, M., Bowden, C., et al.[2023]

The Hub and Spoke model significantly increased access to buprenorphine for patients with opioid use disorder, reaching 45.48% of patients over 2 years, with 78.85% receiving a prescription after initial intake.

Patients in the program were 2.44 times more likely to receive a buprenorphine prescription compared to those at a site without the Hub and Spoke model, indicating its effectiveness in improving treatment access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(RE-)AIMing for Rapid Uptake: Pilot Evaluation of a Modified Hub and Spoke Model of Medication for Opioid Use Disorder. Heavey, SC., Beehler, GP., Funderburk, J.[2023]

Among 572,582 patients in community health centers, only 3.0% had documented alcohol use disorders (AUDs) and 1.1% had opioid use disorders (OUDs), indicating a significant prevalence of substance use disorders in this population.

Medication-assisted treatments (MAT) for AUDs and OUDs were underprescribed, with only 3.2% of AUD patients and 29.0% of OUD patients receiving MAT, despite MAT being associated with increased screening for HIV and hepatitis C.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication-assisted treatment for substance use disorders within a national community health center research network. Rieckmann, T., Muench, J., McBurnie, MA., et al.[2018]

The NavSTAR intervention, which provided patient navigation for hospitalized patients with comorbid substance use disorders, resulted in significant cost savings of $17,780 per participant by reducing emergency department visits and inpatient hospital stays over a 12-month period.

The study suggests that implementing patient navigation services can be an effective strategy for healthcare payors and policymakers to lower hospital costs associated with patients suffering from substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. Orme, S., Zarkin, GA., Dunlap, LJ., et al.[2023]

A case study of a dual-diagnosed adult female with Opioid Use Disorder in rural Kentucky demonstrates the effectiveness of care coordination in overcoming significant healthcare barriers in underserved areas.

The care coordinator provided essential support, including linking the patient to community resources and offering transportation and emotional support, which highlights the importance of addressing health, environmental, and psychosocial needs for successful treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The critical role of care coordinators for persons with substance use disorder in rural settings: a case study. Hardcastle, VG.[2022]

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]

Separating addiction care from general medical care leads to poorer quality of medical treatment for patients with substance use issues, highlighting the need for better integration.

Strategies to improve care coordination include engaging patients in general medical settings, managing substance use disorders in primary care, incorporating family perspectives, and developing payment models that support integrated care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Research Agenda to Advance the Coordination of Care for General Medical and Substance Use Disorders. Quinn, AE., Rubinsky, AD., Fernandez, AC., et al.[2018]

Patient navigation-enhanced case management significantly improved linkage to HIV care within 30 days of release from jail, with an odds ratio of 2.15, indicating it is more effective than standard case management.

This approach also led to better retention in care over 12 months, with an odds ratio of 1.95, suggesting that patient navigation can help individuals maintain their health after incarceration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Patient Navigation on the Likelihood of Engagement in Clinical Care for HIV-Infected Individuals Leaving Jail. Myers, JJ., Kang Dufour, MS., Koester, KA., et al.[2019]

A study involving 801 hospitalized patients with HIV and substance use found that patient navigation, with or without financial incentives, did not improve HIV viral suppression rates compared to standard treatment after 12 months.

Despite the structured interventions aimed at enhancing care coordination and motivation, there were no significant differences in treatment success rates among the three groups, indicating that these approaches may not be effective in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial. Metsch, LR., Feaster, DJ., Gooden, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12522731/

The use of social prescribing and community-based wellbeing ... Social prescribing (SP) initiatives which aim to connect individuals to community-based assets have received increased research and policy ...

2. withpower.com withpower.com/trial/phase-methamphetamine-use-disorder-3-2023-39db7

Care Navigation for Methamphetamine Addiction ... The available research shows that coordinating care for substance use disorders, like methamphetamine addiction, can lead to better health outcomes. For example ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/02692155241258903

The effectiveness of social prescribing in the management ... The objective of this systematic review and meta-analysis was to evaluate the effectiveness of social prescribing interventions in the ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/12/7/e060214

Effectiveness and active ingredients of social prescribing ... This study aims to establish the effectiveness and active ingredients of UK-based social prescribing interventions targeting mental health and well-being ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07143383

CAMHS and Social Prescribing Applications (CASPA) Quantitative data will be collected at baseline, 3-month and 6-month follow-up, including measures of resilience, mental health, wellbeing, service use, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9644316/

Effect of social prescribing link workers on health outcomes ... Two US studies found improved ratings of high-quality care and reduced hospitalisations for people with multimorbidity experiencing deprivation.

7. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-020-01264-0

Social prescribing for individuals with mental health problems This study elucidates the barriers and enablers to social prescribing for patients with mental health problems, from the perspectives of GPs.

8. pew.org pew.org/-/media/assets/2020/04/carecoordinationbrief.pdf

Care Coordination Strategies for Patients Can Improve ... To improve outcomes, health professionals are developing care coordination approaches that address SUDs and aim to increase patient engagement and retention in ...