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

Trial Summary

What is the purpose of this trial?

The Addressing Barriers to Care for Substance Use Disorder Pilot (ABC-SUD Pilot) was a randomized pilot study that preceded a larger trial. The ABC-SUD Pilot was a parallel group, cluster-randomized pilot feasibility trial, with clinicians (care coordinators) as the unit of randomization. This study was conducted in a mental health treatment access center within the Washington region of Kaiser Permanente. As part of usual care, patients contacted the mental health access center to speak to a "care coordinator" to obtain contact information for potential venues to obtain treatment for substance use disorder. The experimental intervention, Care Navigation, was evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contacted the mental health treatment access center. The investigators note that Care Navigation was delivered by study "care navigators", who were distinct from the health system's care coordinators.

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 data supports the effectiveness of the treatment Care Navigation for Substance Use Disorder?

Research shows that coordinating care for substance use disorders, like integrating behavioral health staff with primary care teams, can lead to better health outcomes. Additionally, care coordination has been effective in helping people with substance use issues in rural areas access necessary resources and support. ^{1 2 3 4 5}

Is Care Navigation safe for humans?

The research does not specifically address safety concerns for Care Navigation, but it is generally used to improve coordination of care and treatment adherence, which suggests it is considered safe in practice. ^{1 3 6 7 8}

How is Care Navigation treatment different from other treatments for substance use disorder?

Care Navigation is unique because it focuses on guiding patients through the healthcare system, helping them access various services and support, rather than directly treating the substance use itself. This approach is different from traditional treatments that often involve medication or therapy sessions, as it emphasizes coordination and support to improve treatment engagement and adherence. ^{5 6 9 10 11}

Research Team

Joseph E Glass, PhD MSW

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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

I am 18 years old or older.

My mental health assessments and plans are done via video or phone.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Managing care for patients with substance abuse disorders at community health centers. [2013]

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

The Effect of Patient Navigation on the Likelihood of Engagement in Clinical Care for HIV-Infected Individuals Leaving Jail. [2019]

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

A Research Agenda to Advance the Coordination of Care for General Medical and Substance Use Disorders. [2018]

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

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

5. United States 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. [2022]

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

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. [2023]

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

Medication-assisted treatment for substance use disorders within a national community health center research network. [2018]

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

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. [2023]

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

Implementation of an office-based addiction treatment model for Medicaid enrollees: A mixed methods study. [2023]

10. United States 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. [2023]

11. United States 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. [2022]