Care Navigation for Addiction

(ABC-SUD Trial)

Overseen By Tara Beatty, PhD

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

360 Participants Needed

Trial Summary

What is the purpose of this trial?

The Addressing Barriers to Care for Substance Use Disorder Trial (ABC-SUD) is a cluster-randomized crossover trial, with clinicians (care coordinators) as the unit of randomization. This study will be conducted in a mental health access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a care coordinator to obtain an appointment with or contact information for potential venues to obtain treatment for substance use disorder. The experimental intervention, Care Navigation, will be evaluated for its potential to increase engagement in substance use disorder treatment among patients who contact the mental health access center. Care Navigation will be delivered by study care navigators, who are 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. It focuses on care navigation for substance use disorder treatment.

What data supports the effectiveness of the treatment Care Navigation for Addiction?

Research shows that coordinating medical and addiction care can lead to better health outcomes. Integrating behavioral health staff into primary care teams and using patient navigators have been effective in improving care transitions and treatment adherence for substance use disorders. ^{1 2 3 4 5}

Is Care Navigation for Addiction safe for humans?

The research does not specifically address safety concerns for Care Navigation, but it is generally considered a supportive service that helps coordinate care, which is typically safe for humans. ^{1 2 4 6 7}

How is Care Navigation treatment for addiction different from other treatments?

Care Navigation for addiction is unique because it involves a post-discharge support system where patients receive phone calls from a navigator to help them follow their treatment plan and overcome barriers to care. This approach focuses on enhancing care coordination and engagement rather than directly reducing substance use, which is different from traditional treatments that may focus more on medication or therapy sessions. ^{1 4 8 9 10}

Research Team

Joseph E Glass, PhD MSW

Principal Investigator

Kaiser Permanente

Eligibility Criteria

This trial is for individuals seeking treatment for substance use disorders at a mental health access center within the Washington region of Kaiser Permanente. Participants must be contacting the center to get an appointment or information about treatment options.

Inclusion Criteria

Clinician has completed trainings related to their clinical role in the health system

Patient visits an enrolled care coordinator during the patient eligibility period

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 covered by Kaiser Permanente or Medicaid insurance.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Period 1: Services as Usual

Care coordinators offer substance use resources and treatment options as usual

Approximately half of the trial duration

Period 2: Care Navigation

Care coordinators offer care navigation and refer patients to care navigators

Approximately half of the trial duration

Follow-up

Participants are monitored for engagement in substance use disorder treatment

48 days

Treatment Details

Interventions

• Care Navigation

Trial Overview The study tests 'Care Navigation'—a support process by special care navigators aimed at improving patient engagement in substance use disorder treatments, compared to usual care coordination.

Participant Groups

Group I: Care Navigation Experimental Treatment 1 Intervention

Mental health care coordinators are able to 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 Active Control 1 Intervention

Mental health care coordinators will continue offering 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

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]

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]

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]

A pilot study involving 40 socioeconomically disadvantaged smokers showed that using smoking cessation treatment navigators significantly increased the use of evidence-based cessation treatments, with 71% of participants starting nicotine replacement therapy.

The intervention was well-received, with high satisfaction ratings and a self-reported abstinence rate of 21%, suggesting that this community-based approach could effectively support smoking cessation efforts among low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers. Levinson, AH., Valverde, P., Garrett, K., 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 navigation program for cancer patients showed marginally lower rates of emergency room visits and unplanned hospitalizations among those who used the service, indicating some potential benefits in care coordination.

However, the program had low visibility and utilization among patients, and overall patient experiences were mixed, suggesting that a more focused approach may be needed to effectively support high-risk or anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. Winget, M., Holdsworth, L., Wang, S., et al.[2021]

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]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

References

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

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

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

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

3. 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]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers. [2023]

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

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

7. 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]

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

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. [2021]

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

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

10. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]