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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new approach called Care Navigation, a personalized support service, can assist individuals in adhering to their substance use disorder treatment. Typically, patients receive basic information and referrals from care coordinators at a mental health center. In this trial, patients may also receive assistance from a care navigator, who provides more personalized support. Individuals who have had a treatment planning visit for substance use disorder with a care coordinator at Kaiser Permanente might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore personalized support options that could enhance the treatment journey.

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

Research has shown that care navigation, which assists individuals with substance use issues in finding and accessing treatment, can be beneficial. In similar contexts, care navigation has been linked to improved health outcomes and fewer hospital visits. Studies indicate that when individuals with multiple health problems receive assistance navigating the healthcare system, they report greater satisfaction with their care.

These findings suggest that care navigation is generally safe and does not pose significant risks to participants. This approach has been used in other areas without major safety concerns. Although this trial's phase is "Not Applicable," indicating it doesn't fit into the usual clinical trial stages, using care navigation for similar purposes has demonstrated promise in terms of safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Care Navigation approach for addiction because it goes beyond traditional methods by integrating care navigators into the treatment process. Unlike standard care, which typically involves providing substance use resources and treatment options directly, this approach adds a dedicated care navigator to help guide patients through their recovery journey. This personalized support can potentially improve treatment adherence and outcomes by ensuring patients receive the right care at the right time, addressing barriers to recovery, and providing a more tailored approach to managing addiction.

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

Research has shown that having a care navigator, which participants in this trial may receive, can improve outcomes for people with substance use disorder (SUD). This trial will compare the Care Navigation approach with Services as Usual. Studies have found that similar methods, such as social prescribing, improve healthcare quality and reduce hospital visits for people with various health issues. Care coordination, which involves helping patients find resources and support, has successfully improved SUD treatment outcomes. This evidence suggests that a care navigator could enhance patient engagement with SUD treatment by providing personalized guidance and support. ^{1 3 5 6 7}

Who Is on the Research Team?

Joseph E Glass, PhD MSW

Principal Investigator

Chestnut Health Systems

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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 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]

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]

Citations

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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.

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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 ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2468266725000660?dgcid=rss_sd_all

Social prescribing in the USA: emerging learning and ...

We outline some of the different forms that social prescribing is taking across the USA, which draws on 23 programmes we identified across 11 states that ...

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pew.org

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

Care Coordination Strategies for Patients Can Improve ...

This document outlines key components of various models that use care coordination to improve outcomes for patients with SUD and discusses two examples—the ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07143383

CAMHS and Social Prescribing Applications (CASPA)

These trials gather additional information about a drug's safety, efficacy, or optimal use. Phase Not Applicable. Describes trials without FDA-defined phases ...

7.

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 ...