Shared Decision Making for Substance Use Disorders

Overseen By Cynthia Frank, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Severe disability, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates two support methods for individuals with substance use disorders and HIV prevention or treatment. One method involves traditional guidance from professionals with similar life experiences, known as Standard PN. The other method, called Patient Choice, allows participants to select from various community health services. The trial seeks participants who have interacted with the justice system in the past six months, have a history of opioid or stimulant use, and are either not currently on HIV treatment or eligible for HIV prevention. As an unphased trial, it offers participants the opportunity to explore innovative support methods that could enhance their health and well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these Patient Navigation models are safe for participants?

Research has shown that both the Standard Patient Navigation (PN) and Patient Choice (PC) models are generally safe for people with substance use disorders (SUD). These models assist individuals in finding the right care and support for their needs.

Studies have found that patient-centered care, such as PC, often leads to positive results in SUD services. People tend to do better when they can choose their treatment options. No reports of serious side effects have emerged from these care models.

Overall, both approaches are well-tolerated and aim to improve access to care for those with substance use issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Shared Decision Making for Substance Use Disorders" trial because it explores innovative ways to improve patient engagement and care through personalized choices. Unlike traditional approaches where patients follow a set treatment plan, this trial offers a "Patient Choice" arm where participants can select from a tailored menu of substance use disorder (SUD) and HIV prevention services. This patient-centered approach leverages the expertise of patient navigators with similar lived experiences, which might enhance trust and effectiveness. By empowering patients to participate actively in their treatment decisions, researchers hope to boost engagement and outcomes in managing substance use disorders.

What evidence suggests that this trial's treatments could be effective for substance use disorders?

Research has shown that care models focused on patient needs, such as the Patient Choice (PN+PC) arm in this trial, effectively treat substance use disorders (SUD). One study found that when individuals could choose their treatment options, they were more likely to start and continue their SUD treatment. Another study demonstrated that making decisions collaboratively with healthcare providers can enhance patient involvement and satisfaction with their care. Meanwhile, the Standard Patient Navigation (PN) arm, where trained professionals assist individuals in finding necessary care, has also successfully connected patients to essential services. Both methods are being tested in this trial and appear promising in aiding individuals with substance use issues. ^{2 6 7 8 9}

Who Is on the Research Team?

Sandra Springer, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals with substance use disorders who are involved in the justice system. It aims to help them start treatment for HIV prevention (PrEP/ART) and manage their substance use or disorder.

Inclusion Criteria

Have a current DSM-5 SUD (opioid and/or stimulant)

Able to provide written informed consent in English or Spanish

Willing to have HIV testing to determine negative or positive status

Exclusion Criteria

Severe medical or psychiatric disability making participation unsafe

I am unable to give my consent.

Persons self-reporting pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

Development and pilot testing of the patient choice menu of options for PrEP/ART and SUD treatment services

12 months

3 focus group visits

Follow-up

Participants are monitored for access to and receipt of PrEP/ART services, and engagement in SUD treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Choice
• Standard PN

Trial Overview The study compares two types of support: Standard Patient Navigation (PN), which guides patients through treatment, versus Patient Choice (PC), where patients pick from a menu of community health services.

How Is the Trial Designed?

Group I: PN + Patient Choice (PC) (PN+PC) Experimental Treatment 2 Interventions

PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB.

Group II: Standard Patient Navigation (PN) Active Control 1 Intervention

PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides appointment scheduling to brick and mortar services only, and not to MHU or telehealth services.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0955395925000696

The relationship between patient-centred care for ... The findings from this review suggest largely positive associations between these PCC components and the outcomes of generalist and specialist SUD services.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5823027/

Effect of Patient Choice in an Adaptive Sequential ... The outcomes were measures of alcohol and cocaine use, and weeks of treatment engagement. The MI-PC condition was hypothesized to yield better engagement and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123004900

Shared decision making in patients with substance use ... The study aimed to evaluate patient's preferences, perceived participation in treatment decisions and activation level; and how they predict retention, ...

4. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-019-0227-0

Conceptualizing patient-centered care for substance use ... Examples of such outcomes have included consultation processes (e.g., communication skills, quality of care, treatment satisfaction) [29, 113], ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5871558/

Linking Individuals with Substance Use Disorders (SUD) in ... Findings showed that patients in the RMC-PC intervention (n=92) had significantly higher rates of SUD treatment entry and received more days of SUD treatment ...

6. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07223398

Standard PN and Patient Choice in Substance Use Disorders This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3682930/

Attendance and Substance Use Outcomes for the Seeking ... This study uses data from the largest effectiveness trial to date on treatment of co-occurring posttraumatic stress and substance use disorders.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1955364/

Primary Care Quality and Addiction Severity: A Prospective ... The aim of this study was to prospectively examine if higher PCQ is associated with lower addiction severity among patients with substance use disorders.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547221002312

Findings from the veterans outcomes assessment survey The relationship between patient-centred care for substance use disorders and patient outcomes: A scoping review. 2025, International Journal of Drug Policy.