Patient-Centered Care for Alcoholism

Overseen By Katharine Bradley, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Request not to participate, Vanguard pilot, others

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

Compensation: Varies

Number of Visits: Unknown

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance decision-making between doctors and patients regarding alcohol use treatment. Researchers are testing two new approaches for patients with alcohol-related symptoms: one provides extra support from a primary care doctor (Primary Care Intervention), and the other offers assistance from a social worker or counselor (Centralized Intervention). The trial includes patients with multiple symptoms from alcohol use who are at risk of developing more severe issues. Participants will join one of three groups: receiving usual care, additional support from primary care, or support from a specialized counselor. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in alcohol 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. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a centralized approach to addressing alcohol use issues succeeds in similar situations. For example, one study found that these interventions increased alcohol screening and preventive counseling, helping to identify and treat alcohol use disorders. This suggests that the centralized method is effective and well-accepted.

Regarding the primary care approach, studies have shown that involving patients in primary care settings can lead to reduced alcohol use and better health outcomes. Managing alcohol use disorder in primary care is linked to less severe addiction and lower death rates. These findings suggest that this approach is generally safe and helpful.

Both the centralized and primary care methods in this trial aim to involve patients in decision-making about their alcohol-related symptoms, which past research has positively received. Overall, these methods appear safe, with studies supporting their effectiveness and acceptance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for alcoholism because they focus on patient-centered care that enhances traditional treatment methods. Unlike standard treatments that primarily rely on medications like disulfiram or naltrexone, these new approaches integrate shared decision-making directly into primary care settings. The Primary Care Intervention empowers healthcare providers to routinely engage patients in their treatment decisions, potentially improving adherence and outcomes. Meanwhile, the Centralized Intervention offers structured outreach by social workers or counselors, making it easier for patients to access help and actively participate in their recovery process. These innovative strategies aim to make care more personalized and accessible, promising a more holistic approach to managing alcohol use disorders.

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

This trial will compare different interventions for alcoholism. The Centralized Intervention, which participants in this trial may receive, involves social workers or counselors engaging individuals in decisions about their alcohol use. Studies have shown that such programs can greatly reduce heavy drinking compared to regular care. Another treatment arm in this trial is the Primary Care Intervention, where doctors in primary care settings regularly involve patients in decision-making. Research shows that this approach helps reduce drinking in those who drink excessively. Brief sessions in these settings, which include alcohol screening and counseling, have also led to better drinking habits. Both methods hold promise for helping people reduce alcohol consumption and improve their health. ^{1 6 7 8 9}

Who Is on the Research Team?

Gwen Lapham, PhD, MPH, MSW

Principal Investigator

Kaiser Permanente

Katharine Bradley, MD, MPH

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for individuals who are dealing with alcohol use problems, such as alcoholism or problem drinking. They should be patients at one of the participating primary care clinics. Specific details about who can and cannot join are not provided here.

Inclusion Criteria

I am 18 years or older and visiting my primary care doctor.

>= 4 symptoms on the Alcohol Symptom Checklist, or 2-3 symptoms on the Alcohol Symptom Checklist with at least one symptom associated with high risk of progression to severe symptoms, on the day of the primary care visit or the prior 30 days documented in the electronic health record

High-risk drinking on alcohol screening questionnaire (AUDIT-C >=7) on the day of the primary care visit or in the prior 30 days documented in the electronic health record

Exclusion Criteria

I have formally opted out of research participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either usual care, a primary care intervention, or a centralized intervention focusing on shared decision-making for alcohol use symptoms

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Centralized Intervention
• Primary Care Intervention

Trial Overview The trial is testing two different ways to help people with alcohol use issues by making decisions together with their doctors: a 'primary care intervention' done in local clinics and a 'centralized intervention'. Clinics will either continue usual care or try one of these new approaches.

How Is the Trial Designed?

Group I: Primary Care Intervention Experimental Treatment 1 Intervention

A primary care intervention added to usual care that uses state-of-the-art implementation interventions to systematically encourage primary care providers to offer routine shared decision-making for symptoms due to alcohol use.

Group II: Centralized Intervention Experimental Treatment 1 Intervention

A centralized intervention by a social worker or counselor, added to usual care that systematically offers outreach and shared decision-making for symptoms due to alcohol use.

Group III: Usual Care Active Control 1 Intervention

Usual primary care

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Kaiser Permanente Washington

Collaborator

Trials

3

Recruited

6,500+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

A scoping review of 149 studies on patient-centered care (PCC) in substance use disorder treatment found that the therapeutic alliance was the most frequently described principle, emphasizing empathy and non-judgment as key characteristics.

Shared decision-making and individualized care were also important, with 36% and 30% of studies discussing these principles, respectively, highlighting the need for negotiation in treatment planning and personalized assessment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptualizing patient-centered care for substance use disorder treatment: findings from a systematic scoping review. Marchand, K., Beaumont, S., Westfall, J., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0376871624003296

Integrated behavioral interventions for adults with alcohol ... Studies revealed that integrated intervention led to significant reductions in heavy drinking compared to usual care or other interventions. •.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10882804/

Predictors of treatment outcome for individuals with alcohol ... A total of 57% of individuals in BSCT attained a level of CD, as opposed to 43% in MET. Females were significantly better in attaining low-risk ...

3. academic.oup.com academic.oup.com/alcalc/article/58/5/478/7234661

Efficacy of psychosocial interventions to reduce alcohol use in ... Primary outcomes were alcohol reduction and abstinence at the longest follow-up. Ten RCTs were included, evaluating interventions such as ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-15152-6

Which interventions for alcohol use should be included in a ... This study aimed to identify targeted interventions for the prevention and treatment of harmful alcohol use.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4837467/

Electronic Interventions for Alcohol Misuse and Alcohol Use ... Evidence suggests that low-intensity e-interventions produce small reductions in alcohol consumption at 6 months, but there is little evidence for longer-term, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK436003/

Alcohol Use Disorder: Screening, Evaluation, and Management This loss of control results in negative consequences that impact relationships, physical and mental health, and the ability to fulfill role obligations.

7. mdpi.com mdpi.com/1660-4601/17/21/7994

Community Based Interventions for Problematic Substance ... Some studies compared outcomes for different groups. A study which compared Brief Intervention with a stepped approach found that both groups reduced alcohol ...

8. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230488

Overview of Alcohol Use Disorder | American Journal of ... The study showed that during treatment, there was a small effect of naltrexone, such that 68.2% of participants who received it had one or more ...

9. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2801752

Integrating Alcohol-Related Prevention and Treatment Into ... The intervention increased alcohol screening, brief preventive alcohol counseling, new diagnosis of alcohol use disorders, and alcohol treatment initiation.