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

Trial Summary

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.

What data supports the effectiveness of the treatment Centralized Intervention, Primary Care Intervention for alcoholism?

Research shows that integrating alcohol-related care into primary care settings significantly increases alcohol screening and assessment rates, leading to more diagnoses and treatment of alcohol use disorders. This suggests that primary care interventions can effectively address alcoholism by making it easier for patients to receive timely care. ^{1 2 3 4 5}

Is the Patient-Centered Care for Alcoholism treatment safe for humans?

Research on the Patient-Centered Medical Home (PCMH) model, which is similar to Patient-Centered Care, shows that it includes safety measures to improve patient care. These measures focus on safe diagnosis, treatment, medication use, and communication, suggesting a general emphasis on safety in such care models. ^{6 7 8 9 10}

How is the Patient-Centered Care for Alcoholism treatment different from other treatments?

This treatment is unique because it integrates patient-centered care principles, such as a holistic and individualized approach, shared decision-making, and a strong therapeutic alliance, into primary care settings to address alcohol use disorders. It emphasizes integrating alcohol-related care into routine primary care, which is not commonly done, and has shown significant improvements in screening and diagnosis rates. ^{1 11 12 13 14}

What is the purpose of this trial?

The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions in Kaiser Permanente Washington to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 25 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions.

Research Team

Gwen Lapham, PhD, MPH, MSW

Principal Investigator

Kaiser Permanente

Katharine Bradley, MD, MPH

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of a Pilot Implementation to Integrate Alcohol-Related Care within Primary Care. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Treatment for Alcohol Dependence in Primary Care Compared to Outpatient Specialist Treatment-A Randomized Controlled Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Brief patient-centered clinician-delivered counseling for high-risk drinking: 4-year results. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Treatment interventions to maintain abstinence from alcohol in primary care: systematic review and network meta-analysis. [2021]

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

Primary medical care and reductions in addiction severity: a prospective cohort study. [2007]

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

Frequency of and harm associated with primary care safety incidents. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Interventions in primary care to reduce medication related adverse events and hospital admissions: systematic review and meta-analysis. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

[Avoidable adverse events in primary care. Retrospective cohort study to determine their frequency and severity]. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Implementing the patient-centered medical home in residency education. [2022]

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

Implementation of Patient Safety Structures and Processes in the Patient-Centered Medical Home. [2023]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-centered care interventions for the management of alcohol use disorders: a systematic review of randomized controlled trials. [2020]

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

The BRENDA model: a psychosocial addiction model to identify and treat alcohol disorders in elders. [2007]

13. England pubmed.ncbi.nlm.nih.gov

Evaluation of early intervention strategies used in primary health care: a report on the World Health Organization (WHO) Project on Identification and Treatment of Persons with Harmful Alcohol Consumption. [2015]

14. England pubmed.ncbi.nlm.nih.gov

Conceptualizing patient-centered care for substance use disorder treatment: findings from a systematic scoping review. [2023]