Primary Care Linkage for Addiction Treatment

(Linkage Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Dementia, Mental retardation, Psychotic, Suicidal, others

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

Compensation: Varies

Number of Visits: 6

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to better integrate drug abuse treatment with regular health care to improve recovery outcomes. It compares usual care, which includes therapy and medical education, with a new approach called the Linkage patient activation intervention. This method adds focused education sessions and a personalized follow-up call or email, aiming to help patients feel more supported as they transition between different types of care. The trial suits adults who have received treatment for drug addiction at Kaiser Permanente San Francisco for at least two weeks. As an unphased trial, it offers a unique opportunity to contribute to innovative strategies that could enhance recovery support systems.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the linkage patient activation intervention is safe?

Research has shown that the Linkage patient activation program is generally well-tolerated by participants. Those who completed all six sessions were more likely to use patient portals, indicating active involvement in their health care. Studies have not found significant negative effects on short-term abstinence or depression, suggesting the program does not cause major side effects. Overall, based on the available evidence, the treatment appears safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Linkage patient activation intervention because it offers a fresh approach to addiction treatment. Unlike standard care, which typically includes therapy, individual counseling, and medical education, this intervention integrates patient activation through dedicated education sessions and a personalized connection with healthcare providers. This approach emphasizes active patient involvement and direct communication with primary care physicians, which could enhance patient engagement and improve treatment outcomes. By focusing on building these connections, the intervention has the potential to strengthen the support system for individuals battling addiction, potentially leading to more sustained recovery efforts.

What evidence suggests that the Linkage patient activation intervention is effective for improving treatment for drug abuse?

Research shows that the Linkage patient activation program, a treatment arm in this trial, helps individuals manage their health care more effectively over time. Studies found that participants who completed all sessions of the program used health care services more efficiently than those who did not finish. They also achieved better outcomes in alcohol and drug use. By connecting addiction treatment with regular health care, the program appears to have a positive impact. Such programs encourage patients to take control of their health, and research has shown they are beneficial. ^{1 2 6 7 8}

Who Is on the Research Team?

Constance M Weisner, DrPH, LCSW

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for adults at the Kaiser Permanente San Francisco Chemical Dependency Recovery Program who have finished at least 2 weeks of treatment for substance use disorders, including addiction and alcoholism. Those with dementia, mental retardation, or current psychosis or suicidal tendencies cannot participate.

Inclusion Criteria

I am an adult who has completed 2 weeks at Kaiser's San Francisco addiction recovery program.

Exclusion Criteria

Patients with a diagnosis of dementia

Patients with a diagnosis of mental retardation

Patients who are actively psychotic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Usual Care or Usual Care plus Linkage intervention, including therapy groups, individual counseling, and medical education or activation sessions

3 months

Follow-up

Participants are monitored for patient engagement, substance use, mental health outcomes, and health care utilization

24 months

Follow-up interviews at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Linkage patient activation intervention

Trial Overview The study tests a 'linkage patient activation intervention' designed to improve connections between specialty drug treatment and primary health care as part of enhancing overall drug abuse treatment.

How Is the Trial Designed?

Group I: Linkage patient activation intervention Experimental Treatment 1 Intervention

Usual Care with the exception that the six 45-min Linkage patient activation education groups replaced the six 45-min Usual Care medical education groups, plus a linkage phone call (and/or a facilitated email) with the patient, clinician, and Primary Care physician.

Group II: Usual Care Active Control 1 Intervention

Usual CD treatment, including therapy groups and individual counseling sessions, and six 45-min medical education groups. Physician appointments, pharmacotherapy, and SUD medications were be available as needed.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Kaiser Foundation Research Institute

Collaborator

Trials

28

Recruited

21,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4972645/

Examination of the Effects of an Intervention Aiming to Link ... Among LINKAGE participants, those receiving all 6 sessions had higher patient portal use than those receiving fewer sessions. They also had higher alcohol ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798247

Health Care Use After Linking Patients in Addiction ... In this study, a patient activation intervention provided with addiction treatment was associated with improved long-term health care engagement patterns.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01621711

Continuing Care Following Drug Abuse Treatment ... The Linkage intervention includes Usual Care plus 1) sessions on activation regarding overall health behaviors and on selecting a Primary Care physician and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27332703/

Examination of the Effects of an Intervention Aiming to Link ... Those who received all intervention components had significantly better alcohol and other drug outcomes than those who received fewer ...

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-10558-3

A patient activation intervention in primary care for patients ... This trial evaluated the effectiveness of a primary care intervention in improving patient activation and patient-reported outcomes among adults with chronic ...

6. db.cngb.org db.cngb.org/data_resources/literature/27332703

Examination of the Effects of an Intervention Aiming to Link ... The intervention did not affect short-term abstinence or depression outcomes. Understanding if the LINKAGE intervention helps prevent relapse and manage long- ...

7. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/counter/pdf/10.1186/s12913-024-10558-3.pdf?utm_source=consensus

A patient activation intervention in primary care for ... Conclusion This trial evaluated the effectiveness of a primary care intervention in improving patient activa‑ tion and patient‑reported outcomes ...

8. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/26734af3-b4c3-4e88-a92f-78c52a818ee2/download

Patient Activation of Persons with Opioid Use Disorder in ... High patient activation is associated with a variety of positive health outcomes. Although increasing patient activation in persons with opioid use disorder ( ...