CClinicalTrials.gg
Active, not recruitingNCT01621711LinkageUpdated May 2, 2024

Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care

An interventional study of Linkage patient activation intervention in Substance Abuse, Substance Dependence and Substance, Addiction, sponsored by Kaiser Permanente. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
504
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This component of a larger Center of Research Excellence Grant improves treatment for drug abuse by developing effective linkages between specialty drug treatment and primary health care.

Read the detailed description

This is a longitudinal two-arm quasi-experimental 3-month alternating off/on design over a 30 month period in which, after a random start, the Linkage condition alternately is added to Usual Care in the Chemical Dependency (CD) clinic and then removed. We compare Usual Care to Usual Care plus Linkage. Follow-up interviews will be conducted at 6, 12 and 24 months. The Linkage intervention includes Usual Care plus 1) sessions on activation regarding overall health behaviors and on selecting a Primary Care physician and communicating with him/her, and 2) a linkage phone call (and/or a facilitated email) with the patient, clinician, and Primary Care physician. The intervention aims to place drug abuse problems in the context of overall health and health care and to activate patients to increase involvement in their own health care.

02

Conditions studied

  • Substance Abuse
  • Substance Dependence
  • Substance, Addiction
  • Alcohol Abuse

Keywords

  • substance abuse
  • Substance Dependence
  • Substance, addiction
  • Alcohol Abuse
  • prevention and control
  • preventative health services
  • patient centered care
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 504 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Research participants will be adult patients at the Kaiser Permanente San Francisco Chemical Dependency Recovery Program, who have completed 2 weeks of treatment.

Exclusion criteria

Exclusion Criteria:

  • Patients with a diagnosis of dementia, mental retardation, or who are actively psychotic or suicidal will be excluded by their clinician.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
504 participants (actual)

Study arms

  • No intervention
    Usual Care

    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.

  • Experimental
    Linkage patient activation 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.

    Behavioral: Linkage patient activation intervention

Interventions

  • BehavioralLinkage patient activation intervention

    Usual Care plus Linkage encompassed 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. The patient activation intervention components -- 1) six 45-min Linkage sessions on activation regarding overall health behaviors and 2) a linkage phone call (and/or a facilitated email) with the patient, clinician, and PC physician -- were delivered by a clinical psychologist.

06

What researchers measure

Primary outcomes

  1. patient activation measure

    Measured by Patient Activation Measure (PAM) from interview data

    Time frame: 6 months post baseline

  2. patient engagement in health care (including patient portal use, familiarity and satisfaction with Primary Care physician, and CD treatment length of stay)

    Measured by data from interviews and Electronic Health Record (EHR)

    Time frame: 6 months post baseline

  3. Substance use and mental health outcomes

    Measures include past 30-day alcohol, drug and total abstinence; Patient Health Questionnaire (PHQ-9) and Addiction Severity Index using interview data

    Time frame: 6 months post baseline

Secondary outcomes

  1. patient activation measure at 12 and 24 months

    Measured by Patient Activation Measure (PAM) from interview data

    Time frame: 12 and 24 months post baseline

  2. patient engagement in health care at 12 and 24 months

    Measured by data from interviews and Electronic Health Record (EHR)

    Time frame: 12 and 24 months post baseline

  3. Substance use and mental health outcomes at 12 and 24 months

    Measures include past 30-day alcohol, drug and total abstinence; Patient Health Questionnaire (PHQ-9) and Addiction Severity Index using interview data

    Time frame: 12 and 24 months post baseline

  4. Health care utilization and cost

    Measured by data from interviews and adminstrative data

    Time frame: 12 and 24 months post baseline

07

Study locations

1 site
  • Kaiser Permanente, Chemical Dependency Recovery Program
    San Francisco, California 94115, United States
08

References and documents

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  • Weisner CM, Chi FW, Lu Y, Ross TB, Wood SB, Hinman A, Pating D, Satre D, Sterling SA. Examination of the Effects of an Intervention Aiming to Link Patients Receiving Addiction Treatment With Health Care: The LINKAGE Clinical Trial. JAMA Psychiatry. 2016 Aug 1;73(8):804-14. doi: 10.1001/jamapsychiatry.2016.0970. PubMed 27332703 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01621711
Lead sponsor
Kaiser Permanente
Collaborators
Kaiser Foundation Research Institute
Responsible party
Sponsor
First posted
Jun 18, 2012
Start date
Mar 2011
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 2, 2024

Study contacts

Constance M Weisner, DrPH, LCSW
principal investigator · Kaiser Permanente

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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