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Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care (Linkage)

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ClinicalTrials.gov Identifier: NCT01621711
Recruitment Status : Active, not recruiting
First Posted : June 18, 2012
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
Kaiser Permanente

Brief 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.

Condition or disease Intervention/treatment Phase
Substance Abuse Substance Dependence Substance, Addiction Alcohol Abuse Behavioral: Linkage patient activation intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care
Study Start Date : March 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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

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.





Primary Outcome Measures :
  1. patient activation measure [ Time Frame: 6 months post baseline ]
    Measured by Patient Activation Measure (PAM) from interview data

  2. patient engagement in health care (including patient portal use, familiarity and satisfaction with Primary Care physician, and CD treatment length of stay) [ Time Frame: 6 months post baseline ]
    Measured by data from interviews and Electronic Health Record (EHR)

  3. Substance use and mental health outcomes [ Time Frame: 6 months post baseline ]
    Measures include past 30-day alcohol, drug and total abstinence; Patient Health Questionnaire (PHQ-9) and Addiction Severity Index using interview data


Secondary Outcome Measures :
  1. patient activation measure at 12 and 24 months [ Time Frame: 12 and 24 months post baseline ]
    Measured by Patient Activation Measure (PAM) from interview data

  2. patient engagement in health care at 12 and 24 months [ Time Frame: 12 and 24 months post baseline ]
    Measured by data from interviews and Electronic Health Record (EHR)

  3. Substance use and mental health outcomes at 12 and 24 months [ Time Frame: 12 and 24 months post baseline ]
    Measures include past 30-day alcohol, drug and total abstinence; Patient Health Questionnaire (PHQ-9) and Addiction Severity Index using interview data

  4. Health care utilization and cost [ Time Frame: 12 and 24 months post baseline ]
    Measured by data from interviews and adminstrative data



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621711


Locations
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United States, California
Kaiser Permanente, Chemical Dependency Recovery Program
San Francisco, California, United States, 94115
Sponsors and Collaborators
Kaiser Permanente
Kaiser Foundation Research Institute
Investigators
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Principal Investigator: Constance M Weisner, DrPH, LCSW Kaiser Permanente

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01621711     History of Changes
Other Study ID Numbers: 10-01606
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Keywords provided by Kaiser Permanente:
substance abuse
Substance Dependence
Substance, addiction
Alcohol Abuse
prevention and control
preventative health services
patient centered care
Additional relevant MeSH terms:
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Substance-Related Disorders
Alcoholism
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders