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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01621711
First received: June 11, 2012
Last updated: October 29, 2015
Last verified: October 2015
  Purpose
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 Intervention
Substance Abuse
Substance Dependence
Substance, Addiction
Alcohol Abuse
Behavioral: Linkage patient activation intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • patient activation measure [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]
    Measured by Patient Activation Measure (PAM) from interview data

  • 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 ] [ Designated as safety issue: No ]
    Measured by data from interviews and Electronic Health Record (EHR)

  • Substance use and mental health outcomes [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]
    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:
  • patient activation measure at 12 and 24 months [ Time Frame: 12 and 24 months post baseline ] [ Designated as safety issue: No ]
    Measured by Patient Activation Measure (PAM) from interview data

  • patient engagement in health care at 12 and 24 months [ Time Frame: 12 and 24 months post baseline ] [ Designated as safety issue: No ]
    Measured by data from interviews and Electronic Health Record (EHR)

  • Substance use and mental health outcomes at 12 and 24 months [ Time Frame: 12 and 24 months post baseline ] [ Designated as safety issue: No ]
    Measures include past 30-day alcohol, drug and total abstinence; Patient Health Questionnaire (PHQ-9) and Addiction Severity Index using interview data

  • Health care utilization and cost [ Time Frame: 12 and 24 months post baseline ] [ Designated as safety issue: No ]
    Measured by data from interviews and adminstrative data


Estimated Enrollment: 504
Study Start Date: March 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621711

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

Additional Information:
Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01621711     History of Changes
Other Study ID Numbers: 10-01606 
Study First Received: June 11, 2012
Last Updated: October 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
substance abuse
Substance Dependence
Substance, addiction
Alcohol Abuse
prevention and control
preventative health services
patient centered care

Additional relevant MeSH terms:
Substance-Related Disorders
Behavior, Addictive
Alcoholism
Chemically-Induced Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on July 26, 2016