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

Primary Purpose

Substance Abuse, Substance Dependence, Substance, Addiction

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Linkage patient activation intervention
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Abuse focused on measuring substance abuse, Substance Dependence, Substance, addiction, Alcohol Abuse, prevention and control, preventative health services, patient centered care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Permanente, Chemical Dependency Recovery Program

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Linkage patient activation intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

patient activation measure at 12 and 24 months
Measured by Patient Activation Measure (PAM) from interview data
patient engagement in health care at 12 and 24 months
Measured by data from interviews and Electronic Health Record (EHR)
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
Health care utilization and cost
Measured by data from interviews and adminstrative data

Full Information

First Posted
June 11, 2012
Last Updated
April 25, 2023
Sponsor
Kaiser Permanente
Collaborators
Kaiser Foundation Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01621711
Brief Title
Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care
Acronym
Linkage
Official Title
Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Kaiser Foundation Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Linkage patient activation intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Linkage patient activation intervention
Intervention Description
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 Measure Information:
Title
patient activation measure
Description
Measured by Patient Activation Measure (PAM) from interview data
Time Frame
6 months post baseline
Title
patient engagement in health care (including patient portal use, familiarity and satisfaction with Primary Care physician, and CD treatment length of stay)
Description
Measured by data from interviews and Electronic Health Record (EHR)
Time Frame
6 months post baseline
Title
Substance use and mental health outcomes
Description
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 Outcome Measure Information:
Title
patient activation measure at 12 and 24 months
Description
Measured by Patient Activation Measure (PAM) from interview data
Time Frame
12 and 24 months post baseline
Title
patient engagement in health care at 12 and 24 months
Description
Measured by data from interviews and Electronic Health Record (EHR)
Time Frame
12 and 24 months post baseline
Title
Substance use and mental health outcomes at 12 and 24 months
Description
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
Title
Health care utilization and cost
Description
Measured by data from interviews and adminstrative data
Time Frame
12 and 24 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance M Weisner, DrPH, LCSW
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente, Chemical Dependency Recovery Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care

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