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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01621711
Other study ID # 10-01606
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2011
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 504
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Kaiser Permanente, Chemical Dependency Recovery Program San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Kaiser Permanente Kaiser Foundation Research Institute

Country where clinical trial is conducted

United States, 

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* Note: There are 111 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary patient activation measure Measured by Patient Activation Measure (PAM) from interview data 6 months post baseline
Primary 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) 6 months post baseline
Primary 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 6 months post baseline
Secondary patient activation measure at 12 and 24 months Measured by Patient Activation Measure (PAM) from interview data 12 and 24 months post baseline
Secondary patient engagement in health care at 12 and 24 months Measured by data from interviews and Electronic Health Record (EHR) 12 and 24 months post baseline
Secondary 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 12 and 24 months post baseline
Secondary Health care utilization and cost Measured by data from interviews and adminstrative data 12 and 24 months post baseline
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