Substance AbuseLinkageNCT01621711
Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care
A study testing Linkage patient activation intervention in people with Substance Abuse and Substance Dependence, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse, Substance Dependence, Substance, Addiction
- What is being tested?
- Linkage patient activation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Research participants will be adult patients at the Kaiser Permanente San Francisco Chemical Dependency Recovery Program, who have completed 2 weeks of treatment.
Who cannot join
- Patients with a diagnosis of dementia, mental retardation, or who are actively psychotic or suicidal will be excluded by their clinician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente, Chemical Dependency Recovery Program
San Francisco, California, 94115
About this study
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.
- Being tested
- Linkage patient activation intervention
- Keywords
- substance abuse, Substance Dependence, Substance, addiction, Alcohol Abuse, prevention and control, preventative health services, patient centered care
- Medical subject headings
- Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linkage patient activation interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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. |
| Linkage patient activation intervention | Experimental | 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. Receives: Behavioral: Linkage patient activation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient activation measure
Measured by Patient Activation Measure (PAM) from interview data
Measured: 6 months post baseline
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)
Measured: 6 months post baseline
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
Measured: 6 months post baseline
Secondary outcomes (4)
patient activation measure at 12 and 24 months
Measured by Patient Activation Measure (PAM) from interview data
Measured: 12 and 24 months post baseline
patient engagement in health care at 12 and 24 months
Measured by data from interviews and Electronic Health Record (EHR)
Measured: 12 and 24 months post baseline
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
Measured: 12 and 24 months post baseline
Health care utilization and cost
Measured by data from interviews and adminstrative data
Measured: 12 and 24 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMar 2011
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (113)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Research Institute
- Responsible party
- Sponsor
- Investigators
- Constance M Weisner, DrPH, LCSW, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621711
- Sponsor's protocol ID
- 10-01606
- Acronym
- Linkage
- Status last verified
- May 2024
- First submitted
- 11 Jun 2012
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saitz R, Horton NJ, Larson MJ, Winter M, Samet JH. Primary medical care and reductions in addiction severity: a prospective cohort study. Addiction. 2005 Jan;100(1):70-8. doi: 10.1111/j.1360-0443.2005.00916.x.
PubMed 15598194Mertens JR, Flisher AJ, Satre DD, Weisner CM. The role of medical conditions and primary care services in 5-year substance use outcomes among chemical dependency treatment patients. Drug Alcohol Depend. 2008 Nov 1;98(1-2):45-53. doi: 10.1016/j.drugalcdep.2008.04.007. Epub 2008 Jun 20.
PubMed 18571875Von Korff M, Gruman J, Schaefer J, Curry SJ, Wagner EH. Collaborative management of chronic illness. Ann Intern Med. 1997 Dec 15;127(12):1097-102. doi: 10.7326/0003-4819-127-12-199712150-00008.
PubMed 9412313Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. JAMA. 2002 Oct 9;288(14):1775-9. doi: 10.1001/jama.288.14.1775.
PubMed 12365965Tsuang MT, Lyons MJ, Eisen SA, Goldberg J, True W, Lin N, Meyer JM, Toomey R, Faraone SV, Eaves L. Genetic influences on DSM-III-R drug abuse and dependence: a study of 3,372 twin pairs. Am J Med Genet. 1996 Sep 20;67(5):473-7. doi: 10.1002/(SICI)1096-8628(19960920)67:53.0.CO;2-L.
PubMed 8886164Schuckit MA, Smith TL. An 8-year follow-up of 450 sons of alcoholic and control subjects. Arch Gen Psychiatry. 1996 Mar;53(3):202-10. doi: 10.1001/archpsyc.1996.01830030020005.
PubMed 8611056Dennis M, Scott CK. Managing addiction as a chronic condition. Addict Sci Clin Pract. 2007 Dec;4(1):45-55. doi: 10.1151/ascp074145.
PubMed 18292710Dennis ML, Scott CK, Funk R, Foss MA. The duration and correlates of addiction and treatment careers. J Subst Abuse Treat. 2005;28 Suppl 1:S51-62. doi: 10.1016/j.jsat.2004.10.013.
PubMed 15797639Weisner C, Ray GT, Mertens JR, Satre DD, Moore C. Short-term alcohol and drug treatment outcomes predict long-term outcome. Drug Alcohol Depend. 2003 Sep 10;71(3):281-94. doi: 10.1016/s0376-8716(03)00167-4.
PubMed 12957346Hser YI, Anglin MD, Grella C, Longshore D, Prendergast ML. Drug treatment careers. A conceptual framework and existing research findings. J Subst Abuse Treat. 1997 Nov-Dec;14(6):543-58. doi: 10.1016/s0740-5472(97)00016-0.
PubMed 9437626Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.
PubMed 12377092Mosen DM, Schmittdiel J, Hibbard J, Sobel D, Remmers C, Bellows J. Is patient activation associated with outcomes of care for adults with chronic conditions? J Ambul Care Manage. 2007 Jan-Mar;30(1):21-9. doi: 10.1097/00004479-200701000-00005.
PubMed 17170635Schmittdiel J, Mosen DM, Glasgow RE, Hibbard J, Remmers C, Bellows J. Patient Assessment of Chronic Illness Care (PACIC) and improved patient-centered outcomes for chronic conditions. J Gen Intern Med. 2008 Jan;23(1):77-80. doi: 10.1007/s11606-007-0452-5. Epub 2007 Nov 21.
PubMed 18030539Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
PubMed 15230939Holman H, Lorig K. Patients as partners in managing chronic disease. Partnership is a prerequisite for effective and efficient health care. BMJ. 2000 Feb 26;320(7234):526-7. doi: 10.1136/bmj.320.7234.526. No abstract available.
PubMed 10688539
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care
- ClinicalTrials.gov ID
- NCT01621711
- Acronym / sponsor ID
- Linkage / 10-01606
- Keywords
- substance abuse, Substance Dependence, Substance, addiction, Alcohol Abuse, prevention and control, preventative health services, patient centered care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Kaiser Foundation Research Institute
- Study start
- Mar 2011
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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. |
| Linkage patient activation intervention | Experimental | Behavioral: Linkage patient activation interventionUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Research participants will be adult patients at the Kaiser Permanente San Francisco Chemical Dependency Recovery Program, who have completed 2 weeks of treatment.
Key exclusion criteria (1 listed)
- Patients with a diagnosis of dementia, mental retardation, or who are actively psychotic or suicidal will be excluded by their clinician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linkage patient activation interventionUsual 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. | Behavioural | Linkage patient activation intervention |
Primary outcome
patient activation measure
Time frame: 6 months post baseline
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
Measured by data from interviews and Electronic Health Record (EHR)
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
4 secondary outcomes
patient activation measure at 12 and 24 months
Time frame: 12 and 24 months post baseline
patient engagement in health care at 12 and 24 months
Time frame: 12 and 24 months post baseline
Substance use and mental health outcomes at 12 and 24 months
Time frame: 12 and 24 months post baseline
Health care utilization and cost
Time frame: 12 and 24 months post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 15598194Saitz R, Horton NJ, Larson MJ, Winter M, Samet JH. Primary medical care and reductions in addiction severity: a prospective cohort study. Addiction. 2005 Jan;100(1):70-8. doi: 10.1111/j.1360-0443.2005.00916.x.
- Background: PubMed 18571875Mertens JR, Flisher AJ, Satre DD, Weisner CM. The role of medical conditions and primary care services in 5-year substance use outcomes among chemical dependency treatment patients. Drug Alcohol Depend. 2008 Nov 1;98(1-2):45-53. doi: 10.1016/j.drugalcdep.2008.04.007. Epub 2008 Jun 20.
- Background: PubMed 9412313Von Korff M, Gruman J, Schaefer J, Curry SJ, Wagner EH. Collaborative management of chronic illness. Ann Intern Med. 1997 Dec 15;127(12):1097-102. doi: 10.7326/0003-4819-127-12-199712150-00008.
- Background: PubMed 12365965Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. JAMA. 2002 Oct 9;288(14):1775-9. doi: 10.1001/jama.288.14.1775.
- Background: PubMed 8886164Tsuang MT, Lyons MJ, Eisen SA, Goldberg J, True W, Lin N, Meyer JM, Toomey R, Faraone SV, Eaves L. Genetic influences on DSM-III-R drug abuse and dependence: a study of 3,372 twin pairs. Am J Med Genet. 1996 Sep 20;67(5):473-7. doi: 10.1002/(SICI)1096-8628(19960920)67:53.0.CO;2-L.
- Background: PubMed 8611056Schuckit MA, Smith TL. An 8-year follow-up of 450 sons of alcoholic and control subjects. Arch Gen Psychiatry. 1996 Mar;53(3):202-10. doi: 10.1001/archpsyc.1996.01830030020005.
- Background: PubMed 18292710Dennis M, Scott CK. Managing addiction as a chronic condition. Addict Sci Clin Pract. 2007 Dec;4(1):45-55. doi: 10.1151/ascp074145.
- Background: PubMed 15797639Dennis ML, Scott CK, Funk R, Foss MA. The duration and correlates of addiction and treatment careers. J Subst Abuse Treat. 2005;28 Suppl 1:S51-62. doi: 10.1016/j.jsat.2004.10.013.
- Background: PubMed 12957346Weisner C, Ray GT, Mertens JR, Satre DD, Moore C. Short-term alcohol and drug treatment outcomes predict long-term outcome. Drug Alcohol Depend. 2003 Sep 10;71(3):281-94. doi: 10.1016/s0376-8716(03)00167-4.
- Background: PubMed 9437626Hser YI, Anglin MD, Grella C, Longshore D, Prendergast ML. Drug treatment careers. A conceptual framework and existing research findings. J Subst Abuse Treat. 1997 Nov-Dec;14(6):543-58. doi: 10.1016/s0740-5472(97)00016-0.
- Background: PubMed 12377092Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.
- Background: PubMed 17170635Mosen DM, Schmittdiel J, Hibbard J, Sobel D, Remmers C, Bellows J. Is patient activation associated with outcomes of care for adults with chronic conditions? J Ambul Care Manage. 2007 Jan-Mar;30(1):21-9. doi: 10.1097/00004479-200701000-00005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constance M Weisner, DrPH, LCSW principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linkage patient activation intervention in people with Substance Abuse and Substance Dependence, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient activation measure (time frame: 6 months post baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621711, which also lists 113 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.