LINK: Aftercare Monitoring Project

NCT ID: NCT00265512

Last Updated: 2019-01-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

667 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-01-31

Brief Summary

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The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the most commonly diagnosed disorders in the VA. A substantial body of data attests to the effectiveness of substance use disorder treatment; further the predictor most consistently associated with positive addiction treatment outcomes is duration. Despite the body of evidence supporting length of treatment as one of the stronger predictors of long-term SUD outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care performance criterion specified by the Office of Quality Performance. This randomized clinical trial investigates whether substance use disorder patients assigned to telephone case monitoring (TCM) for continuing care will do better than those attending face-to-face continuing care as usual (CCAU)(standard outpatient care).

Detailed Description

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Background: The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the most commonly diagnosed disorders in the VA. A substantial body of data attests to the effectiveness of substance use disorder treatment; further the predictor most consistently associated with positive addiction treatment outcomes is duration. Despite the body of evidence supporting length of treatment as one of the stronger predictors of long-term SUD outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care performance criterion specified by the Office of Quality Performance. The proposed randomized clinical trial investigates whether substance use disorder patients assigned to telephone case monitoring (TCM) for continuing care will do better than those attending face-to-face continuing care as usual (CCAU)(standard outpatient care).

Objectives: The objective of this research is to test, in a randomized clinical trial, whether in-person CCAU following intensive outpatient SUD treatment leads to better SUD outcomes when compared with TCM. In addition, we will investigate whether continuing care condition interacts with distance from providers such that telephone case monitoring (TCM) produces increasingly stronger results relative to continuing care as usual (CCAU) as distance from care increases. Should we find an interaction, we will test whether the interaction is due to TCM producing better proximal outcomes such as level of participation in continuing care and satisfaction with treatment. Finally, we will investigate the cost of providing telephone care relative to continuing care as usual.

Methods: The design of this study is a randomized controlled trial of telephone case monitoring versus face-to-face continuing care as usual with 2 sites and up to 500 patients per site recruited over 1.5 years for a total of up to 1000 patients. Patients will be involved in the intervention for up to 6 months and data collection will occur at baseline, 3, 6 and 12 months via mailed surveys. Data of interest include self-report of substance use, psychiatric symptoms, and quality of life. Data analyses will be conducted using hierarchical linear modeling.

Status: Patient recruitment has ended. Treatment and follow-up are on-going.

Conditions

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Alcohol Dependence Drug Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telephone Case Monitoring Aftercare

Telephone Case Monitoring Aftercare

Group Type ACTIVE_COMPARATOR

Telephone Case Monitoring

Intervention Type BEHAVIORAL

Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.

Continuing Care as Usual

Continuing Care as Usual

Group Type ACTIVE_COMPARATOR

Continuing Care as Usual

Intervention Type BEHAVIORAL

Continuing Care as Usual will include standard group outpatient SUD treatment.

Interventions

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Telephone Case Monitoring

Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.

Intervention Type BEHAVIORAL

Continuing Care as Usual

Continuing Care as Usual will include standard group outpatient SUD treatment.

Intervention Type BEHAVIORAL

Other Intervention Names

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TCM CCAU

Eligibility Criteria

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Inclusion Criteria

Participants will be recruited from all patients who complete at least 14 days of intensive outpatient (IOP) substance use disorder treatment over an 18-month period in 2 VA IOP SUD programs.

Exclusion Criteria

Completion of less than 14 days of IOP treatment.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D. McKellar, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

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VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

VA Eastern Kansas Health Care System Colmery-O'Neil VA Medical Center, Topeka, KS

Topeka, Kansas, United States

Site Status

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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McKellar J, Wagner T, Harris A, Oehlert M, Buckley S, Moos R. One-year outcomes of telephone case monitoring for patients with substance use disorder. Addict Behav. 2012 Oct;37(10):1069-74. doi: 10.1016/j.addbeh.2012.03.009. Epub 2012 Mar 13.

Reference Type RESULT
PMID: 22651986 (View on PubMed)

Oser M, Cucciare M, McKellar J, Weingardt K. Correlates of hazardous drinking among Veterans with and without hepatitis C. J Behav Med. 2012 Dec;35(6):634-41. doi: 10.1007/s10865-011-9394-9. Epub 2012 Jan 11.

Reference Type RESULT
PMID: 22234384 (View on PubMed)

Austin J, McKellar JD, Moos R. The influence of co-occurring axis I disorders on treatment utilization and outcome in homeless patients with substance use disorders. Addict Behav. 2011 Sep;36(9):941-4. doi: 10.1016/j.addbeh.2011.05.001. Epub 2011 May 7.

Reference Type RESULT
PMID: 21620571 (View on PubMed)

Oser ML, McKellar J, Moos BS, Moos RH. Changes in ambivalence mediate the relation between entering treatment and change in alcohol use and problems. Addict Behav. 2010 Apr;35(4):367-9. doi: 10.1016/j.addbeh.2009.10.024. Epub 2009 Oct 30.

Reference Type RESULT
PMID: 19926399 (View on PubMed)

Barbosa PV, Thomas IC, Srinivas S, Buyyounouski MK, Chung BI, Chertow GM, Asch SM, Wagner TH, Brooks JD, Leppert JT. Overall Survival in Patients with Localized Prostate Cancer in the US Veterans Health Administration: Is PIVOT Generalizable? Eur Urol. 2016 Aug;70(2):227-30. doi: 10.1016/j.eururo.2016.02.037. Epub 2016 Mar 2.

Reference Type RESULT
PMID: 26948397 (View on PubMed)

Wagner TH, Burstin H, Frakt AB, Krein SL, Lorenz K, Maciejewski ML, Pizer SD, Weiner M, Yoon J, Zulman DM, Asch SM. Opportunities to Enhance Value-Related Research in the U.S. Department of Veterans Affairs. J Gen Intern Med. 2016 Apr;31 Suppl 1(Suppl 1):78-83. doi: 10.1007/s11606-015-3538-5. No abstract available.

Reference Type RESULT
PMID: 26951279 (View on PubMed)

Gidwani R, Joyce N, Kinosian B, Faricy-Anderson K, Levy C, Miller SC, Ersek M, Wagner T, Mor V. Gap between Recommendations and Practice of Palliative Care and Hospice in Cancer Patients. J Palliat Med. 2016 Sep;19(9):957-63. doi: 10.1089/jpm.2015.0514. Epub 2016 May 26.

Reference Type RESULT
PMID: 27228478 (View on PubMed)

Other Identifiers

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IIR 05-021

Identifier Type: -

Identifier Source: org_study_id

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