NCT00265512

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
667

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

October 17, 2014

Completed
Last Updated

January 16, 2019

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

December 12, 2005

Results QC Date

October 2, 2014

Last Update Submit

July 26, 2018

Conditions

Alcohol DependenceDrug Dependence

Keywords

TelemedicineAftercare

Outcome Measures

Primary Outcomes (1)

  • Rates of Substance Use

    Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).

    Rates of substance use measured at 3 months

Secondary Outcomes (2)

  • Psychiatric Symptoms

    Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization

  • Health Related Quality of Life

    3 months, 6 months and 12 months after randomization

Study Arms (2)

Telephone Case Monitoring Aftercare

ACTIVE COMPARATOR

Telephone Case Monitoring Aftercare

Behavioral: Telephone Case Monitoring

Continuing Care as Usual

ACTIVE COMPARATOR

Continuing Care as Usual

Behavioral: Continuing Care as Usual

Interventions

Telephone Case MonitoringBEHAVIORAL

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.

Also known as: TCM
Telephone Case Monitoring Aftercare
Continuing Care as UsualBEHAVIORAL

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

Also known as: CCAU
Continuing Care as Usual

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Completion of less than 14 days of IOP treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

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

Topeka, Kansas, 66622, United States

Location

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

St Louis, Missouri, 63106, United States

Location

Related Publications (7)

  • 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.

    PMID: 22651986RESULT

  • 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.

    PMID: 22234384RESULT

  • 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.

    PMID: 21620571RESULT

  • 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.

    PMID: 19926399RESULT

  • 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.

    PMID: 26948397RESULT

  • 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.

    PMID: 26951279RESULT

  • 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.

    PMID: 27228478RESULT

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Todd Wagner
Organization
VA Center for Innovation to Implementation
todd.wagner@va.gov
6504935000

Study Officials

  • John D. McKellar, PhD

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 14, 2005

Study Start

November 1, 2006

Primary Completion

June 1, 2009

Study Completion

January 1, 2010

Last Updated

January 16, 2019

Results First Posted

October 17, 2014

Record last verified: 2018-07

Locations

US(3)