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Telephone Disease Management At-Risk Drinking (TDM II)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 22, 2005
Last Update Posted: April 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
July 20, 2005
July 22, 2005
September 26, 2014
November 4, 2014
April 24, 2015
January 2004
August 2008   (Final data collection date for primary outcome measure)
Reduced Alcohol Use [ Time Frame: 12 months ]
Alcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.
Reduced Alcohol Use
Complete list of historical versions of study NCT00123409 on ClinicalTrials.gov Archive Site
Reduced Problems Related to Alcohol [ Time Frame: 12 months ]
The Short Inventory of Problmes was used to measure the number of alcohol related problems encountered in the prior 3 months. The scale has a minimum of 0 with lower as better. The max score is 15 with each problem rated as present or absent.
Improved quality of life.
Not Provided
Not Provided
Telephone Disease Management At-Risk Drinking (TDM II)
Telephone Disease Management At-Risk Drinking (TDM 11)

The aim of this study is to test for improvements in treatment outcomes for primary care patients with at-risk drinking when cared for using telephone disease management (TDM) compared to those treated with usual care. Based on our pilot data, TDM for at-risk drinking may be a viable method for reducing alcohol consumption in this population.

Hypotheses: The hypotheses for this research plan are: 1. A significantly greater proportion of patients assigned to TDM will obtain improvement in drinking outcomes compared to usual care. 2. TDM will lead to greater access to behavioral health care and higher intensity of treatment relative to usual care. This effect will be moderated by logistics such as transportation problems, physical functioning, and employment status. 3. More patients assigned to TDM will receive guideline adherent care.

We propose to randomize 200 patients with at-risk drinking from four primary care clinics at the PVAMC and three Community Based Outpatient Clinics (CBOCs). Patients will be identified for participation by 1. referrals from primary care clinicians based on existing screening and clinical exams or 2. from the screening of a random subset of patients with an appointment in the primary care clinic. A baseline assessment will establish eligibility for participation in the study. The baseline assessment will also allow identification of those patients who screen positive but do not have a definable behavioral health problem and those with severe symptoms who may need more intensive help than provided by the study.

Consenting eligible patients will be randomly assigned to TDM or the lower intensity intervention of usual care. For those patients assigned to usual care, the physician will administer further evaluations and treatment as he/she sees fit. For those assigned to TDM, the primary care provider remains the agent of treatment, but a Behavioral Health Specialist (BHS) is made available to: maintain regularly scheduled telephone contact, develop a treatment plan, monitor treatment effectiveness, assess and encourage treatment adherence, and offer support and education. The role of the health specialist is defined by a treatment manual that adheres to the recommendations of VA practice guidelines. TDM is based on a chronic care model of treatment and includes a minimum of three BAI sessions. The health specialist will communicate assessment information with the PCP in order to coordinate treatment decisions.

The principal outcomes of the study relate to reduction in alcohol use within recommended guidelines as well as access and utilization of behavioral health services over the course of 12 months. Results favoring TDM may provide a low-cost, highly efficient mechanism for integrating behavioral health with primary care for these patients. This project thus meets several of the priority areas for HSR&D funding including improving access to care, the implementation of practice guidelines, use of telemedicine, and patient-centered care.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Abuse
  • Behavioral: Telephone disease management
    Telephone based care management
  • Behavioral: Usual Care
    Usual care
  • Experimental: Telephone Disease Management
    Telephone based disease management or counseling used to promote a reducution in alcohol misuse
    Intervention: Behavioral: Telephone disease management
  • Placebo Comparator: Usual Care
    Usual Care
    Intervention: Behavioral: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2009
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • be 18 years of age and over, male or female.
  • meet criteria for at-risk drinking as defined by drinking more than 21 standard drinks per week (14 for women or those over age 65).

Exclusion Criteria:

  • show an absence of any of the following:

    1. active suicidal ideation,
    2. regular current use of illicit substances other than alcohol
    3. diagnosis of current alcohol dependence
    4. current hallucinations and delusions
    5. current symptoms of PTSD
    6. a history of mania or hypomania.
  • have adequate hearing to participate in telephone assessments and access to a telephone. Subjects will also show an absence of other barriers to verbal communication (e.g., aphasia) and will be cognitively intact (Brief Orientation Memory and Concentration task greater than 15 for those over age 54).
  • not actively participating in specialized addiction treatment within the prior 3-months.
  • not currently enrolled in another clinical trial
  • not expected to move from the VISN 4 area within 12 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
IIR 02-108
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: David W. Oslin, MD Philadelphia VA Medical Center, Philadelphia, PA
VA Office of Research and Development
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP