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Telephone Disease Management At-Risk Drinking (TDM II)

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone disease management
Usual Care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Primary Care, Telephone, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: active suicidal ideation, regular current use of illicit substances other than alcohol diagnosis of current alcohol dependence current hallucinations and delusions current symptoms of PTSD 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

Sites / Locations

  • Philadelphia VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Telephone Disease Management

Usual Care

Arm Description

Telephone based disease management or counseling used to promote a reducution in alcohol misuse

Usual Care

Outcomes

Primary Outcome Measures

Reduced Alcohol Use
Alcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.

Secondary Outcome Measures

Reduced Problems Related to Alcohol
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.

Full Information

First Posted
July 20, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00123409
Brief Title
Telephone Disease Management At-Risk Drinking (TDM II)
Official Title
Telephone Disease Management At-Risk Drinking (TDM 11)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Primary Care, Telephone, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Disease Management
Arm Type
Experimental
Arm Description
Telephone based disease management or counseling used to promote a reducution in alcohol misuse
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Telephone disease management
Intervention Description
Telephone based care management
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Reduced Alcohol Use
Description
Alcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Reduced Problems Related to Alcohol
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: active suicidal ideation, regular current use of illicit substances other than alcohol diagnosis of current alcohol dependence current hallucinations and delusions current symptoms of PTSD 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W. Oslin, MD
Organizational Affiliation
Philadelphia VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12748029
Citation
Datto CJ, Thompson R, Horowitz D, Disbot M, Oslin DW. The pilot study of a telephone disease management program for depression. Gen Hosp Psychiatry. 2003 May-Jun;25(3):169-77. doi: 10.1016/s0163-8343(03)00019-7.
Results Reference
result
PubMed Identifier
16423122
Citation
Oslin DW, Ross J, Sayers S, Murphy J, Kane V, Katz IR. Screening, assessment, and management of depression in VA primary care clinics. The Behavioral Health Laboratory. J Gen Intern Med. 2006 Jan;21(1):46-50. doi: 10.1111/j.1525-1497.2005.0267.x.
Results Reference
result
PubMed Identifier
14645769
Citation
Oslin DW, Sayers S, Ross J, Kane V, Ten Have T, Conigliaro J, Cornelius J. Disease management for depression and at-risk drinking via telephone in an older population of veterans. Psychosom Med. 2003 Nov-Dec;65(6):931-7. doi: 10.1097/01.psy.0000097335.35776.fb.
Results Reference
result
PubMed Identifier
20873894
Citation
McKay JR, Van Horn DH, Oslin DW, Lynch KG, Ivey M, Ward K, Drapkin ML, Becher JR, Coviello DM. A randomized trial of extended telephone-based continuing care for alcohol dependence: within-treatment substance use outcomes. J Consult Clin Psychol. 2010 Dec;78(6):912-23. doi: 10.1037/a0020700.
Results Reference
result
PubMed Identifier
21545667
Citation
McKay JR, Van Horn D, Oslin DW, Ivey M, Drapkin ML, Coviello DM, Yu Q, Lynch KG. Extended telephone-based continuing care for alcohol dependence: 24-month outcomes and subgroup analyses. Addiction. 2011 Oct;106(10):1760-9. doi: 10.1111/j.1360-0443.2011.03483.x. Epub 2011 Aug 8.
Results Reference
result

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Telephone Disease Management At-Risk Drinking (TDM II)

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