Telephone Disease Management At-Risk Drinking (TDM II)

NCT00123409 | Completed Results

• 1 other identifier: IIR 02-108
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse

Keywords

Primary Care; Telephone; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Reduced Problems Related to Alcohol

  12 months

Study Arms (2)

Telephone Disease Management

EXPERIMENTAL

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

Behavioral: Telephone disease management

Usual Care

PLACEBO COMPARATOR

Usual Care

Behavioral: Usual Care

Interventions

Telephone disease management BEHAVIORAL

Telephone based care management

Telephone Disease Management

Usual Care BEHAVIORAL

Usual care

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• 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.

  PMID: 12748029 RESULT

• 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.

  PMID: 16423122 RESULT

• 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.

  PMID: 14645769 RESULT

• 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.

  PMID: 20873894 RESULT

• 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.

  PMID: 21545667 RESULT

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: David Oslin
• Organization: Philadelphia VAMC

dave.oslin@upenn.edu

2158235894

Study Officials

• David W. Oslin, MD

  Philadelphia VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2005
• First Posted: July 22, 2005
• Study Start: January 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: February 1, 2009
• Last Updated: April 24, 2015
• Results First Posted: November 4, 2014

Record last verified: 2014-06

Locations

US (1)