Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


Study summary:

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.


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: 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


Study is Available At:


Original ID:

IIR 02-108


NCT ID:

NCT00123409


Secondary ID:


Study Acronym:


Brief Title:

Telephone Disease Management At-Risk Drinking (TDM II)


Official Title:

Telephone Disease Management At-Risk Drinking (TDM 11)


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Actual


Overall Contact Information

Official Name:David W. Oslin, MD
Principal Investigator
Philadelphia VA Medical Center, Philadelphia, PA

Study Dates

Start Date:January 2004
Completion Date:February 2009
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:June 2014
Last Changed Date:June 4, 2014
First Received Date:July 20, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Improved quality of life.
Time Frame:12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Reduced alcohol use
Time Frame:12 months
Safety Issues:True

Study Interventions

Intervention Type:Behavioral
Name:Telephone disease management
Description:Telephone based care management
Arm Name:Arm 1
Intervention Type:Behavioral
Name:Usual Care
Description:Usual care
Arm Name:Arm 2

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Arm 2
Description:Usual Care
Study Arm Type:Experimental
Arm Name:Arm 1
Description:Telephone Based care management for reducing alcohol use

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:21545667
Reference Type:Results Reference
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.
PMID:20873894
Reference Type:Results Reference
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.
PMID:14645769
Reference Type:Results Reference
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.
PMID:16423122
Reference Type:Results Reference
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.
PMID:12748029

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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