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Telephone Disease Management At-Risk Drinking (TDM II)

Telephone Disease Management At-Risk Drinking (TDM 11)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00123409
Enrollment
146
Registered
2005-07-22
Start date
2004-01-31
Completion date
2009-02-28
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse

Keywords

Primary Care, Telephone, Quality of Life

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.

Interventions

BEHAVIORALTelephone disease management

Telephone based care management

BEHAVIORALUsual Care

Usual care

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reduced Alcohol Use12 monthsAlcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.

Secondary

MeasureTime frameDescription
Reduced Problems Related to Alcohol12 monthsThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Telephone Disease Management
Telephone Based care management for reducing alcohol use Telephone disease management: Telephone based care management
68
Usual Care
Usual Care Usual Care: Usual care
71
Total139

Baseline characteristics

CharacteristicUsual CareTotalTelephone Disease Management
Age, Continuous57 years
STANDARD_DEVIATION 13.9
57.1 years
STANDARD_DEVIATION 14
57.3 years
STANDARD_DEVIATION 15.1
# of Days Drinking in last 28 days20.2 # of days drinking
STANDARD_DEVIATION 8.12
19.9 # of days drinking
STANDARD_DEVIATION 8.8
19.53 # of days drinking
STANDARD_DEVIATION 9.44
Problems related to alcohol4.7 # problems
STANDARD_DEVIATION 5.52
4.5 # problems
STANDARD_DEVIATION 5.52
4.31 # problems
STANDARD_DEVIATION 5.52
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
33 Participants63 Participants30 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
38 Participants76 Participants38 Participants
Region of Enrollment
United States
71 participants139 participants68 participants
Sex: Female, Male
Female
2 Participants3 Participants1 Participants
Sex: Female, Male
Male
69 Participants136 Participants67 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 680 / 71
serious
Total, serious adverse events
0 / 680 / 71

Outcome results

Primary

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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Telephone Based ManagementReduced Alcohol Use14.96 Days drinkingStandard Deviation 12.55
Usual CareReduced Alcohol Use15.52 Days drinkingStandard Deviation 10.12
Secondary

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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Telephone Based ManagementReduced Problems Related to Alcohol2.37 # of alcohol problemsStandard Deviation 5.11
Usual CareReduced Problems Related to Alcohol2.77 # of alcohol problemsStandard Deviation 6.24

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026