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A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings.
Background: Alcohol dependence is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments less than 20% of individuals with alcohol dependence are actively engaged in treatment. Within the VA system systematic screening was implemented to increase the identification of patients with both abuse and dependence. However, there continues to be a marked discrepancy in the care offered or accessed among those identified with alcohol dependence. Existing treatment guidelines suggest that all persons with dependence receive care in specialty addiction treatment. Data from our center indicate that among those individuals screened in primary care who have AUDIT - C scores of >7, only 30% are formally evaluated with 50% receiving only brief advice and 20% having no evidence of assessment or referral. Of those assessed and referred to specialty care only 60% attend an initial visit and only 33% meet the EPRP performance measure of 2 visits per month for 90 days. This disparity in treatment access exists even though Veterans self report a desire to cut down and readiness to change drinking behaviors. (VA ACQUIP) and a willingness to consider pharmacotherapy.
Aims: Available evidence suggests that primary care may be a key component in the identification of alcohol dependent patients, delivery of initial interventions, and to the success of addiction treatment. Indeed, the vast majority of screening and new case identification occurs within primary care. The primary aims of this proposal are to test the effectiveness of a primary care based Alcohol Care Management (ACM) program and to evaluate the barriers and facilitators to accessing and engaging individuals into treatment. The ACM program uses a Behavioral Health Specialist to deliver care focused on the use of pharmacotherapy in combination with psychosocial support (Medication Management). This model may overcome barriers to care such as frequent intensive visit schedules often required in specialty settings, stigma associated with specialty care or group therapy approaches, access to specialty care in remote areas, and the current focus on a 12 step model of treatment. Secondary aims are to establish the acceptability of primary care based treatments and defining treatment modifiers such as age, barriers, co-occurring depression, and pharmacogenetic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol Care Management | Experimental | Care management for alcohol dependence delivered in primary care |
|
| Usual Care | Active Comparator | Usual care included a referral to specialty addiction treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol Care Management | Behavioral | Care management for alcohol dependence with a focus on pharmacotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Engagement | This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Days of Heavy Alcohol Use | This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W. Oslin, MD | Philadelphia VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York | 13210 | United States | ||
| Philadelphia VA Medical Center, Philadelphia, PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24052453 | Result | Oslin DW, Lynch KG, Maisto SA, Lantinga LJ, McKay JR, Possemato K, Ingram E, Wierzbicki M. A randomized clinical trial of alcohol care management delivered in Department of Veterans Affairs primary care clinics versus specialty addiction treatment. J Gen Intern Med. 2014 Jan;29(1):162-8. doi: 10.1007/s11606-013-2625-8. Epub 2013 Sep 20. | |
| 30003479 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Care management for alcohol dependence Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy |
| FG001 | Arm 2 | Usual care Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Care management for alcohol dependence Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy |
| BG001 | Arm 2 | Usual care Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Engagement | This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial. | Posted | Number | percentage of participants engaged | 6 months |
|
the 6 months of the intervention trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Care management for alcohol dependence Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy |
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The data presented in the results does not provide a true measure of the longitudinal effects done with GEE modeling.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Oslin | Philadelphia VA Medical Center | 215 823 5894 | dave.oslin@va.gov |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Usual Care | Behavioral | Usual care included a referral to a specialty addiction treatment program. |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Rotenberg JR, Leong SH, Maisto SA, McKay JR, Possemato K, Ingram E, Oslin DW. Post-intervention Durability of Alcohol Care Management: 1-Year Follow-up of a Randomized Controlled Trial. J Gen Intern Med. 2018 Oct;33(10):1626-1628. doi: 10.1007/s11606-018-4567-7. No abstract available. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| % Days of Heavy Drinking | The measures the percent of days in the 60 days prior to randomization in which a participant drank more than 4 standard drinks (3 or more for women) in a given day. | Mean | Standard Deviation | % days of heavy drinking |
|
| The number of Subjects Engaged in Treatment at Baseline | This was a measure of the proportion of patients engaged in addiction treatment at the time of randomization. It was a requirement that no of the subjects were engaged at baseline. | Number | Participants engaged in treatment |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percent Days of Heavy Alcohol Use | This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women). | Posted | Mean | Standard Deviation | percentage of heavy drinking days | 6 months |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | Arm 2 | Usual care Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy | 0 | 78 | 0 | 78 |
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