- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00419315
A Randomized Clinical Trial of Alcohol Care Management
Primary Care Based Disease Management for Alcohol Dependence
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
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-
New York
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Syracuse, New York, Förenta staterna, 13210
- Syracuse VA Medical Center, Syracuse, NY
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Philadelphia VA Medical Center, Philadelphia, PA
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- be men and women = 18 years of age;
- meet criteria for alcohol dependence;
- drink more than an average of 2 drinks per day prior to study entry (over the last 60 days);
- have adequate hearing to participate in assessment
Exclusion Criteria:
- show no evidence of current abuse or dependence of illicit substances other than marijuana;
- no current hallucinations;
- no current symptoms of mania;
- be relatively cognitively intact
- not actively participate in specialized addition or behavioral health treatment within the prior 12 months
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Alcohol Care Management
Care management for alcohol dependence delivered in primary care
|
Care management for alcohol dependence with a focus on pharmacotherapy
|
Aktiv komparator: Usual Care
Usual care included a referral to specialty addiction treatment
|
Usual care included a referral to a specialty addiction treatment program.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Treatment Engagement
Tidsram: 6 months
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percent Days of Heavy Alcohol Use
Tidsram: 6 months
|
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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: David W. Oslin, MD, Philadelphia VA Medical Center, Philadelphia, PA
Publikationer och användbara länkar
Allmänna publikationer
- 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. Erratum In: J Gen Intern Med. 2016 Apr;31(4):449.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIR 06-058
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Kliniska prövningar på Alcohol Care Management
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Peking Union Medical College HospitalOkändKronisk sjukdom | KostfiberKina
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University of ChicagoRekryteringHjärtsvikt | Höger ventrikulär dysfunktion | HögerkammarsviktFörenta staterna
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AvslutadLeversjukdomar | Alkoholrelaterade störningarFörenta staterna
-
Wake Forest University Health SciencesAvslutadHypertoni SekundärFörenta staterna
-
University of MichiganRekrytering
-
Shanghai Jiao Tong University School of MedicineRekrytering
-
William Beaumont HospitalsAvslutadBröstsmärta | Akut koronarsyndrom | Hjärtsjukdom, kranskärlssjukdomFörenta staterna
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Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI); American Lung Association och andra samarbetspartnersAktiv, inte rekryterandeUnga vuxna | Okontrollerad astmaFörenta staterna
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Sygehus LillebaeltOkändBakteriella infektioner | Kirurgiskt ingrepp, ospecificerat | Operation sår; InfektionDanmark
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University of MichiganNational Institutes of Health (NIH); National Institute on Aging (NIA); Blue...Avslutad