Addiction Health Evaluation And Disease Management (AHEAD) Study
Linkage of Alcohol Abusers to Primary Care
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Chronic disease management (CDM) is a collaborative, longitudinal, proven effective approach to the treatment of chronic medical illnesses that addresses individual patient and health systems barriers to receipt of needed treatment. The objective of this Addiction Health Evaluation And Disease management (AHEAD) Study is to test the effectiveness of CDM for substance dependence in primary care. The study will enroll and randomize subjects to attend a substance dependence CDM program (the AHEAD Unit) integrated into a real-world primary care clinic or to referral to usual primary care. All subjects will be assessed regarding alcohol and/or drug diagnosis, consumption and problems, readiness to change, health-related quality of life, and medical and substance abuse treatment utilization. Primary outcomes are alcohol and drug use, alcohol and drug-related problems, emergency department visits, and hospitalizations. Additional outcomes are health-related quality of life, readiness to change, medical and psychiatric comorbidity, HIV risk behaviors, and treatment utilization and costs. The hypothesis is that compared with standard care, a health services intervention -- chronic disease management for alcohol and drug dependence integrated in primary care -- will decrease alcohol and drug use and related problems, and improve health care utilization patterns.
This study contains two studies (and study populations):
- 1. 320 alcohol dependent subjects with current risky drinking, and
- 2. 320 drug dependent subjects with current drug use.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston Medical Center / Boston University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 years of age or older
- Fluent in English or Spanish
- Alcohol or drug dependent
- Heavy drinking in the past 30 days or recent drug use
- Provide 2 contacts to assist with follow-up
- Have no plans to move from the local area within a year of screening
- Score >21 on Mini-Mental State Examination (no serious cognitive impairment)
Exclusion Criteria:
- Pregnant (self-report)
- Breath alcohol >100 mg/dL
- Inability to provide informed consent determined by trained research associates
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 1) CDM
Chronic Disease Management
|
Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
|
|
Comparateur actif: 2) Standard care
Standard care
|
Referral to primary medical care for persons with substance dependence.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Alcohol and drug use
Délai: 3, 6, and 12 months after baseline
|
3, 6, and 12 months after baseline
|
|
Alcohol and drug-related problems
Délai: 3, 6, and 12 months after baseline
|
3, 6, and 12 months after baseline
|
|
Nights Hospitalized
Délai: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
|
3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
|
|
Emergency department visits
Délai: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
|
3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Health-related quality of life
Délai: 3, 6, and 12 months after baseline
|
3, 6, and 12 months after baseline
|
|
Readiness to change
Délai: 3, 6, and 12 months after baseline
|
3, 6, and 12 months after baseline
|
|
Medical comorbidity
Délai: 3, 6, and 12 months after baseline
|
3, 6, and 12 months after baseline
|
|
Psychiatric comorbidity
Délai: 3, 6, and 12 months after baseline
|
3, 6, and 12 months after baseline
|
|
HIV risk behaviors
Délai: 3, 6, and 12 months after baseline
|
3, 6, and 12 months after baseline
|
|
Treatment utilization and costs
Délai: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
|
3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Publications générales
- Park TW, Samet JH, Cheng DM, Winter MR, Kim TW, Fitzgerald A, Saitz R. The prescription of addiction medications after implementation of chronic care management for substance dependence in primary care. J Subst Abuse Treat. 2015 May;52:17-23. doi: 10.1016/j.jsat.2014.11.008. Epub 2014 Dec 2.
- Park TW, Cheng DM, Samet JH, Winter MR, Saitz R. Chronic care management for substance dependence in primary care among patients with co-occurring disorders. Psychiatr Serv. 2015 Jan 1;66(1):72-9. doi: 10.1176/appi.ps.201300414. Epub 2014 Nov 17.
- Saitz R, Cheng DM, Winter M, Kim TW, Meli SM, Allensworth-Davies D, Lloyd-Travaglini CA, Samet JH. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial. JAMA. 2013 Sep 18;310(11):1156-67. doi: 10.1001/jama.2013.277609.
- D'Amore MM, Cheng DM, Allensworth-Davies D, Samet JH, Saitz R. Disparities in safe sex counseling & behavior among individuals with substance dependence: a cross-sectional study. Reprod Health. 2012 Dec 31;9:35. doi: 10.1186/1742-4755-9-35.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SAI-010870-06A2
- P60AA013759 (Subvention/contrat des NIH des États-Unis)
- NIAAA Grant 2R01 AA010870-06A2
- NIDA Grant 2R01 DA010019-07A1
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