AHEAD Study
Principal Investigators
NIAAA: Richard Saitz, MD, MPH
NIDA: Jeffrey Samet, MD, MA, MPH
Key Personnel
Debbie Cheng, ScD, Biostatistician, Boston University School of Public Health
Colleen LaBelle, RN, Disease Management Expert, Boston Medical Center
Theresa Kim, MD, Co-Investigator, Boston University School of Medicine
Project Manager
Seville Meli, MPH
617-414-6917
Seville.Meli@bmc.org
Staff
Laura Wulach, Project Coordinator
Grant Abstract
NIAAA:
In this application we aim to continue research on effectively linking health services for adults with alcoholism. Alcoholism is a chronic disease for which many adults receive no treatment. Like other chronic diseases (e.g. diabetes, congestive heart failure), alcoholism has no cure, and is characterized by relapses requiring longitudinal care. Medical and psychiatric comorbidities are the rule rather than the exception. As a result, care delivery can be complex both for clinicians and patients. In the US, systems of care for alcoholism are rarely integrated with those for medical and psychiatric illnesses. Specialty alcoholism treatment is efficacious, but many patients do not access available alcohol treatment after detoxification or from medical care. Others enter alcoholism treatment but do not receive medical or psychiatric care. Some have called to expand the frame of health services research on addictions to include services outside the specialty treatment sector, including psychological and behavioral care integrated into primary care (Humphreys and Tucker, 2002; Trask et. al., 2002; Weisner and Schmidt, 1995). Primary care settings provide longitudinal, comprehensive, coordinated care but their potential to effectively treat alcoholism and related comorbidities has not been realized. Medical, mental health, and alcoholism treatment are not coordinated. Primary care settings hold the promise of simultaneously improving medical and psychiatric health while decreasing alcohol problems. For other diseases, chronic disease management (CDM)—longitudinal care delivery linking and integrating primary and specialty health care—is effective. Of the >100 studies of CDM, none address alcoholism.
Since the last competitive review, we randomized 298 adults detoxifying from alcohol who did not have regular doctors to standard referral or a multidisciplinary intervention to link them with primary medical care (HELP study, see 3.2). During the subsequent year, significantly more intervention than control subjects linked with primary medical care. Secondary analyses suggest that linkage with primary care improved alcoholism outcomes. The logical continuation of this line of research is to ask how to improve outcomes for patients with alcoholism once linked with primary medical care, beyond an initial visit.
Therefore, the objective of this study, the Alcohol Health Evaluation And Disease management (AHEAD) Study, is to test the effectiveness of a chronic disease management (CDM) program providing linked health services for alcoholism in primary care. This study will achieve the following specific aims:
1) To implement a chronic disease management (CDM) program for adults with alcohol dependence.
2) To recruit a cohort of 320 adults with current alcohol dependence from health care settings in which they are not receiving specialty alcoholism treatment and randomize them to alcoholism chronic disease management (CDM) integrated into a real-world primary care clinic in an Alcohol Health Evaluation And Disease management (AHEAD) program or to an enhanced care control group (referral to primary care).
3) To assess the cohort at baseline before randomization and at 3, 6 and 12 months regarding alcohol use, alcohol-related problems, alcohol-related medical and psychiatric illnesses, and HIV risk behaviors, and to assess healthcare utilization at those time points, and through 24 months using a statewide database.
By achieving these aims the AHEAD Study will test the following major hypotheses:
Linkage of patients with alcoholism to chronic disease management (CDM) integrated into primary care will:
I) Decrease alcohol use and alcohol-related problems, including injury, medical problems, HIV-related risk behaviors, and improve health-related quality of life.
II) Improve health care utilization patterns by decreasing hospitalizations and emergency department visits.
The Alcohol Health Evaluation And Disease management (AHEAD) program is based on a proven model of linking patients with alcoholism to primary care, and an approach for evaluating and managing a chronic disease in primary care using a multidisciplinary team to impact behavioral and medical aspects of the disease. We will test the effectiveness of this novel health services delivery approach, chronic disease management (CDM) in primary care, for reducing the significant morbidity associated with alcoholism.
NIDA:
We aim to continue research on effectively linking health services for adults with drug dependence. Drug dependence (DD) is a chronic disease for which many adults receive no treatment. Like other chronic diseases (e.g. diabetes, depression, asthma, and congestive heart failure), DD has no cure, and is characterized by relapses requiring longitudinal care. Furthermore, medical and psychiatric comorbidities are the rule rather than the exception. As a result, care delivery can be complex both for clinicians and patients.
In the US, systems of care for DD are rarely integrated with those for medical and psychiatric illnesses and as a result treatment for conditions in these three areas is not coordinated. Specialty DD treatment is efficacious, but many patients do not access available substance abuse treatment either after detoxification or from medical care. Others enter DD treatment but do not receive medical or psychiatric care. Primary care settings hold the promise of simultaneously improving medical and psychiatric health while decreasing drug problems. Ideally, these settings provide longitudinal, comprehensive, coordinated care. But their potential to effectively treat DD and related comorbidities has not been realized. Now that buprenorphine, a medication to treat opioid dependence by generalist physicians, is available, the imperative to integrate treatment of drug dependence in primary care has become more urgent. Some have called to expand the frame of health services research on addictions to include services outside the specialty treatment sector by integrating psychological and behavioral care with primary care. Chronic disease management (CDM), longitudinal care delivery linking and integrating primary and specialty health care, is effective for many diseases. Of the >100 studies of CDM none address DD.
Since the last competitive review, we randomized 354 adults whose first or second drug of choice was cocaine or heroin and who did not have PC to a single multidisciplinary assessment in the detoxification unit in order to link them with primary medical care (Health Evaluation and Linkage to Primary Care [HELP] study). During the subsequent year, linkage to primary care was improved, as significantly more intervention than control subjects linked with primary medical care,(1) and secondary analyses suggest that receipt of primary care improved addiction severity.(2) The logical continuation of this line of research is to ask how to improve outcomes for patients with DD once linked with primary medical care.
Therefore, the objective of this study, the Addiction Health Evaluation And Disease management (AHEAD) Study, is to test the effectiveness of a chronic disease management (CDM) program providing linked health services for DD in primary care. This study will achieve the following specific aims:
4) To develop a chronic disease management (CDM) program for adults with DD;
5) To recruit a cohort of 320 adults with current DD from health care settings in which they are not receiving specialty drug dependence treatment and randomize them to DD CDM integrated into a real-world primary care clinic in the AHEAD program or to an enhanced care control group (referral to primary care);
6) To assess the cohort at baseline before randomization and at 3, 6 and 12 months regarding drug use, drug-related problems, drug-related medical and psychiatric illnesses, and HIV risk behaviors, and to assess healthcare utilization at those time points, and through 24 months using administrative databases.
By achieving these aims, the AHEAD Study will test the following major hypotheses:
Linkage of patients with DD to chronic disease management (CDM) integrated into primary care will
III) Decrease drug use and drug-related problems, including injury, medical problems, HIV-related risk behaviors, and improve health-related quality of life; and
IV) Improve utilization patterns by decreasing hospitalizations and emergency department visits.
The AHEAD program is based on a proven model of linking patients with DD to primary care, and an approach for evaluating and managing a chronic disease in primary care using a multidisciplinary team to treat behavioral and medical aspects of the disease. We will test the effectiveness of this novel health services delivery approach, chronic disease management (CDM) in primary care, for reducing consequences of DD.
Publications
do Amaral-Sabadini MB, Cheng D, Lloyd-Travaglini C, Samet J, Saitz R. Is a patients’ type of substance dependence (alcohol, drug or both) associated with the quality of primary care they receive? Qual Prim Care, 2012; 20(6):391-9.
Allensworth-Davies D, Saitz R, Cheng DM, Smith PC, Samet JH. The Short Inventory of Problems – Modified for Drug Use (SIP-DU): Validity in a Primary Care Sample. Am J Addict, 2012; 21(3):257-62. PMCID: PMC3889861
D’Amore M, Cheng D, Allensworth-Davies D, Samet J, Saitz R. Disparities in receipt of safe sex counseling among substance dependent persons in primary care. Reprod Health, 2012; 9:35. PMCID: PMC3565911
Kim TW, Saitz R, Cheng DM, Winter MR, Witas J, Samet JH. Effect of quality chronic disease management for alcohol and drug dependence on addiction outcomes. J Subst Abuse Treat, 2012; 43: 389-396. PMCID: PMC3507538
Kim TW, Saitz R, Cheng DM, Winter MR, Witas J, Samet JH. Initiation and engagement in chronic disease management care for substance dependence. J Drug Alc Dep, 2011; 115: 80-86. PMCID: PMC3749847
Reif S, Larson MJ, Cheng D, Allensworth-Davies D, Samet J, Saitz R. Chronic disease and recent addiction treatment utilization among alcohol and drug dependent adults. Subst Abuse Treat Prev Pol, 2011; 6:28. PMCID: PMC3220629
Damore M, Cheng D, Kressin K, Jones J, Samet JH, Winter M, Kim T, Saitz R. Oral health of substance-dependent individuals: Impact of specific substances. J Subst Abuse Treat, 2011; 41(2): 179-85. PMCID: PMC3384491
Smith PC, Schmidt SM, Allensworth-Davies D, Saitz R. A Single-Question Screening Test for Drug Use in Primary Care. Arch Intern Med, 2010; 170(13): 1155-1160. PMCID: PMC2911954
Smith PC, Schmidt SM, Allensworth-Davies D, Saitz R. Primary care validation of single question alcohol screening test. J Gen Intern Med, 2010; 24(7): 783-788. PMCID: PMC2695521
Saitz R, Larson MJ, LaBelle C, Richardson J, Samet JH. The case for chronic disease management for addiction. J Addict Med, 2008; 2: 55-65. PMCID: PMC2756688
Kim TW, Saitz R, Cheng DM, Winter M, Witas J, Samet JH. Will patients initiate chronic disease management care for substance dependence? Alcoholism: Clin Exp Res, 2008 June; 32(s1): 268A
Saitz R, Richardson JM, Larson MJ, LaBelle C, Meli S, Samet JH. Alcoholism chronic disease management: Rationale and design of the alcohol health evaluation and disease management study. Alcoholism: Clin Exp Res, 2007 June; 31(s2): 299A.
Saitz R. Alcohol dependence: Chronic care for a chronic disease. J Bras Psiquiatr, 2005; 54(4): 268-269.
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. PMCID: PMC3902022