Clinical trial NCT00876941: Assessing Screening Plus Brief Intervention's Resulting Efficacy (ASPIRE) to Stop Drug Use
Official title: Efficacy/Effectiveness of Unhealthy Drug Use Screening/Brief Intervention Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Drug Usage
Drug Abuse
Drug Dependence
Keywords: Drug
Drug Use
Screening
Brief Intervention
Primary Care
Utilization
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Boston University
name: RTI International
First posted: 2009-04-07
Enrollment: 589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test whether screening and brief intervention for drug use among primary care patients leads to improved drug-related outcomes (such as decreased drug use and consequences).

Detailed description: The efficacy of screening and brief intervention (SBI) for drug use among primary care patients is unknown. National organizations do not recommend universal screening. But policy is at odds with the evidence: federal efforts to disseminate SBI are underway, and reimbursement codes to compensate clinicians have been developed. Thus there is a need to study SBI for drug use. The objective of this study is to determine the efficacy of two models of brief intervention (BI) for decreasing drug use and consequences in primary care patients. In collaboration with a state project implementing SBI as part of a federal program, we will screen patients in a large hospital-based primary care practice for drug use. We will then enroll screen-positive subjects, randomly assign them to 1 of 3 groups, and follow them for 6 months. Subjects in 1 intervention group will be assigned to a standard BI model, conducted by trained health advocates implementing a Federal program locally. In another group, subjects will be assigned to an enhanced BI model that includes an optional booster contact and is conducted by master's-level counselors trained and monitored intensively. The control group will receive information (i.e., a written list of local resources to help people using drugs) and, at the end of six months, standard BI if they are still using drugs.

All subjects will be assessed regarding substance use and consequences, HIV risk behaviors, costs, healthcare utilization and receipt of substance dependence treatment. The primary outcome is drug use at 6 months; secondary outcomes are drug use consequences, including HIV risk behaviors, and receipt of substance dependence treatment (among those with dependence). We hypothesize that the standard BI and the enhanced BI will each have greater efficacy than screening and resource information alone for decreasing drug use, decreasing drug use consequences and HIV risk behaviors and increasing receipt of treatment for those with dependence.

Additionally, costs will also be compared. Results of this study re: efficacy and costs of brief intervention for drug use will be essential for making decisions about disseminating drug use SBI in primary care settings.

This study will enroll two cohorts:

1. We will enroll 450 subjects with an ASSIST Substance-Specific Involvement (SSI) Score of 4 or greater in order to test our primary hypotheses. Primary analyses (i.e., effect of each BI on unhealthy drug use) will be restricted to subjects with an ASSIST SSI Score of 4 or greater.
2. We will enroll an additional 200 subjects with an ASSIST SSI Score of 2 or 3, indicating some, but lower risk drug use. Patients with these scores are included in clinical interventions, but because there are no data on effectiveness in the literature, this cohort will not be included in primary analyses and instead will be included only in secondary and exploratory analyses. We will examine potential preventive effects of BI (either) on subjects with lower level drug use.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Arrived for a visit in primary care
* ASSIST Substance Specific Involvement Score of greater than or equal to 4 for subjects included in primary analyses; ASSIST Substance-Specific Involvement Scores of 2 or 3 for subjects included only in exploratory analyses
* No previous MASBIRT intervention in the past 3 months
* Fluent in English or Spanish
* Two contacts who can assist with locating the subject for follow-up
* Able to return to Boston Medical Center in the next 6 months for research study visits
* Not pregnant (because care systems and resources differ greatly for such subjects)
* Able to be interviewed by trained research staff (excluding those in acute discomfort or with significantly impaired cognition)

Exclusion Criteria:

* NOT 18 years of age or older
* NOT Arrived for a visit in primary care
* NO ASSIST Substance Specific Involvement Score of greater than or equal to 4 for subjects included in primary analyses; or NO ASSIST Substance-Specific Involvement Scores of 2 or 3 for subjects included only in exploratory analyses
* ANY previous MASBIRT intervention in the past 3 months
* NOT Fluent in English or Spanish
* FEWER THAN two contacts who can assist with locating the subject for follow-up
* NOT able to return to Boston Medical Center in the next 6 months for research study visits
* Pregnant (because care systems and resources differ greatly for such subjects)
* UN-Able to be interviewed by trained research staff (excluding those in acute discomfort or with significantly impaired cognition)

Primary outcomes:
measure: Drug use
timeFrame: Six Months
Secondary outcomes:
measure: Drug use consequences
timeFrame: Six Months
measure: HIV risk behaviors
timeFrame: Six Months
measure: Substance abuse treatment utilization
timeFrame: Six Months
measure: Costs
timeFrame: Six Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Richard Saitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alford DP, German JS, Samet JH, Cheng DM, Lloyd-Travaglini CA, Saitz R. Primary Care Patients with Drug Use Report Chronic Pain and Self-Medicate with Alcohol and Other Drugs. J Gen Intern Med. 2016 May;31(5):486-91. doi: 10.1007/s11606-016-3586-5. Epub 2016 Jan 25.
citation: Saitz R, Palfai TP, Cheng DM, Alford DP, Bernstein JA, Lloyd-Travaglini CA, Meli SM, Chaisson CE, Samet JH. Screening and brief intervention for drug use in primary care: the ASPIRE randomized clinical trial. JAMA. 2014 Aug 6;312(5):502-13. doi: 10.1001/jama.2014.7862.