Assessing Screening Plus Brief Intervention's Resulting Efficacy (ASPIRE) to Stop Drug Use

Drug Abuse Clinical Trial

— ASPIRE  

Official title:

Efficacy/Effectiveness of Unhealthy Drug Use Screening/Brief Intervention Models

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876941
• Other study ID #: DESPR DA025068
• Secondary ID: R01DA025068Grant
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2009
• Last updated: October 1, 2014
• Start date: April 2009
• Est. completion date: September 2014

Study information

• Verified date: February 2012
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: September 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Abuse
• Drug Dependence
• Drug Usage

Intervention

Behavioral:
• Standard Brief Intervention
Intervention: Structured, brief negotiated interview. Intervention preparation and content: Preparation: review of ASSIST results; Content: The intervention involves 4 major parts: 1) establishing rapport and asking the subject for permission to raise the topic of drug use; 2) exploring the pros and cons of use; 3) providing feedback and assessing readiness to change; and 4) advising and negotiating a plan. Counselor: Health Promotion Advocate, High School graduate or GED minimum Training specific to the brief intervention: Didactic and experiential; competency demonstrated by observation and/or video recordings which are content scored using a standardized form. Contacts, Duration: One, 10-15 minutes. Communication content delivered to primary care physician: Results of screening and BI. Supervision: Weekly 1-hour meeting with supervisor to discuss job performance and discuss cases; biannual shadowing by supervisor.
• Enhanced Brief Intervention
Intervention: Less structured, motivational interview. Intervention preparation and content: Preparation: review of ASSIST, drug consequences (SIP-D), risk behaviors, CIDI Short Form, and medical record for discussion; Content: Motivational interviewing discussing above. Counselor: Master's level/Doctoral student. Training specific to the brief intervention: Didactic and experiential, followed by additional work towards, and confirmation of, proficiency using audio recordings coded for motivational interviewing content. Contacts, Duration: One plus offer of one optional booster contact, each 30-45 minutes; 2nd by telephone or in person depending on subject's preference; availability of counselor for further readiness discussions. Communication content delivered to primary care physician: Results of screening, BI, and plan including follow-up. Supervision: Weekly 1.5-hour meeting with supervisor with review of coded audio recordings.
• Control: Information and Feedback
Subjects randomized to the control group will not receive a BI at enrollment. But, all study subjects will receive screening and its results as part of the informed consent process (that they are at least at risk for drug use health hazards) along with a written list of resources available, including local options.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston Medical Center	Boston University, National Institute on Drug Abuse (NIDA), RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug use		Six Months	No
Secondary	Drug use consequences		Six Months	No
Secondary	HIV risk behaviors		Six Months	No
Secondary	Substance abuse treatment utilization		Six Months	No
Secondary	Costs		Six Months	No