NCT00876941

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
589

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 2, 2014

Status Verified

February 1, 2012

Enrollment Period

3.5 years

First QC Date

April 6, 2009

Last Update Submit

October 1, 2014

Conditions

Drug UsageDrug AbuseDrug Dependence

Keywords

DrugDrug UseScreeningBrief InterventionPrimary CareUtilization

Outcome Measures

Primary Outcomes (1)

  • Drug use

    Six Months

Secondary Outcomes (4)

  • Drug use consequences

    Six Months

  • HIV risk behaviors

    Six Months

  • Substance abuse treatment utilization

    Six Months

  • Costs

    Six Months

Study Arms (3)

Standard Brief Intervention

EXPERIMENTAL
Behavioral: Standard Brief Intervention

Enhanced Brief Intervention

EXPERIMENTAL
Behavioral: Enhanced Brief Intervention

Control

ACTIVE COMPARATOR
Behavioral: Control: Information and Feedback

Interventions

Standard Brief InterventionBEHAVIORAL

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.

Also known as: BI-S
Standard Brief Intervention
Enhanced Brief InterventionBEHAVIORAL

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.

Also known as: BI-E
Enhanced Brief Intervention
Control: Information and FeedbackBEHAVIORAL

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

  • 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.

    PMID: 26809204DERIVED

  • 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.

    PMID: 25096690DERIVED

MeSH Terms

Conditions

Substance-Related DisordersPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Richard Saitz, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2012

Study Completion

September 1, 2014

Last Updated

October 2, 2014

Record last verified: 2012-02

Locations

US(1)