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

1. oktober 2014 opdateret af: Boston Medical Center

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

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).

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

589

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Styring
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.
Eksperimentel: 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.

Andre navne:
  • BI-S
Eksperimentel: 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.

Andre navne:
  • BI-E

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Drug use
Tidsramme: Six Months
Six Months

Sekundære resultatmål

Resultatmål
Tidsramme
Drug use consequences
Tidsramme: Six Months
Six Months
HIV risk behaviors
Tidsramme: Six Months
Six Months
Substance abuse treatment utilization
Tidsramme: Six Months
Six Months
Costs
Tidsramme: Six Months
Six Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Richard Saitz, MD, Boston Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. september 2014

Datoer for studieregistrering

Først indsendt

6. april 2009

Først indsendt, der opfyldte QC-kriterier

6. april 2009

Først opslået (Skøn)

7. april 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2014

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DESPR DA025068
  • R01DA025068 (U.S. NIH-bevilling/kontrakt)
  • Grant Number: 1R01DA025068

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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