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

2014년 10월 1일 업데이트: 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).

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

589

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02118
        • Boston Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 제어
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.
실험적: 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.

다른 이름들:
  • BI-S
실험적: 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.

다른 이름들:
  • BI-E

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Drug use
기간: Six Months
Six Months

2차 결과 측정

결과 측정
기간
Drug use consequences
기간: Six Months
Six Months
HIV risk behaviors
기간: Six Months
Six Months
Substance abuse treatment utilization
기간: Six Months
Six Months
Costs
기간: Six Months
Six Months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Richard Saitz, MD, Boston Medical Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 4월 1일

기본 완료 (실제)

2012년 10월 1일

연구 완료 (실제)

2014년 9월 1일

연구 등록 날짜

최초 제출

2009년 4월 6일

QC 기준을 충족하는 최초 제출

2009년 4월 6일

처음 게시됨 (추정)

2009년 4월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 10월 1일

마지막으로 확인됨

2012년 2월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • DESPR DA025068
  • R01DA025068 (미국 NIH 보조금/계약)
  • Grant Number: 1R01DA025068

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