청소년 알코올 및 약물 사용 선별검사: 1차 진료 제공자에 대한 연구
2023년 7월 14일 업데이트: Kaiser Permanente
이 연구는 대규모 소아과 클리닉에서 청소년 알코올 및 기타 약물(AOD) 사용을 줄이기 위해 스크리닝, 단기 개입 및 치료 의뢰(SBIRT)의 두 가지 양식의 구현 및 효과를 평가합니다.
연구 개요
상세 설명
건강 시스템은 그 효과가 입증된 연구에도 불구하고 청소년을 위한 SBIRT(검진, 단기 개입 및 치료 의뢰)를 시행하지 않았습니다.
소아 1차 진료(PC)에서 청소년을 위한 AOD 선별 검사의 장벽을 확인한 이전 연구와 SBIRT가 실행 가능하고 호평을 받았으며 전문 치료에 대한 소개 및 시작을 촉진한 파일럿 연구를 기반으로 현재 연구 응용 프로그램은 45개를 무작위로 추출할 것을 제안합니다. 대규모 관리 의료 시스템인 Kaiser Permanente Northern California 내 의료 센터의 소아과 클리닉에 있는 1차 진료 의사(PCP)는 3개의 팔로 - 1) 일반 진료; 2) PCP가 제공하는 SBIRT; 3) 행동 의학 전문가(BMS)가 제공하는 SBIRT.
연구 목적은 세 가지 연구 부문에서 PC 청소년을 위한 SBIRT의 구현, 효과 및 비용 효율성을 비교하는 것입니다.
환자는 건강 플랜의 전자 의료 기록(EMR)에 포함된 증거 기반 선별 및 AOD 평가 조치를 완료합니다.
혼합 모델을 사용하여 12개월에 구현 결과(선별 및 식별 비율, 단기 개입, 화학적 의존성 치료로의 의뢰 및 치료 시작) 및 효과(AOD 사용 및 절제의 환자 결과)를 비교합니다.
이 모델은 제공자 내의 환자 간 클래스 내 상관 관계를 설명합니다.
구현 및 환자 결과와 관련된 비용 효율성이 검사됩니다.
실행의 장벽과 촉진제, 임상의 및 관리자와의 질적 인터뷰를 통한 실행 가능성도 검토됩니다.
이 연구는 SBIRT의 광범위한 적용을 촉진하기 위해 해결해야 할 문제를 검토했다는 점에서 의의가 있습니다.
제안된 개입은 증가된 자원과 연방 공인 건강 센터 및 민간 건강 플랜에 대한 교육으로 인해 현재의 건강 개혁 환경에서 매우 실현 가능합니다.
EMR을 사용하여 임상진료를 변화시키고 AOD를 PC에 체계적으로 통합하고 연구 데이터 수집을 위한 플랫폼으로 사용하는 것은 혁신적입니다.
연구 유형
중재적
등록 (실제)
9084
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Oakland, California, 미국, 94612
- Stacy A Sterling
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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
12년 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
설명
아래에 설명된 바와 같이 두 가지 연구 모집단이 있으므로 연령 제한 범위가 큽니다.
포함 기준:
- 소아 1차 진료 클리닉의 모든 청소년 1차 진료 제공자가 포함됩니다.
- 소아 1차 진료에서 12-18세의 모든 청소년 환자 전자 기록을 검사합니다.
제외 기준:
- 소아 1차 진료 클리닉 연구 현장에서 일하지 않는 모든 청소년 1차 진료 제공자는 제외됩니다.
- 연구기관 소아과 진료소의 일부가 아닌 청소년 전자 기록은 제외됩니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 주치의
청소년이 약물 사용 위험이 있는 것으로 확인된 경우, 제공되는 치료에 대한 스크리닝 및 간단한 개입 의뢰는 주치의가 수행합니다.
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1차 진료 의사가 선별 검사, 간단한 개입 및 치료 의뢰를 제공합니다.
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실험적: 행동 의학 전문가
청소년이 약물 사용의 위험이 있는 것으로 확인되면 선별 검사 및 행동 의학 전문의가 제공하는 치료에 대한 간단한 개입 의뢰
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선별 검사, 간단한 개입 및 치료 의뢰는 행동 의학 전문가가 제공합니다.
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간섭 없음: 평상시 관리
케어는 평소와 같이 관리됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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검진율
기간: 초진율 - 인덱스웰방문 시
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Teen Well-Child 방문을 하는 모든 환자 중 Teen Well Check Questionnaire AOD 사용 또는 기분 증상 질문으로 선별된 환자의 비율.
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초진율 - 인덱스웰방문 시
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문제 식별률
기간: 초기 문제 식별률 - 인덱스 웰 방문 시, 스크리닝 후
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지난 12개월 동안 AOD 사용 또는 기분 증상에 "예"라고 대답하고 적어도 하나의 비 자동차 CRAFFT 질문에 "예"라고 대답한 선별된 환자의 비율.
(AOD를 사용하는 사람과 함께 차에 있는 것은 어린이 문제와 관련이 없을 수 있지만 음주/사용하는 동안 운전한 부모/다른 성인이 있는 것과 관련이 있을 수 있습니다.)
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초기 문제 식별률 - 인덱스 웰 방문 시, 스크리닝 후
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평가율
기간: 인덱스 웰 방문일로부터 2주 이내
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CRAFFT 도구를 사용하여 추가로 평가되는 알코올 또는 기타 약물 또는 정신 건강 위험에 대해 양성으로 선별된 환자의 비율.
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인덱스 웰 방문일로부터 2주 이내
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간략한 개입 비율
기간: 인덱스 웰 방문 시 평가 후 14일 이내
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AOD 위험이 있는 것으로 확인된 환자 중 14일 이내에 개입을 받은 환자의 비율(CRAFFT 점수 기준).
약물 사용 상담 또는 행동 상담을 위해 ICD-9 관리 V 코드를 사용하여 임상의가 EHR에 문서화합니다.
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인덱스 웰 방문 시 평가 후 14일 이내
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전문진료 의뢰율
기간: 인덱스 웰 방문 후 6개월 이내
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CRAFFT를 통해 그러한 치료가 필요하다고 식별된 환자 중 특수 행동 건강 치료에 의뢰를 받은 환자의 비율.
EHR에 문서화되어 있습니다.
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인덱스 웰 방문 후 6개월 이내
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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전문 행동 건강 치료 시작
기간: 개입 후 2년 이내
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행동 건강 문제가 있는 것으로 확인된 사람들 중 최소 한 번 이상 전문 행동 건강 방문을 받은 의뢰인의 백분율로 정의됩니다.
EHR에 문서화되어 있습니다.
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개입 후 2년 이내
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알코올 및 기타 약물 사용
기간: 지난 6개월 동안, 개입 후 1년 및 2년 동안 사용
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알코올 및 약물 사용: EHR의 항목은 지난 30일 및 6개월 동안의 알코올, 마리화나 및 기타 약물 및 담배 사용을 측정합니다. 폭음(3+ 및 5+).
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지난 6개월 동안, 개입 후 1년 및 2년 동안 사용
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물질 사용 관련 결과
기간: 지난 6개월, 개입 후 1년 및 2년
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AOD 관련 법률, 학교 및 가족 문제: EHR 질문에는 교육, 법률 및 가족 관계 영역 전반에 걸쳐 청소년 건강 및 기능을 측정하는 반구조화된 설문지인 CASI(Comprehensive Adolescent Severity Inventory)148의 측정값도 포함됩니다.
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지난 6개월, 개입 후 1년 및 2년
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi: 10.1001/jama.282.15.1458.
- Killip S, Mahfoud Z, Pearce K. What is an intracluster correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004 May-Jun;2(3):204-8. doi: 10.1370/afm.141.
- Windle M, Spear LP, Fuligni AJ, Angold A, Brown JD, Pine D, Smith GT, Giedd J, Dahl RE. Transitions into underage and problem drinking: developmental processes and mechanisms between 10 and 15 years of age. Pediatrics. 2008 Apr;121 Suppl 4(Suppl 4):S273-89. doi: 10.1542/peds.2007-2243C.
- Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. doi: 10.1001/archpedi.156.6.607.
- Schmittdiel JA, Shortell SM, Rundall TG, Bodenheimer T, Selby JV. Effect of primary health care orientation on chronic care management. Ann Fam Med. 2006 Mar-Apr;4(2):117-23. doi: 10.1370/afm.520.
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- Mertens JR, Weisner CM. Predictors of substance abuse treatment retention among women and men in an HMO. Alcohol Clin Exp Res. 2000 Oct;24(10):1525-33.
- Weisner C, Delucchi K, Matzger H, Schmidt L. The role of community services and informal support on five-year drinking trajectories of alcohol dependent and problem drinkers. J Stud Alcohol. 2003 Nov;64(6):862-73. doi: 10.15288/jsa.2003.64.862.
- Weisner C, Matzger H. Missed opportunities in addressing drinking behavior in medical and mental health services. Alcohol Clin Exp Res. 2003 Jul;27(7):1132-41. doi: 10.1097/01.ALC.0000075546.38349.69.
- Weisner C, Schmidt LA. Rethinking access to alcohol treatment. Recent Dev Alcohol. 2001;15:107-36. doi: 10.1007/978-0-306-47193-3_7. No abstract available.
- Sterling S, Parthasarathy S, Jones A, Weisner C, Metz V, Hartman L, Saba K, Kline-Simon AH. Young Adult Substance Use and Healthcare Use Associated With Screening, Brief Intervention and Referral to Treatment in Pediatric Primary Care. J Adolesc Health. 2022 Oct;71(4S):S15-S23. doi: 10.1016/j.jadohealth.2021.11.033.
- Parthasarathy S, Kline-Simon AH, Jones A, Hartman L, Saba K, Weisner C, Sterling S. Three-Year Outcomes After Brief Treatment of Substance Use and Mood Symptoms. Pediatrics. 2021 Jan;147(1):e2020009191. doi: 10.1542/peds.2020-009191.
- Sterling S, Kline-Simon AH, Weisner C, Jones A, Satre DD. Pediatrician and Behavioral Clinician-Delivered Screening, Brief Intervention and Referral to Treatment: Substance Use and Depression Outcomes. J Adolesc Health. 2018 Apr;62(4):390-396. doi: 10.1016/j.jadohealth.2017.10.016. Epub 2018 Feb 1.
- Sterling S, Kline-Simon AH, Jones A, Satre DD, Parthasarathy S, Weisner C. Specialty addiction and psychiatry treatment initiation and engagement: Results from an SBIRT randomized trial in pediatrics. J Subst Abuse Treat. 2017 Nov;82:48-54. doi: 10.1016/j.jsat.2017.09.005. Epub 2017 Sep 10.
- Sterling S, Kline-Simon AH, Satre DD, Jones A, Mertens J, Wong A, Weisner C. Implementation of Screening, Brief Intervention, and Referral to Treatment for Adolescents in Pediatric Primary Care: A Cluster Randomized Trial. JAMA Pediatr. 2015 Nov;169(11):e153145. doi: 10.1001/jamapediatrics.2015.3145. Epub 2015 Nov 2.
- Elster A. The American Medical Association Guidelines for Adolescent Preventive Services. Arch Pediatr Adolesc Med. 1997 Sep;151(9):958-9. doi: 10.1001/archpedi.1997.02170460096021. No abstract available.
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 (실제)
2011년 10월 1일
기본 완료 (실제)
2013년 10월 1일
연구 완료 (추정된)
2025년 12월 31일
연구 등록 날짜
최초 제출
2015년 3월 20일
QC 기준을 충족하는 최초 제출
2015년 3월 31일
처음 게시됨 (추정된)
2015년 4월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2023년 7월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2023년 7월 14일
마지막으로 확인됨
2023년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 11-07796
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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