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临床试验/NCT03560076
NCT03560076已完成不适用

Phased Multisite Cluster Randomized Trial Testing Screening, Brief Intervention, Referral to Treatment for People That Use Tobacco, Alcohol, and Non-prescription Drugs

Indiana University1 个研究点 分布在 1 个国家目标入组 2,562 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,562
试验地点
1
主要终点
SBIRT Process

研究概览

简要总结

Alarming rates of unhealthy alcohol, non-prescription drug, and tobacco use highlight the preventable health risks of substance abuse and the urgent need to advance behavioral health systems. Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an efficacious and effective strategy for the delivery of early intervention and treatment services for people with substance use disorders as well as for those who are at-risk for developing these disorders. A mixed methods phased cluster randomized approach is used to evaluate SBIRT implementation in one medical surgical unit from each of 14 hospitals to inform SBIRT implementation methods for rural, community and urban settings in Indiana. The long-term objective is to develop an SBIRT toolkit to disseminate and sustain SBIRT use to increase the screening of substance use, delivery of brief interventions, and referral to treatment services. A broader dissemination will follow based on results of this study.

详细描述

Aim 1: Test if implementation of SBIRT improves processes of care for hospital inpatients currently using tobacco, alcohol or non-prescription drugs.

Aim 2: Estimate the cost of SBIRT implementation and delivery for the health system.

Design and Sample:

A phased cluster randomized mixed methods design using a wait-list usual care control on one medical surgical unit in 14 hospitals will be conducted. The intervention is an SBIRT toolkit.

Each hospital within the healthcare system is eligible to participate, and has agreed to participate (N=14). A computer generated allocation based on a stratified random sampling approach using SPSS was used to randomize hospitals into an intervention (Group 1, n=7) or wait-list usual care control (Group 2, n=7) group. Prior to randomization, hospitals were stratified by type (academic health center, community hospital, or critical access hospital). Allocation to the intervention or wait-list usual care control groups is based on cluster, and participants will be aware of their cluster allocation. One medical surgical unit within each hospital will be selected by the nurse executive to participate. All hospitals will receive the intervention. Group 1 (n=7) hospitals will participate in the implementation and intervention first, with Group 2 (n=7) following six months later.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a. Medical surgical unit designated as study unit

排除标准

  • Medical surgical unit not designated as study unit
  • Units that do not admit medical surgical patients
  • Inclusion Criteria:
  • a. Nurses employed on study unit
  • Exclusion Criteria:
  • a. Nurses not employed on study unit
  • Patient Electronic Medical Records (EMRs)
  • Inclusion Criteria:
  • Age 18 or older admitted to study unit
  • Records randomly selected from each units
  • Exclusion Criteria:
  • Age younger than 18 admitted to study unit
  • EMRs of patients admitted to units other than the study unit
  • EMRs of patients admitted to the study unit that are not randomly selected

结局指标

主要结局

SBIRT Process

时间窗: 6 months

Differences in screening, brief intervention and referral to treatment between intervention group and wait-list control

次要结局

  • Cost of SBIRT implementation(12 months)
  • SBIRT Process(6 and 12 months post group 1 baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robin P. Newhouse

Dean and Distinguished Professor

Indiana University

研究点 (1)

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