Substance Use Disorders Clinical Trial
Official title:
Phased Multisite Cluster Randomized Trial Testing Screening, Brief Intervention, Referral to Treatment for People That Use Tobacco, Alcohol, and Non-prescription Drugs
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.
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.
Methods:
Smoking cessation practices will be collected from nurses (N=560) at baseline. SBIRT use will
be collected from nurses on randomly selected days via survey. Observations of SBIRT use and
interviews with study coordinators will also be conducted.
SBIRT process delivery for patients will be assessed through review of de-identified
electronic medical records (EMRs) abstracted at three time points: baseline, six-months post
and 12 months using a random sample of 61 patient EMRs from the participating hospital units
at each time point (N=2,562). Data abstracted is retrospective, and consists of SBIRT process
elements only.
This study protocol incorporates standardized education on using SBIRT through a
train-the-trainer approach. Site coordinators will receive information about the nurse survey
and secondary data abstraction procedures. Each group will receive training on the SBIRT
intervention (Group 1 first, then Group 2 six months later). Training for site coordinators
will include skills in how to teach SBIRT to others and systems strategies for promoting
SBIRT uptake. After the site coordinator training is completed, each hospital (via the site
coordinator) will train additional nurses, validate skills in SBIRT and develop a referral
process specific to its needs.
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